Evaluating Yoga for Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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
Sites / Locations
- Group Health Cooperative
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00056212
First Posted
March 7, 2003
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00056212
Brief Title
Evaluating Yoga for Chronic Low Back Pain
Official Title
Evaluating Yoga for Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Type
Behavioral
Intervention Name(s)
Exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J. Sherman, Ph.D.
Organizational Affiliation
Center for Health Studies, Group Health Cooperative
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Cooperative
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16365466
Citation
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. doi: 10.7326/0003-4819-143-12-200512200-00003.
Results Reference
result
Learn more about this trial
Evaluating Yoga for Chronic Low Back Pain
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