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

NCT06102291 | Active Not Recruiting

• 1 other identifier: YD202218
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• McGill pain questionnaire

  Change from baseline to Week 8 (follow-up)

• Oswestry Dysfunction Index (ODI)

  Change from baseline to Week 4 and Week 8

• Item Short Form Health Survey (SF-36)

  Change from baseline to Week 4 and Week 8

• Tenderness threshold

  Change from baseline to Week 4 and Week 8

Study Arms (2)

Acupoint application with Yanqing Zhitong Ointment

EXPERIMENTAL

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

Acupuncture

ACTIVE COMPARATOR

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

Interventions

Yanqing Zhitong Ointment Acupoint application 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.

Acupoint application with Yanqing Zhitong Ointment

Acupuncture 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.

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• With skin ulcers or contusion wounds
• Past history of severe allergy to transdermal preparations
• Complicated with serious diseases

Sponsors & Collaborators

• ZhanYJ: lead

Study Sites (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, 200032, China

Location

Related Publications (2)

• Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.

  PMID: 28192789 BACKGROUND

• Wen BL, Liu BY, Jin P, Wang XF, Xiang XX, Liu XF, Hu JQ, Lu F, He LY, Zhu WZ, Fang YG, Wang Y. Clinical research of acupoint application for "treatment of winter disease in summer" used to prevent and treat bronchial asthma in children. J Tradit Chin Med. 2012 Mar;32(1):31-9.

  PMID: 22594099 BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yijun Zhan

  Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai University of Traditional Chinese Medicine

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: July 1, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)