Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia (Fibrepik)

Remedee Labs

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: Immediate Remedee Solution; Device: Delayed Remedee Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05058092

Remedee3/Fibrepik

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Intervention

Experimental group

Description:

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)

Treatment:

Device: Immediate Remedee Solution

Control

Other group

Description:

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

Treatment:

Device: Delayed Remedee Solution