The Effect of Yoga Practice on Chronic Back Pain

Study 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.

Official Title
-----------------
A Prospective, Randomized-controlled Study to Evaluate the Effect of a Standardized Yoga Practice on Chronic Back Pain

Conditions
-----------------
Chronic Back Pain

Intervention / Treatment
-----------------
* Behavioral: Yoga program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections | |
| Experimental: Yoga Arm<br>The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs. | Behavioral: Yoga program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Enrollment visit, 6 months after enrollment visit | 
| 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. | Enrollment visit, 6 months after enrollment visit | 
| 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. | Enrollment visit, 6 months after enrollment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit | 
| 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. | Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit | 
| 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. | Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit |