FibromyalgiaNEFINCT03347669
A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan®
A study testing Sudoscan® in people with Fibromyalgia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. 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?
- Sudoscan®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2017to Sep 2018
- 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
Who may be able to join
- - Patient over 18 years of age and under 65 years of age,
- Male or female patient,
- Patient with fibromyalgia (according to the ACR criteria of 2016),
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance of written consent,
- Affiliation to the French Social Security system.
Show all 13Show fewer
- Subject of more than 18 years,
- Woman or man,
- Healthy voluntary non-painful subjects matched by age (+/- 5 years), by sex, by BMI (+/- 10%) 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.
Who cannot join
- Patient with a physical inability to place the palms of the hands or the soles of the feet on the electrodes of Sudoscan®,
- Patient with a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test (in particular a disease known to give neuropathies of small fibers: diabetes, Gougerot-Sjögren's disease, vasculitis, sarcoidosis, chronic ethylism ...),
- Pregnant or nursing woman
- Patient participating in another clinical trial, or in a period of exclusion, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
- Patient benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
- Patient not affiliated to the French Social Security system.
Show all 13Show fewer
- Physical inability to place the palms of the hands or the soles of the feet on the electrodes of Sudoscan®.
- Medical and / or surgical history judged by the investigator or his representative to be incompatible with the test,
- 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,
- Cooperation and an understanding that does not permit strict compliance with the conditions laid down in the Protocol,
- Benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
- Not affiliated to the French Social Security system.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Gisèle PICKERING
About this study
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.
Read the detailed description
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
- Conditions
- Fibromyalgia
- Being tested
- Sudoscan®
- Keywords
- Fibromyalgia, Small fiber neuropathy, Sudoscan®
- Medical subject headings
- Fibromyalgia, Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudoscan®Device
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.
| Study group | Role | What they receive |
|---|---|---|
| FM patients | Experimental | 50 fibromyalgia patients/50 healthy subjects Receives: Device: Sudoscan® |
| Healthy subjects | Active comparator | 50 fibromyalgia patients/50 healthy subjects Receives: Device: Sudoscan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®.
Measured: at day 1
Secondary outcomes (15)
Biometric criteria
Collection of the age in years
Measured: at day 1
Biometric criteria
Collection of sex, (male or female)
Measured: at day 1
Biometric criteria
Collection weight in kilograms, height in meters, weight and eight will be combined to report BMI in kg/m²,
Measured: at day 1
Biometric criteria
phototype Fitzpatrick classification
Measured: 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.
Measured: at day 1
Brief Pain Inventory
The BPI gives two main scores: a pain severity score and a pain interference score
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start6 Nov 2017
- Primary completionApr 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347669
- Sponsor's protocol ID
- CHU-362
- Acronym
- NEFI
- Status last verified
- Dec 2017
- First submitted
- 8 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perrot S, Choy E, Petersel D, Ginovker A, Kramer E. Survey of physician experiences and perceptions about the diagnosis and treatment of fibromyalgia. BMC Health Serv Res. 2012 Oct 10;12:356. doi: 10.1186/1472-6963-12-356.
PubMed 23051101Tagami J, Tao L, Pashley DH. Correlation among dentin depth, permeability, and bond strength of adhesive resins. Dent Mater. 1990 Jan;6(1):45-50. doi: 10.1016/0109-5641(90)90044-f.
PubMed 2198182Aktas A, Walsh D, Rybicki L. Symptom clusters: myth or reality? Palliat Med. 2010 Jun;24(4):373-85. doi: 10.1177/0269216310367842.
PubMed 20507866Flor H, Turk DC. Psychophysiology of chronic pain: do chronic pain patients exhibit symptom-specific psychophysiological responses? Psychol Bull. 1989 Mar;105(2):215-59. doi: 10.1037/0033-2909.105.2.215.
PubMed 2648442Giesecke T, Williams DA, Harris RE, Cupps TR, Tian X, Tian TX, Gracely RH, Clauw DJ. Subgrouping of fibromyalgia patients on the basis of pressure-pain thresholds and psychological factors. Arthritis Rheum. 2003 Oct;48(10):2916-22. doi: 10.1002/art.11272.
PubMed 14558098Wilson HD, Robinson JP, Turk DC. Toward the identification of symptom patterns in people with fibromyalgia. Arthritis Rheum. 2009 Apr 15;61(4):527-34. doi: 10.1002/art.24163.
PubMed 19333980de Souza JB, Goffaux P, Julien N, Potvin S, Charest J, Marchand S. Fibromyalgia subgroups: profiling distinct subgroups using the Fibromyalgia Impact Questionnaire. A preliminary study. Rheumatol Int. 2009 Mar;29(5):509-15. doi: 10.1007/s00296-008-0722-5. Epub 2008 Sep 27.
PubMed 18820930Bergman S. Psychosocial aspects of chronic widespread pain and fibromyalgia. Disabil Rehabil. 2005 Jun 17;27(12):675-83. doi: 10.1080/09638280400009030.
PubMed 16012060Salaffi F, Mozzani F, Draghessi A, Atzeni F, Catellani R, Ciapetti A, Di Carlo M, Sarzi-Puttini P. Identifying the symptom and functional domains in patients with fibromyalgia: results of a cross-sectional Internet-based survey in Italy. J Pain Res. 2016 May 13;9:279-86. doi: 10.2147/JPR.S100829. eCollection 2016.
PubMed 27257392Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
PubMed 27377815Caro XJ, Winter EF. Evidence of abnormal epidermal nerve fiber density in fibromyalgia: clinical and immunologic implications. Arthritis Rheumatol. 2014 Jul;66(7):1945-54. doi: 10.1002/art.38662.
PubMed 24719395Doppler K, Rittner HL, Deckart M, Sommer C. Reduced dermal nerve fiber diameter in skin biopsies of patients with fibromyalgia. Pain. 2015 Nov;156(11):2319-2325. doi: 10.1097/j.pain.0000000000000285.
PubMed 26164586Oaklander AL, Herzog ZD, Downs HM, Klein MM. Objective evidence that small-fiber polyneuropathy underlies some illnesses currently labeled as fibromyalgia. Pain. 2013 Nov;154(11):2310-2316. doi: 10.1016/j.pain.2013.06.001. Epub 2013 Jun 5.
PubMed 23748113Uceyler N, Zeller D, Kahn AK, Kewenig S, Kittel-Schneider S, Schmid A, Casanova-Molla J, Reiners K, Sommer C. Small fibre pathology in patients with fibromyalgia syndrome. Brain. 2013 Jun;136(Pt 6):1857-67. doi: 10.1093/brain/awt053. Epub 2013 Mar 9.
PubMed 23474848Ramirez M, Martinez-Martinez LA, Hernandez-Quintela E, Velazco-Casapia J, Vargas A, Martinez-Lavin M. Small fiber neuropathy in women with fibromyalgia. An in vivo assessment using corneal confocal bio-microscopy. Semin Arthritis Rheum. 2015 Oct;45(2):214-9. doi: 10.1016/j.semarthrit.2015.03.003. Epub 2015 Mar 19.
PubMed 26094164
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Small Fiber Neuropathy Prevalence in Fibromyalgia Patients Compared to Healthy Subjects Using Sudoscan®
- ClinicalTrials.gov ID
- NCT03347669
- Acronym / sponsor ID
- NEFI / CHU-362
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Small fiber neuropathy, Sudoscan®
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 20 Nov 2017 (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 (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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FM patients | Experimental | Device: Sudoscan®50 fibromyalgia patients/50 healthy subjects |
| Healthy subjects | Active comparator | Device: Sudoscan®50 fibromyalgia patients/50 healthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- - Patient over 18 years of age and under 65 years of age,
- Male or female patient,
- Patient with fibromyalgia (according to the ACR criteria of 2016),
- Cooperation and understanding sufficient to comply with the requirements of the study,
- Acceptance of written consent,
Key exclusion criteria (13 listed)
- Patient with a physical inability to place the palms of the hands or the soles of the feet on the electrodes of Sudoscan®,
- Patient with a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test (in particular a disease known to give neuropathies of small fibers: diabetes, Gougerot-Sjögren's disease, vasculitis, sarcoidosis, chronic ethylism ...),
- Pregnant or nursing woman
- Patient participating in another clinical trial, or in a period of exclusion, or having received a total amount of compensation in excess of EUR 4500 over the 12 months preceding the start of the trial,
- Patient benefiting from a measure of legal protection (curatorship, guardianship, safeguard of justice ...),
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 |
|---|---|---|
| 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. | Device | FM patients, Healthy subjects |
Primary outcome
Measure of the electrochemical conductance (µS) using Sudoscan®
Time frame: at day 1
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®.
