NCT05058092: Fibrepik

Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia

Completed NA Last updated 6 March 2023

What this trial tests

NA trial testing Immediate Remedee Solution in Fibromyalgia in 170 participants. Completed in 28 February 2023.

Timeline

15 November 2021

Primary endpoint
15 July 2022

28 February 2023

Quick facts

Lead sponsor	Remedee SA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	170
Start date	15 November 2021
Primary completion	15 July 2022
Estimated completion	28 February 2023
Sites	8 locations across France

Drugs / interventions tested

• Immediate Remedee Solution
• Delayed Remedee Solution

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Remedee SA

Who can join

18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial.
   Chipon E, Bosson JL, Minier L, Dumolard A, et al · · 2022 · cited 5× · PMID 36064731 · DOI 10.1186/s13063-022-06693-z
2. Millimetre wave-based neuromodulation combined with coaching improves quality of life in fibromyalgia patients: A 9-month prospective, multicenter, open, randomized, controlled trial.
   Maindet C, Minier L, Chipon E, Véloso M, et al · · 2025 · cited 1× · PMID 40068068 · DOI 10.1097/md.0000000000041706
3. Millimeter wave neuromodulation for the management of osteoarthritis pain: a real word evidence study.
   Chipon E, Treillet E, Bros J, Zanini P, et al · · 2025 · PMID 41159242 · DOI 10.1080/17581869.2025.2578549
4. A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial.
   CHIPON E, BOSSON J, MINIER L, DUMOLARD A, et al · · 2022 · DOI 10.21203/rs.3.rs-1721998/v1