Pain assessment system and method based on dynamic monitoring

Abstract

The invention discloses a pain assessment system and method based on dynamic monitoring, and relates to the technical field of medical data monitoring and assessment. The system comprises a test scheme generation unit used for generating a test scheme comprising multiple rounds of stimulation tasks for a subject, implementing the multiple rounds of stimulation tasks in a test time period, each round of stimulation task corresponding to a time interval of the subject and at least comprising one stimulation test, each stimulation test comprises a process of applying multiple stimuli between step-by-step increase of stimulation intensity and step-by-step decrease of stimulation intensity; the stimulation applying and monitoring unit is used for applying stimulation to the subject in a corresponding time interval according to multiple rounds of stimulation tasks and acquiring pain stress information of the subject aiming at the stimulation tasks; and the pain quantification unit is used for calculating a pain threshold according to the pain stress information and performing conversion to obtain a standard pain threshold score. The pain state of the patient can be dynamically evaluated, and guidance or reference is provided for treatment of the patient.

Description

Technical Field

[0001] This invention relates to the field of medical data monitoring and evaluation technology, and in particular to a pain assessment system and method based on dynamic monitoring. Background Technology

[0002] Pain is a common, unpleasant sensory and emotional experience in clinical practice. It is a complex, multidimensional human sensory experience and is often associated with disease. Medically, pain is a warning sign and has been identified by the World Health Organization as one of the five vital signs, alongside blood pressure, pulse, body temperature, and respiration. Parameters for pain assessment mainly include pain intensity, pain threshold, pain sensitivity, duration of pain, bodily response to pain, and pain relief status.

[0003] Traditional pain assessment relies heavily on subjective descriptions, primarily employing two methods: patient self-assessment and observer assessment. Patient self-assessment is convenient and subjective; in clinical research, it typically involves healthcare professionals verbally inquiring with patients. Currently, a 0-10 scale is commonly used to describe pain, with 0 (or level 0) representing no pain and 10 (or level 10) representing the most severe pain. Self-assessment is a valuable reference and is the most widely used method. However, for certain populations (such as unconscious patients, aphasic patients, patients in intensive care, dementia patients, newborns, and patients with mental impairment), accurate descriptions of pain location and intensity are often impossible. In these cases, observers (such as the patient's representative, caregiver, or medical professional) assess the pain level. This method relies on continuous observation and interpretation, resulting in lower efficiency and susceptibility to observer subjectivity, making accurate and reliable assessments difficult to guarantee and complicating treatment.

[0004] On the other hand, although pain is inherently subjective, objective assessment is generally desired for treatment purposes. Accurate, objective, and effective pain assessment is a prerequisite for pain intervention and treatment in clinical practice, and is particularly important for disease observation and treatment. Therefore, considering the shortcomings of traditional pain assessment methods, with the development of automatic pain identification and assessment technologies based on emotion recognition and deep learning, existing technologies have also proposed technical solutions based on patients' physiological indicators—such as electroencephalogram (EEG), electromyography (EMG), blood pressure (BP), respiratory rate (RR), and heart rate (HR)—to automatically identify pain and assess its level. For example, Chinese patent application CN202111297927.2 discloses a pain level assessment system, including: a pain acquisition module for acquiring pain characteristic information of a target user—such as heart rate, pulse rate, pulse signal, and blood pressure data—based on a preset pain acquisition device, and then extracting features from the pain characteristic information through a preset artificial neural network system to determine pain characteristic data; a pain level classification module for analyzing the pain characteristic data based on a preset hierarchical analysis mechanism to determine the pain level; a pain level assessment mechanism module for acquiring pain levels through a preset big data center and constructing a pain level assessment mechanism; and an assessment optimization module for optimizing the pain level assessment mechanism based on a preset optimization mechanism, using the assessment results, and verifying the results. The above solution mainly determines the pain level based on the patient's pain characteristic information, and uses a pain level assessment mechanism to quickly assess and determine the patient's pain value, reducing the workload of doctors and improving hospital efficiency. For example, Chinese patent application CN202310528850.8 discloses a pain monitoring and assessment system, including an input module, a data acquisition module, a transmission module, an assessment module, and an early warning module. The input module is used to input the patient's basic information; the data acquisition module is used to collect the patient's pain information, including physical signs and subjective perception information, such as heart rate, blood pressure, temperature, electromyography amplitude, and respiratory rate; the transmission module is used to complete the information transmission between the data acquisition module and the assessment module; the assessment module is used to assess the patient's pain level online based on the basic and pain information; and the early warning module is used to issue warnings to medical staff when the patient's pain level is high. This solution comprehensively considers the patient's physiological signs and subjective feelings when assessing pain levels, monitoring and assessing pain by acquiring these factors.

[0005] However, the existing technologies mentioned above have the following drawbacks: the determination of pain level in the pain assessment system is based on a semi-quantitative pain assessment method, which is usually a single measurement and cannot dynamically and continuously assess the patient's pain information, making it difficult to dynamically assess the patient's status; at the same time, it cannot monitor the change of pain intensity over time; on the other hand, the evaluation indicators and numerical units of the pain assessment system are diverse, and there is a lack of comparison with existing standard pain numerical scoring systems. Medical staff often need to manually convert and compare during processing, which affects the efficiency of pain assessment and treatment. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of existing technologies and provide a pain assessment system and method based on dynamic monitoring. The pain assessment system proposed in this invention can generate a test plan for the subject, including multiple rounds of stimulation tasks. These tasks are implemented according to a preset time pattern within a set test period. Each round of stimulation tasks includes at least one stimulation test, and each test involves applying stimulation multiple times, alternating between progressively increasing and decreasing stimulation intensity. Simultaneously, a pain quantification unit is included to calculate the pain threshold based on pain stress information. The pain threshold value is then converted to a corresponding standard pain threshold score based on a standard numerical pain scoring system, facilitating comparison of the measured pain threshold value with existing standard numerical pain scoring systems by medical personnel. This invention can dynamically and continuously monitor and assess the patient's pain information and intuitively quantify the measured pain threshold value, improving the systematic nature, accuracy, and reliability of pain assessment. Furthermore, it can monitor the change of the pain threshold value over time as needed, providing guidance or reference for patient treatment.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] A pain assessment system based on dynamic monitoring, the system comprising:

[0009] The test plan generation unit is used to generate a test plan for the subject that includes multiple rounds of stimulation tasks. The test plan configures the test time period of the stimulation tasks. Within the test time period, the aforementioned multiple rounds of stimulation tasks are implemented according to a preset time pattern. Each round of stimulation tasks corresponds to its own time interval. Each round of stimulation tasks includes at least one stimulation test. Each stimulation test includes a process of applying stimulation multiple times between progressively increasing and progressively decreasing stimulation intensity.

[0010] The stimulus application and monitoring unit is used to apply stimulation to the test site of the subject in the corresponding time interval according to the multi-round stimulus task in the aforementioned test plan, and to obtain the pain stress information of the subject in response to the aforementioned stimulus task; after the stimulus test of one round of stimulus task is completed, the stimulus application and monitoring unit enters a waiting state until the stimulus test time of the next round of stimulus task arrives.

[0011] The pain quantification unit is used to calculate the pain threshold value based on the subject's pain stress information, and convert the pain threshold value based on a preset standard pain numerical scoring system to obtain the corresponding standard pain threshold score.

[0012] Furthermore, it also includes an information input unit, used to input the subject's basic information and / or the stimulus test configuration information selected by the user for the subject, and send the acquired information to the test plan generation unit;

[0013] After receiving the aforementioned basic information of the subject and / or stimulus test configuration information, the test plan generation unit generates a test plan that matches the aforementioned subject and includes multiple rounds of stimulus tasks based on the basic information of the subject and / or stimulus test configuration information.

[0014] In the test scheme, multiple rounds of stimulation tasks are set for the daytime and nighttime periods of the test time period. The stimulation energy value corresponding to the subject's awakening due to pain is obtained through one round of stimulation task in the nighttime period. The stimulation energy value corresponding to the subject's awakening due to pain is used for the aforementioned conversion.

[0015] Furthermore, the test plan generation unit configures the stimulus mode corresponding to the stimulus task when generating the test plan. The stimulus mode includes a single stimulus mode and a multi-stimulus mode. In the single stimulus mode, the same stimulus type is used for stimulus testing throughout the entire test time period. In the multi-stimulus mode, multiple stimulus types are used for stimulus testing, and the multiple stimulus types are alternated in one round of stimulus task.

[0016] The stimulation types include mechanical stimulation, temperature stimulation, and electrical stimulation; in the single stimulation mode, one of mechanical stimulation, temperature stimulation, and electrical stimulation is used; in the multi-stimulation mode, two or three of the mechanical stimulation, temperature stimulation, and electrical stimulation types are used.

[0017] Furthermore, the stimulus application and monitoring unit includes at least an excitation end and a monitoring end;

[0018] The excitation end can be worn on the subject's test site and facing the test site. When the stimulation test time of a stimulation task arrives, the excitation end applies stimulation according to the stimulation pattern corresponding to the stimulation task.

[0019] The monitoring terminal corresponds to the subject's body setting and is used to detect whether the subject exhibits a somatic avoidance reflex when stimulation is applied at the excitation terminal. When the subject exhibits a somatic avoidance reflex, pain stress is determined and pain stress information is recorded.

[0020] Furthermore, in single-stimulus mode, the test protocol generation unit is configured to: for each round of stimulus task within the test time period, set N stimulus energy values ​​T with sequentially increasing stimulus intensities based on the target stimulus type. n Configure the time step Δt for stimulus application and the energy difference Δd between adjacent stimuli in a stimulus task, where N represents the number of stimuli, N is a natural number greater than or equal to 1, n = 0, 1, 2, ..., N-1; T0 represents the base value of the stimulus corresponding to the target stimulus type, T... N-1 This represents the upper limit of the stimulus type corresponding to the target stimulus type. The total time length corresponding to N time steps Δt is less than the time length of the time interval of one round of stimulus task.

[0021] In each round of the stimulation task, the stimulation application and monitoring unit first applies stimulation to the test site using a baseline stimulation value T0. If no pain stress response is detected at the monitoring end, the stimulation intensity is gradually increased based on the aforementioned baseline stimulation value T0 and the energy difference Δd, and the corresponding stimulation energy value is applied to the test site according to the time step Δt until a pain stress response is detected in the subject, at which point the stimulation energy value T is recorded. j The first pain value S for this round of stimulation tasks i Where j is a natural number less than or equal to N-1, and i represents the i-th round of stimulus task, where i is a natural number greater than or equal to 1; then, the aforementioned stimulus energy value T is used. j The stimulation intensity is gradually decreased based on the energy difference Δd, and the corresponding stimulation energy value is applied to the test site according to the time step Δt until the subject no longer exhibits a pain stress response. The stimulation energy value T of the next higher level is recorded. k The second pain value P in this round of stimulation tasks i Where k is a natural number less than or equal to j; for the aforementioned first pain value S i With the second pain value P i The third pain value R is obtained after performing an arithmetic mean. i And based on this third pain value R i Update the aforementioned baseline stimulus value T0; within the time interval corresponding to this round of stimulus task, repeat the aforementioned stimulus application steps, that is, alternate between gradually increasing and gradually decreasing the stimulus intensity, until the third pain value R is recorded. i The quantity has reached the preset quantity;

[0022] The pain quantification unit calculates the average of the third pain values ​​of all rounds of stimulation tasks in the test period based on the multiple third pain values ​​recorded in each round of stimulation tasks, and uses the average value as the pain threshold Q of the subject in the test period.

[0023] Furthermore, in the multi-stimulation mode, M stimulus types are alternated within the time interval of each round of stimulus task, where M is a natural number greater than or equal to 2;

[0024] At this point, after setting the order of each of the M stimulus types, a time sub-interval for each stimulus type is configured within the time interval of each round of stimulus task; in one round of stimulus task, for each stimulus type, stimulation is applied to the subject's test site within its corresponding time sub-interval and the subject's pain stress information is obtained; after the stimulation test of one stimulus type is completed, the stimulation application and monitoring unit enters a waiting state until the time for the next stimulus type arrives, and so on, until the stimulation tests of all M stimulus types in one round of stimulus task are completed.

[0025] Furthermore, the test scheme generation unit is configured to: for each stimulus type m among the M stimulus types, m = 1, 2, ..., M, set Nm stimulus energy values ​​Tm with sequentially increasing stimulus intensities. n Configure the time step Δtm for applying the stimulus of this stimulus type in a round of stimulus task and the energy difference Δdm between adjacent stimuli, where Nm represents the number of stimuli corresponding to the m-th stimulus type, Nm is a natural number greater than or equal to 1, n = 0, 1, 2, ..., Nm-1, Tm0 represents the base value of the stimulus corresponding to the m-th stimulus type, Tm (Nm-1) This represents the upper limit value of the stimulus type corresponding to the m-th stimulus type;

[0026] In each round of the stimulation task, following the order of M stimulus types, when the time for the m-th stimulus type arrives, the following steps are performed: The stimulus application and monitoring unit first applies stimulation to the test site using the baseline stimulus value Tm0; if no pain stress response is detected at the monitoring end, the stimulus intensity is progressively increased based on the aforementioned baseline stimulus value Tm0 and the energy difference Δdm, and the corresponding stimulus energy value is applied to the test site according to the time step Δtm until a pain stress response is detected in the subject, and the stimulus energy value Tm at this time is recorded. j Sm represents the first pain value of the m-th stimulus type in this round of stimulation tasks. i Where j is a natural number less than or equal to Nm-1, and i represents the i-th round of stimulus task, where i is a natural number greater than or equal to 1; then, the aforementioned stimulus energy value Tm is used. jThe stimulation intensity is progressively decreased based on the energy difference Δdm, and the corresponding stimulation energy value is applied to the test site according to the time step Δtm until the subject no longer exhibits a pain stress response. The stimulation energy value Tm of the next higher level is then recorded. k The second pain level Pm in this round of stimulation tasks i Where k is a natural number less than or equal to j; for the aforementioned first pain value Sm i With the second pain value Pm i The third pain value Rm is obtained after performing an arithmetic mean. i And based on this third pain value Rm i Update the aforementioned baseline stimulus value Tm0; within the time sub-interval corresponding to the aforementioned m-th stimulus type, repeat the aforementioned stimulus application steps, that is, alternate between gradually increasing and gradually decreasing the stimulus intensity, until the recorded third pain value Rm is reached. i The quantity has reached the preset quantity;

[0027] For any stimulus type m, the pain quantification unit calculates multiple third pain values ​​Rm for that stimulus type m based on the previously recorded rounds of stimulus tasks. i Calculate the third pain value Rm for stimulus type m in all rounds of the stimulus task during the test period. i The average value is taken as the pain threshold Qm of the subject under that stimulus type; for M stimulus types, M pain thresholds Q1, Q2, ..., QM are obtained.

[0028] Furthermore, the standard pain numerical rating system defines standard scores for no pain, standard scores for stimuli that cause awakening, and standard scores for the most painful.

[0029] The stimulus application and monitoring unit is configured to record the stimulus energy value T when a subject is awakened by pain under a specific stimulus type. wake and the stimulation energy value T wake The stimulus is sent to the pain quantification unit, and each stimulus type corresponds to its own stimulus energy value T. wake ;

[0030] In single-stimulation mode, the pain quantification unit is configured to convert the pain threshold Q to obtain a standard pain threshold score Q in the following manner. 标 Q 标 =Q*(Standard score corresponding to stimulus-induced pain awakening / Stimulus energy value of stimulus-induced pain awakening);

[0031] In multi-stimulation mode, the pain quantification unit is configured to convert the pain threshold to obtain a standard pain threshold score Q in the following manner. 标 Q 标= [Q1*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)+Q2*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)+……+QM*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)] / M.

[0032] Furthermore, when calculating the pain threshold, the pain quantification unit filters the acquired pain stress information, and the filtering is performed in one or more of the following ways:

[0033] Method 1: After acquiring the subject's pain stress information, the pain quantification unit removes the highest and lowest values ​​based on the corresponding values ​​of the pain stress information, and then calculates the pain threshold using the remaining pain stress information.

[0034] Method 2: Configure the data confidence interval information under resting state and send the data confidence interval information under resting state to the pain quantification unit; after obtaining the pain stress information of the subject, the pain quantification unit first determines whether the value corresponding to the pain stress information is within the aforementioned data confidence interval. When the corresponding value exceeds the aforementioned data confidence interval, the pain stress information is determined to be invalid information and is not included in the calculation of the pain threshold.

[0035] Method 3: The stimulus application and monitoring unit further includes an interference identification module, which is configured to: collect sound information, light information and / or image information in the surrounding environment during stimulus testing; analyze the acquired sound information, light information and / or image information to determine whether there are test interference factors in the surrounding environment; and when test interference factors are determined to exist, record the time information of the occurrence of the test interference factors, and compare the time information with the time interval of each round of stimulus tasks to obtain the information of the stimulus tasks that have interference; and process the stimulus tasks that have interference so that the pain quantification unit does not include the pain stress information of the aforementioned stimulus tasks that have interference when calculating the pain threshold.

[0036] The processing includes: determining that the pain stress information collected under the interfering stimulus task is invalid; or deleting the pain stress information collected under the interfering stimulus task; or stopping the stimulus test for that round of stimulus task and marking that round of stimulus task as a test abnormal until the time for the next stimulus task arrives to restart a new round of stimulus.

[0037] This invention also provides a pain assessment method based on dynamic monitoring, comprising the following steps:

[0038] A test plan including multiple rounds of stimulation tasks is generated for the subjects. The test plan configures the test time period of the stimulation tasks. The aforementioned multiple rounds of stimulation tasks are implemented according to a preset time pattern within the test time period. Each round of stimulation tasks corresponds to its own time interval. Each round of stimulation tasks includes at least one stimulation test. Each stimulation test includes the process of applying stimulation multiple times between gradually increasing and gradually decreasing stimulation intensity.

[0039] According to the multi-round stimulation task in the aforementioned test plan, the stimulation application and monitoring unit applies stimulation to the test site of the subject in the corresponding time interval and obtains the subject's pain stress information in response to the aforementioned stimulation task; after the stimulation test of one round of stimulation task is completed, the stimulation application and monitoring unit enters a waiting state until the stimulation test time of the next round of stimulation task arrives.

[0040] Based on the subject's pain stress information, the pain threshold value is calculated, and the pain threshold value is converted based on a preset standard pain numerical rating system to obtain the corresponding standard pain threshold score.

[0041] Compared with existing technologies, this invention, employing the above technical solutions, has the following advantages and positive effects: The pain assessment system proposed in this invention can generate test plans for subjects that include multiple rounds of stimulation tasks. These tasks are implemented according to a preset time pattern within a set test period. Each round of stimulation tasks includes at least one stimulation test, and each test involves applying stimulation multiple times, alternating between progressively increasing and decreasing stimulation intensity. Simultaneously, a pain quantification unit is included to calculate the pain threshold based on pain stress information. The pain threshold value is then converted using a standard pain digital scoring system to obtain a corresponding standard pain threshold score, facilitating comparison between the measured pain threshold value and existing standard pain digital scoring systems by medical personnel. This invention can dynamically and continuously monitor and assess patients' pain information and intuitively quantify the measured pain threshold value, improving the systematic nature, accuracy, and reliability of pain assessment. Furthermore, it can monitor the changes in pain threshold value over time as needed, providing guidance or reference for patient treatment.

[0042] On the other hand, in the aforementioned testing scheme, stimulation tasks are set for both daytime and nighttime segments within the testing period. The stimulation energy value corresponding to the subject's awakening due to pain is obtained through one round of stimulation tasks during the nighttime segment. This stimulation energy value is used to convert the pain threshold value obtained by this system into the score value of a standard numerical pain rating system. Thus, by introducing nighttime pain testing and assessment, a correlation is established between the system's test data and the scoring information of currently commonly used standard numerical pain rating systems in clinical practice. This allows the pain threshold of this system to be converted into a specific value from an existing clinical pain rating system, facilitating judgment and treatment by medical personnel.

[0043] On the other hand, the testing protocol can also be configured with multiple stimulus modes to improve the applicability of the evaluation system. Specifically, these include single-stimulation modes and multi-stimulation modes. Users can choose a single-stimulation mode with one type of stimulus or a multi-stimulation mode with alternating stimulation of multiple types of stimulus, and different stimulus testing procedures are configured for different stimulus modes.

[0044] On the other hand, when configuring the test tasks, the stimulation tests are repeated within the time interval corresponding to the stimulation task, alternating between gradually increasing and gradually decreasing the stimulation intensity, to reach a preset number. During the stimulation tests, the subject's body movement information is monitored, and pain stress is determined based on the subject's somatic avoidance reflex. After obtaining multiple stimulation energy values ​​indicating pain stress, the average of these multiple values ​​is used to obtain the subject's pain threshold under external force stimulation, thus improving the accuracy and reliability of the pain threshold value obtained from the test. Preferably, when conducting repeated stimulation tests, the baseline stimulation value used at the beginning of each test is dynamically set. Attached Figure Description

[0045] Figure 1 This is a schematic diagram of information transmission in a pain assessment system based on dynamic monitoring provided in an embodiment of the present invention. Figure 1 .

[0046] Figure 2 This is a schematic diagram of information transmission in a pain assessment system based on dynamic monitoring provided in an embodiment of the present invention. Figure 2 .

[0047] Figure 3 The following is a time sequence diagram for implementing multiple rounds of stimulation tasks within a 24-hour testing period, as provided in an embodiment of the present invention.

[0048] Figure 4 A flowchart of a pain assessment method based on dynamic monitoring provided in an embodiment of the present invention. Detailed Implementation

[0049] The following detailed description of the dynamic monitoring-based pain assessment system and method disclosed in this invention, in conjunction with the accompanying drawings and specific embodiments, provides further insight. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be considered isolated; they can be combined to achieve better technical results. In the accompanying drawings of the following embodiments, the same reference numerals in each drawing represent the same features or components, which can be applied to different embodiments. Therefore, once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0050] It should be noted that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes and to aid those skilled in the art in understanding and reading the invention. They are not intended to limit the conditions under which the invention can be implemented. Any modifications to the structure, changes in proportions, or adjustments to size, provided they do not affect the effectiveness or purpose of the invention, should fall within the scope of the technical content disclosed in the invention. The scope of the preferred embodiments of the present invention includes other implementations, wherein functions may be performed not in the order stated or discussed, including substantially simultaneously or in reverse order, depending on the functions involved. This should be understood by those skilled in the art to which the embodiments of the present invention pertain.

[0051] Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and apparatus should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0052] In the description of the embodiments of this application, " / " means "or", and "and / or" is used to describe the relationship between related objects, indicating that there can be three relationships. For example, "A and / or B" means: A and B exist alone, B exists alone, and A and B exist simultaneously. In the description of the embodiments of this application, "multiple" refers to two or more, and "multi-level" refers to two or more levels.

[0053] Explanation of technical terms:

[0054] 1. Pain threshold: also known as the pain perception threshold, is used to assess whether a person experiences pain or not. It is the minimum stimulus intensity required to cause pain in a subject. During a stimulus test, the stimulus energy value at which the subject experiences pain (e.g., exhibiting a somatic avoidance reflex, corresponding to a physical pain stress response) is the subject's pain threshold.

[0055] 2. Pain tolerance threshold: Used to assess the maximum pain stimulus a human body can tolerate. The pain tolerance threshold requires a high stimulus intensity, typically already considered noxious. This invention avoids testing stimuli at the pain tolerance threshold intensity.

[0056] 3. Somatic avoidance reflex: also known as the nociceptive flexion reflex (NFR), is a physiological reflex. It is a natural stress response in which the limbs involuntarily withdraw when the body experiences a painful stimulus. For example, when a part of the body is stimulated by pain, the muscles in that part will automatically contract, causing the limb to flex in order to avoid or reduce the pain.

[0057] 4. The VAS (Visual Analogue Scale) scoring system is a linear scale ranging from 0 to 100 mm, where 0 represents no pain and 100 represents severe pain. Patients mark their perceived pain on the line, and the distance from the left end of the line to the vertical line drawn by the patient represents their subjective pain intensity. The VAS is simple, fast, accurate, and easy to use; a VAS pain score can usually be completed in just 1 minute.

[0058] 5. NRS (Number Rating Scale) scoring system. Developed from VAS, the NRS consists of 11 points from 0 to 10, with numbers ranging from low to high representing pain levels from no pain to severe pain. 0 points indicate no pain, and 10 points indicate severe pain. Patients choose different scores to quantify their pain intensity; higher scores indicate greater pain. It is currently a widely used pain assessment system.

[0059] Example

[0060] See Figure 1 As shown, the present invention provides a pain assessment system based on dynamic monitoring, which mainly includes a test scheme generation unit, a stimulus application and monitoring unit, and a pain quantification unit.

[0061] The test plan generation unit is used to generate a test plan for the subject that includes multiple rounds of stimulus tasks. The test plan configures the test time period of the stimulus tasks, and the aforementioned multiple rounds of stimulus tasks are implemented according to a preset time pattern within the test time period. Each round of stimulus task corresponds to its own time interval.

[0062] The testing period can be configured to 24 hours, 48 ​​hours, 72 hours, or longer as needed, and can be adaptively adjusted according to the subject's baseline condition. Furthermore, based on the subject's disease progression and treatment needs, a single testing protocol can be configured with multiple testing periods. These periods can be consecutive—that is, immediately proceeding to the next testing period after completing one period—or intermittent—that is, waiting a preset time, such as one week, after completing one period before starting the next.

