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

IF 3.5 2区 医学 Q1 ANESTHESIOLOGY
Joseph G. Mattar, Moussa A. Chalah, Naoufel Ouerchefani, Marc Sorel, Johan Le Guilloux, Jean‐Pascal Lefaucheur, Georges N. Abi Lahoud, Samar S. Ayache
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引用次数: 0

Abstract

BackgroundFibromyalgia 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.MethodsAdult 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.ResultsThirty‐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 (X2 = 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 (X2 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.ConclusionsThis 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.SignificancePatients 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.
EXOPULSE 莫利套装对疼痛和纤维肌痛相关症状的影响--随机假对照交叉试验
背景纤维肌痛及相关症状在已获批准的药物和替代性干预措施中治疗效果不佳。本试验旨在评估 EXOPULSE Mollii 套装--一种多部位经皮神经电刺激装置--对纤维肌痛疼痛、疲劳、情感症状、疾病影响和生活质量的影响。第一阶段为随机、假对照、交叉、双盲试验,每天进行 1 小时的主动或假干预,为期 2 周(2 周为清洗期)。在第二阶段的开放标签试验中,所有患者都接受了为期 4 周的每日主动干预。采用弗里德曼检验、Wilcoxon符号秩检验和Chi2检验对疼痛、疲劳、疾病影响、情感症状、生活质量、临床印象和舒适度评分进行比较。结果33名患者完成了研究(93.9%为女性,平均年龄:51.3岁)。与假干预相比(X2 = 10.60,P = 0.014),主动干预后疼痛(通过视觉模拟量表评估的主要终点)明显减轻(主动干预前:6.9 ± 1.4,主动干预后:5.9 ± 1.8,假干预前:6.8 ± 1.4,假干预后:6.6 ± 1.5)。除抑郁和生活质量外,其他次要终点(即疲劳、焦虑和疾病影响)也是如此。临床总体变化印象(CGI-C)在积极干预期和假干预期之间存在显著差异(X2 p = 0.035),不同类别的比例如下:分别为 "恶化"(假干预:18.2% 对积极干预:0.0%)、"改善"(假干预:48.5% 对积极干预:63.6%)或 "无变化"(假干预:33.3% 对积极干预:36.4%)。结论这项研究表明,EXOPULSE Mollii 套餐在缓解疼痛、纤维肌痛相关疲劳、情绪症状和疾病影响方面具有临床疗效。值得注意的是,这项研究存在一些局限性,包括参与人数较少、第一阶段盲法对照的短期效果分析以及第二阶段的开放标签性质。未来的研究需要更大的群体和更长的治疗方案,以进一步证实目前的结果,并评估这种技术的长期效果。意义纤维肌痛患者遭受疼痛、疲劳、睡眠障碍、情感障碍和生活质量改变之苦。经皮神经电刺激可能有助于控制这些症状,但现有的经皮神经电刺激系统受到限制,因为它们最多只能应用于两个部位。这项随机对照研究首次应用了多部位经皮神经电刺激装置 EXOPULSE Mollii Suit,对纤维肌痛和相关症状有显著效果。
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来源期刊
European Journal of Pain
European Journal of Pain 医学-临床神经学
CiteScore
7.50
自引率
5.60%
发文量
163
审稿时长
4-8 weeks
期刊介绍: European Journal of Pain (EJP) publishes clinical and basic science research papers relevant to all aspects of pain and its management, including specialties such as anaesthesia, dentistry, neurology and neurosurgery, orthopaedics, palliative care, pharmacology, physiology, psychiatry, psychology and rehabilitation; socio-economic aspects of pain are also covered. Regular sections in the journal are as follows: • Editorials and Commentaries • Position Papers and Guidelines • Reviews • Original Articles • Letters • Bookshelf The journal particularly welcomes clinical trials, which are published on an occasional basis. Research articles are published under the following subject headings: • Neurobiology • Neurology • Experimental Pharmacology • Clinical Pharmacology • Psychology • Behavioural Therapy • Epidemiology • Cancer Pain • Acute Pain • Clinical Trials.
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