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

摘要 本行政补充母公司赠款UH 3AR 076387与斯卢卡和克罗夫德作为多个 首席研究员将用于为教职员工提供额外的工资支持， 增加差旅，以支持征聘和留用工作， 物理治疗研究中的纤维肌痛TENS（FM-TIPS）。FM-TIPS是一项实用的临床试验， 将TENS加入常规物理治疗实践的有效性和可行性。这个项目的总体目标是 建议是（1）证明在真实的- 世界PT实践设置和（2）确定在PT中添加TENS是否减少疼痛，增加 坚持PT，并允许FM患者达到其特定的功能目标。我们假设 在PT设置中使用TENS是可行的，并且使用TENS的FM患者更有可能达到他们的 治疗目标，减少药物使用。为了验证这些假设，我们将使用以下内容 具体目标UH 3目标1：评估除物理治疗外， 使用常规PT（作为 由治疗师在个体基础上选择）有或没有TENS。UH 3目标2：确定是否使用TENS 改善FM的症状，增加对物理治疗的坚持，增加 达到治疗目标。这项研究将解决迫切需要制定一项战略， 对FM实施有效的非药物治疗。我们的多学科研究团队将 利用他们最近完成的随机对照试验的经验， TENS在初级保健实践中的研究，以完成在PT环境中TENS治疗FM的真实世界试验。 本试验的成功完成将为转诊提供者提供可推广的有效性数据， 物理治疗师和保险公司，并将告知未来的非药物的务实试验 在PT实践中进行的治疗。

Abstract This administrative supplement to parent grant UH3AR076387 with Sluka and Crofford as Multiple Principal Investigators will be used to provide additional salary support for faculty and staff, and additional travel to support recruitment and retention efforts, to complete project goals for the Fibromyalgia TENS in Physical Therapy Study (FM-TIPS). FM-TIPS is a pragmatic clinical trial testing the efficacy and feasibility of adding TENS to regular physical therapy practice. 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. 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 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. 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.