A virtual or augmented reality pain treatment device and equipment based on visual synthesis

Abstract

This invention relates to a virtual or augmented reality pain treatment device and apparatus based on visual synthesis. In the device, an interactive control unit generates a pain stimulation scheme matching the patient to be treated and sends the pain stimulation scheme to a data processing unit. The data processing unit generates a virtual reality environment and a virtual stimulus source visible to the patient in the virtual reality environment based on the received pain stimulation scheme. A display unit displays the virtual reality environment and the virtual stimulus source to the patient to be treated. The data processing unit determines the parameters of the stimulation target point of the limb and the virtual stimulus source based on the pain category to be induced. The display unit drives the virtual stimulus source to perform visual approach movement towards the stimulation target point of the patient to achieve non-real stimulation. The patient's somatosensory system is activated through a visual-neural coupling mechanism, thereby inducing the patient to generate tactile, thermal, and / or cold sensations in and around the stimulation target point, thereby achieving neuromodulation therapy of the pain pathway.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and in particular to a virtual or augmented reality pain treatment device and equipment based on visual synthesis. Background Technology

[0002] The article "Decreasing Pain Ratings in Chronic Arm Pain Through Changing a Virtual Body: Different Strategies for Different Pain Types," published in Volume 20, Issue 6 (pp. 685-697) of *The Journal of Pain* in 2019 by Marta Matamala-Gomez, Ana M. Diaz Gonzalez, et al., explored the impact of altering virtual arm characteristics in virtual reality (VR) on pain scores in patients with chronic arm pain (Complex Regional Pain Syndrome Type 1 (CRPSI) and Peripheral Nerve Injury Type 2 (PNI)). The study included 19 patients (9 in the CRPSI group and 10 in the PNI group), with no significant differences between the two groups in age, cognitive function (MMSE / FAB ​​scores), and baseline pain scores. The experiment used virtual arm transparency tests (0%, 25%, 50%, and 75% transparency) and size tests (normal, enlarged, and reduced sizes). Results showed that all seven experimental conditions reduced pain scores by approximately 50% overall (baseline mean pain scores: CRPS 4.78±2.53, PNI 5.44±2.62, significantly decreasing after the experiment). In the CRPS group, increased transparency significantly reduced pain (75% transparency showed the best effect, interaction term coefficient -0.87, p=0.03), while the PNI group showed the opposite trend (increased transparency increased pain, interaction term coefficient 0.32, p=0.85); increased size only had a slight pain-enhancing effect in the CRPS group (coefficient 0.14, p=0.75). Both groups of patients had similar perceptions of "ownership" (mean Q1-Q3 scores 1.5-2.0) and "agency" (mean Q6 score 1.8) of the virtual arm as healthy individuals, and there was no difference between the groups in attention span (Q7 score 2.1). The study emphasizes that pain type determines the effectiveness of intervention strategies; CRPS patients, due to distorted limb mental representations (85.7% reported limb morphological abnormalities), are more easily modulated by visual body representations, while pain relief in PNI patients primarily stems from the presence of the virtual body itself. This study suggests that virtual reality (augmented reality) has potential in pain management.

[0003] Matteo Martini, D. Perez-Marcos, and MV Sanchez-Vives published an article in 2013 entitled "What color is my arm? Changes in skin color of an embodied virtual arm modulate pain threshold," *Frontiers in Human Neuroscience*, 7, 438. As an original study, this article explored the influence of skin color on human pain threshold in a virtual reality environment. The study used a head-mounted display and thermal stimulation technology to analyze the pain threshold of 30 healthy female participants (mean age 23.9 ± 5.7 years) under four experimental conditions: (1) a virtual arm turning blue, (2) turning red, (3) turning green, and (4) a red dot appearing on a table next to the arm. The results showed that the pain threshold under the red arm condition (42.0 ± 1.1℃) was significantly lower than that under the blue arm condition (42.8 ± 1.2℃, p = 0.020) and the external red dot condition (42.9 ± 1.0℃, p = 0.001), while the green arm threshold (42.4 ± 1.2℃) was between that of red and blue. The pain threshold was highest when red appeared in non-body areas (desktop), indicating that color modulation of pain is body-specific. One-way repeated measures ANOVA showed a significant conditional main effect (F(3,87)=5.93, p<0.001). Subjective performance scores (7-point scale) showed no significant differences among conditions (blue 5.47±1.09, red 5.75±0.85). This study is the first to demonstrate that skin color modulates pain perception through a visual-body integration mechanism, providing a theoretical basis for virtual reality pain therapy.

[0004] Specific examples of virtual reality (VR) or augmented reality (AR) technology in pain management include mirror therapy, which activates neurons by allowing patients to observe a mirror image of their healthy limb, promoting the recovery of motor function in the affected limb and reducing pain. See, for example, the article "Effectiveness of Mirror Therapy, Motor Imagery, and Virtual Feedback on Phantom Limb Pain Following Amputation: A Systematic Review" published in *Prosthetics and Orthotics International* in 2018 by Laura Herrador Colmenero et al. This study aimed to evaluate the therapeutic effects of mirror therapy (MT), motor imagery (MI), and virtual visual feedback (VVF) on phantom limb pain (PLP) following amputation, covering literature from eight databases including PubMed and Scopus up to April 2017. The results showed that the concept of "mirror visual feedback" first proposed by Ramachandran et al. (1995) is feasible. That is, by having patients observe the reflection of their unaffected limb in a mirror to form the visual illusion that the "phantom limb can move voluntarily," the imbalance of sensorimotor cortex reorganization caused by amputation can be reset to alleviate PLP. In particular, in inhibiting cortical reorganization, activating the mirror neuron system, and correcting perceptual dysregulation (i.e., after amputation, the "limb presence mapping" of the brain's sensorimotor cortex conflicts with the missing limb input signal, causing pain), mirror therapy can reconstruct the coherent perception of limb presence through visual-tactile-motor integration. It can activate the mirror neuron system (i.e., when the unaffected limb moves, the mirror neurons synchronously activate the corresponding motor cortex area on the affected side, inhibiting abnormal pain signals), and can also inhibit cortical reorganization, reduce the "encroachment" of the affected side cortex on adjacent body areas, and alleviate central sensitization. Herrador Colmenero et al., by incorporating multiple studies based on Ramachandran's theory, not only further validated the efficacy of MT, but also pointed out that a single VVF (such as virtual limb movement) could reduce PLP intensity by an average of 64% (Cole et al., 2009), and some patients experienced complete pain relief (Ortiz-Catalan et al., 2016). Furthermore, combining MI (inner mental simulation) with VVF (external visual feedback) could enhance the reactivation of the motor cortex. For example, guiding patients to synchronously imagine phantom limb movements through VR could increase the pain relief rate to 70% (Ortiz-Catalan et al., 2016).Therefore, in clinical trials, in addition to the early cases of Ramachandran (where patients experienced a significant decrease in PLP intensity (VAS score reduction >50%) through 15 minutes of daily image training, and some patients experienced complete pain relief), interventions such as motor imagery (MI) and virtual visual feedback (VVF) can also effectively alleviate pain.

[0005] Visual feedback therapy restores the integrity of the sensory-motor pathway by "tricking" the brain to replace missing proprioception with visual input (such as mirrored prosthetic movements). Visual-tactile synthesis technology further extends this principle, for example, in enhancing immersion through touch: by using force feedback gloves or tactile stimulators, the touch of the phantom limb is simultaneously simulated (such as the pressure when "clenching a fist"), forming a multimodal sensory match with virtual visual input, strengthening the brain's acceptance of the "presence of the phantom limb" (Ramachandran, 2011). In terms of suppressing pain signals, tactile stimulation activates the primary somatosensory cortex (S1), which, together with visual input, inhibits abnormal activity in the thalamic-cortical pain pathway (Haggard et al., 2013).

[0006] Furthermore, Herrador Colmenero et al.'s review also pointed out that the limitation of traditional mirror therapy lies in the insufficient efficacy for some patients due to visual-motor asynchrony (such as the inability to imagine phantom limb movement). Visual and tactile synthesis technology can specifically address this problem. For example, by leveraging the synergistic effect of tactile and visual perception, tactile feedback can be added to virtual reality therapy, increasing the PLP relief rate from 55% to 78% (Murray et al., 2007). Through tactile substitution therapy, vibration stimulation of specific areas of the residual limb (corresponding to the phantom limb pain site) can reduce pain intensity by up to 40% (Nonomura et al., 2019), confirming the hypothesis that "tactile input resets somatosensory mapping." Since then, there have been successful cases in MR and VR pain relief research, such as the chronic pain relief system based on MR technology disclosed in CN118039077A. This system includes an MR device; by wearing the MR device, a 3D model is displayed in front of the user, and the virtual object is integrated with the real environment through gesture interaction with the model. The patent describes an example: "For instance, we see a scene presented before us, and we immerse ourselves in it. In the spring breeze, various petals and butterflies dance freely in the air. We extend our hands to interact with the butterflies, and they may even land on our hands. This is a relaxation exercise; unconsciously, the pain is alleviated." The description here proposes the principle of tactile synthesis through a butterfly landing on the palm, which belongs to the principle of visual and tactile synthesis. This further verifies the Herrador Colmenero review's emphasis that the essence of pain is the brain's abnormal interpretation of sensory input. However, the drawback of this MR technology is that, because the principle of visual and tactile synthesis requires extremely high precision in positional alignment, it places very high demands on the treatment environment. On the one hand, it requires higher capabilities from virtual reality hardware and software; on the other hand, ambient light has a significant impact on image acquisition. Both of these aspects create a dynamic tracking requirement for high-precision positional alignment in visual and tactile synthesis.

[0007] In addition, there has been a great deal of research on the neural transmission of heat / cold sensation. For example, Magerl, Walter, Ali, Zahid, Ellrich, Jens, et al. published an article in 1999 entitled "C- and Aδ-fiber components of heat-evoked cerebral potentials in healthy human subjects," Pain, 82(2):127-137. This article describes an experimental method in which a feedback-controlled laser heating device is used to stimulate hairy skin areas on the back of the hand and forearm, and heat-evoked cerebral potentials generated from central (Fz, Cz, Pz) and temporal (T3, T4) scalp locations are recorded. These potentials are the brain's response to specific temperature changes and can be used to study the role of different types of nerve fibers (such as Aδ fibers and C fibers) in pain perception. In order to specifically stimulate C fibers without simultaneously activating Aδ fibers, the researchers chose a stimulation level of 40°C, which is higher than the thermal threshold of C fibers but lower than the thermal threshold of Aδ nerve fibers. When this temperature-controlled, stepped thermal stimulation was used, so-called "ultralate laser evoked potentials" (LEPs) were recorded in most experiments (90%). Calculations of the latency shift of ultralate LEPs from the hand and forearm regions estimated a conduction velocity of 2.4 m / s, consistent with the conduction velocity of unmyelinated nerve fibers (i.e., pain receptors and / or temperature-sensitive fibers). When a strong thermal stimulus of 48°C was applied, this temperature was above the threshold for most nociceptors in Aδ and C fibers, thus evoking known late LEPs mediated by nociceptive Aδ fibers—a finding consistent with other previous studies.

[0008] Furthermore, the feasibility study published in 2014 by Hunter G. Hoffman et al., "Feasibility of Articulated Arm Mounted Oculus Rift Virtual Reality Goggles for Adjunctive Pain Control During Occupational Therapy in Pediatric Burn Patients" (Cyberpsychology, Behavior, and Social Networking, 17(6), 397-401), showed that virtual reality can reduce pain in burn care. In particular, it emphasized that the high immersion of wide-field VR devices (such as Oculus Rift) is the key to the analgesic effect (illusion of presence is critical for pain reduction). In addition, the study also mentioned that patients actively participate by interacting with the virtual world through the mouse (aiming and throwing snowballs), which further enhances attentional engagement and is more effective than passive distraction.

[0009] Hunter G. Hoffman et al. subsequently published a study in *Scientific Reports* in 2023 entitled "Adding tactile feedback increases avatar ownership and makes virtual reality more effective at reducing pain in a randomized crossover study" (article ID: s41598-023-31038-4). This randomized crossover study investigated the effect of adding tactile feedback (simulating the tactile sensation of virtual water through real water) to virtual reality (VR) on acute pain relief. The study included 48 healthy volunteers (aged 18-34 years, mean 19.6 years, 54% male, 46% female), using a within-subjects design, comparing three conditions: no VR (baseline), visual VR only (no tactile feedback), and VR + real water (tactile feedback). Their conclusion was that tactile feedback increased the analgesic effect of VR by 35%, equivalent to the analgesic effect of a medium dose of hydromorphone, while also enhancing the realism of the virtual experience. This conclusion provides direct evidence for the application of mixed reality in chronic pain (such as phantom limb pain) by enhancing avatar fusion to optimize treatment outcomes. In particular, it further supports the role of attention distraction mechanisms in VR analgesia and offers a new direction for non-pharmacological analgesia. The following key data and results are presented in particular in this study:

[0010] (1) Pain intensity: VR with tactile feedback significantly reduced the "most painful" score (mean 3.08 vs. 4.71 in the non-VR group, p<0.001, effect size r=0.7), and further reduced it compared with non-tactile VR (mean 3.56) (p<0.01, r=0.4). The unpleasant pain score decreased to 2.59 in tactile VR (baseline 4.45, p<0.001), but there was no significant difference between tactile and non-tactile VR (p=0.05).

[0011] (2) The accuracy of the distracted task (identifying consecutive odd numbers) was 93% (mean 9.34 / 10) without VR, 84% (8.35) without VR, and 82% (8.19) with VR. The error increased significantly under VR conditions (p<0.001).

[0012] (3) Sense of Presence and Ownership: Haptic VR enhances the sense of "immersion" (mean 5.44 vs. 4.64 without haptic feedback, p<0.005) and improves the "sense of ownership" of virtual hands (5.94 vs. 5.19, p<0.001). The realism score of virtual water increased from 3.76 without haptic feedback to 6.30 with haptic feedback (p<0.001).

[0013] (4) Conditional pain modulation (CPM): When wrist and foot heat stimulation were applied simultaneously, the foot pain score decreased from 4.74 to 2.96 (p<0.001), and the CPM effect was positively correlated with the tactile VR analgesic effect (r=0.46, p<0.005).

[0014] Furthermore, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making this invention, but due to space limitations, not all details and contents were listed in detail. However, this does not mean that the present invention does not possess the features of these prior art. On the contrary, the present invention already possesses all the features of the prior art, and the applicant reserves the right to add relevant prior art to the background art. Summary of the Invention

[0015] Given that the visual and tactile synthesis technology essentially continues the core framework of Herrador Colmenero's review, namely, reshaping the brain's pain perception through multi-sensory input and making up for the shortcomings of single visual feedback at the technical level, this invention aims to propose a virtual reality pain treatment device with reduced requirements for ambient light and virtual reality hardware and software, and in particular, to provide a device that uses the principle of visual and tactile, thermal and / or cold sensation synthesis to intervene (inhibit or improve) pain in the corresponding parts of the patient's body.

[0016] In view of the conclusion by Hoffman et al. that "tactile + VR" mixed reality has promising applications in chronic pain (such as phantom limb pain), this invention further expands the VR object of the virtual reality pain treatment device to multiple types of virtual stimulus sources to generate heat and cold sensations, and accordingly adds capsaicin (heat sensation), menthol (cold sensation), and mustard oil (freezing sensation) to enhance the therapeutic effect. Preferably, freezing sensation belongs to cold sensation.

[0017] To address the shortcomings of existing technologies, this invention provides a virtual or augmented reality pain treatment device based on visual synthesis, comprising an interactive control unit, a data processing unit, and a display unit. The interactive control unit generates a pain stimulation scheme matching the patient currently being treated and sends the scheme to the data processing unit. The data processing unit generates a virtual reality environment and a virtual stimulus source visible to the patient within that environment based on the received pain stimulation scheme, and sends parameters including the virtual reality environment and the virtual stimulus source to the display unit. The display unit displays the virtual reality environment and the virtual stimulus source to the patient. The data processing unit determines the parameters of the stimulation target point of the limb and the virtual stimulus source based on the pain category to be induced. In response to the receipt of these parameters, the display unit drives the virtual stimulus source to perform a visual approach motion towards the patient's stimulation target point to achieve non-real stimulation. This activates the patient's somatosensory system through a visual-neural coupling mechanism, thereby inducing the patient to experience tactile, thermal, and / or cold sensations in and around the stimulation target point, thus achieving neuromodulation therapy of the pain pathway.

[0018] According to a preferred embodiment, the data processing unit generates parameters of the virtual stimulus source by stimulating the virtual stimulus source, chemical stimulus source, and physical stimulus source in a set triggering sequence; when the virtual stimulus source, chemical stimulus source, and physical stimulus source stimulate the patient's vision and nerves in a set sequence, the patient's thermal or cold sensation is induced in the virtual reality environment.

[0019] According to a preferred embodiment, the interactive control unit adjusts the parameters of the virtual stimulus source in the pain stimulation scheme based on the patient's neural perception feedback of pain during the treatment process, so as to enhance the patient's neural perception in the virtual reality environment.

[0020] According to a preferred embodiment, the data processing unit determines the parameters of the stimulation target point of the limb and the virtual stimulation source based on the pain category to be induced, and determines the types of chemical and / or physical stimulation sources that can be used in conjunction with the virtual stimulation source and the timing of the stimulation application.

[0021] According to a preferred embodiment, the data processing unit determines the color parameters of the virtual stimulus source based on the pain category to be induced; the interaction control unit adjusts the color parameters of the virtual stimulus source in the pain stimulation scheme based on the patient's neural perception feedback of pain during the treatment process, so as to change the patient's pain perception in the virtual reality environment and enhance the patient's neural perception in the virtual reality environment.

[0022] According to a preferred embodiment, the data processing unit dynamically adjusts the triggering sequence of virtual stimuli and chemical / physical stimuli based on the patient's skin type at the stimulation target. Specifically, the nerve fiber type is determined based on the skin type of the stimulation target, including Aδ fiber-dominant and C fiber-dominant types. For Aδ fiber-dominant types, the data processing unit determines the triggering sequence for synchronous stimulation of virtual and physical stimuli. For C fiber-dominant types, the data processing unit determines the triggering sequence for delayed stimulation of virtual and chemical stimuli at set time intervals.

[0023] According to a preferred embodiment, the interactive control unit receives the temperature of the target area where the stimulation target is located from the temperature acquisition module connected to it. When the target area of ​​the C-fiber dominant type reaches the first high-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the interactive control unit sends a display command for the virtual stimulus source to the display unit, and after a first delay, sends a chemical stimulation command to the chemical stimulus source control unit to apply chemical stimulation; when the target area of ​​the Aδ-fiber dominant type reaches the second high-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the interactive control unit sends a display command for the virtual stimulus source to the display unit.

[0024] According to a preferred embodiment, the interactive control unit receives the temperature of the target area where the stimulation target is located from the temperature acquisition module connected to it. When the target area dominated by both Aδ and C fibers reaches a first low-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the interactive control unit sends a display command for the virtual stimulus source to the display unit, and after a second delay, sends a chemical stimulation command to the chemical stimulus source control unit to apply chemical stimulation. When the target area dominated by both Aδ and C fibers reaches a second low-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the interactive control unit sends a display command for the virtual stimulus source to the display unit, and after a third delay, sends a chemical stimulation command to the chemical stimulus source control unit to apply chemical stimulation.

[0025] According to a preferred embodiment, when the pain category to be induced is heat sensation, the data processing unit determines the chemical stimulus source as a heat-specific stimulant; when the pain category to be induced is cold sensation, the data processing unit determines the chemical stimulus source as a cold-specific stimulant.

[0026] This invention provides, from a second aspect, a virtual or augmented reality pain treatment device based on visual synthesis, comprising a terminal, a server, and a virtual reality device. The terminal generates a pain stimulation scheme matching the currently treated patient and sends the scheme to the server. The server generates a virtual reality environment and a virtual stimulus source visible to the patient within that environment based on the received pain stimulation scheme, and sends parameters including the virtual reality environment and the virtual stimulus source to the virtual reality device. The virtual reality device displays the virtual reality environment and the virtual stimulus source to the currently treated patient. A data processing unit determines the parameters of the stimulation target point of the limb and the virtual stimulus source based on the pain category to be induced. In response to the receipt of the parameters of the stimulation target point and the virtual stimulus source, the display unit drives the virtual stimulus source to perform visual approach motion towards the patient's stimulation target point to achieve non-real stimulation. This activates the patient's somatosensory system through a visual-neural coupling mechanism, thereby inducing the patient to generate tactile, thermal, and / or cold sensations in and around the stimulation target point, thus achieving neuromodulation therapy of the pain pathway.

[0027] According to a preferred embodiment, the server generates parameters of the virtual stimulus source by stimulating the virtual stimulus source along with chemical and physical stimuli sources in a set triggering sequence; when the virtual stimulus source, chemical stimulus source, and physical stimulus source stimulate the patient's vision and nerves in a set sequence, the patient's thermal or cold sensation is induced in the virtual reality environment.

[0028] According to a preferred embodiment, the device further includes a temperature acquisition module. The temperature acquisition module is preferably a temperature sensor. The temperature acquisition module is communicatively connected to a terminal to transmit the temperature of the target area where the stimulation target is located to the terminal. When the target area dominated by C fibers reaches a first high-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the terminal sends a virtual stimulus source display command to the virtual reality device, and after a first delay, sends a chemical stimulation command to the chemical stimulus source control unit to apply chemical stimulation. When the target area dominated by Aδ fibers reaches a second high-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the terminal sends a virtual stimulus source display command to the virtual reality device. When the target area dominated by both Aδ and C fibers reaches a first low-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the terminal sends a virtual stimulus source display command to the virtual reality device, and after a second delay, sends a chemical stimulation command to the chemical stimulus source control unit to apply chemical stimulation. When the target area dominated by both Aδ and C fibers reaches a second low-temperature trigger temperature based on the stimulation effect of the physical stimulus source, the terminal sends a virtual stimulus source display command to the virtual reality device, and after a third delay, sends a chemical stimulation command to the chemical stimulus source control unit to apply chemical stimulation. Attached Figure Description

[0029] Figure 1 This is a simplified diagram showing the connection relationship of the modules of the virtual reality pain treatment device provided by the present invention;

[0030] Figure 2 This is a schematic diagram of the logical relationship of the virtual reality pain treatment device provided by the present invention;

[0031] Figure 3 This is a schematic diagram of a therapeutic scenario in which the stimulation unit provided by the present invention is used to induce thermal sensation;

[0032] Figure 4 This is another schematic diagram of a therapeutic scenario in which the stimulation unit provided by the present invention is used to induce thermal sensation;

[0033] Figure 5 This is a schematic diagram of a therapeutic scenario in which the stimulation unit provided by the present invention is used to induce cold sensation;

[0034] Figure 6 This is another schematic diagram of a therapeutic scenario in which the stimulation unit provided by the present invention is used to induce cold sensation;

[0035] Figure 7 This is a scoring diagram comparing the average pain intensity of the experimental group and the control group;

[0036] Figure 8 This is a diagram showing the pain scores for activity, sleep, stress, and mood disturbances in the experimental and control groups.

[0037] Figure 9 This is a diagram showing the scores of the Patient Global Impression of Pain Scale (PGIC) for patients in the experimental and control groups.

[0038] Figure 10 This is a diagram showing the scores of the Physiological Function and Sleep Disorders Scale (PROMIS-A) for the experimental and control groups.

[0039] Figure 11 This is a diagram showing the scores of the Physiological Function and Sleep Disorders Scale (PROMIS-B) for the experimental and control groups.

[0040] Figure 12 This is a diagram showing the scores of the Pain Catastrophizing Scale (PCS) for the experimental and control groups.

[0041] Figure 13 This is a diagram showing the scores of the Pain Self-Efficacy Questionnaire (PSEQ) for the experimental and control groups.

[0042] Figure 14 This is a diagram showing the scores of the Chronic Pain Acceptance Questionnaire-8 (CAPQ-8) for the experimental and control groups.

[0043] Figure 15 These are the specific data on the VAS scores of patients in the experimental group;

[0044] Figure 16 These are the specific data on the VAS scores of patients in the control group;

[0045] Figure 17 This is a diagram illustrating the information of the test subjects.

[0046] List of reference numerals

[0047] 100: Pain treatment device; 110: Display unit; 120: Data processing unit; 121: Second processor; 122: Memory; 130: Interactive control unit; 131: User interface; 132: Third processor; 200: Virtual stimulus source; 300: Chemical stimulus source control unit; 400: Physical stimulus source control unit; 500: Main control unit; 600: Stimulation unit; 610: Motion module; 620: Stimulation source output module. Detailed Implementation

[0048] The following is a detailed explanation with reference to the accompanying drawings.

[0049] Based on the unique characteristics of thermal and cold sensations in their perception principles, this invention proposes a virtual or augmented reality pain treatment device and apparatus based on visual synthesis. Preferably, this invention can also provide a multi-source stimulus timing control method for the visual synthesis-based virtual or augmented reality pain treatment device 100. Preferably, this invention can also provide a server for data analysis and forming the multi-source stimulus timing control method. This invention can also provide a stimulation device for pain treatment.

[0050] This invention provides explanations for some terms and nouns.

[0051] The Virtual Stimulus Source 200 of the present invention refers to a simulated physical phenomenon or object generated and rendered in real time through a predetermined model in an immersive reality environment, which can stimulate patients to produce contact or non-contact perception, and is intended to provide specific sensory stimulation for treatment, training or research.

[0052] Virtual stimuli 200 can take on various forms, and these forms can be adjusted and changed based on the patient's psychological or physiological changes to adapt to different treatment or experiential needs. Examples of virtual stimuli 200 include virtual flames, virtual snowflakes, virtual hot needles, and virtual ice picks. Figures 3 to 6As shown. Virtual flames and virtual hot needles can stimulate a patient's sensation of heat. The sensation of heat is the intense feeling of high temperature evoked by a hot object, often accompanied by pain and a burning sensation. Virtual snowflakes and virtual ice picks can stimulate a patient's sensation of cold. The sensation of cold is the feeling of low temperature, and snowflakes are typically below normal human body temperature, thus triggering a cold response.

[0053] A chemical stimulant is a specific chemical substance that can activate the biochemical sensory pathways of specific types of nerve fibers (such as Aδ fibers and C fibers). The chemical stimulant acts on the patient's skin surface and works synergistically with the virtual stimulant 200 to induce neurosensory responses in nerve fibers. In this invention, preferably, when the pain category to be induced is heat sensation, the chemical stimulant is a heat-specific stimulant. The heat-specific stimulant is preferably a capsaicin inclusion complex. When the pain category to be induced is cold sensation, the chemical stimulant is a cold-specific stimulant. The cold-specific stimulant is preferably a substance containing menthol. When the pain category to be induced is freezing sensation, the chemical stimulant is a freezing-specific stimulant. The freezing-specific stimulant is preferably a substance containing mustard oil.

[0054] A physical stimulation source is a mechanical component that directly activates specific types of nerve fibers (such as Aδ fibers) through mechanical or thermodynamic means. The physical stimulation source acts on the patient's skin surface or deep tissues, triggered synchronously or with a delay in conjunction with a virtual stimulation source 200 to achieve spatiotemporal integration of neural signals. Physical stimulation components include temperature modulation components, mechanical vibration components, and electrical stimulation components. For example, a temperature modulation component can be a rapid temperature-changing device based on a thermoelectric cooler (TEC), capable of achieving a rapid temperature change of ±20°C in the epidermis within milliseconds, used to alter the skin surface temperature. A mechanical vibration component can employ a linear motor or piezoelectric ceramic actuator to generate tunable mechanical vibration waves of 0.1-100Hz, vibrating the target area of ​​the skin to achieve nerve activation or temperature regulation. An electrical stimulation unit can be a transcutaneous electrode used to apply a 0.1-10mA pulsed current to the target area of ​​the skin, activating the ion channels of Aδ fibers.

[0055] Preferably, the physical stimulus source can also be a light component. The light component regulates skin temperature and activates nerve fibers through the photothermal effect. For example, light of a specific wavelength (such as near-infrared 808nm, mid-infrared 3-5μm) is absorbed by skin tissue, and the photothermal effect converts photon energy into heat energy, precisely regulating the temperature of the epidermis and subcutaneous tissue.

[0056] Target area where stimulation is applied: Select a specific location on the patient's body surface to apply stimulation. The selection of this area should be based on neuroscience principles, such as the distribution of nerve endings in the skin surface and the density of specific nerve fibers (such as Aδ fibers or C fibers).

[0057] Categories of pain to be induced: These are types of pain induced by the synergistic stimulation of physical, chemical, and virtual stimuli (200 in total), used to train the patient's pain modulation ability. Categories of pain to be induced include heat and cold. Both heat and cold are types of pain. Heat sensation is the sensation of warmth or burning achieved by activating temperature-sensitive nerve fibers (such as Aδ fibers). Cold sensation is the sensation of cold primarily achieved by activating slow-conducting C fibers. Freezing sensation, a type of cold sensation, is the noxious sensation of icy cold primarily achieved by activating slow-conducting C fibers.

[0058] Trigger timing refers to the time coordination rules between virtual stimulus 200 and chemical / physical stimulus when applying pain intervention. Its core design lies in matching the conduction characteristics and perception delay of different nerve fibers.

[0059] Aδ fiber dominant type: In the target area of ​​stimulation, the pain transmission pattern mainly relies on Aδ myelinated nerve fibers to transmit pain signals. These fibers respond to mechanical or high-temperature stimulation (threshold approximately 42-55°C) with a relatively fast conduction speed (5-30 m / s) and are responsible for transmitting acute, well-localized sharp pain signals.

[0060] C-fiber dominant type: The pain transmission pattern in the target area is dominated by unmyelinated C fibers. These fibers have a slower transmission speed (0.5-2 m / s) and mainly mediate burning pain or persistent dull pain. They have a low activation threshold (about 42°C) and are sensitive to chemical stimuli (such as capsaicin).

[0061] Example 1

[0062] Traditional visual-tactile synthesis principles suffer from the drawback of requiring extremely high precision in positional alignment during pain management. Specifically, traditional visual-tactile synthesis techniques rely on physical contact between a virtual image and the patient's tactilely sensitive areas to stimulate tactile perception. This means the virtual image must achieve sub-millimeter-level spatial matching with specific nerve ending distribution areas in the body. To achieve this high-precision alignment, the system needs to process multi-dimensional data in real time, including limb 3D coordinates, virtual image spatial coordinates, and motion trajectories. This not only leads to an exponential increase in computational load but also negatively impacts treatment effectiveness due to accumulated coordinate transformation errors. More seriously, insufficient system tracking accuracy can disrupt nerve signal transmission, potentially exacerbating the patient's pain perception.

[0063] Based on this deficiency, this invention proposes a technical solution combining visual and thermal or cold sensations, or a synthesis, according to an understanding of the neural mechanisms of temperature perception. This solution attempts to induce thermal or cold sensations using virtual reality technology without actual contact. This not only reduces the precision requirements but also encourages patients to spontaneously regulate the spinal cord's dorsal horn pain gating system by activating the cross-modal neural coding mechanisms of TRPM8 (cold sensation channel) and TRPV1 (thermal sensation channel). This non-contact temperature stimulation is more conducive to precisely modulating the endogenous analgesic pathways in the periaqueductal gray matter (PAG) of the midbrain, while avoiding neural signal conflicts caused by traditional tactile synthesis, thereby achieving neural remodeling and long-term relief of pain perception.

[0064] like Figure 1 and Figure 2 As shown, this embodiment provides a virtual or augmented reality pain treatment device 100 based on visual synthesis, including an interactive control unit 130, a data processing unit 120, and a display unit 110. The interactive control unit 130, the data processing unit 120, and the display unit 110 establish a communication connection with each other via wired or wireless means to transmit data.

[0065] Preferably, the interactive control unit 130 is, for example, a medical-grade control terminal, comprising a human-machine interface consisting of an ARM-based embedded processor and a 7-inch industrial touchscreen. Preferably, the interactive control unit 130 integrates a biometric identification module (including a fingerprint sensor and an iris scanner) and a medical database access interface, and connects to the data processing unit 120 via a PCIe interface through a Gigabit Ethernet connection. The interactive control unit 130 is encapsulated in a metal casing with an IP65 protection rating, and an internal data encryption chip ensures the security of medical information. The medical-grade control terminal generates a pain stimulation plan matching the patient currently being treated and sends the pain stimulation plan to the data processing unit 120.

[0066] like Figure 2As shown, the interactive control unit 130 includes a user interface 131 and a third processor 132. The user interface 131 displays information related to the virtual stimulation protocol and is also used for information interaction between medical personnel and the system. The third processor 132 is connected to the user interface 131 and processes information related to the virtual stimulation protocol, including data on the generation process of the virtual stimulation information and data on the final virtual stimulation protocol. After forming the virtual stimulation protocol, the third processor 132 sends the virtual stimulation protocol to the data processing unit 120. The data processing unit 120 includes a second processor 121 and a memory 122 connected thereto. The second processor 121 receives the virtual stimulation protocol and generates information on the visual form and motion trajectory of the virtual stimulation source 200 corresponding to the virtual stimulation protocol. The second processor 121 also generates parameters for the virtual stimulation source 200 by stimulating the virtual stimulation source 200 with chemical and physical stimulation sources according to a set triggering sequence. That is, the second processor 121 generates parameters for the virtual stimulation source 200, wherein the virtual stimulation source 200, chemical and physical stimulation sources are stimulated on the patient according to a set triggering sequence. The memory 122 is used to store the processing data of the second processor 121.

[0067] The second processor 121 is connected to the display unit 110. For example... Figure 2 As shown, the second processor 121 sends the virtual stimulus 200, along with chemical and physical stimuli, to the display unit 110 according to a set triggering sequence and parameters of the virtual stimulus 200. Preferably, the display unit 110 is a virtual reality or augmented reality device. The display unit 110 receives the virtual stimulus 200, along with chemical and physical stimuli, according to the set triggering sequence and parameters of the virtual stimulus 200, and calculates the application time of the virtual stimulus 200, chemical stimulus, and physical stimulus based on the patient's limb position. The display unit 110 sends the type information of the chemical stimulus and its activation time, and the activation time of the physical stimulus to the stimulation unit 600 according to the set triggering sequence. Preferably, the display unit 110 can also interact with the central control unit 500 in the stimulation unit 600 to achieve time alignment. In the case of time alignment, the stimulation unit 600 applies the chemical stimulus and / or physical stimulus according to the set triggering sequence in conjunction with the virtual stimulus 200.

[0068] More preferably, the display unit 110 serves as a virtual reality or augmented reality device, internally housing components such as a microprocessor and a camera for data processing. In this invention, the display unit 110 is described as representing the microprocessor processing the data.

[0069] Preferably, the pain stimulation scheme includes information such as the target area where the stimulation target is located, the type of pain to be induced, and the type of virtual stimulus 200.

[0070] The type of virtual stimulus 200 can be virtual flame (e.g., Figure 3 (As shown) or visual objects such as virtual hot needles, virtual snowflakes, and virtual ice picks, or other visual objects with the same function of inducing pain.

[0071] like Figures 3 to 6 As shown, the present invention also includes a stimulation unit 600. The stimulation unit 600 is connected to the data processing unit 120 in a wired or wireless manner and is used to apply chemical or physical stimulation to the patient's limbs.

[0072] like Figures 1 to 6 As shown, the stimulation unit 600 includes a frame and a built-in main control unit 500. The main control unit 500 may be an electrical control cabinet. A motion module 610 is mounted on the frame. A stimulation source output module 620 is located at the end of the motion module 610, used to spray liquid in a mist onto the area where the limb is located, so that the limb can receive stimulation from a chemical or physical stimulus in a non-tactile manner. Preferably, the motion module 610 is mounted on the frame of the stimulation unit 600 via a slide rail and is movable. Preferably, the motion module 610 is controlled by the main control unit 500 and moves along the slide rail to a position corresponding to the patient's limb.

[0073] Preferably, such as Figures 3 to 6 As shown, the frame is preferably a near-rectangular, hollow support, meaning it has an open cavity, and the motion module 610 is mounted on the slide rail for horizontal movement. Preferably, the top beam of the frame is equipped with a double linear slide rail system, employing a transmission structure with ball-bearing sliders and V-shaped guide grooves. The motion module 610 is fixed to the slide rail moving platform via a flange connection. The slide rail moving platform is equipped with a precision reduction mechanism driven by a servo motor, which converts rotational motion into linear displacement through a harmonic gearbox, ensuring that the stimulation source output module 620 can achieve sub-millimeter-level positioning accuracy in three-dimensional space.

[0074] Preferably, the output direction of the stimulation source output module 620 is set vertically downward. In this way, when the frame has an open cavity and the motion module 610 is moved above the patient's limb, the stimulation source output module 620 can apply a corresponding chemical or physical stimulation source to the spatial area where the patient's limb is located.

[0075] The stimulant output module 620 adopts a split structure design, comprising two functional modules: an atomizing unit and a light irradiation unit. The atomizing unit is preferably a nozzle. The light irradiation unit is preferably a light assembly. The nozzle is connected to a pump and is connected via a pipe to a storage tank storing the chemical stimulant liquid. Under the control of the main control unit 500, the pump sprays a chemical stimulant that does not produce tactile sensation on the limb. Preferably, the light assembly is a light bead capable of slightly heating the surface of the patient's limb. A switch connected to the light bead is controlled by the main control unit 500.

[0076] Preferably, the main control unit 500 establishes communication links with the chemical stimulus source control unit 300 and the physical stimulus source control unit 400 respectively via the CAN bus protocol. The main control unit 500 sends pulse signals to the motion control card to drive the servo motor. The motion control card is an embedded control device specifically designed for industrial automation, and its core function is to realize precise trajectory planning and multi-axis collaborative control of the mechanical motion system. In the architecture of the stimulation unit 600, the motion control card serves as the key interface between the main control unit 500 and the motion module 610. By parsing the coordinate instructions sent by the host computer, it generates a pulse sequence conforming to an S-shaped acceleration and deceleration curve, driving the servo motor to complete the predetermined motion trajectory. The motion control unit integrates a 32-bit RISC processor and an FPGA programmable logic unit, which can simultaneously process interpolation calculations on the XYZ axes and receive encoder feedback signals in real time to form closed-loop control.

[0077] The main control unit 500 uses a PID algorithm to adjust the stepper motor speed of the pump to control the atomized particle size distribution of the chemical stimuli. Simultaneously, PWM dimming technology is used to control the physical stimuli control unit 400 to achieve gradient control of the LED array's radiation intensity. An open cavity at the bottom of the frame houses an adjustable-height limb support platform covered with a tempered glass panel with 92% light transmittance, ensuring light penetration while preventing liquid leakage. Hall effect sensors are installed at the extreme positions of all moving parts for position feedback.

[0078] The purpose of the structure of the stimulation unit 600 is to allow the patient's limbs ( Figures 3-6(Taking the hand as an example) While observing the virtual stimulus source 200 in a virtual environment, a chemical or physical stimulus source can be applied at the appropriate location to activate the nerves in the limb, thereby assisting the patient in quickly generating pain sensations such as heat or cold, and shortening the response time of the patient's nerve signal transmission. The stimulation unit 600, through the synergistic action of the mechanical positioning system and the electronic control system, enables the stimulus source output module 620 to form a controllable field of action on the patient's limb surface according to the spatial coordinates of the virtual stimulus source 200. When the chemical stimulus atomizes vertically in a laminar flow pattern, combined with light radiation of a specific wavelength, it can generate a gating effect of ion channels at the nerve endings in the epidermis. This spatiotemporal synchronization design of multimodal stimulation effectively reduces the neural adaptability of somatosensory transmission, providing a precise physical carrier for inducing targeted temperature sensation.

[0079] After describing the structural composition of the virtual or augmented reality pain treatment device 100, the present invention describes the implementation principle of the technical solution.

[0080] Neural pathways related to heat sensation include TRPV1 channels, TRPV4 channels, and Aδ fibers. TRPV1 channels can sense high temperatures (>42°C) and are sensitive to capsaicin. TRPV4 channels can sense moderate temperature changes and enhance the perception of warmth. Specifically, heat sensation is transmitted through Aδ fibers and C fibers, with Aδ fibers transmitting rapid high-temperature stimuli and C fibers responsible for slower heat perception. TRPV1 channels can sense low temperatures (<17°C) and are sensitive to mustard oil. Taking the patient's hand as an example, the Aδ fiber-dominant area is mainly distributed on the back of the hand, while the C fiber-dominant area is mainly distributed on the palm.

[0081] The present invention illustrates the neural state related to heat and cold sensations through Table 1 below, “Distribution and Functional Array of Major Temperature Receptors in Aδ and C Fibers”.

[0082] Table 1:

[0083]

[0084]

[0085] As shown in Table 1, TRPV1, TRPV3, TRPV4, and TRPA1 are expressed in keratinocytes, which may make them more susceptible to external stimuli. This is because keratinocytes are the main cells of the epidermis and are directly exposed to the external environment, making them vulnerable to physical, chemical, and temperature stimuli, such as temperature changes (heat / cold), chemical stimuli (e.g., capsaicin, mustard oil), mechanical stimuli (pressure, friction), or ultraviolet radiation. These external factors can activate TRP channels, triggering a series of physiological responses, such as inflammation, pain, or sensory transmission.

[0086] There has been a great deal of research on TRPV1 as a potential target. Since TRPV1 is involved in burn-related thermal pain, virtual reality can be used to treat pain involving TRPV1.

[0087] For example, studies targeting TRPV3 and TRPV4 as potential targets can be found in the article "Mirror therapy for patients with complex regional pain syndrome (CRPS): a systematic review" published in the Journal of Pain Research by Smart et al. (2016). This study showed that mirror therapy can reduce the pain intensity in patients with CRPS. Since TRPV3 is involved in skin temperature regulation and TRPV4 is involved in mechanotherapy and temperature perception, it is affected in CRPS. Therefore, mirror therapy can be used to treat pain involving TRPV3.

[0088] For example, studies on TRPA1 as a potential target can be found in Kenney and Milling's (2016) article "The effectiveness of virtual reality distraction for reducing pain: A meta-analysis" published in Clinical Psychology Review. This study showed that virtual reality can reduce cold pain, and since TRPA1 is involved in cold pain, virtual reality can be used to treat pain involving TRPA1.

[0089] For example, studies on TRPM8 as a potential target can be found in the article "Mirror therapy for patients with complex regional pain syndrome (CRPS): a systematic review" published by Smart et al. (2016) in the Journal of Pain Research. This study showed that mirror therapy can reduce the pain intensity in patients with CRPS. Since TRPM8 is involved in cold hypersensitivity in CRPS, mirror therapy can be used to treat pain involving TRPM8.

[0090] Thermoreceptive innervation of Aδ and C fibers differs between human glabrous and hairy skin. Yelena Granovsky, Dagfinn Matre, et al. published an article in 2005 entitled "Thermoreceptive innervation of human glabrous and hairy skin: a contact heat evoked potential analysis," in Pain 115(3):238-247, DOI:10.1016 / j.pain.2005.02.017. This experimental study aimed to validate this finding. Sixteen healthy volunteers (8 men and 8 women, aged 18-35 years; 1 woman with a history of neck pain was excluded) were included. A contact heat evoked potential stimulator (CHEPS) was used to apply heat stimulation at 42°C and 51°C to the thenar eminence of the palm (glabrous skin) and the back of the hand (hairy skin). Experiments showed that stimulation of hairless skin at 42°C elicited a mild warming sensation (C-fiber mediated, latency 485ms, conduction velocity 0.95-1.35m / s), while stimulation at 51°C elicited a painless, intense heat sensation (C-fiber mediated, latency 433ms). Stimulation of hairy skin at 42°C was mediated by C-fibers (latency 455ms, conduction velocity 1.28m / s), while stimulation at 51°C was mediated by Aδ fibers (latency 267ms, conduction velocity 12.9m / s) and produced moderate pain.

[0091] Table 2 summarizes the data that led to the conclusions of this article:

[0092]

[0093]

[0094] As shown in Table 2, hairy skin, such as the back of the hand, is more sensitive to a painful pricking sensation at 51 degrees Celsius, and nerve conduction speed is faster; hairless skin, such as the thenar eminence of the palm, is more sensitive to a strong but painless heat sensation at 51 degrees Celsius, and nerve conduction speed is faster.

[0095] Based on the above principles, this invention proposes a multi-source stimulation timing control method for a virtual or augmented reality pain treatment device 100, used for pain treatment. The multi-source stimulation includes at least two of the following: a virtual stimulation source 200, a chemical stimulation source, and a physical stimulation source. The virtual stimulation source 200, the chemical stimulation source, and the physical stimulation source stimulate the patient's limb target points according to a set timing sequence to activate nerve fibers and induce the patient's thermal or cold sensations.

[0096] Preferably, the data processing unit 120 determines the stimulation target of the limb, the parameters of the virtual stimulus source 200, and the chemical and / or physical stimuli that stimulate it in conjunction with the pain stimulation scheme based on the pain category to be induced. That is, the data processing unit 120 determines the stimulation sequence and interval of the virtual stimulus source 200, chemical stimulus source, and physical stimulus source on the stimulation target, so as to stimulate the stimulation target in a way that does not produce tactile sensation and activate the nerve fibers of heat or cold sensation, thereby inducing the nerve fibers to more easily produce heat or cold sensation under the action of the brain.

[0097] Preferably, the second processor 121 in the data processing unit 120 determines at least one stimulation target corresponding to a pain category based on a pain category-target mapping table. The pain category-target mapping table is constructed based on the following research.

[0098] The present invention illustrates the mapping of the pain category-target mapping table in the skin of the palm and the selection principle of the virtual stimulus source 200 through the following Table 3.

[0099] Table 3:

[0100] aisle C-fiber nerve endings A△ fiber nerve endings TRPV1 yes No (minority) TRPV2 no yes TRPV3 yes no TRPV4 yes yes TRPM8 yes yes TRPA1 yes no

[0101] For example, for cold sensation, the corresponding stimulation targets include the central area of ​​the back of the hand (hairy skin) and the forefoot area of ​​the foot (hairless skin). For heat sensation, the corresponding stimulation targets include the thenar eminence (hairless skin) and the lateral area of ​​the upper arm (hairy skin). Clearly, pain categories correspond to stimulation targets in different locations, and appropriate stimulation targets need to be selected based on the patient's limb characteristics.

[0102] Current technologies do not provide solutions for utilizing color changes to address various pain perceptions. While a 2013 study by Matteo Martini et al. found that "red images displayed on non-body areas (desktops) have the highest pain threshold, thus confirming the body-specific nature of color in pain modulation," this study did not provide specific measures for projecting the corresponding images onto the patient's target area (embodying the patient). Therefore, this invention proposes a basic pathway to enhance temperature perception using visual cues. For example, in high-temperature scenarios such as flames, direct sunlight, and lava flow, dynamic images in red and yellow, along with visual effects simulating airflow, can induce a perception of heat, i.e., a sensation of heat. In low-temperature scenarios such as snow cover, the flow of frozen gases, and frost, blue and white tones, combined with changes in light and shadow, can induce a expectation of cold, i.e., a sensation of cold. These visual cues formed by the virtual environment stimulate the higher visual cortex, interacting with information from tactile and interoceptive areas to induce tactile, thermal, and / or cold sensations. However, simply using a virtual environment to induce pain has a low success rate. When a patient's nerve fibers have a disordered perception of pain, the virtual environment is unlikely to stimulate the nerves in the patient's body to mobilize nerve fibers in specific locations and generate pain.

[0103] Specifically, in virtual environments (such as fire scenes in VR), visual cues (such as flames approaching the hand) trigger anticipation of heat sensation through the multimodal cortex (posterior parietal cortex). However, the low thermal sensitivity of the skin on the back of the hand and the weak neural projection (small representation area in the somatosensory cortex) make it difficult for the brain to associate visual signals with somatosensory feedback, forming a "perceptual break," thus resulting in a low success rate in inducing pain sensation.

[0104] This invention sets up a virtual stimulus source 200 in a virtual scene. The virtual stimulus source 200 moves closer to the target area in the virtual scene, thereby enabling the patient to specifically activate nerve fibers in the target area and generate a sensation of heat or cold through the visual cortex-brain-nerve fiber pathway. The color parameters of the virtual stimulus source 200 can be controlled by a display unit 110. The display unit 110 adjusts the color parameters of the virtual stimulus source 200 according to the virtual stimulation scheme and the real-time virtual distance d between the virtual stimulus source 200 and the stimulation target point in the target area.

[0105] Preferably, the display unit 110 determines the color parameters of the virtual stimulus source 200 based on the pain category to be induced, and specifically adjusts the color and transparency to achieve a gradient. The real-time virtual distance d (unit: meters) between the virtual stimulus source 200 and the stimulus target is defined as the independent variable, and the display unit 110 adjusts the color parameters according to the following rules.

[0106] For thermal perception: When the virtual distance d changes from 0.5m to 0m, the red channel increases linearly from 150 to 255, and the orange channel (RGB255,165,0) transparency decreases from 80% to 20% (enhancing the burning sensation);

[0107] For cold perception: For every 0.1m decrease in virtual distance d, blue saturation increases by 30%, while a white halo (radius increased by 10%) is superimposed;

[0108] Physiological synchronization: When the virtual distance d < 0.2m, a color mutation is triggered (such as the flame core brightening to 5000 lumens), which strengthens the pain expectation.

[0109] The range and morphological adaptability are adjusted again. When the virtual stimulus source 200 enters within 0.1m of the target area, the display unit 110 sends distance threshold information to the second processor 121. In response to this distance threshold information, the second processor 121 initiates the perspective distortion algorithm and sends the algorithm's result parameters to the display unit 110.

[0110] For heat perception of flames: flame height is reduced from 1.2cm to 0.3cm, while increasing heat wave distortion effect (Perlin noise amplitude +200%);

[0111] For icicles designed to improve cold perception: the cone length is reduced from 5cm to 0.2m, and a crack texture is generated on the surface (crack density and d). 2 (inversely proportional);

[0112] Dynamic collision volume: The effective range of the virtual stimulus source 200 (such as the heat-affected zone of a flame) shrinks as the virtual distance decreases, from an initial diameter of 10cm to 5cm, ensuring the spatial overlap accuracy between the virtual stimulus source 200 and the stimulus target.

[0113] Preferably, when the patient's limb is captured, the display unit 110 determines the coordinates of the limb in the virtual reality environment based on the principle of embodiment. The parameters of the virtual stimulus source 200 adaptively change with the movement coordinates of the patient's limb, the virtual limb, or the mirrored limb, so that the virtual stimulus source 200 gradually approaches the stimulation target in the patient's field of vision, thereby gradually reducing the virtual distance between the virtual stimulus source 200 and the stimulation target.

[0114] Preferably, in a virtual reality system, the dynamic coupling mechanism between virtual stimuli 200 (such as virtual flames) and the patient's limb movements is achieved through multi-level biomechanical and neurocognitive principles to achieve targeted guidance. Currently, cognitive behavioral therapy (CBT) reduces pain susceptibility and enhances social participation by modifying patients' cognitive patterns and behavioral responses to pain. Its core mechanism involves four levels: (1) reshaping pain perception by educating patients to understand the physiological and psychological connections of pain and reducing catastrophic thinking; (2) cultivating proactive coping strategies, such as relaxation training and cognitive restructuring, to enhance individuals' sense of control in pain situations; (3) strengthening self-efficacy by guiding patients to reassess their participation in work, social and leisure activities; and (4) establishing long-term problem-solving abilities to cope with daily challenges caused by pain. This multi-dimensional intervention model modulates pain processing pathways through neuroplasticity while improving patients' social functional adaptability. However, single cognitive behavioral therapy (CBT) cannot accurately induce pain perception at limb targets, mainly because its mechanism of action is multi-dimensionally mismatched with the physiological needs of pain. CBT corrects cognitive biases and emotional responses by modulating the prefrontal-limbic system network, but it cannot directly activate peripheral Aδ / C fibers or regulate spinal dorsal horn-specific synaptic transmission, the latter being a key step in pain induction. In terms of temporal dynamics, CBT relies on long-term synaptic plasticity (such as NMDA receptor-mediated LTP), requiring weeks to change the pain threshold, while target stimulation requires millisecond-level neural signal synchronization. Regarding spatial precision, CBT has a large modulation error in the primary somatosensory cortex (S1), far exceeding the millimeter-level localization requirements of peripheral stimulation. Therefore, based on the mechanisms of cognitive behavioral therapy, using virtual stimulus 200 to stimulate the target point, guiding the patient to generate a more precise pain perception at the stimulation target, is the most significant effect of this invention.

[0115] The display unit 110 acquires real-time six-degree-of-freedom motion data (including three-dimensional translation and rotation angles) of the patient's real, virtual, or mirrored limbs. Based on rigid body kinematics, it establishes a coordinate mapping model between physical and virtual spaces, and uses a nonlinear gain algorithm to convert limb displacements into position offsets of the virtual stimulus source 200. This spatial mapping follows the perceptual characteristics of the Weber-Fechner law, ensuring that small movements produce significant visual feedback, while large movements maintain system stability, forming a visual-proprioceptive coupling effect that conforms to the laws of human motion control.

[0116] If the nerve fibers associated with heat or cold sensation are not activated when the virtual stimulus source 200 moves and approaches the stimulus target in a virtual environment, then even if the brain has a memory of heat or cold sensation associated with the virtual stimulus source 200, the stimulus target may not produce heat or cold sensation when the virtual stimulus source 200 visually virtually contacts the stimulus target; or, the stimulus target may produce heat or cold sensation, but the perception of heat or cold sensation is dulled and cannot reach the heat or cold sensation intensity corresponding to the stimulus intensity of the virtual stimulus source 200.

[0117] First, the virtual stimulus 200 cannot directly activate temperature-sensitive channels such as TRPV1 / TRPM8, resulting in a lack of physiological-level pain signals. Functional magnetic resonance imaging (fMRI) shows that pure virtual stimulation mainly triggers cognitive assessment activity in the prefrontal cortex, while the response intensity in the insula (the core area of ​​subjective pain) and somatosensory cortex is less than 30% of that of real pain. Second, sensory conflict is difficult to avoid: when patients observe that the virtual flame touches their skin but there is no corresponding temperature rise or burning sensation, the contradiction between vision and somatosensory sensation can lead to a break in immersion and even exacerbate pain cognitive dissonance (such as the psychological phenomenon of "threat nullification"). In addition, the parameter adjustment of a single stimulus has rigid limitations—the maximum brightness of the display interface of the display unit 110, the movement speed of the virtual model, and other physical limits make it impossible to meet the needs of patients with high pain thresholds. The lack of closed-loop control for temperature or chemical feedback makes it difficult for the system to adapt to changes in skin blood flow or local inflammatory states in real time. More importantly, complex neuropathic pain (such as burning-pinching mixed pain) requires multi-channel synergistic activation, while a single virtual stimulus can only simulate a single modality and cannot reproduce the multi-pathway pain transmission mechanism in a real pathological environment.

[0118] Therefore, it is best if the nerve fibers stimulating the target point are already activated when the virtual stimulus source 200 virtually contacts the target point, so that at the instant the virtual stimulus source 200 virtually contacts the target point, the nerve fibers are activated by the brain based on memory and induce the corresponding heat or cold sensation. This invention uses chemical or physical stimuli to assist in activating nerve fibers. In other words, this invention employs a multi-source stimulation approach to activate the target point.

[0119] However, ordinary chemical stimuli sprayed onto the target site of a limb produce tactile sensation. For example, liquid sprayed onto the skin surface of a limb produces the tactile sensation of contact with liquid. Or, an object in contact with the skin surface of a limb produces a pressure sensation. Pressure sensation is also a type of tactile sensation. Therefore, tactile sensation is also generated by the nerve fibers of the target site, which can cause confusion between tactile sensation and thermal or cold sensation, thus interfering with the induction of thermal or cold sensation and causing the induction of thermal or cold sensation to fail. Therefore, how to apply chemical or physical stimulation to the target site without producing tactile sensation is a current challenge.

[0120] Preferably, for a chemical irritant, the chemical irritant control unit 300 needs to appropriately control the physical properties and spraying method of the liquid chemical irritant. The main control unit 500 is connected to the chemical irritant control unit 300 via a line and transmits commands.

[0121] Preferably, the nozzle for spraying the chemical irritant is equipped with a constant temperature heating element to heat the liquid chemical irritant to a temperature similar to or even the same as the skin surface temperature, i.e., 32-35°C. When the chemical irritant comes into contact with the target point in a mist form, the thermal receptors (TRPV1 / TRPM8) are avoided from being activated, and the changes in tactile sensitivity caused by temperature difference are reduced.

[0122] Preferably, the flow channel inside the nozzle is equipped with a piezoelectric ceramic vibrating plate. When the liquid chemical stimulus flows through the flow channel, the liquid is broken into nano-droplets by the piezoelectric ceramic vibrating plate and sprayed from the nozzle onto the stimulation target point of the limb.

[0123] Preferably, for physical stimulus sources, the physical stimulus source control unit 400 needs to properly control the light irradiation to avoid tactile sensation on the skin near the stimulation target of the limb. The main control unit 500 is connected to the physical stimulus source control unit 400 via wiring to transmit commands.

