Durability of Yoga for Veterans With Low Back Pain

ConditionChronic Low Back Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

VA patients

Diagnosis of chronic low back pain > 3 months

Pain rated 4/10 or higher

No new pain treatments in the past month

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Standard Yoga
Behavioral
Weekly hatha yoga for 12 weeks augmented by home practice guided by yoga instructional videos.
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 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 and/or experience major life events such as moving, job change, medical issues, etc.

Treatment groups

176 Participants

are divided into 2 treatment groups

Group A: Standard YogaActive comparator 1 intervention

Group B: Enhanced YogaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 18 months

Roland-Morris Disability Questionnaire (RMDQ)

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.

Time frame