The Effect of Yoga Practice on Chronic Back Pain

Not Applicable

Recruiting

• Conditions: Chronic Back Pain
• Interventions: Behavioral: Yoga program

• Registration Number: NCT04270617
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

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Exclusion Criteria

• Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
• Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga Arm	Yoga program	The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

NYULangone; 🇺🇸 New York, New York, United States