The Effect of Yoga Practice on Chronic Back Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Back Pain
• Intervention / Treatment: Behavioral: Yoga program

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erich Anderer, MD; Phone Number: (718) 630-6580; Email: erich.anderer@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • NYULangone
      • Contact: Erich Anderer; Phone Number: 718-630-6580; Email: erich.anderer@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections
Experimental: Yoga Arm; The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Erich Anderer, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 19-00824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No