Durability of Yoga for Veterans With Low Back Pain
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
176 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Erik J Groessl, PhD BA BS
Data sourced from clinicaltrials.gov
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