[0063] A single testing period consists of at least two rounds of stimulation tasks. Each round includes at least one stimulation test. Each stimulation test involves applying stimulation multiple times, alternating between progressively increasing and progressively decreasing stimulation intensity. In other words, each stimulation test completes a process of progressively increasing and decreasing stimulation intensity, and measures two pain thresholds. Multiple pain threshold measurements can be obtained through multiple rounds of stimulation tasks.

[0064] When generating a test plan, the test plan generation unit can also configure the stimulus mode corresponding to the stimulus task. The stimulus mode can include a single stimulus mode and a multiple stimulus mode. In the single stimulus mode, the same stimulus type is used for the stimulus test throughout the entire test period. In the multiple stimulus mode, multiple stimulus types are used for the stimulus test, and these multiple stimulus types are alternated in one round of the stimulus task.

[0065] The stimulation application and monitoring unit is used to apply stimulation to the test site of the subject within the corresponding time interval according to the multi-round stimulation task in the aforementioned test plan, and to acquire the subject's pain stress information in response to the aforementioned stimulation task. After the stimulation test of one round of stimulation task is completed, the stimulation application and monitoring unit can enter a waiting state until the stimulation test time of the next round of stimulation task arrives, at which time the stimulation application and monitoring unit restarts the stimulation test.

[0066] In practice, the stimulus application and monitoring unit includes at least an excitation end and a monitoring end. Depending on the testing requirements, multiple excitation ends and multiple monitoring ends can be configured.

[0067] The excitation device can be worn on the subject's test site and facing the test site. When the stimulation test time of a stimulation task arrives, the excitation device applies stimulation according to the stimulation pattern corresponding to the stimulation task.

[0068] The monitoring terminal corresponds to the subject's body setting and is used to detect whether the subject exhibits a somatic avoidance reflex when stimulation is applied at the excitation terminal. When the subject exhibits a somatic avoidance reflex, pain stress is determined and pain stress information is recorded.

[0069] The pain quantification unit is used to calculate the pain threshold value based on the subject's pain stress information, and to convert the pain threshold value based on a preset standard pain numerical scoring system to obtain the corresponding standard pain threshold score.

[0070] In this embodiment, the testing scheme can set stimulation tasks for the daytime and nighttime segments of the testing time period respectively: during the daytime segment, multiple rounds of stimulation tasks are configured according to the equal time interval rule - that is, the time intervals corresponding to each round of stimulation tasks are of the same length; during the nighttime segment, multiple rounds of stimulation tasks can also be configured according to the equal time interval rule. The stimulation energy value corresponding to the subject being awakened by stimulation pain (due to stimulation causing the subject to change from a sleep state to an awake state) is obtained through one round of stimulation task in the nighttime segment. The stimulation energy value corresponding to the subject being awakened by stimulation pain is used for the aforementioned conversion.

[0071] The duration of the isochronous intervals during the daytime and nighttime can be the same or different. Preferably, multiple rounds of stimulus tasks are configured using a first isochronous interval pattern during the daytime and a second isochronous interval pattern during the nighttime. The duration of the first isochronous interval is longer than that of the second isochronous interval. This reduces the testing frequency during the nighttime, thereby reducing the impact of stimulus testing on the subjects' nighttime rest.

[0072] In this embodiment, the type of stimulation applied by the system can be any stimulus that can be used to test the human pain threshold. Preferably, the type of stimulation can include mechanical stimulation, temperature stimulation, and electrical stimulation.

[0073] The mechanical stimulation refers to stimulation through the application of mechanical force, typically measured using a pressure analgesic device. The pain threshold is measured by changing the magnitude of the mechanical pressure. As an example, and not a limitation, of a typical method, a pressure analgesic device usually consists of a main body with an LCD display, a probe, and a rubber circular probe, typically expressed in kg / cm². 2 The unit for the test results is denoted as ______. During measurement, the probe of the pain meter is positioned above and towards the test site of the subject, with the probe placed perpendicular to the surface of the test site. Pressure is applied slowly and steadily. When pain stress is detected in the subject, the pressure is stopped. At this point, the pressure value (stimulation energy value) displayed on the monitor is obtained, which is the subject's mechanical pain threshold.

[0074] The temperature stimulation refers to stimulation through the application of temperature. Considering that temperature pain thresholds can be divided into cold pain thresholds and heat pain thresholds, the corresponding temperature stimulation structures can include two types: cold pain threshold measuring instruments and heat pain threshold measuring instruments, with heat pain threshold measuring instruments being more commonly used. As an example, rather than a limitation, temperature stimulation can be implemented using the existing Medoc TSA-2001 heat pain threshold measuring instrument. This instrument consists of a temperature controller, a feedback-controlled Peltier sensor head, and a display. The temperature controller controls the rise and fall of the temperature by adjusting the water temperature; the feedback-controlled Peltier sensor is connected to the temperature controller. During the test, the feedback-controlled Peltier sensor is fixed to the surface of the subject's test site, and the temperature rises at a uniform rate from a preset initial temperature value (e.g., 20°C). When pain stress is detected in the subject, the stimulation temperature immediately stops rising. At this time, the temperature value (stimulation energy value) displayed on the display is the subject's temperature pain threshold.

[0075] The electrical stimulation refers to stimulation by applying an electric current. The minimum current value that can cause pain is the electrical pain threshold (the value at which the human body feels pain during electrical stimulation). The frequency of the current is divided into high frequency and low frequency, with low frequency usually chosen. The waveform is usually a square wave because the rise and fall rate of the square wave current is high, and the stimulation intensity (amplitude) can reach its maximum value or drop to zero instantaneously. Moreover, the waveform of the square wave is regular, which is convenient for measurement and calculation. As an example of a typical method rather than a limitation, the electrical stimulation pain meter can use the domestic WQ-9E pain threshold measuring instrument, which is already in use. After locating the test site of the subject, the acupuncture site is routinely disinfected with 75% alcohol. After the acupuncture needle is inserted, the electroacupuncture wire is connected, and current stimulation is applied in a high-voltage constant current pulse mode. The current increases at a uniform rate from a preset initial current value (e.g., 0mA). When the subject shows pain stress, the electroacupuncture wire is disconnected, the stimulation current is stopped, and the current value (stimulation energy value) at this time is recorded, which is the subject's electrical pain threshold.

[0076] It should be noted that the structure of the instrument and the method of stimulus application described above are examples rather than limitations. For example, the instrument may also include an emergency stop switch that the subject can control, and the initial value and limit of stimulus application can be personalized.

[0077] The excitation end, serving as the stimulus application structure, may include pain threshold measuring devices for the various stimulus types described above. Preferably, the pain threshold measuring device is mounted on a wearable structure, allowing it to be worn on the subject's test site and facing the test site. When the stimulus test time for a round of stimulus tasks arrives, the pain threshold measuring device controlling the excitation end is activated to apply stimulation according to the stimulus pattern corresponding to the stimulus task. As a typical example, the excitation end may be worn on the subject's limbs—such as the calves—and stimulation may begin to be applied to the subject when the stimulus task time arrives.

[0078] The monitoring terminal, serving as a pain response monitoring structure, corresponds to the subject's body setup. It detects whether the subject exhibits a somatic avoidance reflex (corresponding to body movement) when stimulation is applied by the excitation terminal. Upon detecting body movement, it determines the presence of pain stress and records the pain stress information. For example, when the excitation terminal is worn on the subject's calf, the monitoring terminal, corresponding to the calf setup, detects whether the calf exhibits human pain-sensory flexion reflex (NFR) body movement upon stimulation. When NFR body movement is detected in the subject's calf—which can be achieved using existing sensors—pain stress is determined, and the pain stress information is recorded.

[0079] The pain stress information may specifically include the time information of the occurrence of the pain stress, the type of stimulus corresponding to the pain stress, the energy value of the stimulus corresponding to the pain stress, and the number of rounds of stimulus tasks and the number of stimulus tests corresponding to the pain stress (i.e., recording in which round of stimulus tasks and in which stimulus test the pain stress occurs).

[0080] See Figure 2 As shown, in another embodiment, the pain assessment system may further include an information input unit.

[0081] The information input unit is used to input the subject's basic information and / or the stimulus test configuration information selected by the user for the subject, and sends the acquired information to the test plan generation unit. As a typical example, the information input unit may be equipped with a first information acquisition interface and a second information acquisition interface. The first information acquisition interface is used to acquire the subject's basic information, and the second information acquisition interface is used to acquire the stimulus test configuration information selected by the user for the subject.

