Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization in two groups of type: Immediate Solution vs. Delayed Solution

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Intervention

The Remedee Solution consists of:

* a wristband designed to deliver millimeter wave
* a mobile application that allows the patient to follow his treatment sessions
* a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment

The use of the Remedee Solution start at the randomization day (D0)

Group Type EXPERIMENTAL

Immediate Remedee Solution

Intervention Type DEVICE

* D0 to M3: Remedee Solution + medical care
* M3 to M6: Remedee Solution without personalized support + medical care
* M6 to M9: medical care only

Control

The Remedee Solution consists of:

* a wristband designed to deliver millimeter wave
* a mobile application that allows the patient to follow his treatment sessions
* a personalized support to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment

The use of the Remedee Solution start at three months (M3) after randomization day

Group Type OTHER

Delayed Remedee Solution

Intervention Type DEVICE

* D0 to M3: medical care only
* M3 to M6: Remedee Solution + medical care
* M6 to M9: Remedee Solution without personalized support + medical care

Interventions

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Immediate Remedee Solution

* D0 to M3: Remedee Solution + medical care
* M3 to M6: Remedee Solution without personalized support + medical care
* M6 to M9: medical care only

Intervention Type DEVICE

Delayed Remedee Solution

* D0 to M3: medical care only
* M3 to M6: Remedee Solution + medical care
* M6 to M9: Remedee Solution without personalized support + medical care

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No