Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain

Study Overview
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Brief Summary
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This is a non-inferiority randomized controlled trial, recruiting 150 patients with chronic non-specific low back pain. The patients will be randomly assigned either to Yanqing Zhitong Ointment acupoint application group (Treatment Group) or the acupuncture group (Control Group) in a 1:1 ratio.

Detailed Description
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This is a non-inferiority randomized controlled trial, 150 patients with chronic non-specific low back pain were randomly assigned to acupoint application group and acupuncture group in a 1:1 ratio. The main acupoints are Ashi points, Shenshu(BL23), Guanyuanshu(BL26). The primary outcome measure is the change of McGill Pain Questionnaire (MPQ) before and after treatment.

Official Title
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Effect of Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain: a Non-inferiority Randomized Controlled Trial

Conditions
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Non-specific Low Back Pain

Intervention / Treatment
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* Other: Yanqing Zhitong Ointment Acupoint application
* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with non-specific low back pain Aage from 18 to 65 VAS between 4 and 7 No other treatment in the past 3 months No other simultaneous relevant treatment Voluntarily joining this study with informed consents Exclusion Criteria: Pregnant women With skin ulcers or contusion wounds Past history of severe allergy to transdermal preparations Complicated with serious diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupoint application with Yanqing Zhitong Ointment<br>Acupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Stick to each acupoint for about 4 hours. If there is a burning sensation or obvious itching or other discomfort on the part after application, it can be removed in advance. Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks | Other: Yanqing Zhitong Ointment Acupoint application<br>* Yanqing Zhitong Ointment is a traditional external preparation of experiential prescription, which is an extract made by water extraction and concentration of Qingfengteng, Corydalis yanhusuo, Interleukin, Kansui, Asarum, etc. Clinical studies in the past ten years have preliminarily shown that it has the effects of warming meridians, promoting blood circulation, dredging collaterals and relieving pain, and has a definite effect.<br>|
| Active Comparator: Acupuncture<br>Acupoint selection: Ashi points, Shenshu (BL23), Guanyuanshu (BL26) Operation: Disposable stainless steel needles (0.25mm×25mm) are used. The needles are retained for 20 mins afte Deqi. Treatment Duration: Three times a week( Monday, Wednesday, and Friday), for four weeks | Other: Acupuncture<br>* The main acupoints are Ashi points, Shenshu (BL23), Guanyuanshu (BL26). There are three sessions per week with each session lasting for 20 min. There will be 4 weeks of treatment for each participant in total.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill pain questionnaire | MPQ is a multi-factor pain score scale, which establishes a three-dimensional structure of the nature of pain. MPQ has a higher evaluation dimension and can evaluate the multi-dimensional factors of pain. The higher the score, the more severe the pain. | Change from baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill pain questionnaire | MPQ is a multi-factor pain score scale, which establishes a three-dimensional structure of the nature of pain. MPQ has a higher evaluation dimension and can evaluate the multi-dimensional factors of pain. The higher the score, the more severe the pain. | Change from baseline to Week 8 (follow-up) | 
| Oswestry Dysfunction Index (ODI) | ODI is a self-evaluation scale for dysfunction of patients with low back pain. It consists of 10 aspects including pain degree, personal living ability (washing, dressing), lifting, walking, sitting, standing, sleep influence, sex life, social activities and travel. Each aspect covers 6 options, with points ranging from 0 to 5 points. The lowest score indicates no abnormal dysfunction, and the highest score indicates severe dysfunction. The corresponding candidate content scores are added up in turn according to the scores, and the percentage of the total score in the highest score (50 points) of all content is obtained, which is called the Oswe-stry dysfunction index. | Change from baseline to Week 4 and Week 8 | 
| Item Short Form Health Survey (SF-36) | SF-36 is currently one of the most widely used universal health-related quality of life measurement tools in the world. SF-36 covers 8 dimensions for assessing health-related quality of life and a total of 36 content items. Each dimension includes: physical function (PF), role physical (RP), bodily pain (BP), General health (GH), vitality (VT), social function (SF), role-emotional (RE) and mental health (MH). SF-36 first calculates the original scores of the eight dimensions, and then obtains the final score after corresponding conversion. The final score is 0-100 points. The higher the final score, the better the health of the testee. | Change from baseline to Week 4 and Week 8 | 
| Tenderness threshold | Use the digital pressure pain meter to measure the pressure pain threshold of soft tissues and muscles, and conduct an objective and quantitative assessment of pain. It is used for auxiliary diagnosis and scientific research of pain in muscles and tendons. | Change from baseline to Week 4 and Week 8 |