[0082] Specifically, the subject's basic information may include the subject's gender, age, weight, and medical history, and the above information in the subject's basic information can affect the subject's pain threshold test.

[0083] The stimulus test configuration information selected for the subject may include the setting of the test time period, the time pattern of implementing multiple rounds of test tasks, the time interval corresponding to each round of stimulus tasks, and the selection of stimulus type and stimulus mode.

[0084] After receiving the aforementioned basic information of the subject and / or stimulus test configuration information, the test plan generation unit generates a test plan that matches the aforementioned subject and includes multiple rounds of stimulus tasks.

[0085] In this embodiment, in single-stimulation mode, the system can apply stimulation to the subject using one of mechanical stimulation, temperature stimulation, or electrical stimulation.

[0086] Indeed, in single-stimulus mode, the test protocol generation unit can be configured to: for each round of stimulus task in the test time period, set N stimulus energy values ​​T with sequentially increasing stimulus intensities according to the target stimulus type. n The time step Δt for stimulus application and the energy difference Δd between adjacent stimuli are configured in a stimulus task. Here, N represents the number of stimuli, where N is a natural number greater than or equal to 1, n = 0, 1, 2, ..., N-1; Tn represents the stimulus energy value of the (n+1)th stimulus; T0 represents the base stimulus value corresponding to the target stimulus type; and T... N-1 This represents the upper limit of the stimulus corresponding to the target stimulus type, and the total time length corresponding to N time steps Δt is less than the time length of the time interval of one round of stimulus task.

[0087] In this embodiment, multiple stimulus tests can be repeated within the time interval corresponding to each round of stimulus task. Each stimulus test includes a process of applying multiple stimuli between gradually increasing and gradually decreasing the stimulus intensity. That is, each stimulus test will complete a test process of gradually increasing and gradually decreasing the stimulus intensity.

[0088] Specifically, in each round of the stimulation task, the stimulation application and monitoring unit first applies stimulation to the test site using a baseline stimulation value T0. If no pain stress response is detected in the subject at the monitoring end, the stimulation intensity is gradually increased based on the aforementioned baseline stimulation value T0 and the energy difference Δd, and the corresponding stimulation energy value is applied to the test site according to the time step Δt until a pain stress response is detected in the subject, at which point the stimulation energy value T is recorded. j The first pain value S for this round of stimulation tasks i Where j is a natural number less than or equal to N-1, and i represents the i-th round of stimulus task, where i is a natural number greater than or equal to 1; then, the aforementioned stimulus energy value T is used. jThe stimulation intensity is gradually decreased based on the energy difference Δd, and the corresponding stimulation energy value is applied to the test site according to the time step Δt until the subject no longer exhibits a pain stress response. The stimulation energy value T of the next higher level is recorded. k The second pain value P in this round of stimulation tasks i Where k is a natural number less than or equal to j; for the aforementioned first pain value S i With the second pain value P i The third pain value R is obtained after performing an arithmetic mean. i And based on this third pain value R i Update the aforementioned baseline stimulus value T0. Within the time interval corresponding to this round of stimulus task, repeat the aforementioned stimulus application steps, that is, alternate between gradually increasing and gradually decreasing the stimulus intensity, until the third pain value R is recorded. i When the number reaches the preset number, the third pain value R i The number is related to the number of stimulus tests in a round of stimulus task; one stimulus test corresponds to one third pain value R. i .

[0089] The pain quantification unit can calculate the average of the third pain values ​​of all rounds of stimulation tasks in the test period based on the multiple third pain values ​​recorded in each round of stimulation tasks, and use the average value as the pain threshold value Q of the subject in the test period.

[0090] The following example uses a test period of 24 hours, combined with... Figure 3 Describe the system’s pain assessment process in detail.

[0091] See Figure 3 The test period is 24 hours, with the time interval between the daytime and nighttime segments configured to be 4 hours. There are 4 rounds of stimulation tasks during the daytime segment and 2 rounds of stimulation tasks during the nighttime segment. The second round of stimulation tasks during the nighttime segment includes a stimulation test that causes the subject to wake up in pain, in order to obtain the stimulation energy value corresponding to the time the subject wakes up in pain.

[0092] Taking temperature stimulation as an example, and not a limitation, for instance, the configuration could be as follows: a base temperature stimulation value T0 = 20 degrees Celsius (the initial base stimulation value can be set by the system default or customized by the user), stimulation frequency N = 31, time step Δt = 2 seconds, energy difference Δd can be uniformly set to 1 degree Celsius, and stimulation upper limit T... N-1 =T 30 =50 degrees, meaning the temperature stimulus starts at 20 degrees and increases by 1 degree every 2 seconds, with a maximum stimulus energy of 50 degrees. Three stimulus tests are set up in one round of the stimulus task.

[0093] When the stimulation test time for the first round of stimulation task (i=1) arrives, the first stimulation test is conducted. The stimulation end starts at 20 degrees and increases step by step in 2-second increments: 20 degrees, 21 degrees, 22 degrees, 23 degrees, and so on, until body movement is detected in the subject. The test temperature value at the time of body movement is recorded, for example, 46 degrees, and the temperature increase is stopped. Then, starting from 46 degrees, the temperature decreases step by step in 2-second increments: 46 degrees, 45 degrees, 44 degrees, 43 degrees, and so on, until body movement ceases to be detected. The test temperature value at the time of cessation of body movement is recorded, for example, 43 degrees, and the temperature decrease is stopped. The temperature stimulation value for the next level is 44 degrees. The first stimulation test is completed, and the second stimulation test begins immediately.

[0094] The first stimulus test recorded a first pain value S1 of 46 degrees and a second pain value P1 of 44 degrees. The arithmetic average of these two values ​​yielded a third pain value R1 of 45 degrees. This 45-degree value was then used to update the baseline stimulus value T0, which became the starting stimulus energy value for the second stimulus test. Specifically, the new baseline stimulus value T0 can be directly taken from the aforementioned third pain value R1, or it can be calculated using a preset formula. For example, the new baseline stimulus value T0 could be equal to the third pain value R1 minus a preset adjustment value of 10, meaning the starting stimulus energy value for the second stimulus test would be 35 degrees. After the second stimulus test begins, the stimulus temperature starts at 35 degrees Celsius and increases incrementally in 2-second increments: 35 degrees, 36 degrees, 37 degrees, 38 degrees… until body movement is detected in the subject. The temperature at which body movement occurs is recorded, for example, 46 degrees Celsius, and the temperature increase stops. Then, starting from 46 degrees Celsius, the temperature decreases incrementally in 2-second increments: 46 degrees Celsius, 45 degrees Celsius, 44 degrees Celsius… until no further body movement is detected. The temperature at which no further body movement occurs is recorded, for example, 44 degrees Celsius, and the temperature decrease stops. The next stimulus level is 45 degrees Celsius. The second stimulus test is complete, and the third stimulus test can begin. The first pain value S1 recorded in the second stimulus test is 46 degrees Celsius, and the second pain value P1 is 45 degrees Celsius. The arithmetic average of these two values ​​yields the third pain value R1, which is 45.5 degrees Celsius. This 45.5 degrees Celsius is then used to update the baseline stimulus value T0 as the starting stimulus energy value for the third stimulus test.

[0095] The process of applying multiple stimuli, alternating between progressively increasing and progressively decreasing stimulus intensity, in the third stimulus test is similar to that in the second stimulus test.

[0096] After completing a round of stimulation tasks, you can obtain three third pain values ​​R1 corresponding to the three stimulation tests, such as 45, 45.5 and 45 respectively.

[0097] Similarly, when the stimulation test time for the second round of the stimulation task (i=2) arrives, three stimulation tests are performed in sequence according to the above process to obtain three third pain values ​​R2 corresponding to the three stimulation tests; when the stimulation test time for the third round of the stimulation task (i=3) arrives, three stimulation tests are performed in sequence to obtain three third pain values ​​R3 corresponding to the three stimulation tests; this process is repeated until all six rounds of stimulation tasks in one testing time cycle are completed.

[0098] In the second round of stimulation tasks during the nighttime segment, after the above process was completed, an additional stimulation test was added that could cause the subject to wake up in pain. This stimulation test is a pain-awakening stimulation test. When the corresponding time arrives, the excitation end starts from the updated stimulation baseline value T0 and increases step by step in 2-second increments: 35 degrees, 36 degrees, 37 degrees, 38 degrees, etc., until the subject is detected to wake up from sleep. The test temperature value at the time of awakening is recorded, for example, 49 degrees, and the temperature increase stops. The difference from the aforementioned stimulation test is that the test stops when the subject is detected to wake up from the stimulation, and the test temperature at this time is recorded. There is no need to perform the stimulation process of gradually decreasing the temperature again.

