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.

摘要