Work

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

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: 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.

Source: Pain Medicine

DOI: 10.1093/pm/pnag010