A double-blind experimental device for evaluating the efficacy of acupuncture

Abstract

The present invention relates to a needle-hidden double-blind experimental device for evaluating the efficacy of acupuncture, the device comprising a base and a needle tube vertically arranged at the center thereof; characterized in that the needle tube is composed of an outer sleeve and an inner sleeve inserted therein, and the inner wall of the outer sleeve is gap-matched with the outer wall of the inner sleeve; a permanent magnetic ring is provided on the head cover of the outer sleeve, and the upper end surfaces of the two are flush; a magnetic conductive metal wire is provided inside or on the inner wall of the inner sleeve along the length direction, and the two ends are flush; the attraction between the permanent magnetic ring and the magnetic conductive metal wire enables the inner sleeve to stay at any position of the outer sleeve, and test needles of different lengths can be hidden in the needle tube. This device not only allows placebo needles and treatment needles to be shared, but also has a good shielding effect and convenient needle insertion operation.

Description

Technical Field

[0001] The invention relates to a physical therapy device, in particular to an acupuncture device for locating or stimulating specific reflex points of a human body for physical therapy. Background Art

[0002] Randomized controlled clinical trials are currently the most rigorous scientific method for evaluating the clinical effects of medical interventions. A difficult problem facing clinical trials of acupuncture treatment is the design and selection of placebo needles for comparison. The ideal placebo needle in acupuncture clinical trials meets the following conditions: (1) It has no or only a very small specific therapeutic effect, so as not to affect the accurate evaluation of the therapeutic effect of acupuncture; (2) It is indistinguishable from the therapeutic measures in all aspects or as similar as possible, so that a blind study can be successfully implemented; (3) The placebo needle should not affect the necessary manipulation of the therapeutic needle and must ensure the realization of the normal therapeutic effect; (4) The placebo needle should also be as simple, safe, easy to operate, and highly applicable as possible. With the progress of research on the essence of meridians and the effects of acupuncture, people continue to propose new placebo needle designs.

[0003] The utility model patent application with the authorization announcement number CN 206183657 U discloses a placebo needle for double-blind experiments, which has two sets of acupuncture sets, real and fake. Both sets of acupuncture sets include a hollow sleeve and a needle inserted into the sleeve from the top of the sleeve. The bottom of the sleeve is provided with an adhesive sticker, which is made of an opaque material and closes the bottom opening of the sleeve. The needle of the real acupuncture set consists of a first needle handle and a first needle tip. The needle of the fake acupuncture set consists of a second needle handle, a second needle tip and an intermediate connector, and the second needle tip is a flat-head needle tip. Moreover, the first needle handle and the second needle handle are connected to the corresponding sleeve bayonet through the threaded surface transition fit. When performing the up and down lifting and inserting action, the fake acupuncture set is consistent with the real acupuncture set, and the needle can be allowed to stay at a fixed height within the lifting and inserting range without rebounding or falling (see paragraphs

[0018] ,

[0011] and

[0027] of its specification). It can be seen from the above scheme of the utility model patent application that it obviously has the following defects: 1. "The needle handle and the bayonet of the corresponding sleeve are connected through the transition fit of the threaded surface". Although it can make "the needle stay at a fixed height and will not bounce back or fall", the needle can only be inserted by twisting the needle handle along the thread, and its insertion speed is obviously limited by the thread; 2. Threads are set on the needle handles of the real needle and the fake needle, and a connecting piece (such as a spring) is strung in the middle of the needle body of the fake needle. Therefore, the real needle and the fake needle must be customized, which undoubtedly increases the cost; 3. Once the length of the needle body is determined, the insertion depth cannot be changed according to the requirements of acupuncture treatment. Therefore, the length of the needle body or the length of the sleeve must be customized according to the insertion depth of the current acupoint; 4. The real needle must pierce the adhesive sticker at the bottom of the sleeve during treatment, which will obviously contaminate the needle body. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a double-blind experimental device for evaluating the efficacy of acupuncture, which does not need to be customized according to the acupoints to be treated and can be directly used with commercially available test needles, while the needle insertion speed can be freely selected.

