UH3 Project: Fibromyalgia TENS in Physical Therapy Study (FM-TIPS)

UH3 Project: Fibromyalgia TENS in Physical Therapy Study (FM-TIPS)

Overview

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Principal Investigators:
Kathleen Sluka v2

Kathleen Sluka, PT, PhD

Leslie-Crofford

Leslie Crofford, MD

Sponsoring Institution: University of Iowa

Collaborators:

  • Advanced Physical Therapy and Sports Medicine
  • Big Stone Physical Therapy
  • Genesis Healthcare Systems
  • Kepros Physical Therapy and Performance
  • Rock Valley Physical Therapy
  • University of Illinois Chicago

NIH Institute Providing Oversight: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Program Official: Charles Washabaugh, PhD (NIAMS)

Project Scientist: Joe Bonner, PhD (National Institute of Child Health and Human Development [NICHD]/National Center for Medical Rehabilitation Research [NCMRR])

ClinicalTrials.gov Identifier: NCT04683042

Trial Status: Enrolling

Study Snapshot

Trial Summary

Fibromyalgia 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 nonpharmacologic treatments are applied in clinical practice. A recently completed trial conclusively demonstrated the efficacy of transcutaneous electrical nerve stimulator (TENS) for reducing musculoskeletal pain. While physical therapists are trained in the use of TENS, it is underused in clinical practice. FM-TIPS is an embedded pragmatic trial comparing the effectiveness of physical therapy with or without the addition of TENS for patients with fibromyalgia within physical therapy clinics. The aims of the trial are to demonstrate the feasibility of adding TENS to the treatment of patients with fibromyalgia in a real-world practice setting and to determine if the addition of TENS reduces pain, increases adherence to physical therapy, and allows patients to reach their specific functional goals with less medication use. FM-TIPS will address the critical need for strategies that implement effective nonpharmacologic treatments for fibromyalgia. Successful completion of this trial will provide generalizable effectiveness data for referring providers, physical therapists, and insurers and will inform future pragmatic trials of nonpharmacologic treatments conducted in physical therapy practices.

NIH Project Information

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Co–principal investigators Dr. Kathleen Sluka and Dr. Leslie Crofford discuss FM-TIPS.

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