Evaluating Yoga for Chronic Low Back Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

March 7, 2003

Last Updated Date

August 17, 2006

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00056212 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Behavioral: Yoga
Behavioral: Exercise

Study Arms / Comparison Groups

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

October 2004

Primary Completion Date

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

Gender

Both

Ages

20 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00056212

Responsible Party

Study ID Numbers ^ICMJE

R21 AT001215-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Karen J. Sherman, Ph.D.

Center for Health Studies, Group Health Cooperative

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

July 2006

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