Efficacy of Acupuncture for Chronic Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2007 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Center for Complementary and Alternative Medicine (NCCAM)

ClinicalTrials.gov Identifier:

NCT00065585

First received: July 28, 2003

Last updated: October 1, 2007

Last verified: October 2007

History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Back Pain

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	640
Study Start Date:	April 2004
Estimated Study Completion Date:	January 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065585

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

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

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

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):

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.

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.

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

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