{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T22:05:50Z","timestamp":1793397950838,"version":"4.5.0"},"reference-count":59,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T00:00:00Z","timestamp":1726617600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["European Journal of Pain"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>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\u2014a multisite transcutaneous electrical nerve stimulation device\u2014on fibromyalgia pain, fatigue, affective symptoms, disease impact, and quality of life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adult patients with fibromyalgia were enrolled. Phase 1 implied a randomized, sham\u2010controlled, cross\u2010over, double\u2010blind trial, applying daily 1\u2009h sessions of active or sham intervention, over 2\u2009weeks (2\u2010week washout). In the open\u2010label phase 2, all patients received daily active intervention for 4\u2009weeks. 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty\u2010three patients completed the study (93.9% female, mean age: 51.3\u2009years). Pain (primary endpoint assessed via a visual analog scale) was significantly reduced after the active (pre\u2010active: 6.9\u2009\u00b1\u20091.4, post\u2010active: 5.9\u2009\u00b1\u20091.8, pre\u2010sham: 6.8\u2009\u00b1\u20091.4, post\u2010sham: 6.6\u2009\u00b1\u20091.5) versus the sham intervention (X<jats:sup>2<\/jats:sup>\u2009=\u200910.60, <jats:italic>p<\/jats:italic>\u2009=\u20090.014). 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\u2010C) was significantly different between the active and sham intervention periods (X<jats:sup>2<\/jats:sup> <jats:italic>p<\/jats:italic>\u2009=\u20090.035), and the different proportions of categories were as follows: \u2018worsening\u2019 (sham: 18.2% vs. active: 0.0%), \u2018improvement\u2019 (sham: 48.5% vs. active 63.6%) or \u2018no 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\u2010C.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study suggests the clinical benefits of the EXOPULSE Mollii Suit in alleviating pain and fibromyalgia\u2010related 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\u2010term analysis of effects in the first blinded and controlled phase, and the open\u2010label 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\u2010term effects of this technique.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>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\u2010site transcutaneous electrical nerve stimulation device, the EXOPULSE Mollii Suit, with significant effects on fibromyalgia pain and related symptoms.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ejp.4729","type":"journal-article","created":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T06:01:15Z","timestamp":1726639275000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The effect of the EXOPULSE Mollii Suit on pain and fibromyalgia\u2010related symptoms\u2014A randomized sham\u2010controlled crossover trial"],"prefix":"10.1002","volume":"29","author":[{"given":"Joseph G.","family":"Mattar","sequence":"first","affiliation":[{"name":"Institut de la Colonne Vert\u00e9brale et Des Neurosciences (ICVNS), Centre M\u00e9dico Chirurgical Bizet  Paris France"},{"name":"EA 4391, Excitabilit\u00e9 Nerveuse et Th\u00e9rapeutique, Facult\u00e9 de Sant\u00e9 Universit\u00e9 Paris Est  Cr\u00e9teil France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0880-8608","authenticated-orcid":false,"given":"Moussa A.","family":"Chalah","sequence":"additional","affiliation":[{"name":"Institut de la Colonne Vert\u00e9brale et Des Neurosciences (ICVNS), Centre M\u00e9dico Chirurgical Bizet  Paris France"},{"name":"EA 4391, Excitabilit\u00e9 Nerveuse et Th\u00e9rapeutique, Facult\u00e9 de Sant\u00e9 Universit\u00e9 Paris Est  Cr\u00e9teil France"},{"name":"Department of Neurology, Gilbert and Rose\u2010Marie Chagoury School of Medicine, Lebanese American University  Byblos Lebanon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoufel","family":"Ouerchefani","sequence":"additional","affiliation":[{"name":"Service de Neurochirurgie H\u00f4pital Foch  Suresnes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Sorel","sequence":"additional","affiliation":[{"name":"EA 4391, Excitabilit\u00e9 Nerveuse et Th\u00e9rapeutique, Facult\u00e9 de Sant\u00e9 Universit\u00e9 Paris Est  Cr\u00e9teil France"},{"name":"Centre d'Evaluation et Traitement de la Douleur, Centre Hospitalier du Sud Seine\u2010et\u2010Marne  Nemours France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan","family":"Le Guilloux","sequence":"additional","affiliation":[{"name":"Service de Neurologie H\u00f4pital Priv\u00e9 Nord Parisien  Sarcelles France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Pascal","family":"Lefaucheur","sequence":"additional","affiliation":[{"name":"EA 4391, Excitabilit\u00e9 Nerveuse et Th\u00e9rapeutique, Facult\u00e9 de Sant\u00e9 Universit\u00e9 Paris Est  Cr\u00e9teil France"},{"name":"Service de Physiologie\u2010Explorations Fonctionnelles, DMU FIxIT H\u00f4pital Henri Mondor  Cr\u00e9teil France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georges N.","family":"Abi Lahoud","sequence":"additional","affiliation":[{"name":"Institut de la Colonne Vert\u00e9brale et Des Neurosciences (ICVNS), Centre M\u00e9dico Chirurgical Bizet  Paris France"},{"name":"Department of Neurosurgery, Gilbert and Rose\u2010Marie Chagoury School of Medicine, Lebanese American University  Byblos Lebanon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0188-1957","authenticated-orcid":false,"given":"Samar S.","family":"Ayache","sequence":"additional","affiliation":[{"name":"Institut de la Colonne Vert\u00e9brale et Des Neurosciences (ICVNS), Centre M\u00e9dico Chirurgical Bizet  Paris France"},{"name":"EA 4391, Excitabilit\u00e9 Nerveuse et Th\u00e9rapeutique, Facult\u00e9 de Sant\u00e9 Universit\u00e9 Paris Est  Cr\u00e9teil France"},{"name":"Department of Neurology, Gilbert and Rose\u2010Marie Chagoury School of Medicine, Lebanese American University  Byblos Lebanon"},{"name":"Service de Physiologie\u2010Explorations Fonctionnelles, DMU FIxIT H\u00f4pital Henri Mondor  Cr\u00e9teil France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,18]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/2022\/1582432"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12888-014-0354-0"},{"key":"e_1_2_10_4_1","volume-title":"Traitement de la Douleur","author":"Brasseur L.","year":"1997"},{"issue":"5","key":"e_1_2_10_5_1","first-page":"728","article-title":"The fibromyalgia impact questionnaire: Development and validation","volume":"18","author":"Burckhardt C. 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