[0005] The technical solution of the present invention to solve the above problems is as follows:

[0006] A double-blind experimental device for evaluating the efficacy of acupuncture, comprising a needle tube and a base, characterized in that:

[0007] The needle tube is composed of an outer sleeve and an inner sleeve inserted therein, and the inner wall of the outer sleeve is loosely matched with the outer wall of the inner sleeve; a permanent magnetic ring is provided on the head cover of the outer sleeve, and the upper end surfaces of the two are flush; a magnetic conductive wire is fixed inside or on the inner wall of the inner sleeve along the length direction, and the two ends are flush; in a vertical state, the attraction generated between the permanent magnetic ring and the magnetic conductive wire makes the outer wall of the inner sleeve adhere to the inner wall of the outer sleeve, and the friction resistance generated between the two is greater than or equal to the sum of the weights of the inner sleeve and the magnetic conductive wire; the outer sleeve and the inner sleeve are both non-transparent medical plastics, and the length of the inner sleeve is greater than the length of the outer sleeve;

[0008] The base is disc-shaped, and a circular adhesive sheet with the same diameter as the base is provided on its lower surface. A circular hole is provided in the bodies of the two along the central axis and passes through the two upwards and downwards. The lower end of the outer sleeve is fixed in the circular hole, and the lower end surface is flush with the lower surface of the circular adhesive sheet, and the upper end surface extends out of the base.

[0009] The circular adhesive sheet is made of double-sided adhesive tape, and a disc-shaped easy-tear protective sticker is pasted on its lower surface. An easy-tear lug extends outward from the circumferential surface of the easy-tear protective sticker.

[0010] In order to facilitate taking, the upper part of the base in the above solution shrinks inwardly into a regular hexagon.

[0011] In the above solution, the permanent magnet ring can be made of ferrite magnetic material; the magnetic conductive metal wire can be made of metal materials such as iron, silicon steel or Permalloy.

[0012] This needle-hidden double-blind experimental device can be used in combination with ordinary needles to form a treatment needle, and can be used in combination with a control needle to form a placebo needle. In order to achieve double blindness, when evaluating the efficacy of acupuncture, first take one of the needle-hidden double-blind experimental devices and put it in an ordinary needle, then move the inner sleeve upwards so that the upper end surface of the inner sleeve is flush with the upper end of the ordinary needle handle, thus forming a treatment needle; then take another needle-hidden double-blind experimental device and put it in a control needle, then move the inner sleeve upwards so that the upper end surface of the inner sleeve is equal to the height of the upper end surface of the inner sleeve in the corresponding treatment needle, thus forming a placebo needle.

[0013] In order to avoid ambiguity due to different understandings, some technical terms of the present invention are defined as follows:

[0014] Ordinary needle: a conventional acupuncture needle used for acupuncture treatment, which consists of a needle body and a needle handle, wherein the end of the needle body is a sharp tip, and the length of the needle body is equal to the sum of the distance between the lower surface of the circular adhesive sheet and the upper end surface of the inner sleeve and the depth of penetration into the subject's skin;

[0015] Control needle: composed of a needle body and a needle handle identical to that of an ordinary needle, wherein the end of the needle body is a flat head, and the length of the needle body is equal to the difference between the distance from the lower surface of the circular adhesive sheet to the upper end surface of the inner cannula and the depth of penetration into the subject's skin, or the length of the needle body is equal to the difference between the length of the ordinary needle body and the depth of penetration into the subject's skin;

[0016] Test needles: including the above-mentioned common needles and control needles;

[0017] Placebo needle: a combination formed by placing a control needle into the needle tube of the needle-free double-blind experimental device of the present invention according to the blind method requirements;

[0018] Treatment needle: A combination formed by placing an ordinary needle into the needle tube of the needle-free double-blind experimental device of the present invention according to the blind method requirements.

