Efficacy of Acupuncture for Chronic Low Back Pain
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Procedure: acupuncture |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | Efficacy of Acupuncture for Chronic Low Back Pain |
| Estimated Enrollment: | 640 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | January 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, California | |
| Kaiser Permanente Northern California, Kaiser Foundation Research Institute | |
| Oakland, California, United States | |
| United States, Washington | |
| Group Health Cooperative, Center for Health Studies | |
| Seattle, Washington, United States | |
| 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 |
More Information
No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00065585 History of Changes |
| Other Study ID Numbers: | U01 AT001110 |
| Study First Received: | July 28, 2003 |
| Last Updated: | October 1, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
low back pain acupuncture |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013