[0124] The physical stimulus source is preferably an optical component, used to momentarily irradiate the stimulation target point, especially at a specified stimulation temperature at the instant the virtual stimulus source 200 comes into contact with the stimulation target point. This allows the stimulation target point to physically perceive the heat of the virtual stimulus source 200, enhancing the realism of the virtual stimulus source 200 and maximizing the conduction speed of nerve fibers, thus inducing the nerve fibers to generate the correct thermal sensation, i.e., pain sensation. Preferably, the stimulation temperature includes 42℃ and 51℃.

[0125] Preferably, the atomizing unit and the illumination unit of the present invention adopt a coaxial nested layout, and the output end face of the stimulation source output module 620 is provided with an anti-interference isolation ring to ensure that the atomizing agent of the chemical stimulation source is spatially separated from the action area of ​​the light component.

[0126] Preferably, in the absence of a virtual stimulus source 200 to achieve virtual contact through visual stimulation, a single light source instantaneously contacts the target area where the stimulus target is located at the stimulation temperature, without interfering with thermal induction. There are three specific reasons: First, light is a massless electromagnetic wave that only transmits energy (heat) and does not exert pressure or shear force on the skin, therefore it does not activate mechanoreceptors such as Meissner corpuscles or Pacinian corpuscles. Photothermal stimulation only activates the heat-related C-type unmyelinated nerve fibers (TRPV1 / TRPA1 channels), which are completely independent of the Aβ myelinated fiber signal transmission pathway for touch, avoiding signal cross-interference at the spinal cord and cortical levels. Second, after TRPV1 (threshold ~42℃) is activated, the signal is transmitted from the C-type nerve fibers to the dorsal horn of the spinal cord and projected to the insular cortex via the spinothalamic tract. This is separate from the thermal pathway at the spinal cord level, avoiding signal cross-interference. Third, light signals are instantaneous stimuli. A light pulse (100-200ms) raises the skin temperature to the target value (e.g., 42℃) within milliseconds and stops before the signal reaches the brain, avoiding continuous stimulation that could activate tactile sensation. Therefore, instantaneous light, as a physical stimulus, achieves pure induction of thermal sensation through non-contact energy transfer, specific channel activation, and precise spatiotemporal control.

[0127] Under the stimulation of chemical and physical stimuli, nerve fibers are in an optimal activation state at the moment of contact with the virtual stimulus 200, thereby reducing the difficulty of activating pain perception in nerve fibers.

[0128] Although it is theoretically possible to activate nerve fibers using physical and chemical stimuli, the timing of their activation, and how to ensure that they are used in a proper sequence to provide effective stimulation, are issues that require further investigation.

[0129] If the time interval (sequence) between the chemical stimulus, physical stimulus, and virtual stimulus 200 is inappropriate, the induction effect of pain (heat and cold sensation) will be significantly reduced. Specifically, when the chemical stimulus, physical stimulus, and virtual stimulus 200 work together, the scientific challenge of timing control stems from the dynamic characteristics of the activation state of nerve fibers and the differences in the conduction delay of multimodal stimuli.

[0130] After an action potential is generated, nerve fibers experience an absolute refractory period of approximately 1 ms and a relative refractory period of 3-4 ms. During this period, the stimulation threshold increases significantly. If the timing of the initiation of a chemical or physical stimulus fails to precisely match the excitability recovery window of the nerve fiber, it will lead to stimulus failure or insufficient signal intensity. The diffusion of atomized molecules from a chemical stimulus (such as capsaicin) from the skin surface to the TRPV1 channel in the dermis takes 50-200 ms. The biochemical processes of channel binding and opening further introduce a delay of 1-10 ms. In contrast, the photothermal stimulation applied by a physical stimulus, such as near-infrared laser (808 nm), can raise the dermal temperature to 42°C within 10 ms. The difference in conduction delay between the two is as high as two orders of magnitude. The overall delay from the generation of the visual contact signal to the output of tactile feedback in the display unit 110 is approximately 20-50 ms, exceeding the brain's synchronous tolerance window for multimodal sensory integration (±50 ms), which may cause perceptual fragmentation. To resolve this contradiction, a motion trajectory prediction algorithm is needed to trigger the chemical spray 50ms in advance, and the real-time nature of photothermal stimulation is utilized to compensate for the temperature gradient 10ms before virtual contact. Simultaneously, nanocarriers (such as liposomes) are employed to compress the chemical molecule diffusion time to within 20ms, ensuring that the effective timing error of the three stimulation sources is controlled within a neural integration tolerance of ±15ms. This multi-source synergistic scheme of the present invention can significantly enhance pain perception intensity while reducing tactile interference to negligible levels, such as below 5%, achieving precise spatiotemporal matching of multimodal stimulation in the sub-millisecond range.

[0131] Preferably, the data processing unit 120 generates parameters of the virtual stimulus source 200 by stimulating the virtual stimulus source 200 with chemical and physical stimulus sources according to a set triggering sequence.

[0132] Preferably, based on the target area where the stimulation target is located in the virtual stimulation scheme, the data processing unit 120 determines the type of chemical stimulation source and / or physical stimulation source that can be used with the virtual stimulation source 200 and the timing of applying the stimulation.

[0133] Figures 3 to 6 In the diagram, the left side shows an image within a virtual scene, while the right side shows an image of the actual device in operation according to the present invention. Preferably, as shown... Figure 3 As shown, since the palm is hairless skin, a region dominated by C fibers, its activation threshold is low (approximately 42°C) and it is sensitive to chemical stimuli (such as capsaicin). Therefore, in the virtual scene, the virtual stimulus 200 appears as a virtual fireball, gradually and slowly descending towards the palm. Simultaneously, as... Figure 3As shown, the patient places their hand, palm up, into the open cavity of the stimulation unit 600. At this time, the display unit 110 sends the coordinates of the palm to the second processor 121 to calculate the distance moved by the motion module 610 and the activation times of the chemical and physical stimulation sources. Preferably, the chemical stimulation source is capsaicin solution. The physical stimulation source is infrared light.

[0134] The steps of the second processor 121 in the data processing unit 120 to calculate the timing are as follows:

[0135] The real-time coordinates of the patient's palm in the stimulation unit 600, as determined by the display unit 110, are (x...). a y a , z a Therefore, the equation of the virtual fireball's trajectory (such as a parabola) is:

[0136]

[0137] v0 represents the initial falling speed of the virtual fireball.

[0138] Calculate the contact time t between the virtual fireball and the palm. p for:

[0139] z v (t p )=z h ;

[0140]

[0141] Where g represents virtual gravitational acceleration; z0 represents the initial height; z h This indicates the altitude of the descent trajectory.

[0142] Calculate the diffusion delay time of the chemical stimulus.

[0143] According to Fick's second law, the diffusion delay time t y for:

[0144]

[0145] d represents skin thickness; D represents diffusion coefficient (the migration rate of molecules in the skin).

[0146] With the piezoelectric atomizing vibrator reducing the droplet diameter of the chemical stimulus to 50 nm, the diffusion coefficient D is increased to 5 × 10⁻⁶. -9 m 2 / s.

[0147]

[0148] Therefore, the TRPV1 channel opening time is approximately 5ms.

[0149] The total chemical delay time of the chemical stimulus is:

[0150] t z =t y +5ms = 33ms + 5ms = 38ms.

[0151] The delay time of the physical stimulus is:

[0152]

[0153] ρ represents skin tissue density, c p d represents the specific heat capacity of the skin; k represents the thermal conductivity of the skin; d represents the specific heat capacity of the skin. 目标深度 Indicates the target depth of photothermal effect.

[0154] For example,

[0155] At this time, t 升温 The data is too high, and the light intensity needs to be optimized.

[0156] Using an 808nm laser (power P = 2W, spot size A = 1mm) 2 Ignoring thermal diffusion, the heating rate is:

[0157]

[0158] Where α = 0.3cm -1 , representing the absorption coefficient.

[0159] So, the total physical delay of the physical stimulus light source

[0160]

[0161] Where ΔT = 0.2℃; P = 2W; A = 1mm 2 =1×10 -6 m 2 ρ = 1100 kg / m 3 ;c p = 3400 J / (kg·k).

[0162] Based on the neural refractory period and stimulation window adaptation and calculation.

[0163] Absolute refractory period (ARP): t ARP =1ms.

[0164] Relative refractory period (RRP): t RRP =4ms (the threshold is increased to 1.5 times during this period).

[0165] The effective stimulation window is: it needs to be at the contact time t pBefore Δt>t RRp Apply stimulation.

[0166] The stimulus initiation time is: t 启动 =t p -max(t z -t 光总 )-t 安全裕度 .

[0167] t 安全裕度 =5ms.

[0168] For example, if the contact time t p If the total chemical activation time of the chemical stimulus is t = 1200 ms, then... 化学生效 =1200ms-38ms-5ms=1157ms.

[0169] The time t when the physical stimulus begins to take effect 物理生效 =1200ms-12ms-5ms=1183ms.

[0170] The time conditions that chemical and physical stimuli need to meet are:

[0171] |t 化学刺激 -t 物理刺激 |<Δt max =30ms.

[0172] 30ms is the tolerance window for multimodal integration in the brain.

[0173] Therefore, the time when the chemical stimulus takes effect is:

[0174] t 化学刺激 =t 化学生效 +t z =1157ms + 38ms = 1195ms.

[0175] The time when physical stimulation takes effect is:

[0176] t 物理刺激 =t 物理生效 +t 光总 =1183ms + 12ms = 1195ms.

[0177] Similarly, Figure 4 This is a schematic diagram of a scenario where a virtual hot needle is used as a virtual stimulation source 200 to provide multi-source stimulation to the back of the hand. Figure 5 This is a schematic diagram of a scenario where a virtual ice hockey puck is used as a virtual stimulus source 200 to provide multi-source stimulation to the back of the hand. Figure 6 This is a schematic diagram of a scenario where a virtual ice cone is used as a virtual stimulus source 200 to provide multi-source stimulation to the back of the hand.

[0178] As shown above, this invention ensures that multimodal stimulation is effective within the neural integration window through calculation. Integrating virtual stimulus source 200 with chemical and physical stimuli in a specific temporal sequence enhances the realism and effectiveness of pain intervention through multisensory synergy. From a neural mechanism perspective, pain perception is not the result of a single sensory input, but rather an integration process of signals from multiple pathways, such as vision, temperature, and chemical pathways, in brain regions. For example, visual stimulation of a virtual flame can activate the threat recognition function of the prefrontal cortex, but without synchronized physical heating (e.g., heating to 45°C using a TEC module) or chemical stimulation (e.g., capsaicin activating the TRPV1 channel), the spinal cord pain transmission pathways (e.g., C-fibers) will not respond adequately, resulting in patients experiencing only "anticipated pain" rather than actual physiological pain. Studies have confirmed that multimodal stimulation, through a time-locked effect (error < 100 ms), can significantly enhance the synergistic activation of the anterior cingulate cortex (ACC) and insula, thereby more accurately simulating the complex sensory experience of burns or frostbite, which is crucial for the neural remodeling treatment of chronic pain. Furthermore, adaptive regulation of individual differences also relies on multimodal complementarity—when patients experience decreased sensitivity to virtual stimuli due to color weakness or visual fatigue, the dosage gradient of chemical stimuli or the temperature change of physical stimuli can dynamically compensate for the intensity of intervention, ensuring the stability of treatment effects.

[0179] The data processing unit 120 sends the total delay time of chemical stimulation, the total delay time of physical stimulation, and parameters including the virtual reality environment and the virtual stimulus source 200 to the display unit 110. The display unit 110 displays the virtual reality environment and the virtual stimulus source 200 to the patient currently being treated according to a pre-set timing sequence. The data processing unit 120 determines the stimulation target point of the limb and the parameters of the virtual stimulus source 200 based on the pain category to be induced. In response to the receipt of the parameters of the stimulation target point and the virtual stimulus source 200, the display unit 110 drives the virtual stimulus source 200 to perform visual approach motion towards the stimulation target point of the patient to achieve non-real stimulation. Through the visual-neural coupling mechanism, the patient's somatosensory system is activated, thereby inducing the patient to generate tactile, thermal, and / or cold sensations in and around the stimulation target point, thereby achieving neuromodulation therapy of the pain pathway.

[0180] When virtual stimulus 200, chemical stimulus, and physical stimulus stimulate the patient's vision and nerves in a predetermined sequence, the patient's sensation of heat or cold is induced in the virtual reality environment. Preferably, the interactive control unit 130 adjusts the parameters of the virtual stimulus 200 in the pain stimulation scheme based on the patient's neural perception feedback of pain during the treatment process, in order to enhance the patient's neural perception in the virtual reality environment. Preferably, the interactive control unit 130 adjusts the color parameters of the virtual stimulus 200 in the pain stimulation scheme based on the patient's neural perception feedback of pain during the treatment process, in order to change the patient's pain perception in the virtual reality environment and enhance the patient's neural perception in the virtual reality environment.

[0181] This invention provides a detailed description of the triggering sequence of the virtual stimulus 200 and the chemical / physical stimulus.

[0182] According to a preferred embodiment, the interactive control unit 130 receives the temperature of the target area where the stimulation target is located from a temperature acquisition module connected thereto. Preferably, the sampling frequency is ≥1kHz.

[0183] According to a preferred embodiment, the data processing unit 120 dynamically adjusts the triggering sequence of the virtual stimulus source 200 and the chemical / physical stimulus source based on the skin type of the patient's stimulation target. The nerve fiber type is determined based on the skin type of the stimulation target. Nerve fiber types include Aδ fiber-dominant types, C fiber-dominant types, and mixed types of both.

[0184] For the Aδ fiber-dominant type, the data processing unit 120 determines that the chemical stimulus source is triggered 26ms earlier than the physical stimulus source, so that the effects of the two arrive synchronously. When the stimulation effect of the physical stimulus source in the target area of ​​the Aδ fiber-dominant type reaches the second high-temperature trigger temperature (51°±0.5°C), the interactive control unit 130 sends a display command for the virtual stimulus source 200 to the display unit 110.

[0185] For example, such as Figure 4As shown, taking the back of the hand as an example, in the virtual scene, the virtual stimulus source 200 is displayed as a virtual hot needle. The virtual hot needle is displayed in a high-temperature state and the needle tip gradually approaches the stimulation target point in the Aδ fiber-dominated area of ​​the back of the hand. The movement trajectory of the virtual hot needle conforms to the minimum acceleration curve planning. As the virtual stimulus source 200 gradually moves towards the back of the hand, the main control unit 500 controls the motion module 610 to move above the back of the hand, and determines the position of the motion module 610 according to the coordinates of the back of the hand, so that the nozzle of the stimulus source output module 620 is aligned with the back of the hand. Preferably, the three-dimensional positioning error is ≤0.3mm. When the countdown of the contact time between the virtual stimulus source 200 and the stimulation target point reaches the total chemical stimulation delay time (i.e., 1162ms), the main control unit 500 responds to the start command sent by the second processor 121 and begins to control the nozzle of the chemical stimulus source (capsaicin) to spray nanoscale mist containing the chemical stimulus source into the air area where the back of the hand is located, so that the back of the hand contacts the chemical stimulus source without producing a tactile sensation. When the countdown of the contact time between the virtual stimulus source 200 and the stimulation target reaches the total physical stimulation delay time (1188ms), the main control unit 500 responds to the start command sent by the second processor 121 and begins to control the infrared light component to emit infrared light towards the back of the hand. The irradiation point of the infrared light coincides with the position of the stimulation target of the virtual stimulus source 200. This means that at the moment the stimulation target of the back of the hand comes into contact with the virtual stimulus source 200, the Aδ fibers in the target area dominated by Aδ fibers have already been stimulated to an activated state by the chemical stimulus source at the second high temperature trigger temperature (51°). As a result, when the patient visually observes the virtual hot needle pricking the back of the hand, the Aδ fibers are more easily stimulated by the brain and produce a painful needle-like sensation.

[0186] For the C-fiber dominant type, the data processing unit 120 determines the triggering sequence of the virtual stimulus source 200 and the chemical stimulus source according to a set time interval, wherein the chemical stimulus source is triggered first, i.e., it starts 38ms in advance. When the stimulation effect of the physical stimulus source in the target area of ​​the C-fiber dominant type reaches the first high temperature triggering temperature (42°), the interactive control unit 130 sends a contact command of the virtual stimulus source 200 to the display unit 110, so that the virtual stimulus source 200 comes into contact with the stimulation target.

[0187] For example, such as Figure 3As shown, in response to the command of the interactive control unit 130, the display unit 110 displays the virtual stimulus source 200, and the virtual reality environment immediately presents a diffuse virtual flame (diffusion rate 0.2m / s, color saturation increases with distance from the core area). The chemical stimulus source is sprayed as nano-sized mist particles and distributed over a large area of ​​the palm so that the palm contacts the chemical stimulus source without producing a tactile sensation. When the virtual fireball is about to contact the stimulation target and the contact countdown time reaches the total physical stimulus delay time (1188ms), infrared light, as the physical stimulus source, raises the skin temperature to 42°C. At the instant the virtual flame contacts the stimulation target, the chemical stimulus takes effect, the physical stimulus takes effect, and the nerve fibers in the palm area dominated by C fibers are already in an activated state and reach the first high temperature trigger temperature (42°C, duration 50±5ms). At this time, the patient sees the virtual fireball starting to burn the palm, and the brain, based on the visual image, stimulates the nerve fibers to produce a thermal sensation, i.e., induces a thermal sensation. Specifically, the brain constructs a predictive model of the world through prior experience. When a patient observes a virtual flame, visual input activates past thermal memories (such as burn experiences or discomfort from proximity to a fire source) stored in the posterior parietal cortex (PPC) and prefrontal cortex (dlPFC). Past experiences of pain or heat stimulation are encoded as emotional memories (such as fear), enhancing predictive signals for threatening visual stimuli. Repeated exposure to heat stimulation strengthens the somatosensory cortex's response threshold to specific temperatures (such as 42°C), forming experience-dependent sensitization. When a patient visually sees a virtual fireball beginning to burn their palm, the basolateral amygdala (BLA) encodes the association between the visual stimulus (flame) and heat sensation (pain); striatal dopaminergic projections reinforce the stability of this association, allowing subsequent visual input to directly trigger C-fiber sensitization in the dorsal horn (DH) of the spinal cord. The posterior cingulate cortex (PCC) spatiotemporally matches past thermal memories with current visual input; the anterior insula (aIns) integrates this information and enhances the synaptic transmission efficiency of the dorsal horn II laminae of the spinal cord through glutamatergic projection, making C fibers more easily activated. Based on the patient's life experience that "fire inevitably leads to burns," the C fibers are stimulated to generate pain.

[0188] For example, the latency of thermal perception was shortened to 180ms ± 20ms.

[0189] Preferably, for target areas dominated by both Aδ and C fibers, the main control unit 500 shuts down the physical stimulation source control unit 400. Upon the patient's interaction with the interactive control unit 130 to indicate readiness, the interactive control unit 130 sends a display command for the virtual stimulation source 200 to the display unit 110, and after a second delay (31 ms), sends a chemical stimulation source activation command to the main control unit 500. The main control unit 500 sends a chemical stimulation command to the chemical stimulation source control unit 300 to apply chemical stimulation. After a third delay (44 ms), the main control unit 500 sends a chemical stimulation command to the chemical stimulation source control unit 300 to apply chemical stimulation.

[0190] like Figure 5 As shown, in the virtual scene, a virtual ice puck, acting as a virtual stimulus 200, slowly descends towards the palm. During this process, when the countdown for the virtual ice puck to contact the palm reaches the total chemical stimulation delay time (1162ms), a chemical stimulus containing menthol is applied. At this time, the chemical stimulus is sprayed from a nozzle in a nano-mist and distributed over the palm area, stimulating the palm area with menthol and activating Aδ and C fibers. The nano-mist spraying of the chemical stimulus avoids the skin's tactile sensation, avoids the circular tactile nerve fibers, and also avoids the precise calculation of coordinates during the spraying process, reducing the data computation load of the second processor 121 and lowering the implementation accuracy. At the instant the virtual stimulus 200 is about to contact the target area dominated by Aδ and C fibers in the palm, the Aδ and C fibers are already activated and within the effective window. At this moment, the patient visually sees the cold virtual ice puck contacting the palm, and the brain responds based on the visual image, stimulating the nerve fibers in the palm to produce a cold sensation.

[0191] like Figure 6As shown, in a virtual scenario, a virtual ice cone, acting as a virtual stimulus 200, slowly descends towards the back of the hand. During this process, when the countdown for the virtual ice cone to contact the back of the hand reaches the total delay time for chemical stimulation, a chemical stimulus containing mustard oil is applied. At this time, the chemical stimulus is sprayed from a nozzle in a nano-mist and distributed over the area of ​​the back of the hand, stimulating the local area of ​​the target area on the back of the hand with mustard oil, thereby activating Aδ and C fibers. The nano-mist spraying of the chemical stimulus avoids the skin's tactile sensation, avoids the circular tactile nerve fibers, and also avoids the precise calculation of coordinates during the spraying process, reducing the data computation load of the second processor 121 and lowering the implementation accuracy. At the instant the virtual ice cone is about to contact the target area on the back of the hand dominated by both Aδ and C fibers, the Aδ and C fibers are already activated and within the effective window. At this moment, the patient visually sees the cold virtual ice cone piercing the back of the hand, and the brain generates a memory feedback corresponding to the puncture based on the visual image, stimulating the nerve fibers in the punctured area on the back of the hand to produce a painful needle-like sensation.

[0192] Example 2

[0193] This embodiment is a further improvement on embodiment 1, and repeated content will not be described again.

[0194] Preferably, the interactive control unit 130 includes a third processor 132 and a user interface 131. The third processor 132 is, for example, an integrated quad-core ARM Cortex-A53 processor with a programmable logic unit (PL). The third processor 132 also includes a storage module and a security chip. The storage module is, for example, a 64GB eMMC 5.1 flash memory, serving as a database for storing patient treatment plans. The user interface 131 is, for example, a capacitive touchscreen. The capacitive touchscreen also includes a capacitive multi-touch layer as an input device, a fingerprint sensor as a biometric unit, and a light sensor as an environmental sensing module.

[0195] The user interface 131 is connected to the third processor 132 via a data bus. The integrated quad-core ARM Cortex-A53 processor and the programmable logic unit (PL) are connected via an AXI-4 on-chip bus for collaborative data processing. The storage module (64GB eMMC 5.1 flash memory) of the third processor 132 is connected to the ARM Cortex-A53 processor via an eMMC interface. The security chip is connected to the ARM Cortex-A53 processor via an internal integrated circuit. The capacitive multi-touch layer in the user interface 131 is connected to the capacitive touchscreen via a touch sensing interface. The fingerprint sensor in the user interface 131 is connected to the capacitive touchscreen via a biometric data interface. The light sensor in the user interface 131 is connected to the capacitive touchscreen via an ambient light sensing interface.

[0196] Preferably, the ARM Cortex-A53 processor accesses the patient treatment protocol database in the storage module (64GB eMMC 5.1 flash memory) via the eMMC interface to retrieve pre-stored pain stimulation protocol templates or historical data.

[0197] The programmable logic unit (PL) works in conjunction with the ARM processor via the AXI-4 on-chip bus to execute customized algorithms (such as machine learning models or rule engines) and dynamically generate personalized solutions based on the following inputs: patient identity, current symptoms or treatment parameters entered by the doctor via a touchscreen, and past treatment records or medical guidelines stored in the database.

[0198] Preferably, medical staff input a virtual stimulation plan via a capacitive touchscreen. The capacitive touchscreen sends the virtual stimulation plan to the ARM Cortex-A53 processor, which generates a preliminary virtual stimulation plan. The generated pain stimulation plan is returned to the capacitive touchscreen via a data bus, presented to the medical staff in a visual format (such as charts and text descriptions) for confirmation or adjustment. The multi-touch layer of the capacitive touchscreen allows doctors to further modify parameters (such as pain intensity thresholds and treatment duration), forming a closed loop of human-computer interaction.

[0199] The completed pain stimulation plan is transmitted by the ARM processor to the data processing unit 120 through an external interface (such as USB, Ethernet or dedicated communication protocol) to trigger the execution of subsequent treatment devices (such as parameter configuration of the pain stimulator).

[0200] Preferably, the data processing unit 120 includes a high-performance computing server, a network communication module, a time synchronization and trigger control module, and a virtual reality rendering and interaction expansion card. The data processing unit 120 can be implemented as a computer host, cloud server, service platform, etc. The high-performance computing server serves as the computing center of the data processing unit 120, running the virtual reality rendering engine, stimulus parameter generation algorithm, and multi-source data synchronization logic. The network communication module, for example, is one of a network card, modem, repeater, or hub, used to achieve real-time data interaction with other hardware units (display unit 110, chemical or physical stimulus control unit). The time synchronization and trigger control module includes a high-precision clock synchronization module (such as the PTP IEEE 1588 protocol) and a real-time operating system (RTOS) or timer chip, used to ensure precise matching of the triggering timing of virtual stimuli and physical / chemical stimuli. The virtual reality rendering and interaction expansion card is used for virtual reality rendering and interaction expansion.

[0201] The high-performance computing server internally includes a multi-core CPU (such as Intel Xeon or AMD EPYC) as a secondary processor 121, a professional-grade GPU (such as NVIDIA RTX series or AMD Radeon Pro) and a large-capacity high-speed storage (such as NVMe SSD or distributed storage array) as memory 122.

[0202] Preferably, the interactive control unit 130 sends the pain stimulation scheme to the high-performance computing server. The high-performance computing server calls the algorithm to generate the virtual environment and stimulus source parameters, and transmits them to the rendering expansion card via PCIe for real-time rendering. The time synchronization module synchronizes the clock with all devices via the PTP protocol to ensure that the triggering sequence of the virtual and chemical / physical stimuli is consistent. The trigger control unit sends precise trigger signals to the chemical / physical stimulus source control unit via GPIO or network interface.

[0203] The virtual reality rendering and interaction expansion card transmits the virtual environment image to the display unit 110 (such as a head-mounted display) via a low-latency interface, allowing the patient to observe the virtual stimulus source 200 in real time. The network communication module sends the virtual stimulus source parameters (such as temperature and drug dosage) to the physical / chemical control unit, synchronously executing the actual stimulation.

[0204] Therefore, the high-performance computing server generates a virtual reality environment and a virtual stimulus source 200 visible to the patient within the virtual reality environment based on the received pain stimulation scheme. It then generates parameters for the virtual stimulus source 200 by stimulating it in conjunction with chemical and physical stimuli according to a set triggering sequence. The high-performance computing server sends the parameters, including the virtual reality environment and the virtual stimulus source 200, to the display unit 110. The high-performance computing server also sends data on the transmission method and timing of the chemical and physical stimuli that work in conjunction with the virtual stimulus source 200 to the communication module of the stimulation unit 600, causing the stimulation unit 600 to apply the chemical and / or physical stimuli to the stimulation location of the limb in a manner coordinated with the stimulation time of the virtual stimulus source 200.

[0205] Preferably, after receiving parameters of the virtual reality environment and virtual stimulus 200 sent from the high-performance computing server of the data processing unit 120, the display unit 110 displays the virtual reality environment and virtual stimulus 200 to the patient currently awaiting treatment. Preferably, the display unit 110 is, for example, a medical-grade VR head-mounted display device. The VR head-mounted display device displays the virtual reality environment and virtual stimulus 200 to the patient currently awaiting treatment. When the virtual stimulus 200, chemical stimulus, and physical stimulus stimulate the patient's vision and nerves in a set sequence, the patient's thermal or cold sensations in the virtual reality environment are induced.

[0206] Preferably, the VR head-mounted display device provides stereoscopic vision of the virtual environment through a binocular high-resolution screen (e.g., 4K / 8K) and a wide viewing angle (above 110°). The VR head-mounted display device has embodied interaction capabilities, with a built-in IMU (Inertial Measurement Unit) capturing the patient's head movements in real time and dynamically adjusting the virtual scene's viewing angle; it uses an external camera or built-in sensor (e.g., Leap Motion) as a motion capture camera to capture the patient's limb movements and limb position coordinates, enabling interaction with the virtual stimulus source 200. The VR head-mounted display device can integrate a force feedback device (e.g., Teslasuit) to provide neural sensory (thermal or cold) feedback when virtual stimuli occur. The VR head-mounted display device's internal dedicated VR SoC (System-on-a-Chip) acts as the first processor 131, implementing lightweight rendering tasks (e.g., local scene updates or sensor data fusion) and display control. The VR head-mounted display's dedicated SoC (System-on-a-Chip) transmits image data to the display via a MIPI-DSI interface or LVDS bus. The VR head-mounted display's dedicated SoC (System-on-a-Chip) and the sensor module IMU communicate via an I / O interface. 2 Connect via C or SPI interface to acquire head motion data.

