Exopulse Mollii Suit and Fibromyalgia (EXOFIB)

Institut De La Colonne Vertebrale Et Des Neurosciences

Status: Completed

Conditions: Fibromyalgia, Primary

Treatments: Device: Exopulse Mollii suit (sham); Device: Exoplulse Mollii suit

Study type: Interventional

Funder types: Other

Identifiers

NCT05361577

2021-A01668-33

Details and patient eligibility

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. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 one month
• Patients should be French speakers, able to understand verbal instructions, and affiliated to the national health insurance

Exclusion criteria

• 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 ")

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Active astimulation

Active Comparator group

Description:

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.

Treatment:

Device: Exoplulse Mollii suit

Sham stimulation

Sham Comparator group

Description:

In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.

Treatment:

Device: Exopulse Mollii suit (sham)