The Effect of Yoga Practice on Chronic Back Pain
Primary Purpose
Chronic Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Back Pain
Eligibility Criteria
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
Sites / Locations
- NYULangoneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm
Yoga Arm
Arm Description
The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections
The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.
Outcomes
Primary Outcome Measures
Changes in VAS(visual analog scale)
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.
Changes in ODI (Oswestry Disability Index)
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.
Changes in SF-36 (Short Form (36) Health Survey )
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.
Secondary Outcome Measures
Long term changes in VAS after intervention
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.
Long term changes in ODI after intervention
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.
Long term changes in SF-36 after intervention
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04270617
Brief Title
The Effect of Yoga Practice on Chronic Back Pain
Official Title
A Prospective, Randomized-controlled Study to Evaluate the Effect of a Standardized Yoga Practice on Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic low back pain is notoriously difficult to treat and is a primary contributor to lost work days and excessive health expenditures, and whose treatment has, in part, contributed to the opioid crisis. Surgery is only an option in a minority of these patients, usually confined to those with structural instability. Yoga is an ancient modality whose benefits are currently being studied.
Detailed Description
The purpose of this research study is to determine whether a 6 week standardized yoga practice is superior to usual conservative therapies in the treatment of chronic back pain at 6 months. There is enough data that the most recent ACP guidelines have included yoga as a treatment for chronic back pain, but more data needs to be generated regarding the efficacy of this modality in treating the chronic back pain population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections
Arm Title
Yoga Arm
Arm Type
Experimental
Arm Description
The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.
Intervention Type
Behavioral
Intervention Name(s)
Yoga program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in VAS(visual analog scale)
Description
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.
Time Frame
Enrollment visit, 6 months after enrollment visit
Title
Changes in ODI (Oswestry Disability Index)
Description
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.
Time Frame
Enrollment visit, 6 months after enrollment visit
Title
Changes in SF-36 (Short Form (36) Health Survey )
Description
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.
Time Frame
Enrollment visit, 6 months after enrollment visit
Secondary Outcome Measure Information:
Title
Long term changes in VAS after intervention
Description
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.
Time Frame
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
Title
Long term changes in ODI after intervention
Description
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.
Time Frame
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
Title
Long term changes in SF-36 after intervention
Description
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.
Time Frame
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erich Anderer, MD
Phone
(718) 630-6580
Email
erich.anderer@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erich Anderer
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYULangone
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erich Anderer
Phone
718-630-6580
Email
erich.anderer@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to jadie.detolla@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
The Effect of Yoga Practice on Chronic Back Pain
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