[0207] Preferably, the feedback unit 140 can be designed as a handle. After receiving data from the high-performance computing server of the data processing unit 120 regarding the transmission method and timing of the chemical and physical stimuli that cooperate with the virtual stimulus 200, the feedback unit 140 applies the chemical and physical stimuli to the location to be stimulated on the patient's limb.

[0208] Example 3

[0209] The present invention uses the device described in the above embodiments to conduct treatment tests on patients, and the effects are as follows. The device used in this test displays the virtual reality environment and virtual stimulus source described in the present invention.

[0210] Test method: The patient's pain has lasted for 3 months or more, and the average pain intensity in the past month is 4 or higher (VAS).

[0211] (1) MR group (pain relief and rehabilitation training software, pain treatment scenarios in MR);

[0212] (2) Sham MR group (2D treatment scene provided in MR mixed reality device)

[0213] In the basic clinical treatment, both groups of patients underwent pain intervention treatment three times over three days, once a day, with four pain treatment scenarios each time, each lasting approximately 15 minutes. Data collection personnel for the basic treatment were not involved in the experiment, and neither the testers nor the participants knew about the experimental group assignments before the trial. Figure 17This is a schematic diagram of the subject's information, showing the basic information, current medical history, and diagnostic information of the patients undergoing the test. For example... Figure 17 As shown, the patient's current medical history includes lumbar disc herniation, neck and shoulder pain, herpes zoster neuralgia, cluster headache syndrome, headache, cervicogenic pain, low back pain with sciatica, discogenic low back pain, cervical disc herniation, thoracic back pain, postherpetic neuralgia, sciatica and other pain symptoms.

[0214] Blinding Setup: This study employed a single-blind randomization method. Eligible participants were randomly assigned to individual treatment groups by a single researcher without blinding. The assignments were evaluated and aggregated, and neither the participants nor the attending physicians knew the assignments before the trial. Statisticians then performed a blinded analysis of the randomly labeled experimental and control datasets.

[0215] Sample size calculation: Preliminary experimental results indicated that a difference of more than 30% in VAS pain score improvement was considered the criterion for the MR group (experimental group) compared to the control group, and the percentage of effective events within each group was the efficacy rate. Preliminary experimental results suggested an efficacy rate of 80% in the MR group and 50% in the control group (Sham MR group). With a two-sided significance level of α = 0.05, β = 0.15, and a dropout rate of 15%, a total of 132 subjects were required to compare preoperative and postoperative data. Each center had 22 subjects, all randomly assigned to different groups. All data below are test data from this invention.

[0216] The treatment plan for the experimental group consisted of a HoloLens 2 all-in-one head-mounted MR device. The MR treatment included five modules: pain education, breathing exercises, nostalgic experiences, focus training, and relaxation training. Pain education aimed to help patients understand pain effectively and alleviate it. Breathing exercises helped relieve physical pain and release tension through conscious breathing. Focus training distracted patients from the pain-causing stimuli, reducing neural activity associated with pain perception. Relaxation training promoted a state of physiological and psychological calm, allowing the body to better manage stress and reduce physiological and psychological factors that contribute to pain perception. These MR treatment methods were expected to rapidly reduce pain intensity and alleviate pain-related stress responses. Each subject received a MR treatment lasting approximately 15 minutes, including pain education, distraction (breathing exercises), nostalgic experiences, focus training, and relaxation training. Subjects could request to stop the MR treatment at any time if they experienced any discomfort.

[0217] The therapeutic effects of virtual reality scenarios are shown below.

[0218] Figure 7This is a scoring diagram comparing the average pain intensity of the experimental group and the control group. Figure 7 In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the VAS score. The black line represents the score change in the experimental group, and the gray line represents the score change in the control group.

[0219] like Figure 7 As shown, the overall trend indicates that the VAS scores of both groups gradually decreased over time. The experimental group's scores were generally lower than the control group's at each time point, suggesting that the experimental group's performance may be superior. Specifically, before and after D1, the experimental group's VAS score decreased from 6.36 to 5.63, a decrease of 0.73; the control group's VAS score decreased from 6.45 to 6.09, a decrease of 0.36. Before and after D2, the experimental group's VAS score decreased from 5.72 to 5.09, a decrease of 0.63; the control group's VAS score decreased from 5.81 to 5.36, a decrease of 0.45. Before and after D3, the experimental group's VAS score decreased from 5.09 to 4.45, a decrease of 0.64; the control group's VAS score decreased from 5.27 to 5.18, a decrease of 0.09. Clearly, after each of the first three treatments, the VAS score of the experimental group decreased more significantly than that of the control group, indicating that the use of virtual reality environment can significantly alleviate the patient's pain.

[0220] At time point D7, the VAS score in the experimental group decreased to 3.72, while the VAS score in the control group decreased to 3.9. At time point D14, the VAS score in the experimental group decreased to 3.09, while the VAS score in the control group decreased to 3.18. Compared to before D1, the overall VAS score in the experimental group decreased from 6.36 to 3.09, a decrease of 51.42%; the overall VAS score in the control group decreased from 6.45 to 3.18, a decrease of 50.7%. Clearly, during virtual reality therapy, the VAS score in the experimental group decreased significantly compared to the control group, indicating greater pain relief. After treatment, the VAS scores in the experimental and control groups became nearly identical. Therefore, Figure 7 This indicates that, over time, both the experimental and control groups experienced relief from pain or symptoms, with the experimental group showing a more significant improvement.

[0221] Figure 15 These are the specific data on the VAS scores of patients in the experimental group. For example... Figure 15As shown, the VAS score showed a significant decreasing trend on the first day after treatment in the experimental group. On the second day after treatment, the VAS score showed a significant decreasing trend. On the third day after treatment, the VAS score maintained a relatively significant decreasing trend. On the third day after treatment and before the first day of treatment in the experimental group, the VAS score showed a significant decreasing trend. On the seventh day after treatment and before the first day of treatment in the experimental group, the VAS score showed a significant decreasing trend. On the fourteenth day after treatment and before the first day of treatment in the experimental group, the VAS score showed a significant decreasing trend.

[0222] Figure 16 These are the specific data on the VAS scores of patients in the control group. There were significant differences between the control and experimental groups. Figure 16 As shown, on the first day after treatment in the control group, the VAS score showed no downward trend. On the second day after treatment in the control group, the VAS score showed no downward trend. On the third day after treatment in the control group, the VAS score showed no significant downward trend. Between the third day of treatment and the first day of treatment in the control group, the VAS score showed a slight downward trend, but remained lower than that in the experimental group. Between the fourteenth day of treatment in the control group and the first day of treatment, the VAS score showed a slight downward trend, but remained lower than that in the experimental group. (This is repeated twice in the original text.)

[0223] Table 4: Pain Interference with Activity, Sleep, Stress and Emotion Scale (DVPRS-II) for the experimental group.

[0224]

[0225] As shown in Table 4, DVPRS-II showed a gradual downward trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the experimental group, suggesting that the treatment had a significant effect in improving the negative effects of pain on function, sleep, stress, and mood.

[0226] Table 5: Pain Interference with Activity, Sleep, Stress and Mood Scale (DVPRS-II) in the control group.

[0227]

[0228] As shown in Table 5, the DVPRS-II in the control group showed a gradual decreasing trend before treatment and on days 1, 2, 3, 7, and 14 after treatment. This suggests that the treatment in the control group had some effect in improving the negative effects of pain on function, sleep, stress, and mood, but it was still worse than that in the treatment group.

[0229] Plot based on data from Tables 4 and 5 Figure 8 A diagram showing the pain scores for activity, sleep, stress, and mood disturbances in the experimental and control groups. Figure 8 In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the DVPRS-II score. The black line represents the change in DVPRS-II score in the experimental group. The gray line represents the change in DVPRS-II score in the control group. DVPRS-II is a pain assessment tool based on the Visual Analog Scale (VAS) principle, used to quantify patients' subjective pain experience. In the DVPRS-II scoring system, 0 represents "no pain," and the higher the pain level, the higher the score.

[0230] like Figure 8 As shown, the overall trend indicates that the DVPRS-II scores of both groups gradually decreased over time. The experimental group consistently scored lower than the control group at each time point, suggesting that the experimental group achieved better pain relief than the control group. By day 14, the score difference between the two groups remained significant, with the experimental group still showing a lower score. In the first three days (days 1-3), the score difference increased from 6.27 (16.36 - 10.09 = 6.27) to 8.36 (15.54 - 7.18 = 8.36). Figure 8 This indicates that, over time, both the experimental and control groups showed improvement in their condition or symptoms, with the experimental group showing more significant and progressively better improvement. The pain relief remained effective even after treatment was discontinued. On days 7 and 14, the DVPRS-II scores in the experimental group were still significantly lower than those in the control group, with differences of 5.45 (D7) and 4.45 (D14), respectively. This suggests that the retention of pain relief was also superior in the experimental group compared to the control group.

[0231] Table 6: Patients in the experimental group's overall impression of pain change scale (PGIC).

[0232]

[0233] As shown in Table 6, PGIC showed a gradual downward trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the experimental group.

[0234] Table 7: Changes in overall perception of pain among patients in the control group (PGIC).

[0235]

[0236] As shown in Table 7, PGIC showed a slight decreasing trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the control group.

[0237] Figure 9This is a diagram showing the scores of the Patient Overall Impression of Pain Scale (PGIC) for patients in the experimental and control groups. Figure 9 In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the PGIC score. The black line represents the change in PGIC score in the experimental group. The gray line represents the change in PGIC score in the control group. The PGIC scale is a patient-reported outcome (PRO) tool used to assess patients' overall feelings about their condition before and after treatment. It uses a simple rating scale, allowing patients to choose an option from "very serious deterioration" to "complete improvement," thus reflecting their subjective evaluation of the treatment effect.

[0238] like Figure 9 As shown, at time point D1, the PGIC score of the experimental group was 5, while that of the control group was 4.09. The PGIC score of the experimental group was higher than that of the control group. After the start of treatment, at time point D3, the PGIC score of the experimental group decreased to 3.36, a decrease of 32.8%. The PGIC score of the control group decreased to 3.45, a decrease of 15.65%. Figure 9 This indicates that the experimental group experienced better pain relief. During the period from Day 3 to Day 7, the PGIC score in the experimental group decreased to 1.72 on Day 7, a decrease of 48.81%. The PGIC score in the control group decreased to 2.81 on Day 7, a decrease of 18.55%. Throughout the period from Day 3 to Day 7, the pain relief effect in the experimental group was significantly better than that in the control group. During the period from Day 7 to Day 14, the PGIC score in the experimental group decreased to 1.18, a decrease of 31.4%. The PGIC score in the control group decreased to 2.27, a decrease of 19.22%. Both during the periods from Day 7 to Day 14 and from Day 3 to Day 7, the pain relief effect in the experimental group remained significantly better than that in the control group. Overall, the PGIC score in the experimental group decreased from 5 to 1.18, an overall decrease of 76.4%. The PGIC score in the control group decreased from 4.09 to 2.27, an overall decrease of 44.48%. From the overall treatment effect, the PGIC score reduction rate in the experimental group was much higher than that in the control group, indicating a significant pain relief effect.

[0239] Table 8: Physiological Function and Sleep Disorders Scale (PROMIS-A) for the experimental group.

[0240]

[0241] As shown in Table 8, PROMIS-A showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the experimental group, indicating that the treatment method had no significant side effects on overall physiological function and sleep disorders.

[0242] Table 9: Physiological Function and Sleep Disorders Scale (PROMIS-A) for the control group.

[0243]

[0244] As shown in Table 9, PROMIS-A showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the control group, indicating that the treatment method had no significant side effects on overall physiological function and sleep disorders.

[0245] Figure 10 This is a diagram showing the scores of the Physiological Function and Sleep Disorders Scale (PROMIS-A) for the experimental and control groups. Figure 10 In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the PROMIS-A score. The black line represents the change in PROMIS-A score in the experimental group. The gray line represents the change in PROMIS-A score in the control group. PROMIS-A, short for Patient-Reported Outcomes Measurement Information System, is a widely used tool in the medical field. It is a standardized computer-based tool used to measure patient-reported health-related quality of life, functional status, and symptoms.

[0246] like Figure 10 As shown, at time point D1, there was no difference in PROMIS-A scores between the experimental and control groups. After three treatments over three days, differences in PROMIS-A scores between the two groups began to appear. During the period from D3 to D14, the PROMIS-A scores in the experimental group were 23.63, 25.63, and 27, with a total increase rate of 14.26%. The PROMIS-A scores in the control group were 22.72, 23.18, and 24.45, with a total increase rate of 7.62%. Figure 10 This indicates that the experimental group had a higher rate of increase in PROMIS-A scores, and patients' health-related quality of life was significantly improved, with a more significant improvement effect than the control group.

[0247] Table 10: Physiological Function and Sleep Disorders Scale (PROMIS-B) for the experimental group.

[0248]

[0249] As shown in Table 10, PROMIS-B showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the experimental group, suggesting that the treatment had no special negative effects on the body.

[0250] Table 11: Physiological Function and Sleep Disorders Scale (PROMIS-B) for the control group.

[0251]

[0252] As shown in Table 11, PROMIS-B showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the control group, suggesting that the treatment had no special negative effects on the body.

[0253] Figure 11 This is a diagram showing the scores of the Physiological Function and Sleep Disorders Scale (PROMIS-B) for the experimental and control groups. Figure 11 In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the PROMIS-B score. The black line represents the change in PROMIS-B score in the experimental group. The gray line represents the change in PROMIS-B score in the control group. PROMIS-B is a specific version of the Patient-Reported Outcomes Measurement Information System and may be used to assess the quality of life or specific health conditions of burn patients.

[0254] like Figure 11 As shown, at time point D1, the PROMIS-B scores of the experimental group and the control group were similar. After three treatments over three days, significant differences in PROMIS-B scores began to appear between the two groups. The PROMIS-B score in the experimental group increased from 23.72 to 25, an increase of 5.4%. The PROMIS-B score in the control group increased from 23.81 to 24, an increase of 0.8%. Clearly, the patients in the experimental group experienced a significant improvement in their quality of life, with a better improvement effect than the control group.

