Low Back Pain Clinical Trial in Kansas City, KS

About This Low Back Pain Study in Kansas City

Chronic low back pain (CLBP) is a highly prevalent and debilitating condition, affecting 84% of the population over a lifetime1. CLBP is the leading cause of disability worldwide 2 and is a top condition for health care expenditure in the US3. Emerging evidence indicates that individuals with low back pain have altered neurophysiological processes within the central nervous system leading to high prevalence of anxiety and depression, and poor sleep quality4-7. Standard treatments often focus on the local source of pain; however, for many patients the persistence and severity of pain cannot be explained by peripheral pathology alone. Yoga is a promising mind-body integrative intervention, as it targets the psychological and neurophysiological aspects of pain. The efficacy of yoga practice for reducing pain8,9 and psychological distress10,11 has been shown by many systematic reviews and randomized control trials (RCTs)12-16. Additionally, mindfulness, meditation, and breathwork interventions produce meaningful improvements in pain17,18, anxiety19,20, depression21, and sleep quality22,23. Evidence clearly indicates yoga is an effective intervention for management of chronic LBP9. However, the majority of prior RCTs have included in-person yoga sessions 24-26, which may be a barrier to many people. Recently, virtual delivery of interventions is gaining popularity. A few recent studies reported promising feasibility of tele-yoga in people with various chronic pain conditions e.g. Alzheimer's 27, dementia 28, and knee osteoarthritis 29. Only one recent RCT conducted tele-yoga intervention for people with CLBP and resulted in decreased pain 14, but is limited to quantitative measures only and did not compare yoga against active therapy. No study has assessed participants' perspective of virtual yoga intervention for chronic low back pain, which is important to determine feasibility of tele-yoga for CLBP management. The objectives of this study are two fold: 1) to investigate the acceptability of yoga intervention using a tele-yoga approach and 2) to compare the effectiveness of a tele-yoga intervention with a mindfulness focus (Y+M) to a tele-yoga intervention without a mindfulness focus (Y-M) in adults with CLBP. Thirty participants27,30 with CLBP aged 30-8014 will be recruited and randomly assigned to Y+M or time-matched Y-M (physical movement without breathing and meditation) group. Each group will participate in video-guided live group sessions 2x a week for 4 weeks28,30. Aim 1: To evaluate acceptability of tele-yoga intervention for CLBP. The investigators will assess acceptability via participants' overall satisfaction using 1) self-reported satisfaction ratings, the Acceptability of Intervention Measure (AIM)31 and 2) semi-structured qualitative interviews to capture participant feedback about their experience (e.g. barriers, facilitators, motivators, perceived effectiveness, self-efficacy). Hypothesis 1: Participants will have good acceptability to tele-yoga intervention. Aim 2: To compare between-group changes in pain and function between tele-yoga with breath regulation, focused attention/meditation and tele-yoga without breath regulation, focused attention/meditation. Efficacy of tele-yoga on pain and function between groups will be assessed at baseline, midpoint, and post-intervention. Pain (VAS) and function (ODI) will serve as primary outcomes. Clinically significant improvement is defined as ODI scores ≥15% and reductions in VAS pain scores ≥2 points as compared to the sham yoga group. Secondary outcomes will include PROMIS Pain Interference Short Form. Hypothesis 2: The Y+M will have greater improvements than the YG. Aim 3: To compare between-group changes in psychological health between tele-yoga with breath regulation, focused attention/meditation and tele-yoga without breath regulation, focused attention/meditation. Psychological measures include Beck Anxiety Inventory, Beck Depression Inventory, Pittsburg Sleep Quality Index and compared between both groups. Secondary measures include symptoms of CS with standard measures of Fibromyalgia 2016 (FM) survey32. Hypothesis 3: The Y+M will have greater improvements than the Y-M. This project is highly innovative in its focus on 1) gaining participants' perspective with tele-yoga delivery and 2) telehealth-delivered, mind-body intervention specifically targeting central pain sensitization in CLBP with potential exploration of underlying mechanisms of yoga. The project is significant with potentially improving access to virtual treatment options that may potentially lead to self-management of CLBP. Expected outcomes of this research include evidence to support tele-yoga as an effective, accessible integrative therapy for reducing centrally mediated pain symptoms.

Sponsor: Taylor Rees