Fibromyalgia, PainEXOFIB3NCT06702176
"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.
A study testing EXOPULSE MOLLII SUIT active in people with Fibromyalgia, Pain, 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, Pain
- What is being tested?
- EXOPULSE MOLLII SUIT active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 30 Jun 2026
- 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 three months
- 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
- 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)
- 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.
Moussa A CHALAH, MD,PhD contact
France1 site, 1 recruiting
- Recruiting
linical Neurophysiology department, Henri Mondor Hospital, Créteil, France
Créteil, VAL DE MARNE, 94000
Samar S AYACHE, MD,PhD
About this study
Official title: "Using a Multisite TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Fibromyalgia-related Symptoms (EXOFIB 3)"
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.
- Conditions
- Fibromyalgia, Pain
- Being tested
- EXOPULSE MOLLII SUIT active, EXOPULSE MOLLII SUIT (sham)
- Keywords
- Exopulse Mollii Suit, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE MOLLII SUIT activeDevice
Exopulse 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)Device
It 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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition | 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. These parameters were previously found to be safe in human studies. Receives: Device: EXOPULSE MOLLII SUIT active |
| Control Condition | Sham comparator | The control arm will be a sham intervention. The patients will receive a sham stimulation, for which the same Exopulse Mollii suit will be used but the control unit will be programmed to start stimulating for 1 minute then it will shut off which could enable cutaneous sensations that mimic the active condition, aiming to achieve an effective blinding integrity. There is no risk related to the sham intervention since it 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 170 µs) but for a shorter duration of time (1 minute). Receives: Device: EXOPULSE MOLLII SUIT (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) at Visit 1(Day 0) ,Visit 2 (Day 15), Visit 3( Day 30) and Visit4 (Day 45)
Secondary outcomes (11)
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.
Measured: This will be assessed during the phase 2 visits (6 months of using the EXOPULSE Mollii suit). The visits will take place monthly, starting from visit 5 and throughout visits 6, 7, 8, 9, 10 and 11.
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.
Measured: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
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).
Measured: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
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).
Measured: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Anti-fatigue effects according to the Visual Analogue Scale (VAS Fatigue) during phases 1 and 2.
Like pain, fatigue will be assessed using VAS fatigue (Visual Analogue Scale)
Measured: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Mood changes as per the Hospital Anxiety and Depression Scale (HADS) (phases 1 and 2)
It 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: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Quality of life using the Short Form 36 Health Survey (SF-36) during phases 1 and 2
It 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.
Measured: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Sleep changes using the Leeds Sleep Evaluation Questionnaire (LSEQ) during phases 1 and 2.
Leeds Sleep Evaluation Questionnaire (LSEQ): it consists of 10 items that evaluate four domains: ease of initiating sleep, quality of sleep, ease of waking, and behavior following wakefulness. 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 large amount of psychological and psychopharmacological studies.
Measured: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Sleep changes using the Pittsburgh Sleep Quality Index (PSQI) during phases 1 and 2.
The Pittsburgh Sleep Quality Index (PSQI): it is a self-rated questionnaire that evaluates sleep quality. Its 19 questions aim to assess the sleep pattern during the previous month. This scale has good psychometric properties and its utility in clinical practice and research activities has been proven.
Measured: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Evaluation of overall improvement using the CGI (Clinical Global Impression)
It consists of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)
Measured: This will be assessed at visit 2 (day 15), visit 4 (day 45), and monthly from the second phase of 6 months of treatment (V5, V6, V7, V8, V9, V10, and V11), as the CGI is designed to be applied after the interventions.
Evaluation of patient's blinding to the type of stimulation in the crossover trial
This blind evaluation will be done in phase 1 using a dedicated questionnaire (only for each treatment condition, since all patients will receive the same active treatment in open phase 2).
Measured: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) of Phase 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Mar 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, PainStudies 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
- The investigators designed a trial that includes two phases: (i) phase 1 which consists of a 2-week intervention of Exopulse Mollii suit "active" versus "sham", separated by a 2-week washout period to prevent any carry-over effects; (ii) phase 2 that will be carried out two weeks following the end of phase 1. Phase 2 will last 6 months (24 weeks: 7 sessions per week) with a monthly assessment aiming to explore the long-term effects of this method on fibromyalgia. Summary: * Phase 1: randomized sham-controlled crossover study (active vs. sham condition/ assessment every two weeks ) * Phase 2: Open-label (active condition, 6 months/monthly assessment)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
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, HDR, Principal investigator, Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702176
- Sponsor's protocol ID
- 2024-A00019-38
- Acronym
- EXOFIB3
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Using a Multisite TENS System (Transcutaneous Electrical Noninvasive Stimulation) to Improve Fibromyalgia-related Symptoms (EXOFIB 3)"
- ClinicalTrials.gov ID
- NCT06702176
- Acronym / sponsor ID
- EXOFIB3 / 2024-A00019-38
- Conditions
- Fibromyalgia, Pain
- Keywords
- Exopulse Mollii Suit, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des NeurosciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Nov 2024 (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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators designed a trial that includes two phases: (i) phase 1 which consists of a 2-week intervention of Exopulse Mollii suit "active" versus "sham", separated by a 2-week washout period to prevent any carry-over effects; (ii) phase 2 that will be carried out two weeks following the end of phase 1. Phase 2 will last 6 months (24 weeks: 7 sessions per week) with a monthly assessment aiming to explore the long-term effects of this method on fibromyalgia. Summary: * Phase 1: randomized sham-controlled crossover study (active vs. sham condition/ assessment every two weeks ) * Phase 2: Open-label (active condition, 6 months/monthly assessment)
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Active comparator | Device: EXOPULSE MOLLII SUIT activeActive 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. These parameters were previously found to be safe in human studies. |
| Control Condition | Sham comparator | Device: EXOPULSE MOLLII SUIT (sham)The control arm will be a sham intervention. The patients will receive a sham stimulation, for which the same Exopulse Mollii suit will be used but the control unit will be programmed to start stimulating for 1 minute then it will shut off which could enable cutaneous sensations that mimic the active condition, aiming to achieve an effective blinding integrity. There is no risk related to the sham intervention since it 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 170 µs) but for a shorter duration of time (1 minute). |
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 three months
- Patients should be French speakers, able to understand verbal instructions, and affiliated with the National Health insurance
Key exclusion criteria (7 listed)
- 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)
- Any change in the pharmacological therapy in the last three months
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 SUIT activeExopulse 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. | Device | Experimental Condition |
| EXOPULSE MOLLII SUIT (sham)It 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). | Device | Control Condition |
Primary outcome
Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) right after the intervention (phase 1)
Time frame: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) at Visit 1(Day 0) ,Visit 2 (Day 15), Visit 3( Day 30) and Visit4 (Day 45)
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)
11 secondary outcomes
Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) throughout the follow-up period (phase 2)
Time frame: This will be assessed during the phase 2 visits (6 months of using the EXOPULSE Mollii suit). The visits will take place monthly, starting from visit 5 and throughout visits 6, 7, 8, 9, 10 and 11.
Analgesic effects based on the Visual Analogue Scale (VAS) during phases 1 and 2.
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Analgesic effects based on the Brief Pain Inventory (BPI) during phases 1 and 2.
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Analgesic effects based on the Pain Catastrophizing Scale (PCS) during phases 1 and 2.
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Anti-fatigue effects according to the Visual Analogue Scale (VAS Fatigue) during phases 1 and 2.
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Mood changes as per the Hospital Anxiety and Depression Scale (HADS) (phases 1 and 2)
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Quality of life using the Short Form 36 Health Survey (SF-36) during phases 1 and 2
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Sleep changes using the Leeds Sleep Evaluation Questionnaire (LSEQ) during phases 1 and 2.
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Sleep changes using the Pittsburgh Sleep Quality Index (PSQI) during phases 1 and 2.
Time frame: This will be assessed through study completion, an average of 8 months (at Visits 1, 2, 3, 4, 5, 6,7,8,9,10 and 11).
Evaluation of overall improvement using the CGI (Clinical Global Impression)
Time frame: This will be assessed at visit 2 (day 15), visit 4 (day 45), and monthly from the second phase of 6 months of treatment (V5, V6, V7, V8, V9, V10, and V11), as the CGI is designed to be applied after the interventions.
Evaluation of patient's blinding to the type of stimulation in the crossover trial
Time frame: This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) of Phase 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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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.
Moussa A CHALAH, MD,PhD contact
Samar S Ayache, MD, PhD, HDR principal investigator
Hopital Henri Mondor, Assistance Publique - Hôpitaux de Paris, Créteil, 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 EXOPULSE MOLLII SUIT active in people with Fibromyalgia, Pain, 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 7 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: status not confirmed, as of the sponsor's last update on 22 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar S AYACHE, MD, PhD, HDR (+33 149814662, samarayache@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of functional disability as per the Fibromyalgia Impact Questionnaire (FIQ) right after the intervention (phase 1) (time frame: This will be assessed before and after each condition (phase 1, 1 session per condition sham or active stimulation) at Visit 1(Day 0) ,Visit 2 (Day 15), Visit 3( Day 30) and Visit4 (Day 45)). 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 22 Nov 2024.