Summary: For the millions living with Fibromyalgia, the greatest paradox is that exercise is the best medicine, yet movement itself causes agonizing pain and crushing fatigue. A real-world clinical trial has found a simple, drug-free solution.
By adding TENS (transcutaneous electrical nerve stimulation) to standard physical therapy, patients saw a significant reduction in movement-evoked pain and—most notably—fatigue. The study, involving 384 participants across 28 clinics, proved that TENS is as effective as FDA-approved medications but with a “dose-dependent” benefit that doesn’t fade over time.
Key Facts
The Fatigue Breakthrough: While many treatments target pain, this is one of the first to significantly reduce fatigue, a primary barrier for fibromyalgia patients.Real-World Success: Unlike many lab-only studies, this “FM-TIPS” trial took place in everyday clinics across the Midwest, proving the treatment works in the “messy” reality of daily life.No Tolerance Build-up: Unlike opioid or non-opioid medications, which often require higher doses over time, TENS maintained its effectiveness for at least six months.The 80% Rule: After the trial, 80% of participants found TENS helpful, and 70% reported feeling better overall, leading to high long-term adherence.
Source: University of Iowa
Adding TENS (transcutaneous electrical nerve stimulation) to outpatient physical therapy reduced movement-based pain and fatigue in patients with fibromyalgia, and the effects lasted for at least six months, according to a new study led by researchers at University of Iowa Health Care.
The study, led by Kathleen Sluka, PT, PhD, is the first real-world trial of TENS for fibromyalgia. The findings, published on March 27 in the journal JAMA Network Open, show that TENS is a safe, effective, inexpensive, and readily available treatment for fibromyalgia, a chronic condition that causes pain, tenderness, and fatigue throughout the body.
TENS is one of the few treatments that specifically targets movement-evoked pain and fatigue. Credit: Neuroscience News
“It is one of the few treatments that specifically targets movement-evoked pain and fatigue, which are major barriers to participation in daily activities,” says Sluka, UI professor of physical therapy and rehabilitation science.
TENS uses a small device with adhesive electrodes to send mild electrical pulses through the skin to block or reduce pain. The study found that the effect of TENS for reducing pain was similar, if not better, than current FDA-approved medications for fibromyalgia.
“We were excited to see that patients also had less fatigue,” Sluka added. “Right now, there are no good treatments for fatigue. So, the fact that we had anything that touched the fatigue was pretty powerful.”
Fibromyalgia: complicated, misunderstood, and hard to treat
Fibromyalgia affects about 4% to 7% of the population. It significantly impacts a person’s physical function, cognitive abilities, and sleep. In addition to chronic pain, a key feature of the condition is whole-body fatigue, which interferes with day-to-day life and contributes to patients’ inability to concentrate and perform functional activities.
Exercise is often the first line of treatment recommended to people with fibromyalgia, and research has shown that it can be beneficial. However, fibromyalgia causes fatigue and pain, which is a key reason why the research team focused on alleviating pain with movement.
“Pain with movement hinders a person’s ability to participate in an effective exercise program and do their day-to-day activities.” Sluka says.
Science translated to real-world benefit
Sluka and her colleagues have spent decades studying the biological mechanisms affected by TENS, developing the ideal parameters of TENS stimulation and testing the efficacy of TENS for treating chronic pain and fatigue in human trials.
They have previously shown that under the ideal conditions of a randomized, controlled clinical trial, TENS in conjunction with physical therapy can significantly decrease movement pain.
The new Fibromyalgia TENS in Physical Therapy (FM-TIPS) study was designed to test the effect of TENS under real-world conditions. The study was conducted in 28 outpatient physical therapy clinics across six health care systems in the Midwest, and included 384 people of different ages, education levels, and socioeconomic backgrounds. Almost 50% of the participants were from rural areas.
“It was a challenge to recruit participants for this study, but the clinics and the physical therapists we worked with were great. This would never have happened without them,” Sluka says.
