FibromyalgiaFIDGISNCT04624581
FIbromyalgia anD GenetIcs Subgroups (FIDGIS)
A study testing Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device in people with Fibromyalgia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2020to 17 Jan 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patient Inclusion criteria :
- Patient between 18 and 65 years old (included),
- Patient with fibromyalgia according to the criteria of the 2016 ACR,
- Patient weighing more than 45kg
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance to give written consent,
- Affiliation to the French Social Security system,
Patient exclusion criteria :
- treated with antibiotics in the three months prior to inclusion,
- who has reported gastroenteritis in the two months prior to inclusion,
- having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test
- of childbearing age not using an effective contraceptive method, pregnant or breastfeeding woman.
- participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 4500 over the 12 months preceding the start of the trial,
- benefiting from a measure of legal protection (guardianship, guardianship, deprivation of liberty, safeguard of justice),
Subject inclusion criteria:
- Aged of more than 18 years,
- weighing more than 45kg
- non-painful subjects matched by age (+/- 5 years), by sex, and by menopausal status for women,
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance of written consent,
- Affiliation to the French Social Security system,
- Registration or acceptance of registration in the National Register of Volunteers participating in research.
Subject exclusion criteria :
- treated with antibiotics in the three months prior to inclusion,
- who has reported gastroenteritis in the two months prior to inclusion,
- Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test,
- Intake of any drugs in the 7 days before inclusion,
- Pregnant or nursing woman
- Participating in another clinical trial, or within the exclusion period, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
- Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome
Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses.
Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain.
Read more
Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS.
The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.
Read the detailed description
This is an exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.
The main objectives of this study are :
Primary: Evaluate the central nociception sensitization characteristics and genetic determinants in fibromyalgic syndrome, comparing a group of patients to matched healthy controls.
Secondary :
- 1) Characterize genetic predispositions of central sensitization in patients with FS compared to matched healthy controls, including confirmation of known genetic markers and potential identification of new genetic variants involved,
- 2) Compare in the area of central sensitization the population of patients with FS and matched healthy controls,
- 3) Compare in the domain of temporal summation the population of patients with FS and matched healthy controls,
- 4) Describe in the clinical field the characteristics of the FS patient population,
- 5) Compare in the areas of quality of life, anxiety/depression and comorbidities, characteristics of the FS patient population and matched healthy controls,
- 6) Compare epigenetic biomarkers of the FS patient population with healthy matched controls,
- 7) Study of the role of the gut microbiota in patients with FS (bio banking)
- 8) Compare in the areas of pain, sound and light sensitivity the population of patients with FS and matched healthy controls.
- Conditions
- Fibromyalgia
- Being tested
- Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device
- Keywords
- Fibromyalgia syndrome, Chronic pain, Widespread pain, genetics, central sensitization
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking deviceDevice
This intervention measures the response to electrical stimulation of the sural nerve using a pair of percutaneous electrodes placed at the external malleolar retro passage of the nerve (2 cm apart) and connected to the stimulation device (Nicolet Vicking). Reflex muscle responses will be collected using surface electrodes placed on the femoral biceps muscle of the participant and connected to an Electromyogram recording device.
The RIII will be determined twice (rest period between each 10-minute). In order to induce the reflex nociceptive flexion response, repeated cutaneous electrical stimulations (30 to 40) will be applied at the level of the sural nerve following a variable interval of 6 to 10 seconds in order to overcome the phenomena of habituation and predictability. Each stimulus test will consist of a single rectangular pulse of 0.5 ms, of variable intensity (0-100mA) until a reflex nociceptive flexion threshold is detected or a maximum current of 100 mA is reached
| Study group | Role | What they receive |
|---|---|---|
| Patient with fibromyalgia syndrome | Experimental | 250 patients with fibromyalgia syndrome (according to American College of Rheumatology 2016) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate the distribution of gene polymorphism. Receives: Device: Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device |
| Healthy subjects | Sham comparator | 50 healthy matched volunteers (age, sex and menopausal status for women) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate distribution of gene polymorphism Receives: Device: Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of nociception flexion reflex (RIII) threshold by electromyography
Patient rested comfortably in a supine position in order to obtain muscular relaxation. Cutaneous electrodes will be applied, and the sural nerve will be stimulated in its retromaleolar track. Electromyographic responses will recorded using the Nicolet Vicking device with a pair of surface electrodes placed over the tendon of the ipsilateral biceps femoris.
