Fibromyalgia, PrimaryEXOFIBNCT05361577
Exopulse Mollii Suit and Fibromyalgia
A study testing Exoplulse Mollii suit in people with Fibromyalgia, Primary, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- Exoplulse Mollii suit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Using a TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Pain Related to Fibromyalgia (EXOFIB)
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.
- Conditions
- Fibromyalgia, Primary
- Being tested
- Exoplulse Mollii suit, Exopulse Mollii suit (sham)
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoplulse Mollii suitDevice
Exopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
Exopulse Mollii suit (sham)Device
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
| Study group | Role | What they receive |
|---|---|---|
| Active astimulation | Active comparator | 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. Receives: Device: Exoplulse Mollii suit |
| Sham stimulation | Sham comparator | In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. Receives: Device: Exopulse Mollii suit (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Visual Analogue Scale for Pain
VAS consists of rating the symptom on a 10 cm horizontal line going from "no pain" to "worst pain imaginable".
Measured: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Secondary outcomes (6)
Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale (PCS) will be employed, which 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). It is possible to calculate a total and three subscale scores (i.e., helplessness, magnification, and rumination)
Measured: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Brief Pain Inventory
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 the participant can imagine/interferes completely).
Measured: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Visual Analogue Scale (VAS) for fatigue
Like pain, fatigue will be assessed using VAS which consists of rating the symptom on a 10 cm horizontal line going from "no fatigue" to "worst fatigue imaginable".
Measured: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Fibromyalgia Impact Questionnaire (FIQ)
It is an 11-item scale that assesses health status and functional disability by exploring the impact of fibromyalgia on work, wellbeing, fatigue, sleep, stiffness, anxiety, and depression. FIQ 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)
Measured: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Hospital Anxiety and Depression Scale (HADS)
It is a 14-item generic scale with good psychometric properties and 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: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Short Form 36 Health Survey (SF-36)
It is a generic survey that contains 36 items which 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.
Measured: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Mar 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, PrimaryStudies 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
- Model description
- Phase 1: randomized sham controlled crossover study (active versus sham condition) Phase 2: Open label study (active condition)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des Neurosciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samar S. Ayache, MD, PhD, Principal investigator, Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361577
- Sponsor's protocol ID
- 2021-A01668-33
- Acronym
- EXOFIB
- Status last verified
- Dec 2023
- First submitted
- 24 Jan 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Pain Related to Fibromyalgia (EXOFIB)
- ClinicalTrials.gov ID
- NCT05361577
- Acronym / sponsor ID
- EXOFIB / 2021-A01668-33
- Conditions
- Fibromyalgia, Primary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des NeurosciencesUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 4 May 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1: randomized sham controlled crossover study (active versus sham condition) Phase 2: Open label study (active condition)
| Arm | Type | Receives |
|---|---|---|
| Active astimulation | Active comparator | Device: Exoplulse Mollii suitActive 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. |
| Sham stimulation | Sham comparator | Device: Exopulse Mollii suit (sham)In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Exoplulse Mollii suitExopulse Mollii suits consists of a body Garments (Jacket and Pants) and a control unit. The body Garments (Jacket and Pants) is a suit with 58 embedded electrodes that can stimulate 40 groups of muscles, conductive wires and connectors to a detachable control unit, whose intended purpose is to transmit electric pulses from the control unit to key nerves and corresponding muscle groups throughout the body. The control unit is a battery powered electrical device which sends low intensity electric pulses through connectors to the Body Garments which in turn transmits the pulses from the connectors to key nerves and corresponding muscle groups throughout the body. | Device | Active astimulation |
| Exopulse Mollii suit (sham)In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off. | Device | Sham stimulation |
Primary outcome
Change in the Visual Analogue Scale for Pain
Time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
VAS consists of rating the symptom on a 10 cm horizontal line going from "no pain" to "worst pain imaginable".
6 secondary outcomes
Pain Catastrophizing Scale (PCS)
Time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Brief Pain Inventory
Time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Visual Analogue Scale (VAS) for fatigue
Time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Hospital Anxiety and Depression Scale (HADS)
Time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Short Form 36 Health Survey (SF-36)
Time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia, Primary
Not yet recruiting
Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers
Fibromyalgia, Fibromyalgia (FM)
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome
Not yet recruiting
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
Hyperthermia, Chronic Primary Pain
Recruiting
The Effect of Remote Electrical Neuromodulation (REN) on Conditioned Pain Modulation (CPM) in Migraine and Fibromyalgia
Migraine, Fibromyalgia
Recruiting
The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients
Fibromyalgia, Fibromyalgia (FM)
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. This study is not recruiting at the moment.
Samar S. Ayache, MD, PhD principal investigator
Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoplulse Mollii suit in people with Fibromyalgia, Primary, run by Institut De La Colonne Vertebrale Et Des Neurosciences at 1 site in France.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Visual Analogue Scale for Pain (time frame: This be assessed at baseline (before intervention) then at 2 weeks, 4 weeks, 6 weeks, 8 weeks and 12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2023.