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

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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.