The R-III reflex (objective threshold) will be identified as a multiphasic signal appearing at least 90 ms but less than 250 ms after each stimulation and will be considered to be present when the corrected computed surface was >0.5 mV/ms (positive response).
Measured: Day 1
Secondary outcomes (14)
Evaluation of genetic polymorphism using OpenArray technology
Genome-wide association studies highlight that genetic factors are possibly responsible for up to 50% of the disease susceptibility, and several potential candidate genes have been found to be associated to fibromyalgia, including catecholaminergic (COMT), serotoninergic (HTR2A, SLC6A4), dopaminergic (GCH1, TAAR1) and glutamatergic (GRIA4) pathways. The participants will be genotyped for selected SNPs (120 SNPs- OpenArray technology) that have been previously investigated in relation to FM susceptibility, symptoms or potential mechanisms (Algynomics and international publications).
A single blood sample will be obtained on visit 1 day 1 and 4 aliquotes will be frozen at -80°C and kept frozen until the Open Array Technology analysis
Measured: day 1
Evaluation of central sensitization
assessed by Central Sensitization Inventory questionnaire
Measured: Day 1
Mechanical temporal summation by numerical scale (0 to 10)
The mechanical temporal summation test will be performed using a 180g (Size 6.45) Von Frey filament applied to the non-dominant arm of the patient/subject who are sitting comfortably in a quiet room. The Von Frey filament will be applied against the skin of the participant at right angle, the manipulator performs a pressure movement until the filament flexes slightly. The participant scores on a numerical verbal scale (0 to 10) the intensity of pain perceived by the application of a single stimulus, and then of ten stimuli
Measured: Day 1
Concise Pain Questionnaire (QCD)
This self-assessment scale allows the patient to characterize the pain in relation to its psychosocial intensity and impact. The patient is asked to answer 9 graduated questions by circling a number from 0 (no pain) to 10 (the most horrible pain you can imagine). Among these questions the patient is asked to blacken the painful areas on a diagram and to put an S if the pain is on the surface or a P if it is deep
Measured: Day 1
Detection of fibromyalgia using the FIRST questionnaire
The FIRST questionnaire is a 6-item self-questionnaire that detects fibromyalgia. The patient is asked to answer "yes" or "no". Five "yes" allow to detect fibromyalgia when pain has persisted for more than 3 months
Measured: Day 1
Evaluation of the impact of fibromyalgia using the FIQ questionnaire
The revised FIQ questionnaire is a 10-item self-questionnaire that assesses the impact of fibromyalgia. The first item is subdivided into 10 questions that assess the impact of the disease in everyday life
Measured: Day 1
Evaluation of the Suspended Symmetrical Dorsal Cellulalgia
The experimenter makes a palpate-roll (by slightly lifting the skin) between the thumb and the other 4 fingers of the hand by following an axis on each side of the patient's spine. The palpate roll begins at the lumbar level and rises to the level of the shoulder blades on each side of the spine. The test is performed on one side of the spine and then on the other. The palpate roll should be performed 5 times on each side of the spine alternately. The investigator should rate for each side and at each pass whether the patient is experiencing pain or not. If the patient does not feel pain after 5 passes, the test is considered negative.
Measured: Day 1
Quality of life by SF-36 quality of life questionnaire
the quality of life of the participants will be assessed by the self-administrated General Questionnaire 36-Item Short Form Survey (SF-36). The SF-36 questionnaire consists of 36 items and assesses an individual's physical and mental health using eleven questions related to eight aspects of health: physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health.Global score ranges from 0 to 100.
Measured: Day 1
Emotional status by Hospital Anxiety and Depression scale (HAD)
The Hospital Anxiety and Depression scale is a self-administered questionnaire in 14 items completed by the participant. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Global score ranges from 0 to 42.
Measured: Day 1
Evaluation of micro ARN using OpenArray technology
Studies have shown that thousands of human protein coding genes are regulated by micro RNAs, indicating that micro RNAs are "master regulators" of many important biological processes and some of this microRNA can be implicated in fibromyalgia continuum. The participants micro RNA's will be analyzed for 754 human selected micro RNA (OpenArray technology) that have been previously investigated in relation to FM susceptibility, symptoms or potential mechanisms. A single blood sample will be obtained on visit 1 day 1 and 6 aliquotes will be frozen at -80°C and kept frozen until the Open Array Technology analysis.
Measured: Day 1
Analysis of the microbiota (stool samples),
Identification of bacterial biodiversity by a genetic sequencing analysis of bacterial DNA. The stool samples will be collected and then frozen at -80°C and kept frozen until analysis.
Measured: Day 1
Evaluation of sensitivity to pain by PSQ questionnaire
the sensitivity to pain of the participants will be assessed by the Pain Sensitivity Questionnaire (PSQ). The PSQ questionnaire explore natural sensitivity to pain using questions simulating more or less intense pain situation using 17 questions.
Measured: Day 1
Evaluation of sensitivity to sound by audiometer
the uncomfortable loudness level (ULL) of the participants will be assessed using the procedure of the British audiology society using a conventional audiometer (pure sound emission). The ULL is the level at which the participant responds or clearly feels uncomfortable and confirms this fact after removing the helmet.
Measured: Day 1
Evaluation of sensitivity to light by led panel
the light sensitivity level of the participants will be assessed using a led panel (Lykos Daylight, Manfrotto) in a room without any source of natural light. The light intensity will be progressive (by step of 1 seconds flash light every 20 seconds) and the participant will stop the test when the intensity of the light will be uncomfortable. The light sensitivity is the level at which the participant feels uncomfortable
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start30 Nov 2020
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Service de pharmacologie et toxicologie cliniques, Hôpitaux Universitaire Genève, Rue Gabrielle Perret-Gentil 4, 1205 Genève, SUISSE, Association des Fibromyalgiques d'Auvergne, 19 Place de la Résistance, 63800 Cournon d'Auvergne, FRANCE
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624581
- Sponsor's protocol ID
- RBHP 2020 PICKERING
- Other IDs
- 2020-A01724-35
- Acronym
- FIDGIS
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2020
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macian N, Duale C, Delay M, Leray V, Pereira B, Renaud Y, Gloor Y, Desmeules J, Pickering G. Relationship Between Central Sensitization and Genetic Polymorphisms-A Case-Control Study in Fibromyalgia. Eur J Pain. 2026 Jul;30(6):e70308. doi: 10.1002/ejp.70308.
PubMed 42246686
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome
- ClinicalTrials.gov ID
- NCT04624581
- Acronym / sponsor ID
- FIDGIS / RBHP 2020 PICKERING
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia syndrome, Chronic pain, Widespread pain, genetics, central sensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Service de pharmacologie et toxicologie cliniques, Hôpitaux Universitaire Genève, Rue Gabrielle Perret-Gentil 4, 1205 Genève, SUISSE, Association des Fibromyalgiques d'Auvergne, 19 Place de la Résistance, 63800 Cournon d'Auvergne, FRANCE
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 12 Nov 2020 (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 syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses.
Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain.
Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS.
The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.
Detailed description
This is an exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.
The main objectives of this study are :
Primary: Evaluate the central nociception sensitization characteristics and genetic determinants in fibromyalgic syndrome, comparing a group of patients to matched healthy controls.
Secondary :
- 1) Characterize genetic predispositions of central sensitization in patients with FS compared to matched healthy controls, including confirmation of known genetic markers and potential identification of new genetic variants involved,
- 2) Compare in the area of central sensitization the population of patients with FS and matched healthy controls,
- 3) Compare in the domain of temporal summation the population of patients with FS and matched healthy controls,
- 4) Describe in the clinical field the characteristics of the FS patient population,
- 5) Compare in the areas of quality of life, anxiety/depression and comorbidities, characteristics of the FS patient population and matched healthy controls,
- 6) Compare epigenetic biomarkers of the FS patient population with healthy matched controls,
- 7) Study of the role of the gut microbiota in patients with FS (bio banking)
- 8) Compare in the areas of pain, sound and light sensitivity the population of patients with FS and matched healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory case control pathophysiology study of psychophysical (central sensitization assessment) and genetic (candidate gene panel) characteristics.
