Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia

NCT05058092 | Completed

• 1 other identifier: Remedee3/Fibrepik
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 8

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.

Conditions

Fibromyalgia

Keywords

pain; sleep disturbances; millimeter waves

Outcome Measures

Primary Outcomes (1)

• 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).

  A decrease in FIQ score ≥ 14% is considered clinically meaningful (Bennett et al., 2009)

  3 months

Secondary Outcomes (16)

• 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 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

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Device: Immediate Remedee Solution

Control

OTHER

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

Device: Delayed Remedee Solution

Interventions

Immediate Remedee Solution DEVICE

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

Intervention

Delayed Remedee Solution DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (Wolfe et al., 2016),
• 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.

You may not qualify if:

• with a characterized depressive episode according to the DSM 5,
• 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

Sponsors & Collaborators

• Remedee SA: lead

Study Sites (8)

University Hospital of Grenoble Alps

Grenoble, France

Location

CHU de Montpellier

Montpellier, France

Location

Cabinet libéral Dr. Lorenzi-Pernot

Mornant, France

Location

Hôpital Lariboisière - Assistance Publique Hôpitaux de Paris

Paris, France

Location

CHU de Rouen

Rouen, France

Location

Hôpital Foch

Suresnes, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, France

Location

Médipôle hôpital mutualiste

Villeurbanne, France

Location

Related Publications (1)

• 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.

  PMID: 36064731 DERIVED

Related Links

• Study protocol

MeSH Terms

Conditions

Fibromyalgia; Pain; Parasomnias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders

Study Officials

• Caroline MAINDET, MD

  University Hospital of Grenoble Alps

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 27, 2021
• Study Start: November 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: February 28, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

FR (8)