The Effect of Acupuncture in Treating Chronic Low-back Pain

Not Applicable

• Conditions: Ankylosing Spondylitis; Low Back Pain
• Interventions: Other: Yaotong points acupuncture; Other: standardized acupuncture; Other: the usual care

• Registration Number: NCT02260284
• Lead Sponsor: Chengdu PLA General Hospital

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-06
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yaotong points acupuncture	Yaotong points acupuncture	patients under the treatment of Yaotong ponts penetration mode
standardized acupuncture	standardized acupuncture	patients under the treatment of standardized acupuncture
the usual care	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)).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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.
Changes from baseline on short-form 36 health survey (SF-36)	at 0 week, 12 weeks, 24 weeks	Physical and mental health component summary scores of the medical outcomes
Changes from baseline on Visual Analog Scale at 24 weeks	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

Trial Locations

Locations (1)

General Hospital of Chengdu Military Area Command PLA; 🇨🇳 Chengdu, Sichuan, China