The effect of the EXOPULSE Mollii Suit on pain and fibromyalgia-related symptoms-A randomized sham-controlled crossover trial.

Autor: Mattar JG; Institut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.; EA 4391, Excitabilité Nerveuse et Thérapeutique, Faculté de Santé, Université Paris Est, Créteil, France., Chalah MA; Institut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.; EA 4391, Excitabilité Nerveuse et Thérapeutique, Faculté de Santé, Université Paris Est, Créteil, France.; Department of Neurology, Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon., Ouerchefani N; Service de Neurochirurgie, Hôpital Foch, Suresnes, France., Sorel M; EA 4391, Excitabilité Nerveuse et Thérapeutique, Faculté de Santé, Université Paris Est, Créteil, France.; Centre d'Evaluation et Traitement de la Douleur, Centre Hospitalier du Sud Seine-et-Marne, Nemours, France., Le Guilloux J; Service de Neurologie, Hôpital Privé Nord Parisien, Sarcelles, France., Lefaucheur JP; EA 4391, Excitabilité Nerveuse et Thérapeutique, Faculté de Santé, Université Paris Est, Créteil, France.; Service de Physiologie-Explorations Fonctionnelles, DMU FIxIT, Hôpital Henri Mondor, Créteil, France., Abi Lahoud GN; Institut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.; Department of Neurosurgery, Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon., Ayache SS; Institut de la Colonne Vertébrale et Des Neurosciences (ICVNS), Centre Médico Chirurgical Bizet, Paris, France.; EA 4391, Excitabilité Nerveuse et Thérapeutique, Faculté de Santé, Université Paris Est, Créteil, France.; Department of Neurology, Gilbert and Rose-Marie Chagoury School of Medicine, Lebanese American University, Byblos, Lebanon.; Service de Physiologie-Explorations Fonctionnelles, DMU FIxIT, Hôpital Henri Mondor, Créteil, France.
Jazyk: angličtina
Zdroj: European journal of pain (London, England) [Eur J Pain] 2025 Feb; Vol. 29 (2), pp. e4729. Date of Electronic Publication: 2024 Sep 18.
DOI: 10.1002/ejp.4729
Abstrakt: Background: Fibromyalgia pain and related symptoms are poorly managed by approved pharmacological and alternative interventions. This trial aimed to evaluate the effects of the EXOPULSE Mollii Suit-a multisite transcutaneous electrical nerve stimulation device-on fibromyalgia pain, fatigue, affective symptoms, disease impact, and quality of life.
Methods: Adult patients with fibromyalgia were enrolled. Phase 1 implied a randomized, sham-controlled, cross-over, double-blind trial, applying daily 1 h sessions of active or sham intervention, over 2 weeks (2-week washout). In the open-label phase 2, all patients received daily active intervention for 4 weeks. Comparisons on pain, fatigue, disease impact, affective symptoms, quality of life, clinical impression, and comfort ratings were performed using Friedman, Wilcoxon signed rank, and Chi2 tests.
Results: Thirty-three patients completed the study (93.9% female, mean age: 51.3 years). Pain (primary endpoint assessed via a visual analog scale) was significantly reduced after the active (pre-active: 6.9 ± 1.4, post-active: 5.9 ± 1.8, pre-sham: 6.8 ± 1.4, post-sham: 6.6 ± 1.5) versus the sham intervention (X 2  = 10.60, p = 0.014). This was also the case of other secondary endpoints (i.e., fatigue, anxiety, and disease impact), except depression and quality of life. The Clinical Global Impression of Change (CGI-C) was significantly different between the active and sham intervention periods (X 2 p = 0.035), and the different proportions of categories were as follows: 'worsening' (sham: 18.2% vs. active: 0.0%), 'improvement' (sham: 48.5% vs. active 63.6%) or 'no change (sham: 33.3% vs. active 36.4%) respectively. After phase 2, significant positive effects were observed for most of the outcomes, and 78.8% of patients reported improvement according to CGI-C.
Conclusions: This study suggests the clinical benefits of the EXOPULSE Mollii Suit in alleviating pain and fibromyalgia-related fatigue, emotional symptoms, and disease impact. It is worth noting that the study has several limitations related to the low number of participants, the short-term analysis of effects in the first blinded and controlled phase, and the open-label nature of phase 2. Future studies with a larger cohort and longer protocol treatment are needed, to further confirm the current results, and evaluate the long-term effects of this technique.
Significance: Patients with fibromyalgia suffer from pain as well as fatigue, sleep impairment, emotional disturbances, and altered quality of life. Transcutaneous electrical nerve stimulation might help manage those symptoms, but the available systems are limited by the fact that they could be applied at best over two sites. This randomized controlled study is the first to apply a multi-site transcutaneous electrical nerve stimulation device, the EXOPULSE Mollii Suit, with significant effects on fibromyalgia pain and related symptoms.
(© 2024 The Author(s). European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation ‐ EFIC ®.)
Databáze: MEDLINE
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