Minier Laure, Zanini Paolo, Chipon Emilie, Gonon-Demoulian Raphaël, Treillet Erwan, Crouzier David
Medical Research, Remedee Labs, Montbonnot Saint-Martin, France.
Pain, Psychosomatics and Functional Disease Department, Montpellier University hospital, Montpellier, France.
J Pain Res. 2025 Mar 10;18:1143-1157. doi: 10.2147/JPR.S498935. eCollection 2025.
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.
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.
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.
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.
纤维肌痛(FM)是一种广泛存在的疼痛病症,与疲劳、睡眠障碍、僵硬和情绪紊乱等其他症状相关。它对患者的生活质量(QoL)有显著影响,并且由于缺乏确切的治愈方法而构成重大挑战。本研究旨在报告基于毫米波(MMW)的神经调节设备和追踪应用长期使用(18个月)的真实世界数据,以及其对自我宣称患有FM的人群在各个健康维度上的影响。
这项回顾性研究基于包括每日MMW腕带使用情况以及在基线(D0)评估并每周(疼痛、僵硬和疲劳)或每季度(生活质量、睡眠质量和变化印象)追踪的健康参数的数据。主要纳入标准是自我报告诊断为FM且设备持续使用至少18个月。
185名用户符合纳入标准。纤维肌痛影响问卷(FIQ)得分有所降低,在前三个月(M3)后平均降低27%,表明生活质量有所改善,此后趋于稳定。在睡眠质量、僵硬和疲劳方面也观察到类似改善。相比之下,疼痛强度在整个18个月期间持续下降。
随着时间推移,生活质量、疼痛强度和睡眠质量的显著改善突显了MMW设备为FM患者提供持续缓解并改善其日常生活的能力。