The Effect of Yoga Practice on Chronic Back Pain

Chronic Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270617
• Other study ID #: 19-00824
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Erich Anderer, MD
• Phone: (718) 630-6580
• Email: erich.anderer[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Back Pain

Intervention

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 designed to be directed by a teacher initially but can be done at home and is only 18 minutes in duration.

Locations

Country	Name	City	State
United States	NYULangone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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