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: 10891041
• 负责人: Leslie J Crofford
• 金额: $ 129.73万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-12 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10891041
• 关键词: Adherence; Administrative Supplement; Affect; Award; Budgets; Caring; Case Report Form; Chronic; Clinical Research; Communities; Data; Disease; Drug usage; Effectiveness; Electronic Health Record; Electronics; 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; Parents; Pathway interactions; Patients; Pharmaceutical Preparations; Phase; Physical therapy; Physiological; Placebos; Population; Postoperative Period; Pragmatic clinical trial; Primary Care Physician; Principal Investigator; Procedures; Process; Provider; Randomized; Randomized, Controlled Trials; Recurrence; Research; Research Personnel; Rural; Site; Sleep disturbances; Structure; Testing; Therapeutic; Therapeutic Intervention; Time; Training; Transcutaneous Electric Nerve Stimulation; Translating; Travel; Variant; Visit; Wages; Woman; Work; chronic pain patient; chronic painful condition; clinical practice; compare effectiveness; efficacy testing; electronic consent; endogenous opioids; experience; faculty support; fibromyalgia pain; fibromyalgia patients; implementation study; improved; meetings; opioid use; pain reduction; parent grant; physical therapist; practice setting; pragmatic trial; primary care patient; primary care practice; primary outcome; recruit; secondary outcome; symptomatic improvement; treatment as usual

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.

抽象的 此行政补充家长补助金 UH3AR076387 与 Sluka 和 Crofford 作为多个 首席研究员将用于为教职员工提供额外的薪资支持，以及 额外出差以支持招聘和保留工作，以完成项目目标 纤维肌痛 TENS 物理治疗研究 (FM-TIPS)。 FM-TIPS 是一项实用的临床试验，测试 将 TENS 添加到常规物理治疗实践中的功效和可行性。本次活动的总体目标 提案的目的是 (1) 证明在真实情况下将 TENS 添加到 FM 患者治疗中的可行性 世界 PT 实践设置和 (2) 确定在 PT 中添加 TENS 是否会减轻疼痛、增加疼痛 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 环境中使用 TENS 是可行的，并且使用 TENS 的 FM 患者更有可能达到预期目标 治疗目标并减少药物使用。为了检验这些假设，我们将利用以下内容 具体目标 UH3 目标 1：评估除物理治疗外使用 TENS 的可行性 使用常规 PT 的整群随机实用临床试验（如 由治疗师根据个人情况选择），有或没有 TENS。 UH3 目标 2：确定是否使用 TENS 改善 FM 症状，提高物理治疗的依从性，增加发生 FM 的可能性 达到治疗目标。这项研究将解决制定战略的迫切需要 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和实施的经验 研究 TENS 在初级保健实践中的应用，以完成 TENS 在 PT 环境中用于 FM 的真实试验。 该试验的成功完成将为推荐提供者提供可推广的有效性数据， 物理治疗师和保险公司，并将为未来的非药物实用试验提供信息 在 PT 实践中进行的治疗。