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Recruiting NCT04270617

The Effect of Yoga Practice on Chronic Back Pain

No phase Interventional Chronic Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Yoga program.
Who it may be relevant to
Registry conditions: Chronic Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Yoga 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

Primary outcome measures

  • Changes in VAS(visual analog scale) [Time frame: Enrollment visit, 6 months after enrollment visit]
  • Changes in ODI (Oswestry Disability Index) [Time frame: Enrollment visit, 6 months after enrollment visit]
  • Changes in SF-36 (Short Form (36) Health Survey ) [Time frame: Enrollment visit, 6 months after enrollment visit]
Secondary outcome measures (3)
  • Long term changes in VAS after intervention [Time frame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit]
  • Long term changes in ODI after intervention [Time frame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit]
  • Long term changes in SF-36 after intervention [Time frame: Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYULangone — New York

Identifiers

NCT: NCT04270617 · 19-00824

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