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

纤维肌痛 TENS 物理治疗研究 (TIPS)：一项嵌入式实用临床试验

• 批准号: 10253306
• 负责人: Leslie J Crofford
• 金额: $ 526.23万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10253306
• 关键词: Address; Adherence; Affect; Budgets; Caring; Case Report Form; Chronic; Clinical; Clinical Research; Clinical Trials; Communities; Consent; Data; Disease; Drug usage; Effectiveness; Electronic Health Record; Enrollment; Ensure; Exercise; Fatigue; Fibromyalgia; Future; Goals; Healthcare; Individual; Infrastructure; Insurance Carriers; Interdisciplinary Study; Interview; Laboratories; Manuals; Methods; Midwestern United States; Movement; Musculoskeletal Pain; Opioid; Pain; Pain management; Pathway interactions; Patients; Pharmaceutical Preparations; Phase; Physical therapy; Physical therapy exercises; Physiological; Placebos; Population; Postoperative Period; Pragmatic clinical trial; Primary Care Physician; Primary Health Care; Procedures; Process; Provider; Randomized; Randomized Controlled Trials; Recommendation; Research; Rural; Site; Sleep disturbances; Structure; Testing; Therapeutic; Therapeutic Intervention; Time; Training; Transcutaneous Electric Nerve Stimulation; Translating; Variant; Visit; Woman; Work; chronic pain; chronic pain patient; chronic painful condition; clinical practice; compare effectiveness; endogenous opioids; experience; fibromyalgia pain; fibromyalgia patients; improved; meetings; opioid use; pain reduction; physical therapist; practice setting; pragmatic trial; primary outcome; recruit; secondary outcome; symptomatic improvement; tool; treatment as usual

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.

项目概要 FM 是一种慢性疼痛，其特征是广泛的肌肉骨骼疼痛、压痛和僵硬 伴有疲劳和睡眠障碍。减少慢性疼痛患者阿片类药物使用的目标需要经过证实的 非药物治疗应用于临床实践。我们最近完成了 FAST（纤维肌痛 TENS 活动研究）试验证明了活性 TENS 与安慰剂 TENS 或不治疗相比的功效 患有纤维肌痛（FM）的女性。 FAST 是第一项最终证明 TENS 对肌肉骨骼功效的研究 疼痛。虽然物理治疗师接受过使用 TENS 的培训，但它在临床实践中并未得到充分利用。这个应用程序 提议进行一项嵌入式实用性试验，以比较有或没有物理治疗的有效性 在物理治疗 (PT) 实践中添加针对 FM 患者的 TENS 作为研究地点。本次活动的总体目标 建议 (1) 证明在真实 PT 实践中将 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 以较少的药物使用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 使用 TENS 的 FM 患者更有可能达到治疗目标并减少药物使用。测试 根据这些假设，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该嵌入式实用临床试验的研究场所并了解常规 为 FM 患者进行练习，以告知试验流程。 UG3 目标 2：确保潜在研究的基础设施充足 网站完成 PT 嵌入式实用试验。 UH3 目标 1：评估除了物理治疗之外使用 TENS 的可行性 使用常规 PT 的整群随机实用临床试验（根据选定的 由治疗师根据个人情况进行），有或没有 TENS。 UH3 目标 2：确定 TENS 的使用是否可以改善 FM 症状，增加对物理治疗的依从性，增加实现治疗目标的可能性，以及 减少药物使用。这项研究将解决制定实施有效的非 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 完成了 TENS 在初级保健实践中的随机对照试验和实施研究，以完成 在 PT 设置中对 FM 进行 TENS 的实际试验。该试验的成功完成将提供普遍的有效性 转介提供者、物理治疗师和保险公司的数据，并将为未来的非 在 PT 实践中进行的药物治疗。