Clinical trial NCT06102291: Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain
Official title: Effect of Acupoint Application With Yanqing Zhitong Ointment for Chronic Non-specific Low Back Pain: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-specific Low Back Pain
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: McGill pain questionnaire
timeFrame: Change from baseline to Week 4
Secondary outcomes:
measure: McGill pain questionnaire
timeFrame: Change from baseline to Week 8 (follow-up)
measure: Oswestry Dysfunction Index (ODI)
timeFrame: Change from baseline to Week 4 and Week 8
measure: Item Short Form Health Survey (SF-36)
timeFrame: Change from baseline to Week 4 and Week 8
measure: Tenderness threshold
timeFrame: Change from baseline to Week 4 and Week 8
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Yijun Zhan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.