TENS With Physical Therapy Meaningfully Reduced Fibromyalgia Movement-Evoked Pain

Transcutaneous electrical nerve stimulation (TENS) in addition to routine physical therapy (PT) meaningfully reduced movement-evoked pain and other outcomes in people with fibromyalgia for at least 6 months.1

These findings are from the cluster-randomized pragmatic FM-TIPS trial, data from which were presented at the American College of Rheumatology (ACR) Convergence 2025, held October 24–29 in Chicago, Illinois, by Leslie Crofford, MD, Wilson Family Chair in Medicine, Professor of Medicine and of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center.

“Fibromyalgia is associated with enhanced central pain transmission, while transcutaneous electrical nerve stimulation (TENS) delivers electrical current through surface electrodes to counteract this central excitability.We previously showed the efficacy of TENS in reducing movement-evoked pain (MEP) and fatigue in individuals with fibromyalgia in a double-blind, randomized controlled trial; however, effectiveness of TENS in a real-world setting has not previously been tested.As physical therapists are trained to use TENS for pain management, we examined if addition of TENS to outpatient physical therapy (PT) would reduce MEP using a pragmatic trial design,” Crofford and colleagues wrote.1

The trial was conducted at 28 outpatient PT clinics and randomized 344 patients to PT+TENS (n = 171) or PT only (n = 173). TENS treatment consisted of 2 TENS devices delivering a waveform with modulating frequency of 2-125 Hz and pulse duration from 100-180 µs at a strong but comfortable intensity for 2 hours daily during activity. Butterfly electrodes were placed on the upper and lower back. Crofford and colleagues used REDCap to capture outcomes on days 1, 30, 60, 90, 180 with the primary outcome as change in MEP from baseline to the end of the randomized phase. After day 60, the PT-Only group received TENS and the PT+TENS continued TENS in an extension phase.1

Crofford and colleagues found that MEP at day 60 was significantly lower in the PT+TENS group (mean, -1.1; 95% CI, -1.58 to -0.7; Cohen's d = .46) in the randomized phase. PT+TENS also reduced resting pain, movement fatigue, and resting fatigue by day 30 which persisted until day 180.1

Compared to the PT-only group, more participants in PT+TENS had at least a 30% reduction in MEP (41% vs 13%; P = .0001) and resting pain (30% vs 21%, P = .004). Patient's Global Impression of Change scores also favored PT+TENS. By 180 days, 81% of respondents that remained in the study found TENS helpful and 55% used TENS daily. In terms of safety, there were no treatment related serious adverse events (AEs) and minor adverse events related to TENS were all ≤7.5%.1

“TENS meaningfully reduces fibromyalgia pain and fatigue. Effectiveness persists for at least 180 days. Treatment effect size is comparable to other fibromyalgia therapies even in this heterogeneous real-world population. TENS is a safe, inexpensive, and readily available treatment for fibromyalgia,” Crofford and colleagues concluded.1

In other recent fibromyalgia news, the FDA approved TNX-102 SL, the first new fibromyalgia therapy in over 15 years, in August 2025. Developed by Tonix Pharmaceuticals and marketed as Tonmya, the therapy is a sublingual formulation of cyclobenzaprine and the first member of a new class of non-opioid analgesics for the condition.2

“I am aware that some rheumatologists have commented that it will just be an expensive version of generic, oral cyclobenzaprine, but the fact that it was able to show statistical separation from placebo and has a unique mechanism of action that yields more enduring effect during the nighttime’s sleep cycles, and that its bioavailability is greater, all add up to our wanting to use it,” Philip Mease, MD, director of Rheumatology Research at Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, told HCPLive about the new approval.

References

1. Crofford L, Dailey D, Van Gorp B, et al. Transcutaneous Electrical Nerve Stimulation Effectively Reduces Pain in Fibromyalgia: A Pragmatic Cluster-Randomized Trial Embedded in Physical Therapy Practice. Presented at: ACR Convergence 2025; October 24-29; Chicago, Illinois. Poster #LB03

2. Johnson V. FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years. Article. HCPLive. August 15, 2025. https://www.hcplive.com/view/fda-approves-tnx-102-sl-first-new-fibromyalgia-therapy-in-15-years