Clinical trial NCT05058092: Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia
Official title: The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: pain
sleep disturbances
millimeter waves
Lead sponsor: Remedee SA
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in two groups of type: Immediate Solution vs. Delayed Solution
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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).
timeFrame: 3 months
Secondary outcomes:
measure: Evolution of the quality of sleep between D0 and M3 on the Pittsburg Sleep Quality Index (PSQI) questionnaire.
timeFrame: 3 months
measure: Evolution between D0 and M3 of the average pain score over the week on a Visual Analogic Scale (VAS).
timeFrame: 3 months
measure: Evolution between D0 and M3 of anxiety and depression on the Hospital and Anxiety Depression scale (HAD).
timeFrame: 3 months
measure: Evolution between D0 and M3 of fatigue between the two groups on the Multidimensional Fatigue Inventory questionnaire (MFI20)
timeFrame: 3 months
measure: Evolution of analgesic, antidepressant and sleeping pill intake between D0 and M3
timeFrame: 3 months
measure: Consumption of care between D0 and M3
timeFrame: 3 months
measure: Evolution between D0 and M3 of the general quality of life on the EQ-5D-5L questionnaire
timeFrame: 3 months
measure: Evolution between D0 and M3 of physical activity on the Global Physical Activity Questionnaire (GPAC).
timeFrame: 3 months
measure: Evolution of number of steps measured by the subject's smartphone collected from D0 to M3 through the Fibrepik mobile application.
timeFrame: 3 months
measure: Impression of the disease change by the patient on the Patient Global Impression of Change (PGIC) at M3
timeFrame: 3 months
measure: Impression of the disease change by the caregiver on the Clinician Global Impression of Change (CGIC) scale at M3
timeFrame: 3 months
measure: Frequency of use of the wristband on the six months of use it
timeFrame: month 6 for Intervention groupe and month 9 for control group
measure: Usability of the wristband on the modular evaluation of key Components of User Experience (meCUE) questionnaire.
timeFrame: month 6 for Intervention groupe and month 9 for control group
measure: Remedee Solution satisfaction questionnaire (questionnaire created by the sponsor)
timeFrame: month 6 for Intervention groupe and month 9 for control group
measure: Number, description, classification (serious/non-serious) of adverse effects
timeFrame: 9 months
measure: Outcomes 1 to 12 evaluated at 6 months and at 9 months.
timeFrame: 9 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble Alps
city: Montpellier
country: France
facility: CHU de Montpellier
city: Mornant
country: France
facility: Cabinet libéral Dr. Lorenzi-Pernot
city: Paris
country: France
facility: Hôpital Lariboisière - Assistance Publique Hôpitaux de Paris
city: Rouen
country: France
facility: CHU de Rouen
city: Suresnes
country: France
facility: Hôpital Foch
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
city: Villeurbanne
country: France
facility: Médipôle hôpital mutualiste
Study officials:
affiliation: University Hospital of Grenoble Alps
name: Caroline MAINDET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chipon E, Bosson JL, Minier L, Dumolard A, Vilotitch A, Crouzier D, Maindet C. A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial. Trials. 2022 Sep 5;23(1):740. doi: 10.1186/s13063-022-06693-z.