The Effect of Yoga Practice on Chronic Back Pain
ConditionChronic Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness to and ability to participate in study procedures
Chronic back pain (pain above the gluteal cleft of at least 3 months duration)
Disqualifiers
Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice
Trial design
Design model
Parallel
Treatments tested in this trial
Yoga program
BehavioralThe 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control armNo intervention 0 interventions
Group B: Yoga ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Enrollment visit, 6 months after enrollment visit2
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.
Time frame
Enrollment visit, 6 months after enrollment visit3
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.
Time frame
Enrollment visit, 6 months after enrollment visitSecondary outcomes
1
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.
Time frame
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit2
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.
Time frame
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit3
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.
Time frame
Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years VisitSponsors and contacts
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Source ClinicalTrials.gov