治験レーダー

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.

Background and Significance

CLPB is a highly prevalent condition worldwide, affecting approximately 619 million people in 2020 with an estimated projection of impacting 843 million by 20502. In the United States, it is a leading cause of disability and work limitation33 and imposes enormous socioeconomic costs, with U.S. healthcare expenditures for CLBP estimated in the tens of billions of dollars annually (around $40 billion in direct costs)34 and total costs exceeding $100 billion per year35. Beyond its economic burden, CLBP significantly can impair physical function and psychological well-being. CLBP is accompanied with substantial psychological distress, with notably elevated rates of both anxiety and depression36. Individuals with CLBP had almost 5x the prevalence of anxiety or depression as compared to those without pain36. In addition to higher anxiety and depressive scores, CLBP has been associated with poorer physical function, greater limitations in daily activities and lower quality of life, even after adjusting for demographics and comorbidities37.

A subpopulation of CLBP patients exhibits evidence of nervous system hyperactivity characterized by widespread hyperalgesia, amplified pain signaling, and impaired pain modulation38. Studies indicate that this subgroup may comprise a substantial fraction of CLBP cases (with prevalence estimates ranging broadly and averaging around 40-50%)33,39. Clinically, these patients tend to have more severe pain manifestations and are less likely to respond to standard treatments40, highlighting the need for tailored therapeutic approaches. One promising non-pharmacological treatment for CLBP is yoga, a mind-body therapy. Systematic reviews and meta-analyses have found that yoga practice leads to significant improvements in pain intensity and functional disability in CLBP patients41. Yoga has been generally well-tolerated with no serious adverse effects, making it a valuable conservative adjunct in the management of CLBP41.

The delivery of yoga interventions via telehealth ("tele-yoga") has rapidly expanded in recent years, especially during the COVID-19 pandemic, to improve access for individuals with chronic health conditions who may have difficulty attending in-person classes 42. Chronic conditions such as persistent pain, cancer, and neurocognitive disorders can limit mobility and increase barriers to participating in on-site exercise programs. Tele-yoga, defined as live-streamed, interactive yoga instruction via videoconferencing, offers a potential solution by allowing patients to engage in supervised mind-body exercise from home 42,43. Early studies have suggested that remotely delivered yoga is feasible across a range of chronic illnesses 43,44. However, the evidence remains limited, with most studies to date being small pilot trials or program evaluations focused on feasibility and acceptability rather than large efficacy trials 44,45. In addition, many prior remote yoga interventions have used asynchronous (pre-recorded) content, whereas fewer have examined synchronous (real-time) group yoga, which may better replicate the social and therapeutic aspects of in-person classes 44,46.

Mindfulness, meditation, and breathwork interventions produce meaningful improvements in pain17,18, anxiety19,20, depression21, and sleep quality22,23. Mindfulness-based interventions such as Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) have been shown to reduce low back pain-related disability and psychological distress, with effects comparable to pharmacologic and cognitive-behavioral therapies47,48 Breathing practices, including slow and structured techniques, similarly improve autonomic regulation and mood18, and meditation-based programs consistently demonstrate moderate improvements in anxiety, depression, and sleep quality. Collectively, these findings highlight the potential of mind-body practices as safe, accessible, and evidence-based approaches to enhance both physical and psychological outcomes.

Patients with chronic conditions and their caregivers have expressed both enthusiasm and concerns regarding online interventions. Convenience, home comfort, and improved access are frequently cited advantages of tele-yoga, while drawbacks include technology challenges, distractions at home, and the absence of hands-on guidance or in-person community support 43. Understanding user perspectives and the outcomes of tele-yoga interventions is essential for determining the role of tele-yoga in chronic disease management. Accordingly, we conducted a systematic review of "TeleYoga for Chronic Conditions" to synthesize the emerging evidence on synchronous tele-yoga interventions for individuals with chronic health conditions. There were only 9 studies that tested tele-yoga to date (manuscript in preparation) that are presented in Table 1 and 2. These studies represent a cross-section of tele-yoga research in chronic pain, cancer survivorship, dementia, and integrated care settings, suggesting current gap related to tele-yoga intervention in CLBP. The investigators additionally draw on related literature for context and discussion, while not duplicating the detailed analysis of any study beyond our scope. Importantly, of the 9 studies, only one study conducted qualitative work. It is important to examine the feasibility of tele-yoga for CLBP management that may potentially facilitate self-management strategies in individuals.

Reviews of literature identify the lack of studies utilizing tele-yoga for CLBP management even though CLBP continues to be reported as the leading cause of disability.

Overall gaps in knowledge:

• There are no studies evaluating qualitative feedback from participants with chronic low back pain being treated with tele-yoga.
• A Recent study14 has looked at utilizing tele yoga to treat CLBP. However, this study only recruited from a single employer health-based health plan and utilized a wait list control instead of an active control.
• Most studies only utilize self-report measures (pain, disability, etc.). One study53 examined central sensitization (CS) subjective information, however did not take all objective measures that are typically associated with central sensitization or pain battery (Quantitative Sensory Testing).

As tele-yoga practice gains traction, it is important to understand participants' perspective of their experiences, barriers, and facilitators to improve implementation of tele-yoga practices.

B. Rationale Our goal is to not only determine the feasibility of tele yoga, but to explore participant feedback that can help further identify barriers to interventions in tele-yoga group session format. By utilizing the stretching intervention as active control group, The investigators will be able to determine the benefit of tele yoga as compared to stretching telehealth intervention. Finally, the investigators plan to give local participants the opportunity to come to KUMC so that the investigators can gather objective data of CS rather than relying solely on self-report data as many other yoga studies have done in previously published literature.

II. Research Plan and Design

A. Study Objectives:

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 with Visual scale analog (VAS) and function with Oswestry Disability Index (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 com...

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