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The Effect of Yoga in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Yvonne Colgrove, PT, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring chronic low back pain, low back pain, yoga

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga in Chronic Low Back Pain

Arm Description

12 weeks of no yoga followed by 12 weeks of yoga, 2 times per week for individuals with chronic low back pain

Outcomes

Primary Outcome Measures

self-perceived pain and disability
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
measured by changes in scores on standard tests of core strength, spinal range of motion and muscular flexibility
change in immunity
measured by serum immune markers

Full Information

First Posted
October 11, 2013
Last Updated
May 22, 2014
Sponsor
Yvonne Colgrove, PT, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT01963871
Brief Title
The Effect of Yoga in Chronic Low Back Pain
Official Title
The Effect of Yoga in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yvonne Colgrove, PT, PhD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if yoga is an effective intervention in treating individuals with chronic low back pain (LBP).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
chronic low back pain, low back pain, yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga in Chronic Low Back Pain
Arm Type
Experimental
Arm Description
12 weeks of no yoga followed by 12 weeks of yoga, 2 times per week for individuals with chronic low back pain
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Twice weekly one hour sessions of Hatha Yoga for 12 weeks
Primary Outcome Measure Information:
Title
self-perceived pain and disability
Description
perceived pain and disability as measured by the standard questionnaires of Numeric Rating Scale and Oswestry Disability Scale
Time Frame
Change in questionnaire scores from baseline to week 24
Secondary Outcome Measure Information:
Title
change in physical function
Description
measured by changes in scores on standard tests of core strength, spinal range of motion and muscular flexibility
Time Frame
Change from baseline to week 24
Title
change in immunity
Description
measured by serum immune markers
Time Frame
Change from baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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The Effect of Yoga in Chronic Low Back Pain

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