The clinics were randomized to provide either physical therapy (PT) with TENS or physical therapy alone. In the PT-TENS group, participants were asked to use TENS for two hours a day for six months. That time could be split into short periods or done all at once. The TENS electrodes were placed on the upper and lower back and delivered a mixed frequency signal at an intensity as strong as the participant could tolerate.
After 60 days, movement-evoked pain during TENS treatment was significantly improved in the PT-TENS group. Adding TENS also significantly reduced resting pain and resting and movement-fatigue. In contrast, participants who received only physical therapy had no change in their movement-evoked pain.
The response also was dose-dependent, with people who used TENS daily for 60 days having the best outcomes.
Unlike many pain-relieving drugs that can become less effective over time as the body develops a tolerance for the medication, the study shows that over time, TENS maintained its ability to improve pain and fatigue at a significant level.
After the primary endpoint at day 60, the PT-only group was also given TENS, and all the participants continued in the study for another four months.
“When we gave the PT-only patients the TENS unit and they started using it, we also saw the same improvements as the PT with TENS patients, which is powerful,” Sluka says.
Overall, the study showed that 80% of patients found TENS helpful. At six months, 80% were still using TENS once a week, and over 70% reported they felt better after using TENS.
TENS adds benefit
Dana Dailey, PT, PhD, UI assistant research scientist and the first author of the study, notes that it’s important for people to realize that the benefit of TENS comes from using it as a part of a total treatment planthat includes physical therapy.
“Using TENS on its own will not give the same benefits,” Dailey says. “However, the study shows that TENS provides an added benefit on top of any relief from other treatments. All the study participants were also using pain medications and receiving physical therapy, yet TENS still provided additional relief.”
Fibromyalgia often needs multiple interventions to help patients feel less pain and fatigue and improve their overall function. The new findings suggest that TENS could be particularly helpful as a part of a multipronged approach because it can be safely and easily used as a self-management tool that uniquely targets movement-associated pain and fatigue.
“Often, when you move a randomized, controlled clinical trial into a real-world setting, it doesn’t work because there are too many confounding factors. But this intervention still works,” Sluka says. “Not only did the treatment reduce movement pain and fatigue during the testing period, but patients continued to use it at six months.”
The study team included researchers from University of Iowa Health Care and the University of Iowa College of Public Health; University of Illinois Chicago and UI Health; Advanced Physical Therapy & Sports Medicine; Kepros Physical Therapy & Performance; Advanced Physical Therapy Associates; Big Stone Therapies; Rock Valley Physical Therapy; Iowa City VA Healthcare System; Grand Valley State University; and Vanderbilt University Medical Center.
Funding: The research was funded as part of the HEAL Initiative by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Key Questions Answered:Q: Can I just buy a TENS unit and skip physical therapy?
A: The researchers are clear on this: No. The study found that TENS provides an “added benefit” on top of physical therapy and medication. It works best as a “self-management tool” that allows you to actually get through your PT and daily activities without the usual “flare-up” of pain.
Q: How exactly does a little zap help with whole-body fatigue?
A: Fatigue in fibromyalgia is often linked to the brain being in a constant state of high-alert due to chronic pain. By using TENS to block those pain signals, the nervous system can finally “calm down,” which preserves the energy that would otherwise be spent processing pain. It’s essentially a “power-save mode” for your brain.
Q: Will the “zaps” stop working if I use it every day?
A: Surprisingly, no. While your body gets used to drugs (tolerance), the study showed that the response to TENS was dose-dependent. Those who used it consistently for two hours a day for 60 days had the best outcomes, and the relief lasted through the full six-month follow-up.
Editorial Notes:This article was edited by a Neuroscience News editor.Journal paper reviewed in full.Additional context added by our staff.About this fibromyalgia and pain research news
Author: Jennifer Brown
Source: University of Iowa
Contact: Jennifer Brown – University of Iowa
Image: The image is credited to Neuroscience News
Original Research: Open access.
