NCT00447668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

March 13, 2007

Last Update Submit

October 11, 2017

Conditions

Keywords

Chronic Low Back PainYoga

Outcome Measures

Primary Outcomes (2)

  • Back-related function

    6 months

  • Pain

    6 months

Study Arms (3)

1

EXPERIMENTAL
Behavioral: Yoga

2

ACTIVE COMPARATOR

Exercise

Behavioral: Exercise

3

ACTIVE COMPARATOR

Self-care book recommendations

Behavioral: Self-care book recommendations

Interventions

YogaBEHAVIORAL

Yoga for back pain

1
ExerciseBEHAVIORAL

exercises for back pain

2

Self-care book for back pain

3

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

YogaExercise

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karen J. Sherman, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2011

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations