The Effect of Yoga in Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effect of Yoga in Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963871
• Other study ID #: 13763
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: May 22, 2014
• Start date: August 2013

Study information

• Verified date: May 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Yoga
Twice weekly one hour sessions of Hatha Yoga for 12 weeks

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Yvonne Colgrove, PT, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	change in immunity	measured by serum immune markers	Change from baseline to week 24	No