“Transcutaneous Electrical Nerve Stimulation and Pain With Movement in People With Fibromyalgia” by Dana L. Dailey, Carol G. T. Vance, Barbara J. Van Gorp, Elizabeth M. Johnson, Andrew A. Post, Ruth L. Chimenti, Kari G. Vance, Carla Franck, Josiah Sault, Ezgi Yarasir, Heather S. Reisinger, Alexandra Anderson, Jesse Anderson, Randy Capelle, Amanda Crouch, Jeffrey Donatelle, Dennis Kaster, Ted Kepros, Emily Nicklies, Bill Rein, Robert Worth, Mariah Balinski, David-Erick Lafontant, E. J. Slade, Fangfang Jiang, Dixie Ecklund, Tina Neill-Hudson, Maxine Koepp, Michele Costigan, Maggie Spencer, Kristin R. Archer, Bridget M. Zimmerman, Emine O. Bayman, Leslie J. Crofford, and Kathleen A. Sluka.. JAMA Network Open
DOI:10.1001/jamanetworkopen.2026.2450
Abstract
Transcutaneous Electrical Nerve Stimulation and Pain With Movement in People With Fibromyalgia
Importance
Fibromyalgia is characterized by chronic widespread pain that is often exacerbated by movement that interferes with daily activities. Development of effective treatments for movement-evoked pain is essential for improving function for individuals with fibromyalgia.
Objective
To evaluate whether the addition of transcutaneous electrical nerve stimulation (TENS) to outpatient physical therapy improves fibromyalgia-associated movement-evoked pain.
Design, Setting, and Participants
The Fibromyalgia TENS in Physical Therapy (FM-TIPS) study was a cluster-randomized clinical trial of participants with fibromyalgia at 28 outpatient PT clinics from 6 health care systems. Between February 1, 2021, and September 31, 2024, 958 participants were screened, 459 participants enrolled, and 384 completed baseline data collection, with final data collected in March 2025.
Intervention
Clinics were randomized to PT plus TENS (PT-TENS) and PT-only groups. Data were captured on days 1, 30, 60 (primary end point, randomized phase), 90, and 180. Participants in the PT-only group received TENS after day 60 (extension phase). TENS was applied to the upper and lower back with instructions to use 2 hours daily with parameters of modulating frequency of 2 to 125 Hz for 100 to 180 microseconds at a strong but comfortable intensity.
Main Outcomes and Measures
The primary outcome was a change in movement-evoked pain (scale of 0-10, with 0 indicating no pain and 10 indicating worst pain imaginable) from baseline to day 60 rated during a 5-times sit-and-stand task using a linear mixed-effects model. In addition, patient-reported improvement based on the Patient Global Impression of Change score and patient-reported adverse events were assessed.
Results
A total of 384 FM-TIPS participants (mean [SD] age, 53 [15] years; 351 [91%] female) completed baseline data collection (modified intention-to-treat), with 191 individuals in PT-TENS group and 193 in PT-only group. Movement-evoked pain at day 60 during TENS treatment was significantly lower in the PT-TENS group compared with the PT-only group (group mean difference, −1.2; 95 CI, −1.6 to −0.7; d = 0.46). A dose-response effect for TENS was observed, with more participants in the PT-TENS group reporting improvement on the Patient Global Impression of Change (120 [72%] vs 86 [51%], P = .001) and a 30% or greater reduction in movement-evoked pain in responder analysis (66 of 161 [41%] vs 22 of 169 [13%]; P < .001). At day 180, 217 respondents (81%) found TENS helpful and 147 (55%) used TENS daily. There were no serious adverse events, and 109 of 358 (30%) experienced minor adverse events during the entire 6 months of the study.
Conclusions and Relevance
In this cluster randomized clinical trial of TENS in fibromyalgia, TENS meaningfully reduced movement-evoked pain and remained effective for 6 months. This study’s results suggest that TENS is a safe, inexpensive, and readily available treatment for fibromyalgia.
Trial Registration
ClinicalTrials.gov Identifier: NCT04683042