Fibromyalgia

Randomization

Transcutaneous electrical nerve stimulation

Anesthesia

Placebo

Alternative medicine

Physical therapy

Internal medicine

Confidence interval

Medicine

Randomized controlled trial

Pathology

Arthritis & Rheumatology

Objective Fibromyalgia ( FM ) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation ( TENS ) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement‐evoked pain and other patient‐reported outcomes in women with FM . Methods Participants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2–125 Hz) at the highest tolerable intensity. Participants rated movement‐evoked pain (primary outcome measure) and fatigue on an 11‐point scale before and during application of TENS . The primary outcome measure and secondary patient‐reported outcomes were assessed at baseline (time of randomization) and at 4 weeks. Results After 4 weeks, a greater reduction in movement‐evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference –1.0 [95% confidence interval –1.8, –0.2]; P = 0.008) and versus the no TENS group (group mean difference –1.8 [95% confidence interval –2.6, –1.0]; P &lt; 0.0001). A reduction in movement‐evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference –1.4 [95% confidence interval –2.4, –0.4]; P = 0.001) and versus the no TENS group (group mean difference –1.9 [95% confidence interval –2.9, –0.9]; P = &lt;0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P &lt; 0.0001) and the no TENS group (9%; P &lt; 0.0001). There were no TENS ‐related serious adverse events, and &lt;5% of participants experienced minor adverse events from TENS . Conclusion Among women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement‐evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real‐world setting to establish the clinical importance of these findings.

Transcutaneous Electrical Nerve Stimulation Reduces Movement‐Evoked Pain and Fatigue: A Randomized, Controlled Trial