The Effect of Yoga in Chronic Low Back Pain

Study Overview
=================
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

Official Title
-----------------
The Effect of Yoga in Chronic Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Yoga


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-perceived pain and disability | 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 | 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 | measured by serum immune markers | Change from baseline to week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic low back pain, low back pain, yoga