[0099] The pain quantification unit can calculate the arithmetic mean of the 18 third pain values ​​based on the 6 rounds of stimulation tasks recorded above, and use the average value as the pain threshold Q of the subject in this test period.

[0100] The above process describes the testing procedure using temperature stimulation as an example. The testing steps are the same for both electrical and mechanical stimulation; the main difference lies in the parameter settings. This is an example, not a limitation. For instance, the baseline stimulation value for electrical stimulation can start at 0.5 mA, increasing by 0.1 mA every 2 seconds, with an upper limit of 10 mA. Similarly, the baseline stimulation value for mechanical stimulation can start at 15 g, increasing by 1 g every 2 seconds, with an upper limit of 75 g.

[0101] It should be noted that, for a test period, users can configure parameters such as the number of test rounds, the number of stimulus tests in each round, the base stimulus value, the upper limit stimulus value, the time step Δt for stimulus application, and the energy difference Δd between adjacent stimuli as needed.

[0102] Preferably, the energy difference Δd between adjacent stimuli is configured as a fixed percentage. For example, the fixed percentage can be any value between 5% and 20%. In this case, the energy difference can be a fixed percentage of a preset initialization parameter (in which case the energy difference is the same), or it can be based on the energy value of the previous stimulus multiplied by the fixed percentage (in which case the energy difference is different for each stimulus). Alternatively, the energy difference Δd between adjacent stimuli can be configured with a fixed energy step size. For example, the energy step size for temperature stimulation, electrical stimulation, and mechanical stimulation can be configured to be between 0.5-1.5 degrees, 0.1-0.2 mA, and 1-2 g, respectively. Alternatively, the energy difference Δd between adjacent stimuli can be set according to the time step Δt. A longer time step corresponds to a larger energy difference Δd, and a shorter time step corresponds to a smaller energy difference Δd.

[0103] In this embodiment, under the multi-stimulation mode, the system uses two or three types of stimulation, namely mechanical stimulation, temperature stimulation and electrical stimulation, to apply stimulation to the subject.

[0104] Specifically, in the multi-stimulation mode, M stimulus types are alternated within the time interval of each stimulus task, where M is a natural number greater than or equal to 2. After setting the order of the M stimulus types, a time sub-interval for each stimulus type is configured within the time interval of each stimulus task. In one stimulus task, for each stimulus type, stimulation is applied to the subject's test site within its corresponding time sub-interval, and the subject's pain stress information is acquired. After the stimulation test for one stimulus type is completed, the stimulation application and monitoring unit enters a waiting state until the time for the next stimulus type arrives, and so on, until the stimulation tests for all M stimulus types in one stimulus task are completed.

[0105] As an example, and not a limitation, consider a stimulus task with a 4-hour timeframe, including three stimulus types tested in the order of mechanical, temperature, and electrical stimulation. The timeframe can be configured as follows: the first hour is designated as the mechanical stimulation sub-interval (sub-interval 1), the second hour as the mechanical stimulation sub-interval (sub-interval 2), and the third hour as the mechanical stimulation sub-interval (sub-interval 3). When the timeframe for the first stimulus task arrives, mechanical stimulation is performed first, applying mechanical stimulation to the subject's test site during the first sub-interval and obtaining the subject's pain stress information. After the test, a waiting period begins. When the second hour arrives, temperature stimulation is initiated, applying temperature stimulation to the subject's test site during the second sub-interval and obtaining the subject's pain stress information. After the second hour, another waiting period begins. When the third hour arrives, electrical stimulation is initiated, applying electrical stimulation to the subject's test site during the third sub-interval and obtaining the subject's pain stress information. After all three stimulus types in the first stimulus task are tested, a waiting period begins until the next stimulus task arrives.

[0106] In the multi-stimulus mode, the test scheme generation unit can be configured to: for each of the three stimulus types m, m = 1, 2, 3, set Nm stimulus energy values ​​Tm with sequentially increasing stimulus intensities. n Configure the time step Δtm for applying the stimulus of this stimulus type in a round of stimulus task and the energy difference Δdm between adjacent stimuli, where Nm represents the number of stimuli corresponding to the m-th stimulus type, Nm is a natural number greater than or equal to 1, n = 0, 1, 2, ..., Nm-1, Tm0 represents the base value of the stimulus corresponding to the m-th stimulus type, Tm (Nm-1) This represents the upper limit value of the stimulus corresponding to the m-th stimulus type.

[0107] In each round of the stimulation task, following the order of the three stimulus types, when the time for the m-th stimulus type arrives, the following steps are performed: The stimulus application and monitoring unit first applies stimulation to the test site using the baseline stimulus value Tm0; if no pain stress response is detected at the monitoring end, the stimulus intensity is progressively increased based on the aforementioned baseline stimulus value Tm0 and the energy difference Δdm, and the corresponding stimulus energy value is applied to the test site according to the time step Δtm until a pain stress response is detected in the subject, and the stimulus energy value Tm at this time is recorded. j Sm represents the first pain value of the m-th stimulus type in this round of stimulation tasks. i Where j is a natural number less than or equal to Nm-1, and i represents the i-th round of stimulus task, where i is a natural number greater than or equal to 1; then, the aforementioned stimulus energy value Tm is used. jThe stimulation intensity is progressively decreased based on the energy difference Δdm, and the corresponding stimulation energy value is applied to the test site according to the time step Δtm until the subject no longer exhibits a pain stress response. The stimulation energy value Tm of the next higher level is then recorded. k The second pain level Pm in this round of stimulation tasks i Where k is a natural number less than or equal to j; for the aforementioned first pain value Sm i With the second pain value Pm i The third pain value Rm is obtained after performing an arithmetic mean. i And based on this third pain value Rm i Update the aforementioned stimulus baseline value Tm0.

[0108] In this embodiment, within a single stimulation task, multiple stimulation tests can be set within the time sub-interval corresponding to the m-th stimulation type. Each stimulation test includes a process of applying stimulation multiple times between progressively increasing and progressively decreasing stimulation intensity, i.e., alternating between progressively increasing and progressively decreasing stimulation intensity until the recorded third pain value Rm is reached. i The quantity has reached the preset quantity.

[0109] For any stimulus type m, the pain quantification unit calculates multiple third pain values ​​Rm for that stimulus type m based on the previously recorded rounds of stimulus tasks. i Calculate the third pain value Rm for stimulus type m in all rounds of the stimulus task during the test period. i The average value is taken as the pain threshold Qm for that subject under that stimulus type. For three stimulus types, three pain threshold values ​​Q1, Q2, and Q3 can be obtained.

[0110] The testing process for multiple stimulations of each stimulation type under the multi-stimulus mode can refer to the testing process for the corresponding stimulation type under the single-stimulus mode, and will not be repeated here.

[0111] In this embodiment, the standard numerical pain rating system defines standard scores for no pain, standard scores for arousal due to stimulation, and standard scores for the most painful pain. As an example and not a limitation, the preset standard numerical pain rating system is preferably the NRS rating system.

[0112] The stimulus application and monitoring unit is configured to record the stimulus energy value T when a subject is awakened by pain under a specific stimulus type. wake and the stimulation energy value T wake The stimulus is sent to the pain quantification unit, and each stimulus type corresponds to its own stimulus energy value T. wake .

[0113] In single-stimulation mode, the pain quantification unit is configured to convert the pain threshold value Q to obtain a standard pain threshold score Q in the following manner. 标 Q 标 =Q*(Standard score corresponding to stimulus pain awakening / Stimulus energy value of stimulus pain awakening).

[0114] As an example, and not a limitation, let's take the existing standard numerical pain rating system using the NRS scoring system as an example. This system has a scoring table with scores from 0 to 10. The standard score for stimulus arousal is 4 points, and the corresponding stimulus energy value for stimulus arousal measured by this system is 20. Therefore, the standard pain threshold score Q... 标 =Q*(4 / 20) points.

[0115] In multi-stimulation mode, the pain quantification unit is configured to convert the pain threshold value to obtain a standard pain threshold score Q in the following manner. 标 Q 标 = [Q1*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)+Q2*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)+……+QM*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)] / M.

[0116] In this embodiment, the pain quantification unit first filters the acquired pain stress information when calculating the pain threshold value.

[0117] The filtering can be one or more of the following methods:

[0118] In Method 1, after acquiring the subject's pain stress information, the pain quantification unit removes the highest and lowest values ​​based on the corresponding values ​​of the pain stress information, and then calculates the pain threshold value using the remaining pain stress information.

