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The Effect of Yoga in Chronic Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01963871
First Posted: October 16, 2013
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yvonne Colgrove, PT, PhD, University of Kansas Medical Center Research Institute
  Purpose
The purpose of this study is to determine if yoga is an effective intervention in treating individuals with chronic low back pain (LBP).

Condition Intervention
Low Back Pain Other: Yoga

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Yoga in Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Yvonne Colgrove, PT, PhD, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 in immunity [ Time Frame: Change from baseline to week 24 ]
    measured by serum immune markers


Estimated Enrollment: 10
Study Start Date: August 2013
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963871


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Yvonne Colgrove, PT, PhD
  More Information

Responsible Party: Yvonne Colgrove, PT, PhD, Clinical Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01963871     History of Changes
Other Study ID Numbers: 13763
First Submitted: October 11, 2013
First Posted: October 16, 2013
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Yvonne Colgrove, PT, PhD, University of Kansas Medical Center Research Institute:
chronic low back pain
low back pain
yoga

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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