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Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia

NCT05058092 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2023-03-06

No results posted yet for this study

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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • Remedee SA

    lead INDUSTRY

Principal Investigators

  • Caroline MAINDET, MD · University Hospital of Grenoble Alps

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-07-15
Completion
2023-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05058092 on ClinicalTrials.gov