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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-06-30

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.

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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.

Conditions

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Non-specific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Acupoint application with Yanqing Zhitong Ointment

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

Group Type EXPERIMENTAL

Yanqing Zhitong Ointment Acupoint application

Intervention Type OTHER

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.

Acupuncture

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

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

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.

Interventions

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Yanqing Zhitong Ointment Acupoint application

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.

Intervention Type OTHER

Acupuncture

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with non-specific low back pain
2. Aage from 18 to 65
3. VAS between 4 and 7
4. No other treatment in the past 3 months
5. No other simultaneous relevant treatment
6. Voluntarily joining this study with informed consents

Exclusion Criteria

1. Pregnant women
2. With skin ulcers or contusion wounds
3. Past history of severe allergy to transdermal preparations
4. Complicated with serious diseases

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No