Mollii Suit and Fibromyalgia (EXOFIB 2)

Phase

N/A

Condition

Neurologic Disorders

Fibromyalgia

Dystonias

Treatment

EXOPULSE Mollii Suit Stimulation

Clinical Study ID

NCT06226376

EXOFIB2

Ages 18-75
All Genders

Study Summary

The goal of this clinical trial is to demonstrate the improvement of fibromyalgia syndrome obtained following active stimulation compared to sham, with diminished functional disability and improved health status using Exopulse Molli suit stimulation. The main questions it aims to answer are:

Evaluation of pain, fatigue, mood and quality of life changes observed after active stimulation in comparison to sham.

Improvement of fibromyalgia syndrome as per the Fibromyalgia Impact Questionnaire (FIQ)

Study subjects will participate in:

A randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgiaaccording to the American College of Rheumatology (ACR) 2010 criteria, set for atleast one month.
Patients should be able to understand verbal instructions.

Exclusion

Exclusion Criteria:

Patient with VAS < 4
Patient included in another research protocol during the study period
Patient unable to undergo medical monitor for the study purposes due to geographicalor social reasons
Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiacstimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy,and/or body mass index above 35 kg/m2)
Patient with other somatic or psychiatric diagnoses other than anxiety anddepression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causingosteoarticular and muscular pain)
Any change in the pharmacological therapy in the last three months
Introduction of a medical device other than Exopulse Mollii suit during the studyperiod
Patient under juridical protection

Study Design