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
  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: Accupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture for Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Estimated Enrollment: 640
Study Start Date: April 2004
Study Completion Date: June 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Placebo Comparator: non needle control
Sham Comparator: Acupuncture - Standardized Points Procedure: Accupuncture
Experimental: Accupunture - Experimental Points Procedure: Accupuncture

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Group Health Cooperative
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00065585     History of Changes
Other Study ID Numbers: U01 AT001110, U01AT001110
Study First Received: July 28, 2003
Last Updated: February 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:
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 August 28, 2014