TeleYoga for Chronic Low Back Pain: A Quantitative and Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Semi Structured Interview
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-80 year old individuals
- •Ability to speak, read and write English as needed for study LBP for 3 months with frequency of 2 or more days/week or daily low back pain for the most recent three months
- •Pain intensity minimum 3 on 0-10 pain scale where 0=no pain and 10=maximum pain imagined
- •Have internet access and device available for logging into virtual yoga classes
- •Be able to get on and off the floor
排除标准
- •spine compression, tumor, infection, spine surgery within the last 12 months
- •neurological conditions such as stroke, Parkinson's disease, Alzheimer's disease or other cognitive impairments.
- •pregnancy
- •currently performing yoga or has performed yoga on a regular basis within the last 6 months
结局指标
主要结局
Semi Structured Interview
时间窗: Week 4
This interview will take about 30-60 minutes, but we can take a break anytime you need to. If you need to end the interview at any time, please let me know and we will stop. Do you have any other questions before we start? Are you still willing to continue with this interview? Do you mind if we start the audio-recorder? 1. I would like to begin this interview by asking you, before you started this project what your experience with yoga was. 1. \[Clarifying probe\]: Had you ever practiced yoga before? 2. \[If have practiced before\]: Prior to this project what were your main goals for doing yoga? How many times a week were you doing yoga? 3. \[If have not practiced before\] What led you to want to take part in this yoga program? 2. Why did you join a yoga study?: 1. \[Clarifying probe\]: Before you started this program, what were you hoping to get out of doing yoga? 2. \[Clarifying probe\]: What did you hope doing this yoga program would do for you? 3. What was your overall experienc
Acceptability of Intervention Measure (AIM)
时间窗: Week 0, Week 2, Week 4
Acceptability of Intervention Measure (AIM) 1. \[Triple P/Implementation Strategy\] meets my approval. 2. \[Triple P/Implementation Strategy\] is appealing to me. 3. I like \[Triple P/Implementation Strategy\]. 4. I welcome \[Triple P/Implementation Strategy\]. Intervention Appropriateness Measure (IAM) 1\) \[Triple P/Implementation Strategy\] seems fitting. 2) \[Triple P/Implementation Strategy\] seems suitable. 3) \[Triple P/Implementation Strategy\] seems applicable. 4) \[Triple P/Implementation Strategy\] seems like a good match. Feasibility of Intervention Measure (FIM) 1. \[Triple P/Implementation Strategy\] seems implementable. 2. \[Triple P/Implementation Strategy\] seems possible. 3. \[Triple P/Implementation Strategy\] seems doable. 4. \[Triple P/Implementation Strategy\] seems easy to use.
次要结局
- Oswestry Disability Index(Week 0, Week 2, Week 4)
- Promis Short Form(Week 0, Week 2, Week 4)
- Visual Analog Scale(Weekly)
- Beck Anxiety Index(Week 0, Week 2, Week 4)
- Beck Depression Inventory(Week 0, Week 2, Week 4)
- Pittsburgh Sleep Quality Index(Week 0, Week 2, Week 4)
- Fibromyalgia 2016(Week 0, Week 2, Week 4)
研究者
Taylor Rees
Sponsor-Investigator
University of Kansas Medical Center