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)

 

ClinicalTrials.gov Identifier: NCT04683042

 

Trial Status: Completed

Study Snapshot

Trial Summary

Study question and significance: Transcutaneous electrical nerve stimulation (TENS) has been found to improve movement-evoked pain in patients with fibromyalgia in research settings with highly selected populations. It is unknown whether TENS offers the same benefits when combined with routine outpatient physical therapy in real-world clinical settings.

Design and setting: Cluster randomized trial examining the effects of adding TENS to routine physical therapy compared with physical therapy alone among patients with fibromyalgia in 28 outpatient physical therapy clinics in 6 healthcare systems between February 2021 and March 2025.

Intervention and methods: Participating clinics were randomized to physical therapy plus TENS and physical therapy only groups. The study team captured data on days 1, 30, 60, 90, and 180, using day 60 as the primary endpoint. Participants in the physical therapy only group received TENS after day 60 in an extension phase of the study. The primary outcome was change in movement-evoked pain from baseline to day 60.

Findings: A total of 384 patients completed baseline data collection. At 60 days, movement-evoked pain was significantly lower among patients receiving physical therapy plus TENS compared with patients receiving physical therapy alone. The study team also observed a dose-response effect, and there were clinically significant improvements in secondary outcome measures, including resting pain, pain interference, and fatigue. There were similar reductions in pain and fatigue in the physical therapy only group after starting TENS in the extension phase of the study. At 180 days, 81% of patients reported finding TENS to be helpful and 55% were still using it daily.

Conclusions and relevance: TENS offered meaningful reductions in pain and fatigue without serious adverse events. TENS is a safe, inexpensive, and readily available treatment that individuals with fibromyalgia can use at home to manage their pain.

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Co–principal investigator Kathleen Sluka discusses FM-TIPS

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