Fibromyalgia is a chronic and multifactorial disorder characterized by widespread musculoskeletal pain, heightened pain sensitivity, fatigue, sleep disturbances, cognitive complaints, and affective symptoms such as anxiety and depression. Despite the availability of pharmacological and non-pharmacological interventions, symptom control often remains suboptimal, and currently available treatments may be associated with limited efficacy or poor tolerability. Consequently, there is a growing need for effective, safe, and personalized non-pharmacological therapeutic approaches.
In a previous randomized controlled trial (EXOFIB), we investigated the effects of the Exopulse Mollii Suit, a non-invasive neuromodulation device delivering multisite transcutaneous electrical nerve stimulation (TENS), in patients with fibromyalgia.
Using stimulation parameters consisting of a frequency of 20 Hz, a voltage of 20 V, and a pulse width of 55-85 µs, active stimulation was associated with clinically meaningful improvements in pain, fatigue, and quality of life compared with sham stimulation. These findings provided evidence supporting the therapeutic potential of the Exopulse Mollii Suit in the management of fibromyalgia-related symptoms.
However, while EXOFIB established the efficacy of active stimulation relative to sham stimulation, it did not address whether alternative stimulation parameter configurations could yield superior clinical outcomes. To date, no randomized crossover study has directly compared different active stimulation settings of the Exopulse Mollii Suit in patients with fibromyalgia. Consequently, the optimal stimulation parameters for maximizing therapeutic benefit in this population remain unknown.
The present study has therefore been designed to compare the effects of three stimulation modalities delivered by the Exopulse Mollii Suit, including two active stimulation configurations and one sham stimulation condition. The primary objective is to evaluate and compare their effects on functional disability associated with fibromyalgia, assessed using the Fibromyalgia Impact Questionnaire (FIQ).
The inclusion of a sham condition allows assessment of non-specific effects while preserving participant blinding.
The stimulation conditions evaluated in this study are:
* Condition A (active stimulation): frequency 20 Hz, voltage 20 V, pulse width 55-85 µs; * Condition B (active stimulation): frequency 20 Hz, voltage 20 V, pulse width 100-125 µs; * Condition C (sham stimulation): brief initial active stimulation followed by discontinuation of stimulation after one minute, while maintaining identical device settings, session duration, and study procedures in order to preserve participant blinding.
By identifying the most effective stimulation setting, this study aims to optimize the clinical use of the Exopulse Mollii Suit in fibromyalgia and to contribute to the development of more individualized neuromodulation strategies. Ultimately, the findings may improve symptom management, reduce functional disability, and enhance quality of life in patients living with fibromyalgia.
Patients aged between 18 and 75 years,
Patients 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 with the national health insurance.
Patient included in another research protocol during the study period;
Inability to comply with study procedures or follow-up requirements for geographical, social, or organizational reasons;
Any contraindication to the use of the Exopulse Mollii Suit as specified in the device user manual;
Any significant neurological, psychiatric, cardiovascular, musculoskeletal, or other medical condition that, in the opinion of the investigator, could interfere with study participation, outcome assessment, or participant safety, with the exception of anxiety and depression commonly associated with fibromyalgia;
Crossover
EXOPULSE Mollii Suit
DeviceThe Exopulse Mollii Suit is a CE-marked neuromodulation device with a favorable safety profile, good tolerability, and ease of use. Developed by Exoneural Network AB, the device consists of a full-body garment incorporating 58 electrodes capable of delivering transcutaneous electrical stimulation to 40 muscle groups using low-frequency (20 Hz), low-intensity electrical currents (current intensity: 2 mA; pulse width: 25-170 µs). The stimulation is not intended to induce muscle contraction but rather to modulate pain processing through activation of large-diameter afferent fibers, thereby reducing nociceptive transmission in accordance with the gate control theory of pain. The device is intended for pain reduction and is used as a daily, non-pharmacological neuromodulation intervention.
Change from baseline in functional disability as assessed using the Fibromyalgia Impact Questionnaire scores
The primary endpoint is the change in functional disability assessed using the Fibromyalgia Impact Questionnaire across the three stimulation conditions (Condition A, Condition B and sham stimulation). The scores ranges from a minimal score of 0 to a maximal score of 100, with higher scores reflecting a greater impact of fibromyalgia.
Change from baseline in pain intensity as assessed using the Visual Analogue Scale for pain
Visual Analogue scale of Pain consists of rating the symptom on a 10 cm horizontal line going from 0 meaning "no pain" to 10 meaning "worst pain imaginable". It has good psychometric properties for assessing pain and has a high sensibility and sensitivity and a good discriminative power in patients with fibromyalgia.
Change from baseline in pain severity and pain interference, assessed using the Brief Pain Inventory
The validated French version of the Brief Pain Inventory will be used to assess pain severity (4 items) and pain interference (7 items) (Cronbach's alpha ranging from 0.86 to 0.90). Brief Pain Inventory items are rated on a 10-point scale running from 0 (no pain/does not interfere) to 10 (pain as bad as you can/interferes completely).
Change from baseline in pain catastrophizing, assessed using the Pain Catastrophizing Scale
The Pain Catastrophizing Scale 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). The total score ranges from a minimum of 0 to a maximum of 52 with a higher score reflecting worse condition. It is possible to calculate a total and three subscale scores (i.e., helplessness, magnification, and rumination) . The total PCS has good psychometric properties: internal consistency (Cronbach's alpha =0.91) and test-retest reliability (r=0.85 at two weeks and r=0.77 at six weeks).
Change from baseline in fatigue as assessed using the Visual Analogue Scale for fatigue
The visual Analogue Scale for fatigue consists of rating the symptom on a 10 cm horizontal line going from a minimum of 0 reflecting "no fatigue" to a maximum of 10 reflecting the "worst fatigue imaginable". It has good psychometric properties for assessing fatigue and has a high sensibility and sensitivity and a good discriminative power
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