An interventional study of Sudoscan® in Fibromyalgia, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-05.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
Among 49 studies in Fibromyalgia with a site in France — 4 open to participants now, 5 under way, none of them phase 3. Fibromyalgia · France.
Among the 49 studies in Fibromyalgia with a site in France, this one is the 20th largest by planned enrollment of the 46 interventional ones that give a count, is the only one that started in 2017, is one of 31 with no phase, and was the 30th registered.
1,243 studies on the registry are indexed under Fibromyalgia; 255 are open to participants now.
Browse Fibromyalgia studies →4 of the 49 studies in Fibromyalgia with a site in France are open now. Recruiting first, the newest first:
Hospital Ambroise Paré Paris · Sites in France
Ages 18–80
Institut De La Colonne Vertebrale Et Des Neurosciences · Sites in France
Ages 18–75
Nadine ATTAL · Sites in France
Ages 18–80
University Hospital, Montpellier · Sites in France
Ages 18+ · Healthy volunteers
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
49 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Median enrollment 80 across the 46 interventional studies, 125 across the 3 observational. Of the 41 that completed or were terminated, 7 (17%) have results posted.
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12 of 49 have an industry lead sponsor. The 10 most frequent:
University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
University Hospital, Clermont-Ferrand has 4 studies filed under Fibromyalgia — fewer than ten, so there is no comparison to draw.
1 of the studies in Fibromyalgia with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06250491Nadine ATTALDeep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia | 2027-01-30 |
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Among the 49 studies in Fibromyalgia with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Fibromyalgia (FM) is characterized by chronic diffuse pain and affects 0.5 to 5% of the population, with a higher prevalence in women1. This condition is characterized by joint and muscle pain, also associated with fatigue, migraine, sleeps disorders, depression and irritable bowel syndrome2. The presentation of these various symptoms varies greatly from one patient to another, with great heterogeneity in clinical, physical, social, psychological and therapeutic responses. . A recent parliamentary inquiry report called for recognition of the disease and recommended to build a unified care path for patients; a collective expertise is led by INSERM to help in patient care. Faced with the heterogeneity of FM, several international studies have attempted to identify subgroups of patients based essentially on clinical symptoms of the disease3-8, including a recent Korean study of 313 patients9, which suggested four groups, but with methodological limitations, not taking into account the new criteria10 for evaluating FM.
Recent studies have also shown that there is a peripheral neuropathic component in the mechanisms of this pathology, demonstrated by a decrease in the density of the epidermal nerve fibers11-12, called small fiber neuropathy (SFN) neuropathy. It is an attack of small sensory and sympathetic nerve fibers, causing pain, paresthesia as well as disturbances of the autonomous system. Other studies also suggested that a significant proportion of patients diagnosed with fibromyalgia had SFN, demonstrated by cutaneous biopsy13-14 or confocal microscopy of the cornea15. A new device, the Sudoscan®, makes it possible to detect a SFN much simpler, faster and less invasive than the technique of ophthalmology or biopsy. Although this Sudoscan® test has been used extensively in conditions such as diabetes16-19, no study has been used to assess the presence of SFN in FM.
The aim of this pilot study is to identify the prevalence of SFN in FM patients, using this new non-invasive device, in order to have a better defined representation of the prevalence of small-fiber neuropathy in an FM population compared to a group of healthy volunteer matched in age, sex, BMI and by menopausal status for women.
