The Effect of Acupuncture in Treating Chronic Low-back Pain

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

Detailed Description
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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.

Official Title
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The Effect of Acupuncture in Treating Chronic Low-back Pain

Conditions
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Ankylosing Spondylitis, Low Back Pain

Intervention / Treatment
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* Other: Yaotong points acupuncture
* Other: the usual care
* Other: standardized acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yaotong points acupuncture<br>patients under the treatment of Yaotong ponts penetration mode | Other: Yaotong points acupuncture<br>* Patients receive the treatments of Yaotong points penetration<br>|
| Active Comparator: standardized acupuncture<br>patients under the treatment of standardized acupuncture | Other: standardized acupuncture<br>* 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.<br>|
| Other: the usual care<br>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<br>* 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))<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 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) | 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 | 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 |