Actively Recruiting
"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.
Led by Institut De La Colonne Vertebrale Et Des Neurosciences · Updated on 2024-11-22
40
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 75 years with fibromyalgia diagnosed according to American College of Rheumatology 2010 criteria for at least three months
- French speakers able to understand verbal instructions
- Affiliated with the National Health insurance
You will not qualify if you...
- Participating in another research study during the study period
- Unable to undergo medical monitoring due to geographical or social reasons
- Contraindications to wearing the Exopulse Mollii suit, such as cardiac stimulator, ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, or body mass index over 35 kg/m2
- Having somatic or psychiatric diagnoses other than anxiety and depression, including arrhythmias or uncontrolled epilepsy
- Any changes in pharmacological therapy within the last three months
- Use of another medical device besides the Exopulse Mollii suit during the study
- Under juridical protection such as guardianship or curatorship
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
linical Neurophysiology department, Henri Mondor Hospital, Créteil, France
Créteil, VAL DE MARNE, France, 94000
Actively Recruiting
Research Team
S
Samar S AYACHE, MD, PhD, HDR
CONTACT
M
Moussa A CHALAH, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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