A Prospective, Randomized-controlled Study to Evaluate the Effect of a Standardized Yoga Practice on Chronic Back Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Back Pain
- Sponsor
- NYU Langone Health
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Changes in VAS(visual analog scale)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Changes in ODI (Oswestry Disability Index)
Time Frame: 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 )
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.
Secondary Outcomes
- Long term changes in SF-36 after intervention(Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit)
- Long term changes in ODI after intervention(Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit)
- Long term changes in VAS after intervention(Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit)