NCT05058092

Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia

The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Remedee SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-07-15
• Completion: 2023-02-28
• First posted: 2021-09-27
• Last updated: 2023-03-06

Locations

8 sites across 1 country: France