The effects of EXOPULSE Mollii Suit in patients with fibromyalgia: a double-blind randomized sham-controlled trial (EXOFIB2).

IMPORTANCE

Neuromodulation via transcutaneous electrical stimulation shows promise in fibromyalgia, but conventional devices have limited coverage. The EXOPULSE Mollii Suit is a full-body garment with 58 electrodes, potentially addressing widespread pain.

OBJECTIVE

This study evaluated repeated Mollii Suit sessions on disease impact, pain, and fibromyalgia-related symptoms.

DESIGN

This study consisted of a randomized, sham-controlled crossover phase and an open-label phase.

SETTING

Inclusion occurred in a hospital setting.

PARTICIPANTS

Adults with fibromyalgia were enrolled.

INTERVENTIONS: In this double-blind, randomized, sham-controlled crossover trial (phase 1), participants received 2 weeks of daily active or sham stimulation (1 h/day), followed by a ≥2-week washout and crossover. A 4-week open-label extension (phase 2) was proposed.

MAIN OUTCOMES AND MEASURES: The primary outcome was the Fibromyalgia Impact Questionnaire (FIQtotal). Secondary outcomes included pain, anxiety, depression, and quality of life.

RESULTS

Twenty-two patients completed phase 1 and 20 completed phase 2. In phase 1, FIQtotal scores significantly decreased following the active intervention (66.06 ± 13.46 to 50.81 ± 23.22, Friedman's P < .01, Bonferroni-adjusted Dunn's P < .05), whereas no significant effects were observed following the sham intervention. Improvements were also observed in several secondary measures (pain catastrophizing and some quality of life domains). Phase 2 also revealed significant benefits in FIQtotal as well as several secondary outcomes. No severe adverse events occurred at any time.

CONCLUSIONS

EXOPULSE Mollii Suit led to clinically meaningful improvements in fibromyalgia impact and related outcomes.

RELEVANCE: The results of this work are in line with those of previous trials and support its potential as a home-based neuromodulation therapy for fibromyalgia. Future large-scale studies would help further understand the effects of this medical device.