[0255] During the period from day 3 to day 14, i.e., after treatment, the PROMIS-B scores in the experimental group were 25, 24.9, and 26, with an overall increase of 4%. The PROMIS-B scores in the control group were 24, 25, and 24.81, with an overall increase of 3.375%. The increase rates were similar for both groups. Overall, the PROMIS-B score in the experimental group increased from 23.72 to 26, an increase of 9.61%. The PROMIS-B score in the control group increased from 23.81 to 24.81, an increase of 4.2%. Figure 11 This indicates that the patients in the experimental group experienced a more significant improvement in their quality of life after treatment, with a better improvement effect than the control group.

[0256] Table 12: Pain Catastrophism Scale (PCS) for the experimental group.

[0257]

[0258] As shown in Table 12, PCS showed a significant decreasing trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the experimental group, suggesting that treatment can significantly improve the degree of catastrophic expectations in pain patients, with a significant difference compared with the control group.

[0259] Table 13: Pain Catastrophism Scale (PCS) in the control group.

[0260]

[0261] As shown in Table 13, PCS showed a slight decreasing trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the control group, suggesting that the control treatment had a certain degree of catastrophic expectation among patients with pain, but it was still significantly different from the MR treatment group.

[0262] Figure 12 This is a diagram showing the scores of the Pain Catastrophizing Scale (PCS) for the experimental and control groups. Figure 12 In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the PCS score. The black line represents the change in PCS score in the experimental group. The gray line represents the change in PCS score in the control group. Pain catastrophizing refers to an individual's excessive worry, helplessness, and repetitive thinking about pain when faced with it. The PCS is mainly used to measure an individual's functional status and quality of life in terms of physical health, including: physical function (such as daily activity ability, physical activity), physiological role limitations (limitations in work or life due to health problems), pain intensity (such as the impact of chronic pain on the body), and overall health status (such as vitality, fatigue, etc.). A higher PCS score indicates a stronger catastrophic thinking about pain, that is, a greater negative emotion towards pain, a greater tendency to view pain as a threat, and a possible decline in coping ability and increased emotional distress.

[0263] like Figure 12As shown, during the first three days of treatment, the PCS scores in the experimental group were 5.63, 5.09, and 4.72, gradually decreasing, indicating a gradual reduction in pain. The PCS scores in the control group were 3.54, 3.27, and 2.54, also gradually decreasing. The overall PCS score in the experimental group was higher than that in the control group, indicating that patients experienced less functional impairment and better physical condition in the MR environment. After the three-day treatment, during the periods of D7 and D14, the PCS score in the experimental group decreased from 4.72 to 2.18, and then to 0.72, with a reduction rate of 84.75%. The PCS score in the control group decreased from 2.54 to 2, and then to 1.81, with a reduction rate of 28.74%. The experimental group showed a greater decrease in PCS score. Overall, the PCS score in the experimental group decreased from 5.63 to 0.72, with a total decrease rate of 87.21%; while the PCS score in the control group decreased from 3.54 to 1.81, with a total decrease rate of 48.87%. This indicates that patients receiving treatment in an MR setting experienced significant pain relief, with the pain relief effect being superior to that in the control group.

[0264] Table 14: Pain Self-Efficacy Questionnaire (PSEQ) for the experimental group.

[0265]

[0266] As shown in Table 14, PSEQ showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the experimental group, suggesting that the treatment had no specific negative effect on pain self-efficacy.

[0267] Table 15: Pain Self-Efficacy Questionnaire (PSEQ) of the control group.

[0268]

[0269] As shown in Table 15, PSEQ showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the control group, suggesting that the treatment had no specific negative effect on pain self-efficacy.

[0270] Figure 13 This is a diagram showing the scores of the Pain Self-Efficacy Questionnaire (PSEQ) for the experimental and control groups. Figure 13In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the PSEQ score. The black line represents the change in PSEQ score in the experimental group, and the gray line represents the change in PSEQ score in the control group. A higher PSEQ score indicates stronger pain self-efficacy, higher confidence in the patient's ability to control pain and complete daily tasks, better psychological adaptability, lower fear of pain, a greater tendency to adopt positive coping strategies, and better prognosis. High self-efficacy is significantly associated with functional recovery in patients with chronic pain, may shorten the rehabilitation period, and makes it easier to achieve therapeutic effects with interventions.

[0271] like Figure 13 As shown, from D1 to D14, the PSEQ scores of the experimental group were significantly higher than those of the control group, indicating that patients in the experimental group had stronger pain self-efficacy during and after MR treatment. The PSEQ score of the experimental group increased from 35.9 to 46.09, an increase of 28.38%. The PSEQ score of the control group increased from 30.9 to 37.18, an increase of 20.32%. The comparison shows that the experimental group significantly improved patients' pain self-efficacy and gave patients greater confidence in their ability to control pain and complete daily tasks.

[0272] Table 16: Chronic Pain Acceptance Questionnaire (CAPQ-8) for the experimental group.

[0273]

[0274] As shown in Table 16, the CAPQ-8 showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the experimental group, suggesting that the treatment had no particular negative impact on the patients' pain tolerance.

[0275] Table 17: Chronic pain acceptance questionnaire (CAPQ-8) in the control group.

[0276]

[0277] As shown in Table 17, the CAPQ-8 showed a relatively stable trend before treatment and on the first, second, third, seventh, and fourteenth days after treatment in the control group, suggesting that the treatment had no particular negative impact on the patients' pain tolerance.

[0278] Figure 14 This is a diagram showing the scores of the Chronic Pain Acceptance Questionnaire-8 (CAPQ-8) for the experimental and control groups. Figure 14In the graph, the horizontal axis represents the scoring time, with Dx indicating day x; the vertical axis represents the CAPQ-8 score. The black line represents the change in CAPQ-8 score in the experimental group. The gray line represents the change in CAPQ-8 score in the control group. A higher CAPQ-8 score indicates increased acceptance of chronic pain. This means that patients may be more inclined to adopt an active lifestyle despite the continued presence of pain; they may be more accepting of pain as a part of life and try to manage and adapt to it constructively, rather than simply trying to eliminate it.

[0279] like Figure 14 As shown, during the D1-D3 time period, the CAPQ-8 score in the experimental group increased from 21.54 to 32.9, indicating an upward trend and suggesting increased patient acceptance of chronic pain. The CAPQ-8 score in the control group increased from 22.54 to 23.54, with a less pronounced upward trend, indicating no change in patient acceptance of chronic pain. After treatment, the CAPQ-8 score in the experimental group increased from 32.9 to 35.54, and further to 37.09, with an overall increase rate of 12.74%, indicating a more positive attitude towards chronic pain after treatment. The CAPQ-8 score in the control group increased from 23.54 to 24.18, and further to 25.72, with an overall increase rate of 9.26%, indicating a positive tendency towards chronic pain after treatment, but not as pronounced as in the experimental group. Therefore, the CAPQ-8 score in the experimental group was consistently higher than that in the control group, indicating that the experimental group significantly relieved patients' pain and significantly increased their acceptance of chronic pain.

[0280] The above tests demonstrate that clinical research on the effects of MR-based cognitive-distraction-focus-relaxation therapy on chronic pain treatment effectively reduces pain intensity. The treatment results have clear clinical significance, and user engagement and satisfaction with therapeutic MR are both high. MR therapy provides an effective non-pharmacological treatment for chronic pain.

[0281] It should be noted that the specific embodiments described above are exemplary. Those skilled in the art can devise various solutions inspired by the disclosure of this invention, and these solutions all fall within the scope of this invention and its protection. Those skilled in the art should understand that this specification and its accompanying drawings are illustrative and not intended to limit the scope of the claims. The scope of protection of this invention is defined by the claims and their equivalents. This specification contains multiple inventive concepts; phrases such as "preferredly" or "according to a preferred embodiment" indicate that the corresponding paragraph discloses an independent concept. The applicant reserves the right to file divisional applications based on each inventive concept.

Claims

1. A virtual or augmented reality pain treatment device based on visual synthesis, comprising: The interactive control unit (130) generates a pain stimulation plan that matches the current patient to be treated and sends the pain stimulation plan to the data processing unit (120). The data processing unit (120) generates a virtual reality environment and a virtual stimulus source (200) visible to the patient in the virtual reality environment based on the received pain stimulation scheme, and sends parameters including the virtual reality environment and the virtual stimulus source (200) to the display unit (110). The display unit (110) displays the virtual reality environment and virtual stimulus sources (200) to the patient currently being treated; Its features are, The data processing unit (120) determines the parameters of the stimulation target point of the limb and the virtual stimulus source (200) based on the pain category to be induced. In response to the reception of parameters of the stimulation target and the virtual stimulation source (200), the virtual stimulation source (200) is driven to perform visual approach motion toward the stimulation target of the patient in the display unit (110) to achieve non-real stimulation. The patient's somatosensory system is activated through the visual-neural coupling mechanism, thereby inducing the patient to generate touch, heat and / or cold sensations in and around the stimulation target, thereby achieving neuromodulation therapy of the pain pathway. The data processing unit (120) determines the color parameters of the virtual stimulus source (200) based on the pain category to be induced; the interactive control unit (130) adjusts the color parameters of the virtual stimulus source (200) in the pain stimulation scheme based on the patient's neural perception feedback of pain during the treatment process, so as to change the patient's pain perception in the virtual reality environment and enhance the patient's neural perception in the virtual reality environment.

2. The apparatus according to claim 1, characterized in that, The data processing unit (120) generates parameters of the virtual stimulus source (200) by stimulating the virtual stimulus source (200) with the chemical stimulus source control unit (300) and the physical stimulus source control unit (400) according to a set triggering sequence; When the virtual stimulus source (200), the chemical stimulus source control unit (300) and the physical stimulus source control unit (400) stimulate the patient's vision and nerves in a set sequence, the patient's thermal or cold sensation is induced in the virtual reality environment.

3. The apparatus according to claim 1 or 2, characterized in that, The data processing unit (120) determines the type and timing of the chemical stimulus control unit (300) and / or physical stimulus control unit (400) that can be coordinated with the virtual stimulus source (200) based on the pain category to be induced.

4. The apparatus according to claim 3, characterized in that, The data processing unit (120) dynamically adjusts the triggering sequence of the virtual stimulus source (200) and the chemical stimulus source control unit (300) / physical stimulus source control unit (400) based on the patient's skin type at the stimulation target. The nerve fiber type is determined based on the skin type of the stimulation target, and the nerve fiber type includes Aδ fiber dominant type and C fiber dominant type; For the Aδ fiber dominant type, the data processing unit (120) determines the triggering sequence of the virtual stimulus source (200) and the physical stimulus source control unit (400) for synchronous stimulation; For the C-fiber dominant type, the data processing unit (120) determines the triggering sequence of the virtual stimulus source (200) and the chemical stimulus source control unit (300) according to a set time interval, wherein the chemical stimulus source control unit (300) delays the triggering.

5. The apparatus according to claim 3, characterized in that, The interactive control unit (130) receives the temperature of the target area where the stimulation target point is located from the temperature acquisition module connected to it. When the stimulation effect of the physical stimulation source control unit (400) in the target area dominated by C fibers reaches the first high temperature triggering temperature, the interactive control unit (130) sends a display instruction of the virtual stimulation source (200) to the display unit (110), and sends a chemical stimulation instruction to the chemical stimulation source control unit (300) to apply chemical stimulation after a first delay. When the stimulation effect of the physical stimulus source control unit (400) in the target area dominated by Aδ fiber reaches the second high temperature triggering temperature, the interactive control unit (130) sends a display instruction for the virtual stimulus source (200) to the display unit (110).

6. The apparatus according to claim 3, characterized in that, The interactive control unit (130) receives the temperature of the target area where the stimulation target point is located from the temperature acquisition module connected to it. When the stimulation effect of the physical stimulus source control unit (400) in the target area dominated by Aδ and C fibers reaches the first low temperature trigger temperature, the interactive control unit (130) sends a display instruction of the virtual stimulus source (200) to the display unit (110), and sends a chemical stimulation instruction to the chemical stimulus source control unit (300) to apply chemical stimulation after a second delay. When the stimulation effect of the physical stimulus source control unit (400) in the target area dominated by Aδ and C fibers reaches the second low temperature trigger temperature, the interactive control unit (130) sends a display instruction for the virtual stimulus source (200) to the display unit (110), and sends a chemical stimulation instruction to the chemical stimulus source control unit (300) to apply chemical stimulation after a third delay.

7. The apparatus according to claim 3, characterized in that, When the pain category to be induced is thermal sensation, the data processing unit (120) determines that the chemical stimulus source control unit (300) is a thermal-specific stimulant; When the pain category to be induced is cold, the data processing unit (120) determines that the chemical stimulus control unit (300) is a cold-specific stimulant.

8. A virtual or augmented reality pain treatment device based on visual synthesis, characterized in that, include: The terminal generates a pain stimulation plan that matches the patient currently awaiting treatment and sends the plan to the server. The server generates a virtual reality environment and a virtual stimulus source (200) visible to the patient within the virtual reality environment based on the received pain stimulus scheme, and sends parameters including the virtual reality environment and the virtual stimulus source (200) to the virtual reality device. Virtual reality equipment displays a virtual reality environment and virtual stimuli (200) to the patient currently being treated; Its features are, The server determines the parameters of the stimulation target point of the limb and the virtual stimulus source (200) based on the pain category to be induced. In response to the reception of parameters of the stimulation target and the virtual stimulus source (200), the virtual stimulus source (200) is driven by the virtual reality device to perform visual approach motion toward the stimulation target of the patient to achieve non-real stimulation. The patient's somatosensory system is activated through the visual-neural coupling mechanism, thereby inducing the patient to generate touch, heat and / or cold sensations in and around the stimulation target, thereby achieving neuromodulation therapy of the pain pathway. The server determines the color parameters of the virtual stimulus source (200) based on the pain category to be induced; The terminal adjusts the color parameters of the virtual stimulus source (200) in the pain stimulation scheme based on the patient's neural perception feedback of pain during the treatment process, so as to change the patient's pain perception in the virtual reality environment and enhance the patient's neural perception in the virtual reality environment.

9. The device according to claim 8, characterized in that, The server generates parameters for the virtual stimulus source (200) by stimulating the virtual stimulus source (200) in accordance with a set triggering sequence, together with the chemical stimulus source control unit (300) and the physical stimulus source control unit (400). When the virtual stimulus source (200), the chemical stimulus source control unit (300) and the physical stimulus source control unit (400) stimulate the patient's vision and nerves in a set sequence, the patient's thermal or cold sensation is induced in the virtual reality environment.

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