Durability of Yoga for Veterans With Low Back Pain

NCT07053787 | Not Yet Recruiting

• 1 other identifier: RRD2-001-24W
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain; yoga; disability; durability

Outcome Measures

Primary Outcomes (2)

• Days and minutes per week of yoga practice - Ecological Momentary Assessment (EMA) of Yoga

  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.

  Baseline to 18 months

• Roland-Morris Disability Questionnaire

  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.

  Change from baseline to 18 months

Secondary Outcomes (5)

• Pain Severity - Brief Pain Inventory (BPI)

  Change from baseline to 18 months

• Pain Interfernce - Brief Pain Inventory (BPI)

  Change from baseline to 18 months

• Fatigue - Fatigue Severity Scale (FSS)

  Change from baseline to 18 months

• Quality of Life - SF12

  Change from baseline to 18 months

• Yoga Self-Efficacy Scale (YSES)

  Change from baseline to 18 months

Other Outcomes (1)

• Health Care utilization and costs

  Baseline to 18 months

Study Arms (2)

Standard Yoga

ACTIVE COMPARATOR

Hatha yoga designed for Veterans with chronic low back pain.

Behavioral: Standard Yoga

Enhanced Yoga

EXPERIMENTAL

Hatha yoga designed for Veterans with chronic low back pain plus coaching and texts to enhance durability and long-term adherence to yoga.

Behavioral: Enhanced Yoga

Interventions

Standard Yoga BEHAVIORAL

Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos.

Standard Yoga

Enhanced Yoga BEHAVIORAL

Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos ... plus six weekly 50-minute 1-on-1 coaching sessions starting week 10 of the standard yoga intervention and ending week 15 (3 wks after end of standard yoga). During this transition, participants are supported with development and execution of their plan for continuing their yoga practice. Participants will be offered 1 additional ad-hoc coaching session to help them re-start yoga if they get off track and/or experience major life events such as moving, job change, medical issues, etc.

Enhanced Yoga

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

Study Officials

• Erik J. Groessl, PhD BA BS

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik J Groessl, PhD BA BS

CONTACT

(858) 552-8585; Erik.Groessl@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial is a single blind RCT as participants will be exposed to the study conditions allocated but will be unaware of the study hypotheses and details of the differences between the two yoga conditions. At follow-up assessments, assessors will be blinded to the participant group assignment and participants will be asked not to discuss their group assignment when contacted by staff. The investigators will be blinded to group assignment. Only the Study Coordinator is unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months after study completion to allow for results to be published. Data will be available indefinitely.
• Access Criteria: Requests for access to this data must be made in writing signed by a requestor from the United States. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. Should the investigator leave the VASDHS, the requests may be sent to the Associate Chief of Staff for Research.

Locations

US (1)