The Effect of Yoga in Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yvonne Colgrove, PT, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01963871
First received: October 11, 2013
Last updated: May 22, 2014
Last verified: May 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Kansas:

Primary Outcome Measures:
  • self-perceived pain and disability [ Time Frame: Change in questionnaire scores from baseline to week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 11, 2013
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
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

ClinicalTrials.gov processed this record on July 20, 2014