Only one visit (2 to 3h) :
Inclusion of the patient Clinical examination ; evaluation of pain for FM patients Measurement of the electrochemical conductance of the hands and feet using Sudoscan® Evaluation of quality of life, anxiety, depression, sleep quality, fatigue, catastrophizing and social precarity End of study
Inclusion Criteria:
Inclusion criteria healthy subjects:
Exclusion Criteria:
Exclusion criteria healthy subjects :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 fibromyalgia patients/50 healthy subjects
Device: Sudoscan®
50 fibromyalgia patients/50 healthy subjects
Device: Sudoscan®
Sudoscan® is a new device that provides rapid, non-invasive and reproducible quantitative assessment of sweat function. It makes it possible to measure the ability of the sweat glands to release chloride ions in response to electrochemical activation and thus to detect the presence of a neuropathy with small fibers. This new device therefore makes it possible to detect an SFN in a much simpler and faster way than the technique of ophthalmology, or biopsy. Sudoscan® has been tested to assess the neuropathies of small nerve fibers in several diseases, in particular diabetes, chemotherapy-induced polyneuropathy, familial amyloid polyneuropathy or Fabry disease. The interest of Sudoscan® lies in the fact that this device is non-invasive and rapid. Its diagnostic value has been compared with other neurophysiological tests.
Measure of the electrochemical conductance (µS) using Sudoscan®
Evaluation of the prevalence of fibromyalgia patients with small fibro neuropathy in comparison with healthy volunteers by measuring the electrochemical conductance of the palms of the hands (middle right and left hands) and feet (middle right and left) in μS using Sudoscan®.
Time frame: at day 1
Biometric criteria
Collection of the age in years
Time frame: at day 1
Biometric criteria
Collection of sex, (male or female)
Time frame: at day 1
Biometric criteria
Collection weight in kilograms, height in meters, weight and eight will be combined to report BMI in kg/m²,
Time frame: at day 1
Biometric criteria
phototype Fitzpatrick classification
Time frame: at day 1
Numerical scale
This scale allows the patient to note pain on a graduation with a minimum score of 0 and a maximum score of 10. Higher value represent worse outcome.
Time frame: at day 1
Brief Pain Inventory
The BPI gives two main scores: a pain severity score and a pain interference score
Time frame: at day 1
Fibromyalgia Impact 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
Time frame: at day 1
Quality of life (SF-12)
12 questions and an index is determined for both physical and mental health (0-100). Higher scores indicate greater physical and mental health
Time frame: at day 1
Anxiety and Depression (HAD)
The HAD scale is a 14-item self-administered questionnaire completed by the patient. These items are divided into two subscales: 7 items to assess depression and 7 items to assess anxiety. Higher value represent worse outcome.
Time frame: at day 1
Depression (Beck Depression Inventory)
Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity of a symptom: from 0 to 3. In the counting, it is necessary to take into account the highest rating chosen for the same series. The overall score is obtained by adding the scores of the 13 items. The range of the scale is from 0 to 39. The higher the score, the more the subject is depressed.
Time frame: at day 1
Pittsburgh Sleep Quality Index
19-item self-administered questionnaire used to assess the quality of sleep. Higher value represent worse quality of sleep.
Time frame: at day 1
Chronic fatigue Severity Scale
9-item self-questionnaire to assess the patient's fatigue intensity. The patient is asked to circle a number from 1 to 7 for each question, a low value representing a low intensity. Higher value represents worse fatigue.
Time frame: at day 1
Pain Catastrophizing Scale
This questionnaire consists of 13 items. The patient will have to indicate how much he has thoughts or emotions when he feels pain by giving a score between 0 and 4, 0: not at all, 4: all the time. The final score is the sum of the scores for each question. Higher value represent worse outcome.
Time frame: at day 1
Assessment of socio-professional category, precariousness and health inequalities (Score EPICES).
The EPICES questionnaire consists of 11 binary questions (yes / no) to calculate an individual score indicating the precariousness and inequalities of health ranging from 0 to 100. Higher value represent worse outcome.
Time frame: at day 1
Measure of the electrochemical conductance (µS) using Sudoscan®
Assess the reproducibility (2 passes) of Sudoscan® in each participant: measurement of the electrochemical conductance of the palms of the hands (middle right and left hands) and feet (middle right and left) in μS using the Sudoscan®, 30 minutes after the first measurement.
Time frame: at day 1
Started Nov 2017 (actual). Primary completion is estimated for Apr 2018, 5 months after the start.
Of 437 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 5 months is below that.
Counting every sponsor, half of 450 studies reached it within 15 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand →