Status:
COMPLETED
Exopulse Mollii Suit and Fibromyalgia
Lead Sponsor:
Institut De La Colonne Vertebrale Et Des Neurosciences
Conditions:
Fibromyalgia, Primary
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 no...
Eligibility Criteria
Inclusion
- 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 French speakers, able to understand verbal instructions, and affiliated to the national health insurance
Exclusion
- 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 (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05361577
Start Date
March 1 2022
End Date
July 31 2023
Last Update
December 13 2023
Active Locations (1)
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1
Hopital Henri Mondor
Créteil, France, 94010