Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2022-03-01
2023-07-31
Brief Summary
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The investigators designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Phase 2: Open label study (active condition)
TREATMENT
DOUBLE
Study Groups
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Active astimulation
Active sessions will last 1 hour each. The following parameters will be used for electric stimulation: low frequency (20 Hz), low current intensity (2 mA), with a small pulse width of 25-170 microseconds.
Exoplulse Mollii suit
Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
Sham stimulation
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Exopulse Mollii suit (sham)
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Interventions
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Exoplulse Mollii suit
Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
Exopulse Mollii suit (sham)
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Eligibility Criteria
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Inclusion Criteria
* Patients should be French speakers, able to understand verbal instructions, and affiliated to the national health insurance
Exclusion Criteria
* 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 ")
18 Years
75 Years
ALL
No
Sponsors
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Institut De La Colonne Vertebrale Et Des Neurosciences
OTHER
Responsible Party
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Principal Investigators
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Samar S. Ayache, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
Locations
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Hopital Henri Mondor
Créteil, , France
Countries
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Other Identifiers
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2021-A01668-33
Identifier Type: -
Identifier Source: org_study_id