The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain.

INTRODUCTION

Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief in dysmenorrhea. A feasible advantage would be the study of a portable device. The purpose of the study was to evaluate the effectiveness and safety of a new portable TENS device (TANYX®) for menstruation cramps.

MATERIALS AND METHODS

Forty women were evaluated in a double-blind, prospective, randomized fashion, divided into sham and active groups. TENS was applied medially at the suprapubic region, for 30-min duration at eight-hour intervals, up to seven days. The placebo group (PG) received sham device. The TENS group (TG) applied an active 85 Hz frequency TENS. Efficacy measures were pain relief evaluated on a visual analog scale (VAS) and diclofenac intake, and quality of life represented by: 1) capacity to get out of the bed, 2) food or drink intake, 3) missing routine daily activities such as work or school, and 4) quality of sleep.

RESULTS

The active TENS device induced a prompt onset of pain relief in a strictly segmental manner nearby the dermatomes where the TENS was applied at the skin, and there was a drop in mean pain score from 8 to 2 cm (p < 0.001). Diclofenac consumption was also significantly reduced (p < 0.01), compared with the PG. Quality of life improved significantly in TG when compared with PG (p < 0.05). Three months after the beginning of the study, 14/20 of the women were still using the active device regularly. No adverse effects were observed.

CONCLUSIONS

The portable, disposable, active TENS device induced a prompt onset of pain relief and improved the quality of life, without adverse effects, in patients with painful cramps associated with dysmenorrhea.