The Fibromyalgia TENS in Physical Therapy Study (FM-TIPS), a pragmatic cluster-randomized clinical trial published in JAMA Network Open, evaluated the effectiveness of adding transcutaneous electrical nerve stimulation (TENS) to routine outpatient physical therapy (PT) for movement-evoked pain and fatigue in individuals with fibromyalgia.

Dailey et al. (2026) conducted the trial across 28 outpatient PT clinics within six Midwest health systems. Between February 2021 and September 2024, researchers screened 958 adults with fibromyalgia, enrolled 459 participants, and analyzed 384 in the modified intention-to-treat population (191 in the PT + TENS group and 193 in the PT-only group). Participants were representative of typical clinical cohorts: mean age 53.2 years (SD = 15.2), 91% female, 50% from rural areas, and diverse in education, income, and comorbidity profiles. Most were already receiving pharmacologic therapy and met American College of Rheumatology 2016 criteria for fibromyalgia.

Study Design and Participants

Clinics were randomized to PT + TENS or PT-only arms, stratified by health system and clinic size. All participants continued routine PT as prescribed by their physical therapist and any ongoing medications. In the PT + TENS arm, participants received a wearable TENS device (Quell) with instructions to use two units for at least 2 hours daily during physical activity (sessions could be divided). Electrodes were placed on the upper and lower back; the device delivered an asymmetric biphasic waveform with a modulating frequency of 2–125 Hz (pulse duration 100–180 μs) at a strong but comfortable intensity. Outcomes were assessed remotely via REDCap on days 1, 30, 60 (primary endpoint), 90, and 180. After day 60, the PT-only group crossed over to TENS (extension phase).

Key Findings

The primary outcome was change in movement-evoked pain (0–10 numeric rating scale) during a 5-times sit-to-stand task. At day 60, the PT + TENS group demonstrated a statistically significant and clinically meaningful reduction compared with the PT-only group (group mean difference −1.2; 95% CI [−1.6, −0.7]; Cohen’s d = 0.46; p < .001). Improvements were evident by day 30 and sustained through 6 months in within-group analyses. A clear dose-response relationship emerged: greater adherence (defined as ≥8 sessions and 1,600 minutes per month) produced larger reductions in movement-evoked pain.

Secondary outcomes showed parallel benefits. Resting pain, movement-evoked fatigue, resting fatigue, pain interference (Brief Pain Inventory), and overall fibromyalgia impact (Fibromyalgia Impact Questionnaire Revised) were significantly improved in the PT + TENS group at day 60 and remained improved at day 180. The PT-only group exhibited comparable gains once TENS was introduced in the extension phase. Patient Global Impression of Change favored the intervention (72% vs. 51% reporting improvement at day 60; p = .001). Responder analysis indicated that 41% of the PT + TENS group achieved a ≥30% reduction in movement-evoked pain versus 13% in the PT-only group (p < .001). At day 180, 81% of TENS users reported the intervention was helpful, and 55% continued daily use.

Safety data were favorable: no serious adverse events were related to TENS. Minor adverse events (primarily skin irritation, itchiness, or discomfort with stimulation) occurred in 30% of participants across the 6-month period.

Implications for Clinical Practice

• Educating patients on electrode placement and titration to “strong but comfortable” intensity.
• Reinforcing the importance of consistent daily use during physical activity to achieve therapeutic dosing.
• Coordinating with physical therapists to integrate TENS early in the plan of care.
• Monitoring adherence and minor skin reactions.

The observed effect sizes were comparable to those reported for several approved pharmacologic agents, yet TENS demonstrated an excellent safety profile without systemic side effects or tolerance development.

Limitations

As a pragmatic trial embedded in real-world PT clinics, the study prioritized generalizability over strict experimental control. Clinic-level variation and variable PT dosing may have influenced results. Medication changes were not tracked via electronic health records, and longer-term adherence beyond 6 months remains unknown. Racial and ethnic minority representation, while present, was lower than national averages, reflecting the Midwest recruitment sites.

Conclusions

This large-scale pragmatic trial provides high-level evidence that adding TENS to routine physical therapy produces clinically meaningful and sustained reductions in movement-evoked pain and fatigue among individuals with fibromyalgia. The intervention is safe, feasible in outpatient settings, and well-accepted by patients. These results support incorporation of TENS as an accessible, evidence-based option within comprehensive care plans.

Individuals living with fibromyalgia should discuss the potential role of TENS with their physical therapist or healthcare provider to determine suitability for their treatment plan. Evidence-based additions such as this can meaningfully enhance function and quality of life.

References

Dailey, D. L., Vance, C. G. T., Van Gorp, B. J., Johnson, E. M., Post, A. A., Chimenti, R. L., ... & Sluka, K. A. (for the Clinician Group). (2026). Transcutaneous electrical nerve stimulation and pain with movement in people with fibromyalgia: A cluster randomized clinical trial. JAMA Network Open, 9(3), Article e262450. https://doi.org/10.1001/jamanetworkopen.2026.2450