Fibromyalgia TENS in Physical Therapy Study (TIPS):an embedded pragmatic clinical trial

项目摘要 FM是一种慢性疼痛疾病，其特征是广泛的肌肉骨骼疼痛，压痛和僵硬相关 疲劳和睡眠障碍减少慢性疼痛患者使用阿片类药物的目标需要证明 在临床实践中应用非药物治疗。我们最近完成了快速（纤维肌痛 活性研究与TENS）试验，证明活性TENS与安慰剂TENS或无治疗相比， 纤维肌痛（FM）FAST是第一项最终证明TENS在肌肉骨骼系统中有效性的研究。 痛苦虽然物理治疗师接受过使用TENS的培训，但在临床实践中未得到充分利用。本申请 建议进行一项嵌入式务实的试验，以比较有或没有物理治疗的有效性， 在物理治疗（PT）实践中为FM患者增加TENS作为研究中心。这个项目的总体目标是 建议是（1）在现实世界的PT实践中证明将TENS添加到FM患者治疗中的可行性 （2）确定在PT中添加TENS是否可以减轻疼痛，增加对PT的依从性，并允许患者 FM以达到其特定的功能目标，减少药物使用。我们假设在PT设置中使用TENS是可行的 FM患者使用TENS更有可能达到他们的治疗目标并减少药物使用。测试 这些假设，我们将利用以下具体目标规划（UG3）和实施（UH3）阶段。UG3目标 1：招募物理治疗实践作为这项嵌入式实用临床试验的研究地点，并了解通常的 FM患者告知试验过程的实践。UG3目标2：确保潜在研究的基础设施充足 研究中心完成PT嵌入式务实试验。UH3目标1：评估除物理治疗外，使用TENS的可行性 使用常规PT（如所选）的分组随机化实用临床试验治疗FM患者 由治疗师在个体的基础上）有或没有TENS。UH3目标2：确定TENS的使用是否改善了 FM的症状，增加物理治疗的依从性，增加达到治疗目标的可能性， 减少药物使用。这项研究将解决迫切需要制定一项战略， FM的药物治疗。我们的多学科研究团队将利用他们最近的经验， 一项已完成的随机对照试验和一项TENS在初级保健实践中的实施研究， TENS在PT设置中用于FM的真实世界试验。本试验的成功完成将提供可推广的有效性 数据转介提供者，物理治疗师和保险公司，并将告知未来的务实试验， 在PT实践中进行的药物治疗。

Project Summary FM is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness and stiffness associated with fatigue and sleep disturbance. The goal of reducing opioid use in patients with chronic pain requires that proven non-pharmacological treatments are applied in clinical practice. We have recently completed the FAST (Fibromyalgia Activity Study with TENS) trial demonstrating efficacy of Active TENS compared with Placebo TENS or No Treatment in women with fibromyalgia (FM). FAST was the first study to conclusively demonstrate efficacy of TENS in musculoskeletal pain. While physical therapists are trained in the use of TENS, it is underused in clinical practice. This application proposes to conduct an embedded pragmatic trial to compare effectiveness of physical therapy with or without the addition of TENS for FM patients within physical therapy (PT) practices as the study sites. The overall goal of this proposal is to (1) demonstrate the feasibility of adding TENS to treatment of patients with FM in a real-world PT practice setting and (2) to determine if addition of TENS to PT reduces pain, increases adherence to PT and allows patients with FM to reach their specific functional goals with less drug use. We hypothesize that using TENS in a PT setting is feasible and that FM patients using TENS are more likely to reach their therapeutic goals and reduce medication use. To test these hypotheses, we will utilize the following specific aims planning (UG3) and implementation (UH3) phases. UG3 Aim 1: Recruit physical therapy practices as research sites for this embedded pragmatic clinical trial and understand usual practice for patients with FM to inform trial processes. UG3 Aim 2: Ensure adequacy of infrastructure at potential study sites to complete a PT embedded pragmatic trial. UH3 Aim 1: Assess the feasibility of using TENS in addition to physical therapy for treatment of patients with FM using a cluster-randomized pragmatic clinical trial of routine PT (as selected by the therapist on an individual basis) with or without TENS. UH3 Aim 2: Determine if TENS use improves the symptoms of FM, increases adherence to physical therapy, increases the likelihood of meeting therapeutic goals, and reduces medication use. This study will address the critical need to develop a strategy for implementing effective non- pharmacologic treatments for FM. Our multi-disciplinary research team will leverage their experience from a recently completed randomized controlled trial and an implementation study for TENS in primary care practice to complete a real-world trial of TENS for FM in a PT setting. Successful completion of this trial will provide generalizable effectiveness data for referring providers, physical therapists, and insurers and will inform future pragmatic trials of non- pharmacologic treatments conducted in PT practices.