| Arm | Type | Receives |
|---|---|---|
| Patient with fibromyalgia syndrome | Experimental | Device: Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device250 patients with fibromyalgia syndrome (according to American College of Rheumatology 2016) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate the distribution of gene polymorphism. |
| Healthy subjects | Sham comparator | Device: Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device50 healthy matched volunteers (age, sex and menopausal status for women) will realize explorations to characterize central sensitization: reflex nociceptive flexion threshold by electrophysiological measure and blood sampling for evaluate distribution of gene polymorphism |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking deviceThis intervention measures the response to electrical stimulation of the sural nerve using a pair of percutaneous electrodes placed at the external malleolar retro passage of the nerve (2 cm apart) and connected to the stimulation device (Nicolet Vicking). Reflex muscle responses will be collected using surface electrodes placed on the femoral biceps muscle of the participant and connected to an Electromyogram recording device. The RIII will be determined twice (rest period between each 10-minute). In order to induce the reflex nociceptive flexion response, repeated cutaneous electrical stimulations (30 to 40) will be applied at the level of the sural nerve following a variable interval of 6 to 10 seconds in order to overcome the phenomena of habituation and predictability. Each stimulus test will consist of a single rectangular pulse of 0.5 ms, of variable intensity (0-100mA) until a reflex nociceptive flexion threshold is detected or a maximum current of 100 mA is reached | Device | Healthy subjects, Patient with fibromyalgia syndrome |
Primary outcome
Evaluation of nociception flexion reflex (RIII) threshold by electromyography
Time frame: Day 1
Patient rested comfortably in a supine position in order to obtain muscular relaxation. Cutaneous electrodes will be applied, and the sural nerve will be stimulated in its retromaleolar track. Electromyographic responses will recorded using the Nicolet Vicking device with a pair of surface electrodes placed over the tendon of the ipsilateral biceps femoris. The R-III reflex (objective threshold) will be identified as a multiphasic signal appearing at least 90 ms but less than 250 ms after each stimulation and will be considered to be present when the corrected computed surface was >0.5 mV/ms (positive response).
14 secondary outcomes
Evaluation of genetic polymorphism using OpenArray technology
Time frame: day 1
Evaluation of central sensitization
Time frame: Day 1
Mechanical temporal summation by numerical scale (0 to 10)
Time frame: Day 1
Concise Pain Questionnaire (QCD)
Time frame: Day 1
Detection of fibromyalgia using the FIRST questionnaire
Time frame: Day 1
Evaluation of the impact of fibromyalgia using the FIQ questionnaire
Time frame: Day 1
Evaluation of the Suspended Symmetrical Dorsal Cellulalgia
Time frame: Day 1
Quality of life by SF-36 quality of life questionnaire
Time frame: Day 1
Emotional status by Hospital Anxiety and Depression scale (HAD)
Time frame: Day 1
Evaluation of micro ARN using OpenArray technology
Time frame: Day 1
Analysis of the microbiota (stool samples),
Time frame: Day 1
Evaluation of sensitivity to pain by PSQ questionnaire
Time frame: Day 1
Evaluation of sensitivity to sound by audiometer
Time frame: Day 1
Evaluation of sensitivity to light by led panel
Time frame: Day 1
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 5 Aug 2026.
- Results publication: PubMed 42246686Macian N, Duale C, Delay M, Leray V, Pereira B, Renaud Y, Gloor Y, Desmeules J, Pickering G. Relationship Between Central Sensitization and Genetic Polymorphisms-A Case-Control Study in Fibromyalgia. Eur J Pain. 2026 Jul;30(6):e70308. doi: 10.1002/ejp.70308.
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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.
Gisèle Pickering principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device in people with Fibromyalgia, run by University Hospital, Clermont-Ferrand 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?
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 5 Aug 2026. 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?
Evaluation of nociception flexion reflex (RIII) threshold by electromyography (time frame: Day 1). 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 NCT04624581, which also lists 1 linked publication.
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 5 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.