Evolution of the Quality of Life of Long-Term Fibromyalgia Users of Millimeter Wave-Based Neuromodulation: A Real-World Retrospective Study

Laure Minier,1 Paolo Zanini,1 Emilie Chipon,1 Raphaël Gonon-Demoulian,2 Erwan Treillet,3,4 David Crouzier1 1Medical Research, Remedee Labs, Montbonnot Saint-Martin, France; 2Pain, Psychosomatics and Functional Disease Department, Montpellier University hospital, Montpellier, France; 3Pain Management and Palliative Care Unit, APHP Lariboisière Hospital, Paris, France; 4Pain Management, Colmar Civil Hospital, Colmar, FranceCorrespondence: Emilie Chipon, Remedee Labs, 99 chemin de l’étoile, 38330, Montbonnot Saint-Martin, France, Email [email protected]: Fibromyalgia (FM) is a widespread pain condition, associated with other symptoms such as fatigue, sleep disorders, stiffness, and mood disturbances. It significantly impacts patients’ quality of life (QoL) and poses a substantial challenge due to the lack of a definitive cure. This study aimed to report real-world data on the long-term use (18 months) of a millimeter (MMW)-based neuromodulation device and tracking application, and its effects on various health dimensions in a self-declared FM population.Methods: This retrospective study was based on data including daily MMW wristband use and health parameters assessed at baseline (D0) and tracked weekly (pain, stiffness and fatigue) or quarterly (QoL, quality of sleep and impression of change). The primary inclusion criteria were a self-reported diagnosis of FM and consistent device usage for a minimum of 18 months.Results: The inclusion criteria were met by 185 users. There was a reduction in the Fibromyalgia Impact Questionnaire (FIQ) scores, with an average reduction of 27% after the first three months (M3), indicating improved QoL, and stabilization thereafter. Similar improvements were observed in sleep quality, stiffness and fatigue. In contrast, pain intensity showed a continuous decline throughout the 18-month period.Conclusion: The significant improvements in QoL, pain intensity, and sleep quality, maintained over time, underline the MMW device’s ability to provide sustained relief and enhance daily lives of people with FM.Keywords: fibromyalgia, millimeter-waves, neuromodulation, quality of life, pain