Durability of Yoga for Veterans With Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Chronic Low Back Pain

• Registration Number: NCT07053787
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Chronic low back pain is a prevalent condition among VA patients, but many current treatment options have side effects or limited effectiveness. Veterans with chronic low back pain (cLBP) experience increased disability, functional challenges, and reduced quality of life. A prior VA funded study of Yoga for VA patients with cLBP found that yoga can reduce pain and disability at 3 and 6 months after enrollment. However, the long-term effects and maintenance of yoga practice is unknown. The current study will test an intervention designed to promote long-term yoga practice and long-term health outcome benefits at 12 and 18 months after enrollment.

Detailed Description

Significance to VA:

Chronic low back pain (cLBP) is a highly prevalent condition for veterans. In addition to chronic pain, cLBP leads to significant amounts of disability, reduced health-related quality of life (QOL), and increased health care utilization. Our previous results and other studies of yoga for Veterans with cLBP show that yoga participants had reduced pain and disability at follow-up assessments at 6-month follow-up. There is also some evidence indicating that self-care treatments like yoga, especially those provided in group format, may be less expensive and may reduce health care costs, conserving limited resources for other conditions and services. Since persons with cLBP usually live with this chronic condition for the rest of their lives, understanding and facilitating long-term yoga practice for VA patients is an important step for the provision of high-quality VA healthcare.

Innovation and Impact:

If funded, this will be the first study to examine a durability intervention for promoting long-term yoga practice. It uses text messaging for both behavioral reminders, and for ecological momentary assessment of the durability outcome. The study tracks 18 months of follow-up data.

Specific Aims:

The primary aims of the proposed project are to examine the effectiveness of a coaching intervention plus text reminders for promoting long-term maintenance of yoga practice and function among Veterans with cLBP. The investigators will also examine intervention costs and subsequent health care costs.

Methodology:

The investigators will recruit and randomize 176 Veterans with cLBP to either standard yoga or the durability-enhanced yoga intervention. Participants will complete health outcome assessments at baseline, 3 months, 6 months, 12 months, and 18 months. The standard yoga intervention includes weekly in-person yoga sessions for 12 weeks. The enhanced yoga arm will receive weekly behavioral coaching sessions from weeks 10-15 and will receive ongoing text reminders. The co-primary outcomes will be the mean days and minutes per week of yoga practice and the mean change in back pain-related disability at 12 months. The investigators will measure yoga practice and other health outcomes including pain severity, QOL, and fatigue through 18 months. The investigators will measure attendance and home practice. The investigators will monitor and assess adverse events and instructor fidelity.

Path to Translation/Implementation:

If the durability intervention can increase long-term yoga practice and associated health benefits, this will provide very strong evidence for wider implementation of yoga as a specific treatment for chronic low back pain.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2026-07-01
• Primary Completion: 2030-12-01
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• VA patients > 18 years
• Diagnosis of chronic low back pain > 3 mos
• Pain rated 4/10 or higher
• No new pain treatments in the past month.
• Willing to attend intervention;
• Complete 5 assessments;
• Respond to text assessments
• Practiced yoga < 3x in the last 6 months
• Unless medically necessary, agree to not change pain treatment during intervention

Exclusion Criteria

• Back surgery within the last 1 year
• Pain due to specific systemic (eg, scleroderma, fibryomalgia) or non-musculoskeletal problem (neuropathy)
• Positive Romberg test (with or without sensory neuropathy)
• Severe vertebral disk problems, sciatica or nerve compression >3 months
• Serious or unstable psychiatric illness (e.g., unmanaged psychosis, manic episode, or substance dependence)
• Serious coexisting medical illness (eg, cancer, COPD, bmi> 40)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Days and minutes per week of yoga practice - Ecological Momentary Assessment (EMA) of Yoga	Baseline to 18 months	The investigators will employ EMA to assess weekly yoga practices across the whole 18-month study period. Because yoga includes both mind and body components, as well as movements that are not aerobic in nature, yoga cannot be assessed like other physical activities using accelerometers. EMA has been shown to enhance self-report because it occurs randomly, so as not subject to recall bias, and frequently so is not subject to recall errors. The investigators will ask how many minutes of yoga, if any, have been performed on the assessment day and whether it was performed at home or at an in-person class. Participants will receive an EMAs every week across the 18-monthstudy period. If participants do not respond within 90 minutes, a reminder will be sent. If there is still no response, they will be sampled again in the next 24 hours at a different time of day.
Roland-Morris Disability Questionnaire	Change from baseline to 18 months	The RMDQ will serve as the primary health outcome and consists of 23 questions about limitations experienced for a variety of daily activities. The scale has been shown to be reliable and is well validated. It has been used in other studies of yoga studies. Scores range from 0 to 23, with higher scores indicating more back pain-related disability.

Secondary Outcome Measures

Name	Time	Method
Pain Severity - Brief Pain Inventory (BPI)	Change from baseline to 18 months	This subscale assesses pain severity using a Numeric Rating Scale (NRS) from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. The mean of multiple items is used. Higher mean scores indicate greater pain severity.
Pain Interfernce - Brief Pain Inventory (BPI)	Change from baseline to 18 months	This subscale assesses pain interference using a Numeric Rating Scale (NRS) from 0 to 10, where 0 is no pain and 10 is the worst pain interference imaginable. The mean of multiple items is used. Higher mean scores indicate greater pain interference.
Fatigue - Fatigue Severity Scale (FSS)	Change from baseline to 18 months	The Fatigue Severity Scale (FSS) has a score range of 9 to 63. Higher scores indicates more severe fatigue.
Quality of Life - SF12	Change from baseline to 18 months	Physical and mental QOL will be assessed with the Short-form 12 (SF12). The SF-12 uses a norm-based scoring system, where the mean score for the general population is 50, and standard deviation is 10. Scores range from 0 to 100, with higher scores indicating better QOL/ health status.
Yoga Self-Efficacy Scale (YSES)	Change from baseline to 18 months	YSES scores range from 12 to 108, with higher scores indicating greater perceived self-efficacy in yoga practice.

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States