The Effect of Yoga Practice on Chronic Back Pain

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04270617
Collaborator
(none)
200
1
2
49
4.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Yoga program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized-controlled Study to Evaluate the Effect of a Standardized Yoga Practice on Chronic Back Pain
Actual Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control arm

The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections

Experimental: Yoga Arm

The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.

Behavioral: Yoga program
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.

Outcome Measures

Primary Outcome Measures

  1. Changes in VAS(visual analog scale) [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.

  2. Changes in ODI (Oswestry Disability Index) [Enrollment visit, 6 months after enrollment 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.

  3. Changes in SF-36 (Short Form (36) Health Survey ) [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.

Secondary Outcome Measures

  1. Long term changes in VAS after intervention [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.

  2. Long term changes in ODI after intervention [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.

  3. Long term changes in SF-36 after intervention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYULangone New York New York United States 10003

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Erich Anderer, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04270617
Other Study ID Numbers:
  • 19-00824
First Posted:
Feb 17, 2020
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2022