An interventional study of EXOPULSE Mollii Suit in Fibromyalgia, Fibromyalgia (FM) and Fibromyalgia (FM) OR Fibromyalgia Syndrome, sponsored by Institut De La Colonne Vertebrale Et Des Neurosciences. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Institut De La Colonne Vertebrale Et Des Neurosciences · Not applicable, Interventional, and Treatment
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:
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.
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 1,056 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Institut De La Colonne Vertebrale Et Des Neurosciences is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
stimulation parameters: frequency 20 Hz, voltage 20 V, pulse width 55-85 µs
Device: EXOPULSE Mollii Suit
stimulation parameters frequency 20 Hz, voltage 20 V, pulse width 100-125 µs
Device: EXOPULSE Mollii Suit
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.
Device: EXOPULSE Mollii Suit
The 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.
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
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.
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
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).
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
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).
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
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
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
Change from baseline in anxiety and depression symptoms, assessed using the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale is a 14-item generic scale with good psychometric properties. It consists of seven items assessing anxiety and seven others assessing depression. Scores can range from 0 to 21 on each subscale, with higher scores indicating worse symptomatology.
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
Change from baseline in global sleep quality, assessed using the Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is a self-rated questionnaire that evaluates sleep quality. Its 19 questions aim to assess the sleep pattern during the previous month. Scores can range from a minimum of 0 (better sleep quality) to a maximum of 21 (worse sleep quality). This scale has good psychometric properties and its utility in clinical practice and research activities has been proven.
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
Change from baseline in subjective sleep experience, assessed using the Leeds Sleep Evaluation Questionnaire
The Leeds Sleep Evaluation Questionnaire consists of 10 items that evaluate four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness. Items are rated on a 100 mm scale with a minimal score of 0 mm (represents the worst outcome) and a maximal score of 100 mm (represents the best outcome). It is an easy to implement questionnaire that has been widely used to evaluate the subjective aspect of sleep. It has been employed in a huge amount of psychological and psychopharmacological studies.
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
Change from baseline in health-related quality of life, assessed using the Short Form-36 Health Survey
The Short Form-36 Health Survey is a generic survey that contains 36 items that assess the quality of life and yield eight dimensions: physical functioning, physical role, emotional role, bodily pain, general health, vitality, social functioning, and mental health. The score of each dimension ranges from 0 to 100, with higher scales implying better health status. The French version has excellent convergent and discriminant validity (100% and 97.9%, respectively) and good to excellent internal consistency (Cronbach's alpha: 0.76-0.92)
Time frame: before the first intervention (week 1), end of the first intervention (week 5), before the second intervention (weekd 7), after the second intervention (week 11), before the third intervention (week 13), and after the third intervention (week 17)
Overall clinical improvement assessed using the Clinical Global Impression
The Clinical Global Impression is a 7-point measure ranging from "very much improved" to "very much worse" since the initiation of the treatment period
Time frame: After the first intervention (week 5), after the second intervention (week 11), after the third intervention (week 17)
Maintenance of blinding, assessed using the blinding questionnaire
Participants will complete a blinding questionnaire designed to assess the effectiveness of participant blinding and their perception of the stimulation condition received
Time frame: After the first intervention (week 5), after the second intervention (week 11), after the third intervention (week 17)
Difference in daily pain reporting using a Visual Analogue Scale of pain among the three stimulation conditions
Daily pain evolution, assessed using a daily pain diary based on the VAS pain throughout the study period. 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".
Time frame: Pain will be daily recorded between the first visit (week 1) and the last visit of the protocol (week 17)
No study locations are listed for this record.
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Plan to share: Yes — Data could be made available by the corresponding authors of the published article upon reasonable requests.
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
Of 510 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 11 months is below that.
Counting every sponsor, half of 522 studies reached it within 13 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Institut De La Colonne Vertebrale Et Des Neurosciences