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.

Condition	Treatment or Intervention	Phase
Low Back Pain	Procedure: acupuncture	Phase III

Further Study Details: 

Expected Total Enrollment:  640

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.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

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)

Janet Erro, RN       erro.j@ghc.org

California
      Kaiser Permanente Northern California, Kaiser Foundation Research Institute, Oakland,  California,  United States; Recruiting
Washington
      Group Health Cooperative, Center for Health Studies, Seattle,  Washington,  United States; Recruiting

Study chairs or principal investigators

Daniel Cherkin, PhD,  Study Director,  Group Health Cooperative Center for Health Studies   
Karen J Sherman, PhD,  Principal Investigator,  Group Health Cooperative Center for Health Studies   
Andy Avins, MD,  Principal Investigator,  Kaiser Foundation Research Institute, Kaiser Permanente Northern California   

Study ID Numbers:  R01 AT001110-01 A1
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  July 28, 2003
ClinicalTrials.gov Identifier:  NCT00065585
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08