The Effect of Yoga Practice on Chronic Back Pain
A Prospective, Randomized-controlled Study to Evaluate the Effect of a Standardized Yoga Practice on Chronic Back Pain
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Erich Anderer, MD
- Phone Number: (718) 630-6580
- Email: erich.anderer@nyulangone.org
Study Locations
-
-
New York
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New York, New York, United States, 10003
- Recruiting
- NYULangone
-
Contact:
- Erich Anderer
- Phone Number: (718) 630-6580
- Email: erich.anderer@nyulangone.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willingness to and ability to participate in study procedures
- Chronic back pain (pain above the gluteal cleft of at least 3 months duration)
Exclusion Criteria:
- Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
- Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Control arm
The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections
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|
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Experimental: Yoga Arm
The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.
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The intervention will be a 6-week ashtanga yoga program designed by world-renowned yogi Eddie Stern.
Eddie Stern is an internationally known Ashtanga yoga teacher, in independent practice not affiliated with NYULH, who has done significant work exploring the physiology and science of yoga.
He is not currently engaged in his own research.
The yoga protocol for chronic back pain was designed with poses specific to addressing core strength but are gentle enough for patients in pain.
The protocol is designed to be directed by a teacher initially but can be done at home and is only 18 minutes in duration.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in VAS(visual analog scale)
Time Frame: Enrollment visit, 6 months after enrollment visit
|
The visual analogue scale or visual analog scale (VAS) is designed to measure pain intensity with less pain being experienced by those in the intervention group in comparison to the control group.
|
Enrollment visit, 6 months after enrollment visit
|
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Changes in ODI (Oswestry Disability Index)
Time Frame: Enrollment visit, 6 months after enrollment visit
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The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
Improvement will be measured by the lower score out of a 100, which reflects less disability.
|
Enrollment visit, 6 months after enrollment visit
|
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Changes in SF-36 (Short Form (36) Health Survey )
Time Frame: Enrollment visit, 6 months after enrollment visit
|
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Improvement with those with Yoga will be seen by higher scores in SF-36 which indicate lower disability.
|
Enrollment visit, 6 months after enrollment visit
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long term changes in VAS after intervention
Time Frame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
|
The visual analogue scale or visual analog scale (VAS) is designed to measure pain intensity with less pain being experienced by those in the intervention group in comparison to the control group.
|
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
|
|
Long term changes in ODI after intervention
Time Frame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
|
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
Improvement will be measured by the lower score out of a 100, which reflects less disability.
|
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
|
|
Long term changes in SF-36 after intervention
Time Frame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
|
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Improvement with those with Yoga will be seen by higher scores in SF-36 which indicate lower disability.
|
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Erich Anderer, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 19-00824
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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