15 secondary outcomes
Biometric criteria
Time frame: at day 1
Biometric criteria
Time frame: at day 1
Biometric criteria
Time frame: at day 1
Biometric criteria
Time frame: at day 1
Numerical scale
Time frame: at day 1
Brief Pain Inventory
Time frame: at day 1
Fibromyalgia Impact Questionnaire
Time frame: at day 1
Quality of life (SF-12)
Time frame: at day 1
Anxiety and Depression (HAD)
Time frame: at day 1
Depression (Beck Depression Inventory)
Time frame: at day 1
Pittsburgh Sleep Quality Index
Time frame: at day 1
Chronic fatigue Severity Scale
Time frame: at day 1
Pain Catastrophizing Scale
Time frame: at day 1
Assessment of socio-professional category, precariousness and health inequalities (Score EPICES).
Time frame: at day 1
Measure of the electrochemical conductance (µS) using Sudoscan®
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Background: PubMed 23051101Perrot S, Choy E, Petersel D, Ginovker A, Kramer E. Survey of physician experiences and perceptions about the diagnosis and treatment of fibromyalgia. BMC Health Serv Res. 2012 Oct 10;12:356. doi: 10.1186/1472-6963-12-356.
- Background: PubMed 2198182Tagami J, Tao L, Pashley DH. Correlation among dentin depth, permeability, and bond strength of adhesive resins. Dent Mater. 1990 Jan;6(1):45-50. doi: 10.1016/0109-5641(90)90044-f.
- Background: PubMed 20507866Aktas A, Walsh D, Rybicki L. Symptom clusters: myth or reality? Palliat Med. 2010 Jun;24(4):373-85. doi: 10.1177/0269216310367842.
- Background: PubMed 2648442Flor H, Turk DC. Psychophysiology of chronic pain: do chronic pain patients exhibit symptom-specific psychophysiological responses? Psychol Bull. 1989 Mar;105(2):215-59. doi: 10.1037/0033-2909.105.2.215.
- Background: PubMed 14558098Giesecke T, Williams DA, Harris RE, Cupps TR, Tian X, Tian TX, Gracely RH, Clauw DJ. Subgrouping of fibromyalgia patients on the basis of pressure-pain thresholds and psychological factors. Arthritis Rheum. 2003 Oct;48(10):2916-22. doi: 10.1002/art.11272.
- Background: PubMed 19333980Wilson HD, Robinson JP, Turk DC. Toward the identification of symptom patterns in people with fibromyalgia. Arthritis Rheum. 2009 Apr 15;61(4):527-34. doi: 10.1002/art.24163.
- Background: PubMed 18820930de Souza JB, Goffaux P, Julien N, Potvin S, Charest J, Marchand S. Fibromyalgia subgroups: profiling distinct subgroups using the Fibromyalgia Impact Questionnaire. A preliminary study. Rheumatol Int. 2009 Mar;29(5):509-15. doi: 10.1007/s00296-008-0722-5. Epub 2008 Sep 27.
- Background: PubMed 16012060Bergman S. Psychosocial aspects of chronic widespread pain and fibromyalgia. Disabil Rehabil. 2005 Jun 17;27(12):675-83. doi: 10.1080/09638280400009030.
- Background: PubMed 27257392Salaffi F, Mozzani F, Draghessi A, Atzeni F, Catellani R, Ciapetti A, Di Carlo M, Sarzi-Puttini P. Identifying the symptom and functional domains in patients with fibromyalgia: results of a cross-sectional Internet-based survey in Italy. J Pain Res. 2016 May 13;9:279-86. doi: 10.2147/JPR.S100829. eCollection 2016.
- Background: PubMed 27377815Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.
- Background: PubMed 24719395Caro XJ, Winter EF. Evidence of abnormal epidermal nerve fiber density in fibromyalgia: clinical and immunologic implications. Arthritis Rheumatol. 2014 Jul;66(7):1945-54. doi: 10.1002/art.38662.
- Background: PubMed 26164586Doppler K, Rittner HL, Deckart M, Sommer C. Reduced dermal nerve fiber diameter in skin biopsies of patients with fibromyalgia. Pain. 2015 Nov;156(11):2319-2325. doi: 10.1097/j.pain.0000000000000285.
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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 Sudoscan® 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?
The sponsor lists 13 inclusion and 13 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 5 Dec 2017. 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. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the electrochemical conductance (µS) using Sudoscan® (time frame: at 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 NCT03347669, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.