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The following is a summary of “Effect of the EXOPULSE Mollii Suit on pain and fibromyalgia-related symptoms—A randomized sham-controlled crossover trial,” published in the September 2024 issue of Pain by Mattar et al.
Researchers conducted a retrospective study to assess the effects of the EXOPULSE Mollii Suit on fibromyalgia pain, fatigue, affective symptoms, disease impact, and QoL.
They enrolled adult patients with fibromyalgia in a randomized, sham-controlled, cross-over, double-blind trial. Patients received daily 1-hour active or sham intervention sessions for 2 weeks with a 2-week washout period. In the open-label phase 2, all patients received daily active intervention for 4 weeks, and comparisons were made using Friedman, Wilcoxon signed rank, and Chi2 tests.
The results showed that 33 participants completed the study, with 93.9% female and a mean age of 51.3 years. Pain, the primary endpoint was measured using a visual analog scale, significantly decreased after the active intervention (pre-active: 6.9 ± 1.4, post-active: 5.9 ± 1.8) compared to the sham intervention (pre-sham: 6.8 ± 1.4, post-sham: 6.6 ± 1.5) (X2= 10.60, P= 0.014). Similar improvements were noted in secondary endpoints, including fatigue, anxiety, and disease impact, but not in depression or QoL. The Clinical Global Impression of Change (CGI-C) significantly differed between active and sham periods (X2 P=0.035), with proportions categorized as ‘worsening’ (sham: 18.2% vs. active: 0.0%), ‘improvement’ (sham: 48.5% vs active: 63.6%), and ‘no change’ (sham: 33.3% vs active: 36.4%). After phase 2, significant positive effects were observed for most outcomes, with 78.8% of participants reporting improvement per CGI-C.
They concluded that EXOPULSE Mollii Suit may be beneficial for alleviating pain, fatigue, emotional symptoms, and disease impact in patients with fibromyalgia.
Source: onlinelibrary.wiley.com/doi/full/10.1002/ejp.4729