[0019] In this application document, unless otherwise specified, the "needle body" includes the needle body of a reference needle or an ordinary needle, and the "needle handle" includes the needle handle of the reference needle or the ordinary needle.

[0020] The national standard has made clear provisions on the material of the acupuncture needle body, that is: the needle body of the acupuncture needle should be made of 0Cr19Ni9 or other austenitic stainless steel wire in GB / T 4240; although the national standard does not make provisions for the needle handle of the acupuncture needle, the needle handle of the commercially available acupuncture needle is usually made of lightweight aluminum wire, so the existing acupuncture needles are not magnetic. Since the control needle is required by the blind experiment, its structure and material should be the same as the treatment needle except that the end of the needle body is flat, so it is also non-magnetic. It is based on the above characteristics of the existing test needles that the inventor cleverly designed the hidden needle double-blind experimental device described in the present invention. This device uses the gravitational force generated between the permanent magnetic ring and the magnetic metal wire to make the friction resistance generated between the inner sleeve and the outer sleeve greater than or equal to the sum of the weights of the inner sleeve and the magnetic metal wire, thereby achieving that the inner sleeve can stay at any position of the outer sleeve in the vertical state. Therefore, the hidden needle double-blind experimental device described in the present invention has the following beneficial effects:

[0021] 1. The placebo needle and the treatment needle share a set of hidden needle double-blind experimental devices of the present invention; this can not only reduce the difficulty of development and production costs, but also improve the convenience of use;

[0022] 2. Since the length of the needle tube can be changed by moving the inner sleeve up and down, and the test needles of different lengths are hidden therein, it is not necessary to customize the device according to the depth of the acupoints to be treated, and it can be directly used with commercially available test needles, and the needle insertion speed can also be freely selected;

[0023] 3. The appearance of the placebo needle and the treatment needle formed by the device is exactly the same. It not only has a good shielding effect, but also is easy to insert. When inserting the needle, just push the inner sleeve downward with your fingers;

[0024] 4. In the control experiment, the lower end surface of the inner sleeve gave the subjects a relatively obvious pricking sensation, which can cover up the slight pain caused by the acupuncture needle piercing the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figures 1 to 3 This is a schematic diagram of a specific embodiment of the double-blind experimental device for evaluating the efficacy of acupuncture according to the present invention; wherein: Figure 1 For the main view, Figure 2 is a top view, Figure 3 for Figure 2 A-A sectional view, in which the double-dotted line indicates the state where the inner sleeve moves upward.

[0026] Figure 4 and 5 for Figures 1 to 3 The schematic diagram of the structure of the inner sleeve in the embodiment shown, wherein Figure 4 For the main view, Figure 5 for Figure 4 Enlarged view of the B-B section.

[0027] Figure 6 and 7 FIG. 1 is a schematic diagram of the structure of the inner cannula in another specific embodiment of the needle-free double-blind experimental device for evaluating the efficacy of acupuncture according to the present invention, wherein Figure 6 For the main view, Figure 7 for Figure 6 Enlarged view of the C-C section.

[0028] Figure 8 for Figures 1 to 3 The hidden needle double-blind experimental device shown is combined with ordinary needles and control needles to form treatment needles and placebo needles, where (a) is the treatment needle and (b) is the placebo needle.

[0029] Fig. 9 for Figure 8 The treatment needle and the placebo needle are shown in the use state diagram for straight needle insertion, wherein (a) shows the straight needle state of the treatment needle, and (b) shows the straight needle state of the placebo needle. DETAILED DESCRIPTION

[0030] Example 1

[0031] See also Figures 1 to 5 The specific structure of the needle-hidden double-blind experimental device of this embodiment is as follows:

