Chronic Back Pain
Conditions
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.
Interventions
BEHAVIORALYoga 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Countries
United States
Contacts
CONTACTErich Anderer, MD
PRINCIPAL_INVESTIGATORErich Anderer
NYU Langone Health
Outcome results
None listed