The Effect of Acupuncture in Treating Chronic Low-back Pain

Chengdu PLA General Hospital160 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

160

Conditions

Ankylosing Spondylitis Low Back Pain

Interventions

Yaotong points acupunctureOTHER

Patients receive the treatments of Yaotong points penetration

the usual careOTHER

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))

standardized acupunctureOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

General Hospital of Chengdu Military Area Command PLA

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

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.

Time frame: at 0 week, 12 weeks, 24 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: at 0 week, 12 weeks, 24 weeks

Data from ClinicalTrials.gov

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