The Effect of Yoga in Chronic Low Back Pain

May 22, 2014 updated by: Yvonne Colgrove, PT, PhD
The purpose of this study is to determine if yoga is an effective intervention in treating individuals with chronic low back pain (LBP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic LBP is a major public health problem associated with functional and psychological disability. Conservative interventions are often prescribed to people suffering from chronic LBP, but alternative interventions like yoga are not well researched. The regulator practice of yoga may improve pain, disability or quality of life in people with chronic LBP.

Study participation will last approximately 24 weeks. Yoga sessions will last 12 weeks for 2 one hour sessions per week

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a history of chronic LBP with degenerative joint or disc disease > than 3 months (47-48)
  • present with at least minimal pain (3 out on a 0 - 10 pain scale where 0 = no pain, 10 = maximum pain imaginable)
  • disability (30% or more per Oswestry Disability Scale),
  • score more than 24 on the Folstein Mini-Mental State Exam
  • English comprehending individuals naïve to structured yoga practice

Exclusion Criteria:

  • known current pregnancy
  • claustrophobia
  • glaucoma
  • significant or chronic decline in immune function such as reported immune related diagnosis like pneumonia or systemic infection
  • LBP resulting from something other than disc or joint disease
  • spinal stenosis, spinal fusion or other orthopedic surgery in the past six months
  • mental disease/psychosis such as dementia
  • prior history of chronic neurological disorders (e.g. stroke, Parkinson's disease, multiple sclerosis)
  • fibromyalgia
  • radiculopathy
  • standard MRI exclusion criteria
  • inability to make regular time commitments
  • no transportation means to the scheduled yoga sessions
  • experience with regular practice of yoga within the past year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga in Chronic Low Back Pain
12 weeks of no yoga followed by 12 weeks of yoga, 2 times per week for individuals with chronic low back pain
Other: Yoga
Twice weekly one hour sessions of Hatha Yoga for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-perceived pain and disability
Time Frame: Change in questionnaire scores from baseline to week 24
perceived pain and disability as measured by the standard questionnaires of Numeric Rating Scale and Oswestry Disability Scale
Change in questionnaire scores from baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in physical function
Time Frame: Change from baseline to week 24
measured by changes in scores on standard tests of core strength, spinal range of motion and muscular flexibility
Change from baseline to week 24
change in immunity
Time Frame: Change from baseline to week 24
measured by serum immune markers
Change from baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yvonne Colgrove, PT, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

October 11, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13763

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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