Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
176 participants
INTERVENTIONAL
2026-07-01
2031-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard Yoga
Hatha yoga designed for Veterans with chronic low back pain.
Standard Yoga
Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos.
Enhanced Yoga
Hatha yoga designed for Veterans with chronic low back pain plus coaching and texts to enhance durability and long-term adherence to yoga.
Enhanced Yoga
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.
Interventions
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Standard Yoga
Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos.
Enhanced Yoga
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Erik J. Groessl, PhD BA BS
Role: PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA
Locations
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VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RRD2-001-24W
Identifier Type: -
Identifier Source: org_study_id
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