[0119] Method 2: Configure the data confidence interval information under resting state and send the data confidence interval information under resting state to the pain quantification unit; after obtaining the subject's pain stress information, the pain quantification unit first determines whether the value corresponding to the pain stress information is within the aforementioned data confidence interval. When the corresponding value exceeds the aforementioned data confidence interval, the pain stress information is determined to be invalid information and is not included in the calculation of the pain threshold value.

[0120] Method 3: The stimulus application and monitoring unit further includes an interference identification module, which is configured to: collect sound information, light information and / or image information in the surrounding environment during stimulus testing; analyze the acquired sound information, light information and / or image information to determine whether there are test interference factors in the surrounding environment; and when test interference factors are determined to exist, record the time information of the occurrence of the test interference factors, and compare the time information with the time interval of each round of stimulus tasks to obtain the stimulus task information of interference; and process the stimulus tasks of interference so that the pain quantification unit does not include the pain stress information of the aforementioned stimulus tasks of interference when calculating the pain threshold value.

[0121] The processing includes: determining that the pain stress information collected under the interfering stimulus task is invalid; or deleting the pain stress information collected under the interfering stimulus task; or stopping the stimulus test for that round of stimulus task and marking that round of stimulus task as a test abnormal until the time for the next stimulus task arrives to restart a new round of stimulus test.

[0122] The acquisition of sound, light, and image information can be accomplished using audio acquisition devices (such as microphones), light sensing devices (such as photosensitive elements), and image acquisition devices (such as cameras), respectively. The acquired sound, light, and / or image information is transmitted to the system's processor for analysis and identification to determine the presence of sound interference, light interference, human interference, or interference from object movement (such as vibration). In this embodiment, the light sensing device may include photoresistors, photocapacitors, phototransistors, photodiodes, or light sensors, configured to acquire ambient light intensity information, convert the light intensity information into an electrical signal, and then transmit it to the system processor.

[0123] In another embodiment of the present invention, for each round of stimulation task, the pain threshold in each round of stimulation task can be calculated (the average of the pain threshold measurements obtained from each stimulation test in that round of stimulation task). The pain thresholds of each round of stimulation task within one or more test time periods can be statistically analyzed, for example, by plotting a trend graph of pain threshold changes. This facilitates medical personnel in understanding and adjusting the subject's condition. On the one hand, the dynamic changes in a patient's pain threshold can be used to assist and guide doctors in treating patients. For example, when a patient's pain threshold gradually increases, meaning a larger stimulus energy value is required to elicit a physical response, their tolerance to stimulation has increased, which can presume that the previous treatment was effective.

[0124] Another embodiment of the present invention also provides a pain assessment method based on dynamic monitoring.

[0125] See Figure 4As shown, the method includes the following steps.

[0126] S100: A test plan comprising multiple rounds of stimulus tasks is generated for the subject. The test plan configures the test time period for the stimulus tasks. Within the test time period, the aforementioned multiple rounds of stimulus tasks are implemented according to a preset time pattern, with each round of stimulus tasks corresponding to its own time interval. Each round of stimulus tasks includes at least one stimulus test, and each stimulus test includes a process of applying stimulation multiple times between progressively increasing and progressively decreasing stimulus intensity.

[0127] S200, according to the multi-round stimulation task in the aforementioned test scheme, the stimulation application and monitoring unit applies stimulation to the test site of the subject within the corresponding time interval and acquires the subject's pain stress information in response to the aforementioned stimulation task. After the stimulation test of one round of stimulation task is completed, the stimulation application and monitoring unit enters a waiting state until the stimulation test time of the next round of stimulation task arrives.

[0128] S300: Based on the subject's aforementioned pain stress information, calculate the pain threshold value, and convert the aforementioned pain threshold value based on a preset standard pain numerical scoring system to obtain the corresponding standard pain threshold score.

[0129] Other technical features are described in the preceding embodiments and will not be repeated here.

[0130] In the above description, the disclosure of this invention is not intended to limit itself to these aspects. Rather, within the scope of the objectives of this disclosure, components can be selectively and operationally combined in any number. Furthermore, terms such as “comprising,” “encompassing,” and “having” should be interpreted by default as inclusive or open-ended, rather than exclusive or closed, unless explicitly defined as such. All technical, scientific, or other terms are to be understood by those skilled in the art, unless defined as such. Public terms found in dictionaries should not be interpreted in the context of the relevant technical documents in an overly idealistic or impractical manner, unless explicitly defined as such in this disclosure. Any modifications or alterations made by those skilled in the art based on the foregoing disclosure are within the scope of the claims.

Claims

1. A pain assessment system based on dynamic monitoring, characterized in that... include: The test plan generation unit is used to generate a test plan for the subject that includes multiple rounds of stimulation tasks. The test plan configures the test time period of the stimulation tasks. Within the test time period, the aforementioned multiple rounds of stimulation tasks are implemented according to a preset time pattern. Each round of stimulation tasks corresponds to its own time interval. Each round of stimulation tasks includes at least one stimulation test. Each stimulation test includes a process of applying stimulation multiple times between progressively increasing and progressively decreasing stimulation intensity. The stimulus application and monitoring unit is used to apply stimulation to the test site of the subject in the corresponding time interval according to the multi-round stimulus task in the aforementioned test plan, and to obtain the pain stress information of the subject in response to the aforementioned stimulus task; after the stimulus test of one round of stimulus task is completed, the stimulus application and monitoring unit enters a waiting state until the stimulus test time of the next round of stimulus task arrives. The pain quantification unit is used to calculate the pain threshold value based on the subject's pain stress information, and convert the pain threshold value based on a preset standard pain numerical scoring system to obtain the corresponding standard pain threshold score.

2. The system according to claim 1, characterized in that: It also includes an information input unit, which is used to input the subject’s basic information and / or the stimulus test configuration information selected by the user for the subject, and send the acquired information to the test plan generation unit; After receiving the aforementioned basic information of the subject and / or stimulus test configuration information, the test plan generation unit generates a test plan that matches the aforementioned subject and includes multiple rounds of stimulus tasks based on the basic information of the subject and / or stimulus test configuration information. In the test scheme, multiple rounds of stimulation tasks are set for the daytime and nighttime periods of the test time period. The stimulation energy value corresponding to the subject's awakening due to pain is obtained through one round of stimulation task in the nighttime period. The stimulation energy value corresponding to the subject's awakening due to pain is used for the aforementioned conversion.

3. The system according to claim 1, characterized in that: The test plan generation unit configures the stimulus mode corresponding to the stimulus task when generating the test plan. The stimulus mode includes a single stimulus mode and a multi-stimulus mode. In the single stimulus mode, the same stimulus type is used for stimulus testing throughout the entire test time period. In the multi-stimulus mode, multiple stimulus types are used for stimulus testing, and the multiple stimulus types are alternated in one round of stimulus task. The stimulation types include mechanical stimulation, temperature stimulation, and electrical stimulation; in the single stimulation mode, one of mechanical stimulation, temperature stimulation, and electrical stimulation is used; in the multi-stimulation mode, two or three of the mechanical stimulation, temperature stimulation, and electrical stimulation types are used.

4. The system according to claim 3, characterized in that: The stimulus application and monitoring unit includes at least an excitation end and a monitoring end; The excitation end can be worn on the subject's test site and facing the test site. When the stimulation test time of a stimulation task arrives, the excitation end applies stimulation according to the stimulation pattern corresponding to the stimulation task. The monitoring terminal corresponds to the subject's body setting and is used to detect whether the subject exhibits a somatic avoidance reflex when stimulation is applied at the excitation terminal. When the subject exhibits a somatic avoidance reflex, pain stress is determined and pain stress information is recorded.

