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: 9976159
• 负责人: Alison Huang
• 金额: $ 29.69万
• 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 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9976159
• 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 environment; 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; deconditioning; design; disability; efficacy evaluation; feasibility trial; follow-up; gastrointestinal; improved; intervention program; mental practice; mental set; mindfulness; multi-site trial; neuroregulation; patient oriented; perceived stress; physical inactivity; 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.

项目总结 每十名美国女性中就有一名患有慢性盆腔疼痛，这种情况可能会导致抑郁、社交孤立、 性功能障碍，缺乏运动，依赖或滥用止痛药。不幸的是，大多数 用于治疗骨盆疼痛的药物有问题的副作用或成瘾潜力，以及其他临床上的 这种疾病的治疗依赖于昂贵的、一对一的专业医疗从业者的就诊。作为一名 结果，许多患有慢性盆腔疼痛的女性急于寻找替代治疗策略 不仅有效，而且更好地容忍和更容易获得。 瑜伽是一套互补的身体和精神练习，有可能改善慢性盆腔疼痛 通过多种机制。当以一种强调仔细解剖排列的方式练习时，要注意 在练习瑜伽姿势时，注意身体结构和深呼吸，瑜伽可以用来 改善盆底功能障碍，纠正不适应的姿势和身体行为，减少并存 焦虑和感觉到的压力。因此，经常练习瑜伽有可能改善多种因素 这可能会加剧和加剧骨盆疼痛或恶化与疼痛相关的残疾。 为了探索教授女性练习瑜伽以改善慢性盆腔疼痛的可行性，我们的调查 该团队之前与一个瑜伽专家小组合作，开发了一个结构化的、基于小组的瑜伽计划 这一适应症包括每周两次小组课程和一周一次的家庭瑜伽练习。在一个 一项涉及患有骨盆疼痛至少6个月的女性的小型单臂试点研究，坚持 小组课程和家庭实践很多，女性报告疼痛严重程度有显著改善 和疼痛相关的生活质量超过6周。 我们现在建议进行一项后续的随机试点试验，以评估进行 对这个瑜伽项目进行严格的随机试验，为期8周。大约有40名女性患有 慢性盆腔疼痛将从三个地点招募，并随机分配参加集体瑜伽 课程包括每周两次的小组课程和一周一次的家庭练习，重点是具体学习 瑜伽技巧与控制程序的对比，控制程序包括时间相等的小组课程和非 特定的肌肉伸展和强化练习。使用在干预期间和之后收集的数据 计划，我们将评估保留和遵守小组课程和家庭实践，评估参与者 自我效能感和观察到的学习干预技术的成功，以及数据检查率 来自疼痛相关结果测量的完成性和数据质量。 这项研究是迈向未来的重要的下一步，严格评估瑜伽的有效性和安全性 一种潜在的以患者为中心、以社区为基础的慢性盆腔疼痛自我管理策略。