TENS Trial Reports Pain Relief In Fibromyalgia

Investigators report that adding transcutaneous electrical nerve stimulation to physical therapy was associated with lower movement-evoked pain at day 60, with a group mean difference of −1.2 (95% CI, −1.6 to −0.7; d = 0.46). Participants were enrolled across 28 outpatient physical therapy clinics in the FM TIPS cluster randomized clinical trial, which was conducted within six health systems. The trial evaluated TENS as an add-on to routine physical therapy and ran from February 2021 through September 2024. Researchers screened 958 individuals, enrolled 459, and included 384 participants in the modified intention-to-treat population after baseline data collection. Participants had a mean age of 53 years (SD 15), and 91% were female in the analyzed population.

Clinics were assigned to physical therapy plus TENS or to physical therapy only, reflecting the cluster design with randomization at the clinic level. The two groups included 191 and 193 participants, respectively, in the modified intention-to-treat analysis. Change in movement-evoked pain on a 0 to 10 scale at day 60 was the primary outcome, focusing on symptoms triggered by activity. The authors note higher patient-reported improvement in the TENS group, with 72% describing improvement compared with 51% in the comparison group (P = .001). Investigators found that 41% of participants receiving TENS and 13% receiving physical therapy alone achieved at least 30% pain reduction (P < .001).

At the day 180 follow-up, 81% of participants reported TENS was helpful and 55% reported using it daily, extending observation to roughly six months after allocation. Researchers described these later findings as a continuation of benefit after the initial day 60 assessment period. The follow-up data linked perceived helpfulness with continued use in many participants beyond the early treatment window and primary endpoint. Together, these findings formed the longer-term follow-up picture described for the intervention group in outpatient practice.

Investigators also reported no serious adverse events during the trial, adding a concise safety overview to the efficacy findings. Minor adverse events were observed in 30% of participants. These safety data came from the same outpatient clinic population used for the day 60 symptom analyses and day 180 follow-up assessments. The authors did not provide further categorization of those minor events or describe serious complications beyond the reported counts.

Key Takeaways

• Adding TENS to physical therapy was reported to be associated with lower movement-evoked pain at day 60 in fibromyalgia.
• Patient-reported improvement, responder outcomes, and benefit through day 180 were described in the intervention group.
• No serious adverse events were reported, while minor adverse events were observed in a subset of participants.