5. The system according to claim 3, characterized in that: In single-stimulus mode, the test protocol generation unit is configured to: for each round of stimulus task in the test time period, set N stimulus energy values ​​T with sequentially increasing stimulus intensities according to the target stimulus type. n Configure the time step Δt for stimulus application and the energy difference Δd between adjacent stimuli in a stimulus task, where N represents the number of stimuli, N is a natural number greater than or equal to 1, n = 0, 1, 2, ..., N-1; T0 represents the base value of the stimulus corresponding to the target stimulus type, T... N-1 This represents the upper limit of the stimulus type corresponding to the target stimulus type. The total time length corresponding to N time steps Δt is less than the time length of the time interval of one round of stimulus task. In each round of the stimulation task, the stimulation application and monitoring unit first applies stimulation to the test site using a baseline stimulation value T0. If no pain stress response is detected at the monitoring end, the stimulation intensity is gradually increased based on the aforementioned baseline stimulation value T0 and the energy difference Δd, and the corresponding stimulation energy value is applied to the test site according to the time step Δt until a pain stress response is detected in the subject, at which point the stimulation energy value T is recorded. j The first pain value S for this round of stimulation tasks i Where j is a natural number less than or equal to N-1, and i represents the i-th round of stimulus task, where i is a natural number greater than or equal to 1; then, the aforementioned stimulus energy value T is used. j The stimulation intensity is gradually decreased based on the energy difference Δd, and the corresponding stimulation energy value is applied to the test site according to the time step Δt until the subject no longer exhibits a pain stress response. The stimulation energy value T of the next higher level is recorded. k The second pain value P in this round of stimulation tasks i Where k is a natural number less than or equal to j; for the aforementioned first pain value S i With the second pain value P i The third pain value R is obtained after performing an arithmetic mean. i And based on this third pain value R i Update the aforementioned baseline stimulus value T0; within the time interval corresponding to this round of stimulus task, repeat the aforementioned stimulus application steps, that is, alternate between gradually increasing and gradually decreasing the stimulus intensity, until the third pain value R is recorded. i The quantity has reached the preset quantity; The pain quantification unit calculates the average of the third pain values ​​of all rounds of stimulation tasks in the test period based on the multiple third pain values ​​recorded in each round of stimulation tasks, and uses the average value as the pain threshold Q of the subject in the test period.

6. The system according to claim 3, characterized in that: In the multi-stimulation mode, M stimulus types are alternated within the time interval of each round of stimulus task, where M is a natural number greater than or equal to 2; At this point, after setting the order of each of the M stimulus types, a time sub-interval for each stimulus type is configured within the time interval of each round of stimulus task; in one round of stimulus task, for each stimulus type, stimulation is applied to the subject's test site within its corresponding time sub-interval and the subject's pain stress information is obtained; after the stimulation test of one stimulus type is completed, the stimulation application and monitoring unit enters a waiting state until the time for the next stimulus type arrives, and so on, until the stimulation tests of all M stimulus types in one round of stimulus task are completed.

7. The system according to claim 6, characterized in that, The test scheme generation unit is configured to: for each stimulus type m, m = 1, 2, ..., M, set Nm stimulus energy values ​​Tm with sequentially increasing stimulus intensities. n Configure the time step Δtm for applying the stimulus of this stimulus type in a round of stimulus task and the energy difference Δdm between adjacent stimuli, where Nm represents the number of stimuli corresponding to the m-th stimulus type, Nm is a natural number greater than or equal to 1, n = 0, 1, 2, ..., Nm-1, Tm0 represents the base value of the stimulus corresponding to the m-th stimulus type, Tm (Nm-1) This represents the upper limit value of the stimulus type corresponding to the m-th stimulus type; In each round of the stimulation task, following the order of M stimulus types, when the time for the m-th stimulus type arrives, the following steps are performed: The stimulus application and monitoring unit first applies stimulation to the test site using the baseline stimulus value Tm0; if no pain stress response is detected at the monitoring end, the stimulus intensity is progressively increased based on the aforementioned baseline stimulus value Tm0 and the energy difference Δdm, and the corresponding stimulus energy value is applied to the test site according to the time step Δtm until a pain stress response is detected in the subject, and the stimulus energy value Tm at this time is recorded. j Sm represents the first pain value of the m-th stimulus type in this round of stimulation tasks. i Where j is a natural number less than or equal to Nm-1, and i represents the i-th round of stimulus task, where i is a natural number greater than or equal to 1; then, the aforementioned stimulus energy value Tm is used. j The stimulation intensity is progressively decreased based on the energy difference Δdm, and the corresponding stimulation energy value is applied to the test site according to the time step Δtm until the subject no longer exhibits a pain stress response. The stimulation energy value Tm of the next higher level is then recorded. k The second pain level Pm for this round of stimulation tasks i Where k is a natural number less than or equal to j; for the aforementioned first pain value Sm i With the second pain value Pm i The third pain value, Rm, is obtained by performing an arithmetic mean. i And based on this third pain value Rm i Update the aforementioned baseline stimulus value Tm0; within the time sub-interval corresponding to the aforementioned m-th stimulus type, repeat the aforementioned stimulus application steps, that is, alternate between gradually increasing and gradually decreasing the stimulus intensity, until the recorded third pain value Rm is reached. i The quantity has reached the preset quantity; For any stimulus type m, the pain quantification unit calculates multiple third pain values ​​Rm for that stimulus type m based on the previously recorded rounds of stimulus tasks. i Calculate the third pain value Rm for stimulus type m in all rounds of the stimulus task during the test period. i The average value is taken as the pain threshold Qm of the subject under that stimulus type; for M stimulus types, M pain thresholds Q1, Q2, ..., QM are obtained.

8. The system according to claim 5 or 7, characterized in that: The standard pain numerical rating system defines standard scores for no pain, standard scores for stimulating pain to awaken the patient, and standard scores for the most painful pain. The stimulus application and monitoring unit is configured to record the stimulus energy value T when a subject is awakened by pain under a specific stimulus type. wake and the stimulation energy value T wake The stimulus is sent to the pain quantification unit, and each stimulus type corresponds to its own stimulus energy value T. wake ; In single-stimulation mode, the pain quantification unit is configured to convert the pain threshold Q to obtain a standard pain threshold score Q in the following manner. 标 Q 标 =Q*(Standard score corresponding to stimulus-induced pain awakening / Stimulus energy value of stimulus-induced pain awakening); In multi-stimulation mode, the pain quantification unit is configured to convert the pain threshold to obtain a standard pain threshold score Q in the following manner. 标 Q 标 = [Q1*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)+Q2*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)+……+QM*(Standard score corresponding to the stimulus that causes pain / Stimulus energy value of the stimulus type that causes pain)] / M.

9. The system according to claim 1, characterized in that: When calculating the pain threshold, the pain quantification unit filters the acquired pain stress information, and the filtering is performed in one or more of the following ways: Method 1: After acquiring the subject's pain stress information, the pain quantification unit removes the highest and lowest values ​​based on the corresponding values ​​of the pain stress information, and then calculates the pain threshold value using the remaining pain stress information. Method 2: Configure the data confidence interval information under resting state and send the data confidence interval information under resting state to the pain quantification unit; after obtaining the pain stress information of the subject, the pain quantification unit first determines whether the value corresponding to the pain stress information is within the aforementioned data confidence interval. When the corresponding value exceeds the aforementioned data confidence interval, the pain stress information is determined to be invalid information and is not included in the calculation of the pain threshold value. Method 3: The stimulus application and monitoring unit further includes an interference identification module. The interference identification module is configured to: collect sound information, light information and / or image information in the surrounding environment during the stimulus test; analyze the acquired sound information, light information and / or image information to determine whether there are test interference factors in the surrounding environment; and when test interference factors are determined to exist, record the time information of the occurrence of the test interference factors and compare the time information with the time interval of each round of stimulus task to obtain the stimulus task information where interference occurred. In addition, the interference of stimulus tasks is processed so that the pain quantification unit does not include the pain stress information of the aforementioned interference stimulus tasks when calculating the pain threshold value. The processing includes: determining that the pain stress information collected under the interfering stimulus task is invalid; or deleting the pain stress information collected under the interfering stimulus task; or stopping the stimulus test for that round of stimulus task and marking that round of stimulus task as a test abnormal until the time for the next stimulus task arrives to restart a new round of stimulus.

10. A pain assessment method based on dynamic monitoring, characterized in that... Including the following steps: A test plan including multiple rounds of stimulation tasks is generated for the subjects. The test plan configures the test time period of the stimulation tasks. The aforementioned multiple rounds of stimulation tasks are implemented according to a preset time pattern within the test time period. Each round of stimulation tasks corresponds to its own time interval. Each round of stimulation tasks includes at least one stimulation test. Each stimulation test includes the process of applying stimulation multiple times between gradually increasing and gradually decreasing stimulation intensity. According to the multi-round stimulation task in the aforementioned test plan, the stimulation application and monitoring unit applies stimulation to the test site of the subject in the corresponding time interval and obtains the subject's pain stress information in response to the aforementioned stimulation task; after the stimulation test of one round of stimulation task is completed, the stimulation application and monitoring unit enters a waiting state until the stimulation test time of the next round of stimulation task arrives. Based on the subject's pain stress information, the pain threshold value is calculated, and the pain threshold value is converted based on a preset standard pain numerical rating system to obtain the corresponding standard pain threshold score.

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