[0032] The needle tube described in the device is composed of an outer sleeve 2 and an inner sleeve 1 inserted therein, and the inner wall of the outer sleeve 2 is gap-matched with the outer wall of the inner sleeve 1, wherein the inner diameter of the inner sleeve 1 can be determined according to the maximum diameter of the needle handle of the test needle to ensure that it can move freely up and down in the inner sleeve 1; wherein the outer sleeve 2 and the inner sleeve 1 are both medical opaque PVC plastics;

[0033] The outer sleeve 2 is provided with a permanent magnetic ring 7 on the head cover, and the upper end surfaces of the two are flush; the inner wall of the inner sleeve 1 is provided with a magnetic conductive wire 8 made of galvanized iron wire along the length direction, and the two ends are flush; in a vertical state, the attraction generated between the permanent magnetic ring 7 and the magnetic conductive wire 8 makes the outer wall of the inner sleeve 1 attached to the inner wall of the outer sleeve 2, and the friction resistance generated between the two is greater than or equal to the sum of the weights of the inner sleeve 1 and the magnetic conductive wire 8, and the length of the inner sleeve 1 is greater than the length of the outer sleeve 2;

[0034] The base 3 is disc-shaped, and the upper part shrinks inward to form a regular hexagon; the lower surface of the base 3 is provided with a circular adhesive sheet 4 of the same diameter as the base 3, and a circular hole penetrating up and down is provided in the bodies of the two along the central axis; the lower end of the outer sleeve 2 is fixed in the circular hole provided in the base 3 and the circular adhesive sheet 4, and the lower end surface is flush with the lower surface of the circular adhesive sheet 4, and the upper end surface extends out of the base 3;

[0035] The circular adhesive sheet 4 is made of a PE foam double-sided tape, and a disc-shaped easy-tear protective sticker 5 is pasted on its lower surface. An easy-tear lug 6 extends outward from the circumference of the easy-tear protective sticker 5.

[0036] See also Figures 1 to 5 The permanent magnet ring 7 in this example is made of ferrite magnetic material and is bonded and fixed to the upper end of the outer sleeve 2 with a medical adhesive.

[0037] See also Figures 1 to 5 , although there is a matching gap between the outer sleeve 2 and the inner sleeve 1, under the action of the magnetic force between the permanent magnetic ring 7 and the magnetic wire 8, the outer wall of the inner sleeve 1 will inevitably adhere to the outer wall of the outer sleeve 2; at the same time, under the gravity of the outer sleeve 1 and the magnetic wire 8, the inner sleeve 1 has a tendency to slide downward, so there must be friction resistance between the contact surfaces of the inner sleeve 1 and the outer sleeve 2. It can be seen that as long as the permanent magnetic ring 7 with appropriate magnetic field force is selected according to the weight of the outer sleeve 1 and the magnetic wire 8, the friction resistance between the inner sleeve 1 and the outer sleeve 2 is sufficient to prevent the inner sleeve 1 from sliding naturally in the outer sleeve 2. Of course, the magnetic field of the permanent magnetic ring 7 should not be too strong, and it is usually appropriate to prevent the inner sleeve 1 from sliding naturally in the outer sleeve 2.

[0038] When evaluating the efficacy of acupuncture, the hidden needle double-blind experimental device described in this embodiment can be used in combination with ordinary needles to form treatment needles, and can be used in combination with control needles to form placebo needles. The composition and use methods of treatment needles and placebo needles are briefly described below.

[0039] 1. See Figure 8 , according to the requirement of the depth of insertion into the human body, an acupuncture needle with a suitable needle body length is selected as the common needle 10; after the common needle 10 is determined, the needle body length of the control needle 11 is determined according to the requirement that the needle body length of the control needle 11 = the needle body length of the common needle 10 - the depth of insertion into the human body; wherein the needle handles of the common needle 10 and the control needle 11 are exactly the same, and both have a handle ring at the upper end;

[0040] 2. See Figure 8 According to step 1 above, select the common needle 10 and the control needle 11 to be used in practice, then take two needle-hiding double-blind experimental devices, put the common needle 10 into the needle tube from one of the needle-hiding double-blind experimental devices, and make the needle head touch the upper surface of the easy-to-tear protective sticker 5, then move the inner sleeve 1 and make its upper end surface flush with the handle ring of the common needle, so as to form a treatment needle (see Figure 8 (a) of Figure );

