Acupuncture Combined With Yanqing Zhitong Ointment Acupoint Application in Chronic Non-specific Low Back Pain

NCT ID: NCT05040243

Last Updated: 2022-08-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group

On the basis of conventional acupuncture treatment combined with acupoint application of Yanqing Zhitong Ointment.

Acupuncture point:Weizhong,Shenshu,Dachangshu,Jaji,Ashi Acupoint application:Pain in the lumbar spine, Mingmen, Yaoyangguan, Shenshu (double), Ashi (6 points in total); Within 3 inches beside the spine on both sides of the waist, Shenshu (double), Dachangshu (double), Ashi (6 points in total); 3 inches away from the sides of the spine on both sides of the waist, Shenshu (double), Zhishi (double), Ashi (6 points in total).

Stick to each point 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.

Three times a week( Monday, Wednesday, and Friday). Course of treatment: each course lasts for 2 weeks, a total of 2 courses of continuous treatment.

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.

Control Group

The control group was combined with placebo acupoint application on the basis of conventional acupuncture treatment.

Placebo patch: colored and drug-free patch (composition: petrolatum, food coloring) Acupuncture, application of acupuncture points and treatment course were the same as those in the treatment group.

Group Type SHAM_COMPARATOR

placebo acupoint application

Intervention Type OTHER

The control group was combined with placebo acupoint application on the basis of conventional acupuncture treatment.

Placebo patch: colored and drug-free patch (composition: petrolatum, food coloring) Acupuncture, application of acupuncture points and treatment course were the same as those in the treatment group.

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

placebo acupoint application

The control group was combined with placebo acupoint application on the basis of conventional acupuncture treatment.

Placebo patch: colored and drug-free patch (composition: petrolatum, food coloring) Acupuncture, application of acupuncture points and treatment course were the same as those in the treatment group.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JIAN PEI

Role: PRINCIPAL_INVESTIGATOR

Shanghai University of Traditional Chinese Medicine

Locations

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Longhua Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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JIAN PEI

Role: CONTACT

18917763082

Facility Contacts

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PEI JIAN

Role: primary

18917763082

References

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Maatta JH, Wadge S, MacGregor A, Karppinen J, Williams FM. ISSLS Prize Winner: Vertebral Endplate (Modic) Change is an Independent Risk Factor for Episodes of Severe and Disabling Low Back Pain. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1187-93. doi: 10.1097/BRS.0000000000000937.

Reference Type BACKGROUND
PMID: 25893353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25247896 (View on PubMed)

NIH Consensus Conference. Acupuncture. JAMA. 1998 Nov 4;280(17):1518-24.

Reference Type BACKGROUND
PMID: 9809733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22594099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28192789 (View on PubMed)

Other Identifiers

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ZYCCCX-1006

Identifier Type: -

Identifier Source: org_study_id

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