Using the Mollii Suit to treat fibromyalgia symptoms
The Effects of EXOPULSE Mollii Suit on Fibromyalgia Syndrome in Patients With Fibromyalgia (EXOFIB 2): A Sham Controlled Randomized Double-Blind Trial
This study is testing whether wearing the Mollii suit can help improve symptoms like pain and fatigue in people with fibromyalgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sheikh Shakhbout Medical City Academic / other |
| Locations | 1 site (Abu Dhabi) |
| Trial ID | NCT06226376 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Exopulse Mollii suit in improving symptoms of fibromyalgia, including pain, fatigue, mood, and quality of life. Participants will be randomly assigned to receive either active stimulation from the suit or a sham treatment in a double-blind manner. The study will last for two weeks, followed by a washout period, after which an open-label phase will allow all participants to experience the active treatment. The primary outcome will be measured using the Fibromyalgia Impact Questionnaire (FIQ).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of fibromyalgia for at least one month.
Not a fit: Patients with mild pain (VAS < 4) or those with contraindications to using the Mollii suit will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly alleviate fibromyalgia symptoms and improve the quality of life for patients.
How similar studies have performed: While the use of wearable stimulation devices is gaining interest, this specific approach with the Mollii suit is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month. * Patients should be able to understand verbal instructions. 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 geographical or social reasons * Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, 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 and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular 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 study period * Patient under juridical protection
Where this trial is running
Abu Dhabi
- Ssmc — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Study coordinator: Naji J Riachi, MD
- Email: nriachi@ssmc.ae
- Phone: +97123144444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.