The Effect of Acupuncture in Treating Chronic Low-back Pain

December 5, 2017 updated by: Yang Min, Chengdu PLA General Hospital
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We want to know if the Yaotong points penetration or standardized acupuncture mode are more effective than medical care alone for CLBP; and if Yaotong points penetration is more effective than standardized acupuncture.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610083
        • General Hospital of Chengdu Military Area Command PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • with CLBP
  • without taking any other medication for the treatment of CLBP in at least 2 last weeks;
  • aged from 18 to 50 years;
  • without conflict to the written, informed consent signed prior to the enrollment.

Exclusion Criteria:

  • pathological causes of chronic back pain (such as fractures, cancer, spinal stenosis and infections);
  • complicated back problems (such as scoliologic >40° curvature, chronic spondylitis, sciatica, prior back surgery and other medicolegal issues);
  • with contraindications for acupuncture (e.g., cardiac pacemakers, coagulation disfunctions, being in pregnancy, seizure disorder);
  • conditions making treatment difficult (e.g., paralysis, psychoses);
  • conditions that might confound treatment effects or interpretation of results (e.g., severe fibromyalgia, rheumatoid arthritis, concurrent care from other providers);
  • previous acupuncture treatment for any condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yaotong points acupuncture
patients under the treatment of Yaotong ponts penetration mode
Other: Yaotong points acupuncture
Patients receive the treatments of Yaotong points penetration
Active Comparator: standardized acupuncture
patients under the treatment of standardized acupuncture
Other: standardized acupuncture
Patients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg.
Other: the usual care
In the usual care group, participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS)).
Other: the usual care
participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
Time Frame: at 0 week, 12 weeks, 24 weeks
This wellvalidated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
at 0 week, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks
Time Frame: at 0 week, 12 weeks, 24 weeks
It includes curing standard, referring to LBP had disappeared and no difficulty in movement was found; effective standard, referring to the pain was relieved but slight discomfort was found; and ineffective standard, referring to no symptom improvement was found.
at 0 week, 12 weeks, 24 weeks
Changes from baseline on short-form 36 health survey (SF-36)
Time Frame: at 0 week, 12 weeks, 24 weeks
Physical and mental health component summary scores of the medical outcomes
at 0 week, 12 weeks, 24 weeks
Changes from baseline on Visual Analog Scale at 24 weeks
Time Frame: at 0 week, 12 weeks, 24 weeks
This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no painat all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain
at 0 week, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014LBP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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