FibromyalgiaFIBROPULSENCT07872631
Multisite Transcutaneous Electrical Nerve Stimulation in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities
A study testing EXOPULSE Mollii Suit in people with Fibromyalgia and Fibromyalgia (FM), run by Institut De La Colonne Vertebrale Et Des Neurosciences.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia, Fibromyalgia (FM), Fibromyalgia (FM) OR Fibromyalgia Syndrome
- What is being tested?
- EXOPULSE Mollii Suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Modification of pharmacological treatment related to fibromyalgia or initiation/modification of non-pharmacological therapies within the three months preceding inclusion;
- Introduction of another therapeutic medical device during the study period;
Show all 9Show fewer
- Pregnant women;
- Breastfeeding women;
- Individuals subject to a legal protection measure (guardianship, curatorship, or judicial protection order).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multisite Transcutaneous Electrical Nerve Stimulation (Exopulse Mollii Suit) in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities (FIBROPULSE)
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.
Read more
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.
- Being tested
- EXOPULSE Mollii Suit
- Keywords
- EXOPULSE Mollii Suit, TENS, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE Mollii SuitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition A (active stimulation): | Experimental | stimulation parameters: frequency 20 Hz, voltage 20 V, pulse width 55-85 µs Receives: Device: EXOPULSE Mollii Suit |
| Condition B (active stimulation) | Experimental | stimulation parameters frequency 20 Hz, voltage 20 V, pulse width 100-125 µs Receives: Device: EXOPULSE Mollii Suit |
| Condition C (sham stimulation) | Sham comparator | 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. Receives: Device: EXOPULSE Mollii Suit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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".
Measured: Pain will be daily recorded between the first visit (week 1) and the last visit of the protocol (week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des Neurosciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872631
- Sponsor's protocol ID
- 2026-A00768-43
- Acronym
- FIBROPULSE
- Status last verified
- Sep 2026
- First submitted
- 3 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data could be made available by the corresponding authors of the published article upon reasonable requests.
Publications
Mattar JG, Chalah MA, Ouerchefani N, Sorel M, Le Guilloux J, Lefaucheur JP, Abi Lahoud GN, Ayache SS. The effect of the EXOPULSE Mollii Suit on pain and fibromyalgia-related symptoms-A randomized sham-controlled crossover trial. Eur J Pain. 2025 Feb;29(2):e4729. doi: 10.1002/ejp.4729. Epub 2024 Sep 18.
PubMed 39291602Riachi N, Shatila A, Diab S, Jaber H, Jawhari M, Mattar JG, Lefaucheur JP, Chalah MA, Ayache SS. The effects of EXOPULSE Mollii Suit in patients with fibromyalgia: a double-blind randomized sham-controlled trial (EXOFIB2). Pain Med. 2026 Jun 1;27(6):660-670. doi: 10.1093/pm/pnag010.
PubMed 41570081
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Transcutaneous Electrical Nerve Stimulation (Exopulse Mollii Suit) in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities (FIBROPULSE)
- ClinicalTrials.gov ID
- NCT07872631
- Acronym / sponsor ID
- FIBROPULSE / 2026-A00768-43
- Keywords
- EXOPULSE Mollii Suit, TENS, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des NeurosciencesUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Condition A (active stimulation): | Experimental | Device: EXOPULSE Mollii Suitstimulation parameters: frequency 20 Hz, voltage 20 V, pulse width 55-85 µs |
| Condition B (active stimulation) | Experimental | Device: EXOPULSE Mollii Suitstimulation parameters frequency 20 Hz, voltage 20 V, pulse width 100-125 µs |
| Condition C (sham stimulation) | Sham comparator | Device: EXOPULSE Mollii SuitBrief 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
- Modification of pharmacological treatment related to fibromyalgia or initiation/modification of non-pharmacological therapies within the three months preceding inclusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXOPULSE Mollii SuitThe 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. | Device | Condition A (active stimulation):, Condition B (active stimulation), Condition C (sham stimulation) |
Primary outcome
Change from baseline in functional disability as assessed using the Fibromyalgia Impact Questionnaire scores
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)
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.
11 secondary outcomes
Change from baseline in pain intensity as assessed using the Visual Analogue Scale for pain
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
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
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
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
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
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
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
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
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
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
Time frame: Pain will be daily recorded between the first visit (week 1) and the last visit of the protocol (week 17)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 39291602Mattar JG, Chalah MA, Ouerchefani N, Sorel M, Le Guilloux J, Lefaucheur JP, Abi Lahoud GN, Ayache SS. The effect of the EXOPULSE Mollii Suit on pain and fibromyalgia-related symptoms-A randomized sham-controlled crossover trial. Eur J Pain. 2025 Feb;29(2):e4729. doi: 10.1002/ejp.4729. Epub 2024 Sep 18.
- Background: PubMed 41570081Riachi N, Shatila A, Diab S, Jaber H, Jawhari M, Mattar JG, Lefaucheur JP, Chalah MA, Ayache SS. The effects of EXOPULSE Mollii Suit in patients with fibromyalgia: a double-blind randomized sham-controlled trial (EXOFIB2). Pain Med. 2026 Jun 1;27(6):660-670. doi: 10.1093/pm/pnag010.
- Individual participant dataSharing planned: Yes. Data could be made available by the corresponding authors of the published article upon reasonable requests.
Related trials for Fibromyalgia
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Enrolling by invitation
Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation
Arthritis, Fibromyalgia
Active, not recruiting
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Fibromyalgia
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing EXOPULSE Mollii Suit in people with Fibromyalgia and Fibromyalgia (FM), run by Institut De La Colonne Vertebrale Et Des Neurosciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Ayache, MD, PhD, HDR (0149814662, samarayache@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in functional disability as assessed using the Fibromyalgia Impact Questionnaire scores (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07872631, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.