Efficacy of Acupuncture for Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00065585
First received: July 28, 2003
Last updated: February 25, 2014
Last verified: February 2014

July 28, 2003
February 25, 2014
April 2004
September 2006   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00065585 on ClinicalTrials.gov Archive Site
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Efficacy of Acupuncture for Chronic Low Back Pain
Efficacy of Acupuncture for Chronic Low Back Pain

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
Procedure: Accupuncture
  • No Intervention: Usual care
  • Placebo Comparator: non needle control
  • Sham Comparator: Acupuncture - Standardized Points
    Intervention: Procedure: Accupuncture
  • Experimental: Accupunture - Experimental Points
    Intervention: Procedure: Accupuncture

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
640
June 2007
September 2006   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Diagnosis of low back pain including lumbago, unspecified backache, sprains and strains of sacroiliac, lumbar, sacral, or unspecified regions of the spine
  • Back pain must be of at least 3 months duration and rated at least 3 on a symptom bothersomeness scale

Exclusion criteria:

  • non-mechanical causes or potential causes of low back pain (i.e. sciatica, underlying systemic or visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer or unexplained weight loss, recent vertebral fracture)
  • previous treatment with acupuncture
  • inappropriate candidate for acupuncture (i.e. severe clotting disorders or on anticoagulant medication, heart pacemakers)
  • characteristics complicating the interpretation of the findings (severe or progressive neurologic deficits, back surgery within the prior three years, planning to seek other treatment for back pain)
  • characteristics related to ability to complete the study protocol (unable to speak English, plans to move out of town)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065585
U01 AT001110, U01AT001110
Yes
Group Health Cooperative
Group Health Cooperative
National Center for Complementary and Alternative Medicine (NCCAM)
Study Director: Daniel Cherkin, PhD Group Health Cooperative Center for Health Studies
Principal Investigator: Karen J Sherman, PhD Group Health Cooperative Center for Health Studies
Principal Investigator: Andy Avins, MD Kaiser Foundation Research Institute, Kaiser Permanente Northern California
Group Health Cooperative
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP