NCT06226376

Mollii Suit and Fibromyalgia (EXOFIB 2)

The Effects of EXOPULSE Mollii Suit on Fibromyalgia Syndrome in Patients With Fibromyalgia (EXOFIB 2): A Sham Controlled Randomized Double-Blind Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sheikh Shakhbout Medical City · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia
• Rheumatic Diseases
• Muscular Diseases
• Neuromuscular Diseases
• Nervous System Diseases

Interventions

Type	Name	Description
DEVICE	EXOPULSE Mollii Suit Stimulation	We designed 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.

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-03-24
• Completion: 2025-05-24
• First posted: 2024-01-26
• Last updated: 2025-09-08

Locations

1 site across 1 country: United Arab Emirates