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.
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
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)
Crossover
EXOPULSE MOLLII SUIT active
DeviceExopulse Mollii suit is a new assistive device that has been developed by Exoneural Network (initially Inerventions AB), a Swedish med-tech company. Exopulse Mollii suit is a full-body garment with integrated 58 electrodes that can transcutaneously stimulate several groups of muscles. The device is CE labelled and is intended to use for reducing spasticity and improving blood circulation. The outfit is very easy to put on, it can be used for one hour every day and the analgesic effects last 24 hours or more. EXOPULSE Mollii suit consists of transcutaneous stimulation of several muscles by means of a feeble electric current (i.e., low frequency \~20 Hz, low-intensity 2mA), aiming to reduce pain. This treatment method theoretical background primarily refers to the theory of gate control. Based on this theory, the stimulation of large proprioceptive fibers would inhibit the nociceptive information transmitted by small fibers.
EXOPULSE MOLLII SUIT (sham)
DeviceIt consists of applying the same parameters used for the active session (low frequency: 20 Hz; current intensity: 2 mA; pulse width ranging from 25 to 175 µs) but for a shorter duration of time (1 minute).
Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) right after the intervention (phase 1)
It is an 11-item scale that provides the researchers with a global assessment of the fibromyalgia syndrome, by measuring assesses Quality of Life and measures health status and functional disability and by exploring the impact of fibromyalgia on work, wellbeing, fatigue, sleep, stiffness, anxiety, and depression. FIQ ( Fibromyalgia Impact Questionnaire) scores can range from 0 to 100, with higher scores reflecting worse health status. Scores could be used to classify fibromyalgia as mild (scores: 0- 38), moderate (scores: 39-58), and severe (scores: 59-100)
Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) throughout the follow-up period (phase 2)
The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being.
Analgesic effects based on the Visual Analogue Scale (VAS) during phases 1 and 2.
VAS (Visual Analogue Scale ) which consists of rating the symptom on a 10 cm horizontal line going from "no pain" to "worst pain imaginable". Moreover, patients will be asked to fill in a pain diary (average daily pain reporting using a VAS filled in at the end of the day) and a pain medication that will be used to track pain medication use (opioids and nonopioids) one week prior, during, and till two weeks after each block.
Analgesic effects based on the Brief Pain Inventory (BPI) during phases 1 and 2.
The validated French version of the Brief Pain Inventory (BPI) will be used to assess pain severity (4 items) and pain interference (7 items).BPI items are rated on a 10-point scale running from 0 (no pain/does not interfere) to 10 (pain as bad as possible/interferes completely).
Analgesic effects based on the Pain Catastrophizing Scale (PCS) during phases 1 and 2.
The Pain Catastrophizing Scale (PCS) will also be employed, it is a valid and reliable scale that includes 13 items assessing the presence and severity of feelings or thoughts that emerge when experiencing pain. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time).
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