Comparison of the effects on disability of Wii Fit U game-based home yoga and supervised yoga programs versus therapeutic exercise in patients with non-specific chronic low back pain: study protocol for a randomized controlled trial

Abstract

BACKGROUND Chronic low back pain (LBP) is the leading cause of disability worldwide. Mostly non-specific (i.e. no specific structural cause), its aetiology is multi-factorial and complex. Disability could be more related to fear-avoidance beliefs rather than pain itself. First line physiotherapy treatment involves pain education, advice to remain active and exercise. Due to the burden

LBP represents for health systems, cost-effective approaches are increasingly needed. Home- based exercise could be an inexpensive solution, if patients adhere sufficiently to their

program. Non-immersive virtual-reality environments are easily accessible and could increase patient’s motivation to engage into exercise. Growing interest in therapeutic yoga has led to recent studies demonstrating its effectiveness for LBP treatment. This study will compare the effectiveness of Wii Fit U game-based home and supervised yoga to exercise, all combined with education and advice to remain active, on the disability reduction of chronic LBP patients. METHODS This single centre, 3 arms, single blinded, randomized controlled trial will compare the effectiveness of Wii Fit U game-based home yoga and supervised yoga to supervised exercise for adults with non-specific chronic low back pain. All participants will receive pain education and advice to remain active, then 3 sessions of 40- 45 minutes per week of therapeutic yoga or exercise for 8 weeks. Disability will be the primary outcome, measured with the Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaire (RMDQ). Secondary outcomes will include back function (flexibility & endurance tests), pain (NPRS), Kinesiophobia (TKS), pain self-efficacy (PSEQ), adherence (% sessions), physical activity (daily steps), and pain medication use. They will be assessed pre- and post- intervention, then 3, 6 and 12 months later. The statistical analysis will use a mixed-model repeated measures ANCOVA, with time as within group factor, intervention as between group factor, and increased analgesic use as covariant, and p < 0.05 for statistical significance. DISCUSSION Yoga interventions are expected to be more effective than therapeutic exercise in reducing disability and improving other pain-related outcomes. Home-based and supervised yoga being expected to be similarly effective, home-based yoga could be the most cost-effective