Efficacy of Acupuncture for Chronic Low Back Pain

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Accupuncture

• Registration Number: NCT00065585
• Lead Sponsor: Kaiser Permanente

Brief Summary

This is a trial to clarify the extent to which acupuncture needling can diminish the effect of chronic back pain on patient functioning and symptoms.

Detailed Description

This is a 4-arm multi-site randomized controlled trial to clarify the extent to which various types of acupuncture needling can diminish the effect of chronic low back pain on patient functioning and symptoms. Reviews have noted the poor quality of research in this area and urged that scientifically rigorous studies be conducted. Recent higher quality trials suggest acupuncture is a promising treatment for back pain. This study directly addresses methodological shortcomings that have plagued previous studies. A total of 640 subjects (160 per arm) with low back pain lasting at least 3 months will be recruited from group model HMOs in Seattle, WA and Oakland, CA. They will be randomized to one of three different methods of stimulation of acupuncture or to continue usual medical care. Ten treatments will be provided over 7 weeks. The primary outcomes, dysfunction and bothersomeness of low back pain, will be measured at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment. Analysis of covariance within an intention-to-treat context will be used to analyze the data. Because chronic back pain is a major public health problem and the top reason patients seek acupuncture treatment, a clear, unambiguous assessment is critical for making informed decisions about whether acupuncture should be included as part of conventional care for back pain or covered by insurance. Results of this study will provide the clearest evidence to date about the value of acupuncture needling as a treatment for chronic low back pain.

Study Timeline

• Study First Submitted: 2003-07-28
• Study First Submitted QC: 2003-07-30
• Study First Posted: 2003-07-31
• Study Start: 2004-04
• Primary Completion: 2006-09
• Study Completion: 2007-06
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture - Standardized Points	Accupuncture	-
Accupunture - Experimental Points	Accupuncture	-
non needle control	Accupuncture	-

Trial Locations

Locations (2)

Kaiser Permanente Northern California, Kaiser Foundation Research Institute; 🇺🇸 Oakland, California, United States

Group Health Cooperative, Center for Health Studies; 🇺🇸 Seattle, Washington, United States