Using a multisite TENS system to improve fibromyalgia symptoms
"Using a Multisite TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Fibromyalgia-related Symptoms (EXOFIB 3)"
This study is testing if wearing a special suit that uses electrical stimulation can help people with fibromyalgia feel less pain and fatigue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institut De La Colonne Vertebrale Et Des Neurosciences Academic / other |
| Locations | 1 site (Créteil, VAL DE MARNE) |
| Trial ID | NCT06702176 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the Exopulse Mollii suit, a multisite transcutaneous electrical nerve stimulation (TENS) device, in alleviating symptoms associated with fibromyalgia. The study aims to recruit French-speaking patients aged 18 to 75 who have been diagnosed with fibromyalgia for at least three months. Participants will be randomly assigned to receive either the active Exopulse Mollii suit or a sham version to evaluate the impact on pain, fatigue, and overall quality of life. The trial builds on promising results from a previous pilot study that indicated potential benefits of this intervention.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults aged 18 to 75 with a confirmed diagnosis of fibromyalgia for at least three months.
Not a fit: Patients with contraindications to wearing the Exopulse Mollii suit or those with other significant somatic or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce pain and improve the quality of life for patients suffering from fibromyalgia.
How similar studies have performed: Previous studies, such as the EXOFIB-1 trial, have shown promising results with similar approaches, indicating potential for success.
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 three months
* Patients should be French speakers, able to understand verbal instructions, and affiliated with the National Health insurance
Exclusion Criteria:
* Patient included in another research protocol during the study period
* Patient unable to undergo medical monitoring 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 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 (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
Where this trial is running
Créteil, VAL DE MARNE
- linical Neurophysiology department, Henri Mondor Hospital, Créteil, France — Créteil, Val de Marne, France (Recruiting)
Study contacts
- Principal investigator: Samar S Ayache, MD, PhD, HDR — Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France
- Study coordinator: Samar S AYACHE, MD, PhD, HDR
- Email: samarayache@gmail.com
- Phone: +33 149814662
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.