The Effect of Yoga Practice on Chronic Back Pain

NCT04270617 | Recruiting DMC

• 1 other identifier: 19-00824
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Back Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Long term changes in VAS 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 SF-36 after intervention

  Baseline Visit, 6 weeks Visit , 3 months Visit , 1 year Visit , 2 years Visit

Study Arms (2)

Control arm

NO INTERVENTION

The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections

Yoga Arm

EXPERIMENTAL

The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.

Behavioral: Yoga program

Interventions

Yoga program BEHAVIORAL

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.

Yoga Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to and ability to participate in study procedures
• Chronic back pain (pain above the gluteal cleft of at least 3 months duration)

You may not qualify if:

• Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
• Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYULangone

New York, New York, 10003, United States

RECRUITING

Study Officials

• Erich Anderer

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erich Anderer, MD

CONTACT

(718) 630-6580; erich.anderer@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: December 1, 2019
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to jadie.detolla@nyulangone.org To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)