Durability of Yoga for Veterans With Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Yoga, Enhanced Yoga.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Durability of Yoga for Treating Veterans With Chronic Low Back Pain
Overview
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.
Interventions
- Behavioral Standard Yoga
Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos. - Behavioral 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 weeks 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
Primary outcome measures
- Days and minutes per week of yoga practice - Ecological Momentary Assessment (EMA) of Yoga [Time frame: Baseline to 18 months]
- Roland-Morris Disability Questionnaire (RMDQ) [Time frame: Change from baseline to 18 months]
Secondary outcome measures (5)
- Pain Severity - Brief Pain Inventory (BPI) [Time frame: Change from baseline to 18 months]
- Pain Interfernce - Brief Pain Inventory (BPI) [Time frame: Change from baseline to 18 months]
- Fatigue - Fatigue Severity Scale (FSS) [Time frame: Change from baseline to 18 months]
- Quality of Life - SF12 [Time frame: Change from baseline to 18 months]
- Yoga Self-Efficacy Scale (YSES) [Time frame: Change from baseline to 18 months]
Eligibility criteria
Inclusion criteria
- VA patients
- Diagnosis of chronic low back pain > 3 months
- 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 (e.g., scleroderma, fibromyalgia) 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 (e.g., cancer, COPD, BMI> 40)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- VA San Diego Healthcare System, San Diego, CA — San Diego
Identifiers
NCT: NCT07053787 · RRD2-001-24W