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Evaluating Yoga for Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00056212
Recruitment Status : Completed
First Posted : March 10, 2003
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE March 7, 2003
First Posted Date  ICMJE March 10, 2003
Last Update Posted Date August 18, 2006
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Yoga for Chronic Low Back Pain
Official Title  ICMJE Evaluating Yoga for Chronic Low Back Pain
Brief Summary This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.
Detailed Description

Back problems are among the most prevalent conditions affecting adults and are a leading reason for using complementary or alternative medical (CAM) therapies. Despite the common use of CAM therapies for back pain, little is known about how they compare with conventional treatments. This study will lay the groundwork for a full-scale trial that compares yoga with conventional exercise and usual care for chronic low back pain.

This study will randomize 30 people with chronic low back pain to each of the following groups: yoga, a conventional therapeutic exercise program, and usual care. There will be 12 weeks of weekly treatment and follow-up assessments via phone at 6, 12, and 26 weeks to measure each treatment's impact on symptoms, function, quality of life, and utilization and costs of back pain related care.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Behavioral: Yoga
  • Behavioral: Exercise
Study Arms  ICMJE Not Provided
Publications * Sherman KJ, Cherkin DC, Erro J, Miglioretti DL, Deyo RA. Comparing yoga, exercise, and a self-care book for chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2005 Dec 20;143(12):849-56.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Group Health Cooperative enrollee
  • Uncomplicated low back pain
  • At least moderate pain levels

Exclusion criteria:

  • Sciatica persisting 3 or more months after physician visit
  • History of cancer (other than nonmelanoma skin cancer)
  • Severe disk problems
  • Unstable medical conditions
  • Back surgery within past 3 years
  • Physically unable to do the yoga or exercise classes and homework
  • Unable to attend classes
  • Currently doing yoga
  • Taken exercise class for back pain within past year
  • Currently in litigation for back pain
  • Seeking other treatment for back pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00056212
Other Study ID Numbers  ICMJE R21AT001215-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen J. Sherman, Ph.D. Center for Health Studies, Group Health Cooperative
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP