- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00065585
Efficacy of Acupuncture for Chronic Low Back Pain
October 3, 2019 updated by: Kaiser Permanente
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.
Study Overview
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 Type
Interventional
Enrollment
640
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Oakland, California, United States
- Kaiser Permanente Northern California, Kaiser Foundation Research Institute
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Washington
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Seattle, Washington, United States
- Group Health Cooperative, Center for Health Studies
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Usual care
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Placebo Comparator: non needle control
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Sham Comparator: Acupuncture - Standardized Points
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Experimental: Accupunture - Experimental Points
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cherkin DC, Sherman KJ, Hogeboom CJ, Erro JH, Barlow WE, Deyo RA, Avins AL. Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial. Trials. 2008 Feb 28;9:10. doi: 10.1186/1745-6215-9-10.
- Cherkin DC, Sherman KJ, Avins AL, Erro JH, Ichikawa L, Barlow WE, Delaney K, Hawkes R, Hamilton L, Pressman A, Khalsa PS, Deyo RA. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch Intern Med. 2009 May 11;169(9):858-66. doi: 10.1001/archinternmed.2009.65.
- Sherman KJ, Hawkes RJ, Ichikawa L, Cherkin DC, Deyo RA, Avins AL, Khalsa PS. Comparing recruitment strategies in a study of acupuncture for chronic back pain. BMC Med Res Methodol. 2009 Oct 27;9:69. doi: 10.1186/1471-2288-9-69.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
July 28, 2003
First Submitted That Met QC Criteria
July 30, 2003
First Posted (Estimate)
July 31, 2003
Study Record Updates
Last Update Posted (Actual)
October 7, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01AT001110 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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