[0041] The remaining needle-hidden double-blind experimental device is used as a placebo needle, and the control needle 11 is placed in the needle tube. Then the inner sleeve 1 is moved and the height of its upper end surface is equal to the height of the upper end surface of the needle tube in the corresponding treatment needle, so that a placebo needle is formed (see Figure 8 (b) Figure);

[0042] 3. See Fig. 9 , peel off the easy-to-tear protective sticker 5 on the lower surface of the circular adhesive sheet 4 on the treatment needle and the placebo needle (this step can be performed by a nurse who is not involved in the efficacy study), then stick the treatment needle and the placebo needle to the skin of the subject's acupoints respectively, directly press the upper end surface of the inner sleeve 1 in the treatment needle and the placebo needle with your fingers, and push it down until the lower end surface of the two inner sleeves 1 touches the subject's skin; at this time, the head of the ordinary needle 10 directly pierces the human skin 9, while the head of the control needle 11 is only flush with the lower surface of the circular adhesive sheet 4; in this process, although the treatment needle and the placebo needle have a slight pain difference between piercing into the body and not piercing into the body, because the lower end surface of the inner sleeve 1 of both gives the subject a relatively obvious piercing pressure feeling, the above-mentioned slight pain can be covered up by the piercing pressure feeling. This masking effect is also not available in the prior art.

[0043] Example 2

[0044] See also Figure 6 and 7The magnetic conductive wire 8 is made of Permalloy and fixed on the inner wall of the inner sleeve 1 with a medical adhesive.

[0045] The implementation method of this embodiment other than the above is the same as that of Embodiment 1.

[0046] When evaluating the efficacy of acupuncture, how the needle-hidden double-blind experimental device described in this embodiment is used in combination with the test needles to form the treatment needles and the placebo needles and their use methods are also the same as in Example 1.

Claims

1. A double-blind experimental device for evaluating the efficacy of acupuncture, comprising a base and a needle tube vertically arranged at the center thereof, characterized in that: The needle tube is composed of an outer sleeve and an inner sleeve inserted therein, and the inner wall of the outer sleeve is loosely matched with the outer wall of the inner sleeve; a permanent magnetic ring is provided on the head cover of the outer sleeve, and the upper end surfaces of the two are flush; a magnetic conductive wire is provided inside or on the inner wall of the inner sleeve along the length direction, and the two ends are flush; in a vertical state, the gravitational force generated between the permanent magnetic ring and the magnetic conductive wire causes the outer wall of the inner sleeve to adhere to the inner wall of the outer sleeve, and the friction resistance generated between the two is greater than or equal to the sum of the weights of the inner sleeve and the magnetic conductive wire; the outer sleeve and the inner sleeve are both non-transparent medical plastics, and the length of the inner sleeve is greater than the length of the outer sleeve; The base is disc-shaped, and a circular adhesive sheet with the same diameter as the base is provided on its lower surface. A circular hole is provided in the bodies of the two along the central axis and passes through the two upwards and downwards. The lower end of the outer sleeve is fixed in the circular hole, and the lower end surface is flush with the lower surface of the circular adhesive sheet, and the upper end surface extends out of the base. The circular adhesive sheet is made of double-sided adhesive tape, and a disc-shaped easy-tear protective sticker is pasted on its lower surface. An easy-tear lug extends outward from the circumferential surface of the easy-tear protective sticker.

2. A double-blind experimental device for evaluating the efficacy of acupuncture according to claim 1, characterized in that: The upper part of the base shrinks inwardly into a regular hexagon.

3. A double-blind experimental device for evaluating the efficacy of acupuncture according to claim 1 or 2, characterized in that: The magnetic conductive metal wire is iron, silicon steel or Permalloy.

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