Adding transcutaneous electrical nerve stimulation (TENS) to physical therapy reduced pain for patients with fibromyalgia, according to the FM-TIPS pragmatic clinical trial.
The results of the study were published online in JAMA Network Open.
FM-TIPS, an NIH Collaboratory Trial, examined whether the addition of TENS to routine outpatient physical therapy improves movement-evoked pain compared with physical therapy alone among patients with fibromyalgia. TENS is a noninvasive, nondrug therapy that delivers low-voltage electrical currents through electrodes placed on the skin.
The study was led by principal investigators Kathleen Sluka of the University of Iowa and Leslie Crofford of Vanderbilt University.
"TENS is a safe, effective treatment for movement-evoked pain and fatigue in individuals with fibromyalgia," Sluka said."It is an inexpensive and readily available treatment that individuals can use at home to help manage their pain," she added.
The study team randomly assigned 28 outpatient physical therapy clinics in 6 healthcare systems to provide either physical therapy plus TENS or physical therapy alone to patients enrolled in the study. Across the participating clinics, 384 patients completed baseline data collection from February 2021 through September 2024 and completed final data collection by March 2025. Patients in the TENS group were instructed to apply the electrodes to the upper and lower back and wear them for 2 hours per day with a minimum of 30 minutes per session.
After 60 days, movement-evoked pain was significantly lower among patients receiving physical therapy plus TENS compared with patients receiving physical therapy alone. In an extension of the study from day 60 to day 180, patients in the physical therapy only group began receiving TENS and patients in the TENS group continued with the treatment. At 180 days, 81% of patients reported finding TENS to be helpful and 55% were still using it daily.
"The NIH Collaboratory was essential in helping the study team to design and execute FM-TIPS; we could not have done it without their continued consultation and support," Sluka said.
FM-TIPS is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative by a grant administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Learn more about FM-TIPS.