A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women

基于团体的瑜伽干预治疗女性慢性盆腔疼痛的可行性试验

• 批准号: 10402278
• 负责人: Alison Huang
• 金额: $ 8.01万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10402278
• 关键词: Abdomen; Address; Adherence; Adverse event; Analgesics; Anatomy; Anxiety; Awareness; Behavior; Behavioral; Breathing; California; Clinical; Clinical Treatment; Communities; Complex; Conflict (Psychology); Data; Dependence; Development; Disease; Educational process of instructing; Emotions; Enrollment; Equilibrium; Etiology; Evaluation; Exercise; Exhibits; Fright; Future; Gynecologic; Health; Health Personnel; Healthcare; Home; Intervention; Lead; Learning; Location; Measures; Mental Depression; Muscle; Nature; Opioid; Organ; Outcome Measure; Pain; Participant; Pelvic Floor Muscle; Pelvic Pain; Pelvic floor dysfunction; Pelvic floor structure; Pelvis; Pharmaceutical Preparations; Pharmacological Treatment; Physical Function; Physical activity; Physiological; Pilot Projects; Posture; Procedures; Psychotherapy; Quality of life; Randomized; Recurrent pain; Relaxation; Reporting; Research; Safety; Self Efficacy; Self Management; Serious Adverse Event; Severities; Sex Functioning; Sexual Dysfunction; Sexual Partners; Social isolation; Stretching; Structure; Syndrome; Techniques; Testing; Therapeutic; Time; Visceral; Visit; Woman; Work; Yoga; alternative treatment; anxious; arm; attentional control; base; central pain; chronic pain; chronic pelvic pain; clinically relevant; community setting; comorbidity; cost; data quality; debilitating pain; deconditioning; design; efficacy evaluation; feasibility trial; follow-up; gastrointestinal; improved; intervention program; mental practice; mental set; mindfulness; multi-site trial; neuroregulation; pain-related disability; patient oriented; perceived stress; physical inactivity; pilot test; pilot trial; programs; randomized trial; recruit; side effect; success; treatment strategy; urologic

PROJECT SUMMARY One in ten U.S. women suffer from chronic pelvic pain, a condition that can lead to depression, social isolation, sexual dysfunction, physical inactivity, and dependence on or abuse of pain medications. Unfortunately, most medications used to manage pelvic pain have problematic side effects or addictive potential, and other clinical therapies for this condition depend on costly, one-on-one visits with specialized healthcare practitioners. As a result, many women suffering from chronic pelvic pain are anxious to identify alternative treatment strategies that are not only effective, but also better tolerated and more accessible. Yoga is a set of complementary physical and mental practices with the potential to improve chronic pelvic pain through multiple mechanisms. When practiced in a way that emphasizes careful anatomic alignment, mindful awareness of bodily structures, and deep breathing during the practice of yoga postures, yoga can be used to improve pelvic floor dysfunction, correct maladaptive postural and physical behaviors, and decrease comorbid anxiety and perceived stress. As a result, regular practice of yoga has the potential to improve multiple factors that can precipitate and exacerbate pelvic pain or worsen pain-related disability. To explore the feasibility of teaching women to practice yoga to improve chronic pelvic pain, our investigative team previously collaborated with an expert yoga panel to develop a structured, group-based yoga program for this indication, involving twice weekly group classes supplemented by once weekly home yoga practice. In a small single-arm pilot study involving women suffering from pelvic pain for at least 6 months, adherence to group classes and home practice was high, and women reported substantial improvements in pain severity and pain-related quality of life over 6 weeks. We now propose to conduct a follow-up randomized pilot trial to evaluate the feasibility of conducting a rigorous randomized trial of a refined, 8-week version of this yoga program. Approximately 40 women with chronic pelvic pain will be recruited from three locations and randomly assigned to take part in a group yoga program consisting of twice-weekly group classes and once weekly home practice focused on study-specific yoga techniques, versus a control program involving time-equivalent group classes and home practice of non- specific muscle stretching and strengthening exercises. Using data collected during and after the intervention programs, we will assess retention and adherence to group classes and home practice, evaluate participant self-efficacy and observed success in learning to practice intervention techniques, and examine rates of data completion and data quality derived from pain-related outcome measures. This research is an important next step toward future, rigorous evaluation of the efficacy and safety of yoga as a potentially patient-centered, community-based self-management strategy for chronic pelvic pain.

项目摘要 美国十分之一的妇女患有慢性骨盆疼痛，这种疾病会导致抑郁，社会孤立， 性功能障碍，身体不活动以及对止痛药的依赖或滥用。不幸的是，大多数 用于管理骨盆疼痛的药物具有有问题的副作用或上瘾的潜力，其他临床 这种情况的疗法取决于与专门的医疗保健从业人员一对一的昂贵，一对一的访问。作为 结果，许多患有慢性骨盆疼痛的妇女渴望确定替代治疗策略 这不仅有效，而且可以更好地容忍和更容易获得。 瑜伽是一组互补的身体和心理实践，有可能改善慢性骨盆疼痛 通过多种机制。当练习以强调谨慎的解剖对齐方式的方式时，正念 对身体结构的意识和在瑜伽姿势练习期间的深呼吸，瑜伽可用于 改善骨盆底功能障碍，正确适应不良的姿势和身体行为，并减少合并症 焦虑和感知压力。结果，定期练习瑜伽有可能改善多个因素 这会沉淀并加剧骨盆疼痛或恶化与疼痛相关的残疾。 为了探索教妇女练习瑜伽以改善慢性骨盆疼痛的可行性，我们的调查 团队以前与专家瑜伽小组合作，为基于团体的瑜伽计划开发了 这种迹象表明，每周一次的家庭瑜伽练习涉及两次每周的小组课程。在 小型的单臂试点研究涉及至少6个月患有骨盆疼痛的女性，坚持 小组课程和家庭练习很高，妇女报告疼痛严重程度有很大改善 和与疼痛有关的生活质量超过6周。 现在，我们建议进行随机性试验试验，以评估进行一次的可行性 该瑜伽程序的精制，8周版本的严格随机试验。大约40名女性 慢性骨盆疼痛将从三个位置招募，并随机分配参加组瑜伽 计划由每周两次的小组课程和一次专注于研究的每周家庭实践组成 瑜伽技术，与涉及时间等效的小组课程和非家庭实践的控制计划相比 特定的肌肉伸展和增强运动。使用干预期间和之后收集的数据 计划，我们将评估对小组课程和家庭实践的保留和依从性，评估参与者 自我效能和观察到学习练习干预技术的成功，并检查数据速率 从与疼痛相关的结果指标得出的完成和数据质量。 这项研究是迈向未来的重要下一步，严格评估瑜伽的功效和安全性 一种潜在的以患者为中心的，基于社区的自我管理策略，用于慢性骨盆疼痛。