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Effect of Yoga Vs. Stretching on Chronic Back Pain (YES)

Primary Purpose

Chronic Non-specific Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yoga
Exercise
Self-care book recommendations
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Low Back Pain focused on measuring Chronic Low Back Pain, Yoga

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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 yoga or 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Exercise

Self-care book recommendations

Outcomes

Primary Outcome Measures

Back-related function
Pain

Secondary Outcome Measures

Full Information

First Posted
March 13, 2007
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00447668
Brief Title
Effect of Yoga Vs. Stretching on Chronic Back Pain
Acronym
YES
Official Title
Effect of Yoga Vs. Stretching on Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

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.It will also for physical, psychological and physiological factors associated with improvement in back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Low Back Pain
Keywords
Chronic Low Back Pain, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Description
Exercise
Arm Title
3
Arm Type
Active Comparator
Arm Description
Self-care book recommendations
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Yoga for back pain
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
exercises for back pain
Intervention Type
Behavioral
Intervention Name(s)
Self-care book recommendations
Intervention Description
Self-care book for back pain
Primary Outcome Measure Information:
Title
Back-related function
Time Frame
6 months
Title
Pain
Time Frame
6 months

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 yoga or 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, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Cooperative
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22025101
Citation
Sherman KJ, Cherkin DC, Wellman RD, Cook AJ, Hawkes RJ, Delaney K, Deyo RA. A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain. Arch Intern Med. 2011 Dec 12;171(22):2019-26. doi: 10.1001/archinternmed.2011.524. Epub 2011 Oct 24.
Results Reference
derived
PubMed Identifier
20356395
Citation
Sherman KJ, Cherkin DC, Cook AJ, Hawkes RJ, Deyo RA, Wellman R, Khalsa PS. Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial. Trials. 2010 Mar 31;11:36. doi: 10.1186/1745-6215-11-36.
Results Reference
derived

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Effect of Yoga Vs. Stretching on Chronic Back Pain

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