NCT05040243

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 2, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

June 17, 2021

Last Update Submit

August 1, 2022

Conditions

Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Lumbar JOA Scale

    The JOA scale for low back pain consists of the patient's subjective symptoms (0-9 points), clinical signs (0-6 points), daily activity limitation (0-24 points) and bladder function (normal 0 points, slight loss of control-3 points, severe loss of control) -6 points) Four parts, a total score of 29 points. The total score reflects the symptoms and dysfunction of low back pain, and the score indicates the severity of the dysfunction.

    Change from baseline JOA at 4weeks

Secondary Outcomes (7)

  • Lumbar JOA Scale

    Change from baseline JOA at 2weeks and follow up 2weeks

  • Visual Analog Scoring (VAS)

    Change from baseline VAS at 2weeks ,4 weeks and follow up 2weeks

  • Oswestry Dysfunction Index (ODI)

    Change from baseline ODI at 2weeks ,4 weeks and follow up 2weeks

  • McGill Pain Questionnaire (MPQ)

    Change from baseline MPQ at 2weeks ,4 weeks and follow up 2weeks

  • Concise health scale SF-36

    Change from baseline SF-36 at 2weeks ,4 weeks and follow up 2weeks

  • +2 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Other: Yanqing Zhitong Ointment Acupoint application

Control Group

SHAM COMPARATOR

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.

Other: placebo acupoint application

Interventions

Yanqing Zhitong Ointment Acupoint applicationOTHER

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.

Treatment Group
placebo acupoint applicationOTHER

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.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital

Shanghai, 200032, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 25893353BACKGROUND

  • 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.

    PMID: 25247896BACKGROUND

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

    PMID: 9809733BACKGROUND

  • 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: 22594099BACKGROUND

  • 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: 28192789BACKGROUND

Study Officials

  • JIAN PEI

    Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JIAN PEI

CONTACT

18917763082longhuaacup@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

September 10, 2021

Study Start

July 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

August 2, 2022

Record last verified: 2022-08

Locations

CN(1)