The Effects of EXOPULSE Mollii Suit on Fibromyalgia Syndrome in Patients With Fibromyalgia (EXOFIB 2): A Sham Controlled Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The goal of this clinical trial is to demonstrate the improvement of fibromyalgia syndrome obtained following active stimulation compared to sham, with diminished functional disability and improved health status using Exopulse Molli suit stimulation. The main questions it aims to answer are:
Evaluation of pain, fatigue, mood and quality of life changes observed after active stimulation in comparison to sham.
Improvement of fibromyalgia syndrome as per the Fibromyalgia Impact Questionnaire (FIQ)
Study subjects will participate in:
A randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month.
- •Patients should be able to understand verbal instructions.
排除标准
- •Patient with VAS < 4
- •Patient included in another research protocol during the study period
- •Patient unable to undergo medical monitor for the study purposes due to geographical or social reasons
- •Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2)
- •Patient with other somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)
- •Any change in the pharmacological therapy in the last three months
- •Introduction of a medical device other than Exopulse Mollii suit during the study period
- •Patient under juridical protection
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
It is an 11-item scale that assesses health status and functional disability by exploring the impact of fibromyalgia on work, wellbeing, fatigue, sleep, stiffness, anxiety, and depression. FIQ scores can range from 0 to 100, with higher scores reflecting worse health status. Scores could be used to classify fibromyalgia as mild (scores: 0-38), moderate (scores: 39-58), and severe (scores: 59-100)
次要结局
- Hospital Anxiety and Depression Scale (HADS)(This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.)
- Clinical Global Impression (CGI)(This to be assessed at week 2, week 6 and week 12.)
- Brief Pain Inventory (BPI)(This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.)
- Pain Catastrophizing Scale (PCS)(This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.)
- Quality of life as per the Short Form 36 Health Survey (SF-36)(This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.)
- Visual Analogue Scale for Pain(This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.)
- Visual Analogue Scale for Fatigue(This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.)
- Hospital Anxiety and Depression Scale (HADS)(This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.)
- Clinical Global Impression (CGI)(This to be assessed at week 2, week 6 and week 12.)
研究者
Naji Joseph Riachi
Principal Investigator
Sheikh Shakhbout Medical City