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.

项目摘要 FM是一种慢性疼痛状态，以广泛的肌肉骨骼疼痛、压痛和僵硬为特征。 有疲劳和睡眠障碍。减少慢性疼痛患者使用阿片类药物的目标需要证明 非药物治疗在临床实践中得到应用。我们最近完成了禁食(纤维肌痛 TENS的活动研究)试验显示活动TENS与安慰剂TENS或不治疗的疗效比较 女性纤维肌痛(FM)。FAST是第一项最终证明TENS在肌肉骨骼中的有效性的研究 疼痛。虽然物理治疗师接受了TENS使用方面的培训，但在临床实践中使用不足。此应用程序 建议进行一项嵌入式实用试验，以比较使用和不使用物理治疗的效果 在物理治疗(PT)实践中增加FM患者的TENS作为研究地点。这个项目的总体目标是 建议是(1)在真实的PT实践中证明将TENS添加到FM患者的治疗中的可行性 设置和(2)确定在PT中添加TENS是否减轻疼痛，增加对PT的依从性，并允许患者 FM以更少的药物使用达到其特定的功能目标。我们假设在PT设置中使用十进制是可行的 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。为了测试 在这些假设下，我们将利用以下具体目标规划(UG3)和实施(UH3)阶段。UG3目标 1：为这项嵌入式实用临床试验招募物理治疗实践作为研究地点，并了解通常情况 FM患者告知试验过程的实践。UG3目标2：确保潜在研究中基础设施的充分性 网站完成PT嵌入式实用试用。UH3目标1：评估除物理外使用TENS的可行性 常规PT整群随机实用临床试验治疗FM(入选) 由治疗师以个人为基础)使用或不使用十进制。UH3目标2：确定使用TENS是否会改善 FM的症状，增加对物理治疗的坚持，增加达到治疗目标的可能性，以及 减少药物使用。这项研究将解决制定战略的迫切需要，以实施有效的非 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 完成了初级保健实践中TENS的随机对照试验和实施研究，以完成 在PT设置的调频的真实世界的审判。这项试验的成功完成将提供普遍的有效性 为转介提供者、物理治疗师和保险公司提供数据，并将为未来的非 在PT实践中进行的药物治疗。