Low Back Pain Clinical Trial
Official title:
The Effect of Acupuncture in Treating Chronic Low-back Pain
Verified date | December 2017 |
Source | Chengdu PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficiency of acupuncture in treating chronic low-back pain
Status | Enrolling by invitation |
Enrollment | 160 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | General Hospital of Chengdu Military Area Command PLA | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Chengdu PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline on modified Roland-Morris Disability Questionnaire (RMDQ) at 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 | Changes from baseline on Diagnosis and Curative Effect Standard for Syndrome of TCM for CLBP at 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 | |
Secondary | Changes from baseline on short-form 36 health survey (SF-36) | Physical and mental health component summary scores of the medical outcomes | at 0 week, 12 weeks, 24 weeks | |
Secondary | Changes from baseline on Visual Analog Scale at 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 |
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