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Clinical Trials/NCT02260284
NCT02260284
Unknown
Not Applicable

The Effect of Acupuncture in Treating Chronic Low-back Pain

Chengdu PLA General Hospital1 site in 1 country160 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Chengdu PLA General Hospital
Enrollment
160
Locations
1
Primary Endpoint
Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 24 weeks
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chengdu PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yang Min

Ph.D

Chengdu PLA General Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 24 weeks(at 0 week, 12 weeks, 24 weeks)
  • Changes from baseline on short-form 36 health survey (SF-36)(at 0 week, 12 weeks, 24 weeks)
  • Changes from baseline on Visual Analog Scale at 24 weeks(at 0 week, 12 weeks, 24 weeks)

Study Sites (1)

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