"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms. (NCT06702176) | Clinical Trial Compass
RecruitingNot Applicable
"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.
France40 participantsStarted 2024-03-01
Plain-language summary
Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. A previous pilot trial on fibromyalgia (EXOFIB-1 study) was conducted to evaluate the effects of Exopulse Mollii suit on fibromyalgia has showed beneficial and promising results. The intervention significantly alleviated pain, reduced fatigue, decreased physical and psychosocial impact of the disease, and improved the quality of life of patients with fibromyalgia. However, the observed effect sizes were small to medium. The investigators believe that a stimulation duration extended to six months would yield more positive outcomes and higher effect magnitude.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ")
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) right after the intervention (phase 1)
Timeframe: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) at Visit 1(Day 0) ,Visit 2 (Day 15), Visit 3( Day 30) and Visit4 (Day 45)
Trial details
NCT IDNCT06702176
SponsorInstitut De La Colonne Vertebrale Et Des Neurosciences