NCT01963871

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

October 11, 2013

Last Update Submit

May 22, 2014

Conditions

Keywords

chronic low back painlow back painyoga

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • change in physical function

    Change from baseline to week 24

  • change in immunity

    Change from baseline to week 24

Study Arms (1)

Yoga in Chronic Low Back Pain

EXPERIMENTAL

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

Other: Yoga

Interventions

YogaOTHER

Twice weekly one hour sessions of Hatha Yoga for 12 weeks

Yoga in Chronic Low Back Pain

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • inability to make regular time commitments
  • no transportation means to the scheduled yoga sessions
  • experience with regular practice of yoga within the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 11, 2013

First Posted

October 16, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2014

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations