Clinical trial NCT05040243: Acupuncture Combined With Yanqing Zhitong Ointment Acupoint Application in Chronic Non-specific Low Back Pain
Official title: A Randomized Controlled Double-blind Study of Acupuncture Combined With Yanqing Zhitong Ointment Acupoint Application in the Treatment of Chronic Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-specific Low Back Pain
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 86
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: Carry out a randomized controlled double-blind study, the acupuncture combined with placebo application group was compared with the acupuncture combined with Yanqing Zhitong ointment acupoint application group, 86 patients with chronic non-specific low back pain were included.

Detailed description: Treatment group(acupuncture combined with Yanqing Zhitong ointment acupoint sticking) Acupoints for manual acupuncture:Weizhong(BL40), Shenshu(BL23) ,Dachangshu(BL25) ,Geshu(BL17) ,Kunlun(BL60) ,Ashi point Acupoints for sticking:According to the location of pain, we select acupuncture points along the meridian

Controal group(acupuncture combined with placebo application) Interventions are same as Treatment Group.

Both groups were treated 3 times a week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Diagnostic of non-specific low back pain
2. Aage from 18 to 65
3. Last for at least 12 weeks
4. VAS between 4 and 7
5. No other treatment in the past 3 months
6. Patients with no partial skin damage
7. No other relevant treatment methods
8. Sign informed consent and informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Lumbar JOA Scale
timeFrame: Change from baseline JOA at 4weeks
Secondary outcomes:
measure: Lumbar JOA Scale
timeFrame: Change from baseline JOA at 2weeks and follow up 2weeks
measure: Visual Analog Scoring (VAS)
timeFrame: Change from baseline VAS at 2weeks ,4 weeks and follow up 2weeks
measure: Oswestry Dysfunction Index (ODI)
timeFrame: Change from baseline ODI at 2weeks ,4 weeks and follow up 2weeks
measure: McGill Pain Questionnaire (MPQ)
timeFrame: Change from baseline MPQ at 2weeks ,4 weeks and follow up 2weeks
measure: Concise health scale SF-36
timeFrame: Change from baseline SF-36 at 2weeks ,4 weeks and follow up 2weeks
measure: Tenderness threshold
timeFrame: Change from baseline tenderness threshold at 2weeks ,4 weeks and follow up 2weeks
measure: Averaged electromyography, AEMG
timeFrame: Change from baseline AEMG at 2weeks ,4 weeks and follow up 2weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: JIAN PEI
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Garcia JB, Hernandez-Castro JJ, Nunez RG, Pazos MA, Aguirre JO, Jreige A, Delgado W, Serpentegui M, Berenguel M, Cantemir C. Prevalence of low back pain in Latin America: a systematic literature review. Pain Physician. 2014 Sep-Oct;17(5):379-91.
citation: NIH Consensus Conference. Acupuncture. JAMA. 1998 Nov 4;280(17):1518-24.
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.
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.