The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 8
- 主要终点
- Percentage of patients who significantly improve their fibromyalgia-specific quality of life on the FIQ questionnaire between the inclusion visit at D0 and the 3-month visit (M3).
研究概览
简要总结
Fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. These symptoms are due to a dysfunction of the central nervous system, namely increased sympathetic and decreased parasympathetic levels of activity, and a deficit in endogenous pain inhibition.
Remedee Labs is developing a unique technology using millimeter waves to stimulate subcutaneous nerve receptors of the wrist, sending a message to the brain, which in turn releases endorphins. These endorphins induce a hypoalgesic effect and activate the parasympathetic nervous system, which reduces pain, stress, and improves sleep.
The Remedee Solution evaluated in this study is a wristband designed to deliver millimeter wave, a mobile application that allows the patient to follow his treatment sessions and a personalized support which aims to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment.
The hypothesis of this study is that regular use of the Remedee Solution for three months improves the quality of life of fibromyalgia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (Wolfe et al., 2016),
- •FIQ score ≥ 39 (moderate and higher forms) on the day of inclusion (D0),
- •with a smartphone that runs on Android 8 and iOS 12 or later,
- •agreeing the installation of the Fibrepik app on the smartphone,
- •agreeing the collection of the number of steps measured by the smartphone,
- •agreeing the installation of the Google Fit app for patients whose smartphone runs on Android (necessary for the collection of the number of steps),
- •wrist size compatible with the size M or L of the wristband template,
- •affiliated to the social security system or beneficiary of such a system,
- •who have signed a consent to participate.
排除标准
- •with a characterized depressive episode according to the DSM 5,
- •substantial change in treatment in the three months prior to inclusion and in the months to come: change in analgesic level, introduction of a new treatment.
- •with a chronic inflammatory pathology (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, lupus,...),
- •person in civil proceedings,
- •having a dermatological pathology on the wrists, such as oozing dermatosis, hyper sweat or an unhealed lesion,
- •with a surgical implant, tattoo or piercing on one of the wrists,
- •allergic to metals and/or silicone,
- •referred to articles L1121-5 to L1121-8 of the French Public Health Code (CSP): Pregnant, parturient or nursing woman; Person deprived of liberty by judicial or administrative decision; Person subject to a legal protection measure or unable to express his/her consent; Person under psychiatric care
- •in a period of exclusion from other interventional research.
结局指标
主要结局
Percentage of patients who significantly improve their fibromyalgia-specific quality of life on the FIQ questionnaire between the inclusion visit at D0 and the 3-month visit (M3).
时间窗: 3 months
A decrease in FIQ score ≥ 14% is considered clinically meaningful (Bennett et al., 2009)
次要结局
- Evolution of the quality of sleep between D0 and M3 on the Pittsburg Sleep Quality Index (PSQI) questionnaire.(3 months)
- Evolution between D0 and M3 of the average pain score over the week on a Visual Analogic Scale (VAS).(3 months)
- Evolution between D0 and M3 of anxiety and depression on the Hospital and Anxiety Depression scale (HAD).(3 months)
- Evolution between D0 and M3 of the general quality of life on the EQ-5D-5L questionnaire(3 months)
- Evolution between D0 and M3 of physical activity on the Global Physical Activity Questionnaire (GPAC).(3 months)
- Remedee Solution satisfaction questionnaire (questionnaire created by the sponsor)(month 6 for Intervention groupe and month 9 for control group)
- Impression of the disease change by the patient on the Patient Global Impression of Change (PGIC) at M3(3 months)
- Impression of the disease change by the caregiver on the Clinician Global Impression of Change (CGIC) scale at M3(3 months)
- Number, description, classification (serious/non-serious) of adverse effects(9 months)
- Evolution between D0 and M3 of fatigue between the two groups on the Multidimensional Fatigue Inventory questionnaire (MFI20)(3 months)
- Evolution of analgesic, antidepressant and sleeping pill intake between D0 and M3(3 months)
- Consumption of care between D0 and M3(3 months)
- Outcomes 1 to 12 evaluated at 6 months and at 9 months.(9 months)
- Evolution of number of steps measured by the subject's smartphone collected from D0 to M3 through the Fibrepik mobile application.(3 months)
- Usability of the wristband on the modular evaluation of key Components of User Experience (meCUE) questionnaire.(month 6 for Intervention groupe and month 9 for control group)
- Frequency of use of the wristband on the six months of use it(month 6 for Intervention groupe and month 9 for control group)