Autoimmune DiseaseNCT02434458
Sudoscan in Patients With Autoimmune Disorders
An observational study of Autoimmune Disease, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small fiber nerve function, specifically those of the sudomotor, in patients with autoimmune disorders (i.e fibromyalgia and rheumatoid arthritis). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Disease
- How many people
- 85 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2015to Sep 2015
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who meet the following diagnostic criteria for either 1. Fibromyalgia or 2. Rheumatoid arthritis
Who may be able to join
- for healthy control group
- No previous diagnosis of peripheral polyneuropathy, fibromyalgia or rheumatoid arthritis
- For case group
- Fibromyalgia diagnosed by the rheumatology department
- Rheumatoid arthritis diagnosed by the the rheumatology department.
Who cannot join
- For control group
- -Participants with previously diagnosed with medical conditions that are known to cause peripheral polyneuropathy (i.e. diabetes mellitus, chronic renal failure, hepatitis, malnutrition), or participants taking medications related to peripheral polyneuropathy(chemoagents, anti Tbc medication) or manifest with symptoms and signs of tingling sensation and gait disturbance that indicate presence of underlying peripheral polyneuropathy.
- For both control and case groups
- Severe skin deficits or swelling that may impede nerve conduction study
- Concomitant presence of mononeuropathy of the extremities.
- Past surgical or traumatic episodes of the foot and distal extremities subject to nerve conduction study
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- History of chronic alcoholism, of history of heavy alcohol ingestion with the last 24 hours prior o exam
- Pregnant status at time of evaluation
- presence of pacemaker of defibrillator
- physical inability to lay the palms of the hand and soles of the feet on the plate electrodes.
- scars on the palm and soles of the feet that may impair recording from the plate electrodes
- venous insufficiency, foot swelling or foot ulceration or infection
- Abnormal fasting glucose or Vit B12, thyroid dysfunction, Vit D and abnormal levels of lipid profile, HbA1c > 7
- Medications with anticholinergics, TCA, anti-histamine, anti-muscarinic medication within the last 48hours
- Patients currently taking Anti Parkinson agents, ranitidine, or other muscle relaxants, beta blockers and atropine
- Heavy alcohol ingestion within the last 24 hour
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Bucheon St Mary's Hospital, Catholic University of Korea
Bucheon-si, Gyenoggido, 420-717
Bucheon St Mary's Hospital
Bucheon-si
About this study
Official title: Investigation of Sudoscan in the Evaluation of Small Fiber Dysfunction in Korean Patients With Autoimmune Disorders
The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small fiber nerve function, specifically those of the sudomotor, in patients with autoimmune disorders (i.e fibromyalgia and rheumatoid arthritis).
Read the detailed description
Small fiber neuropathy can manifest in different autonomic and painful symptoms, but current diagnostic tools are confined to nerve conduction studies and quantitative sensory testing.
The former can only asses the large nerve fibers and fail to reflect sudomotor function, the latter tool can be subject to technical error. Pain and autonomic dysfunction, which reflect small fiber dysfunction has recently gained much interest in disorders with polyneuropathy but current studies have been confined mostly to diabetic polyneuropathies. There has been growing evidence that autoimmune disorders such as fibromyalgia can also manifest in small fiber dysfunction. Because of the complexity of diagnosing small fiber dysfunction, there are yet no standard protocols on how to assess and treat these patients. Sudoscan uses reverse iontophoresis to assess the function of the sweat glands. The tool is easy to use, non-invasive with quantitative results that are objective.
The objective of this study is to assess the small fiber function; that is the sudomotor function; using Sudoscan in patients diagnosed with fibromyalgia and rheumatoid arthritis.
- Conditions
- Autoimmune Disease
- Keywords
- fibromyalgia,, polyneuropathy, small fiber neuropathy, rheumatoid arthritis, sudomotor
- Medical subject headings
- Autoimmune Diseases, Fibromyalgia, Polyneuropathies, Small Fiber Neuropathy, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia case group | Patients diagnosed with fibromyalgia from the department of rheumatology will be subject to sudoscan evaluation and NCS studies. | |
| Control | Healthy control subjects | |
| Rheumatoid arthritis group | Patients diagnosed with rheumatoid arthritis at the department of rheumatology will be subject to sudoscan evaluation and NCS studies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudoscan values
Small fiber function from sweat glands, using Sudoscan
Measured: once at time of enrollment
Secondary outcomes (1)
NCS studies
NCS values of the upper and lower extremity sensory nerves performed by an electromyographer
Measured: once at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- Su-Jin Monn, M.D., PhD, Study director, Catholic University of Korea, College of Medicine Bucheon St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434458
- Sponsor's protocol ID
- HC15DISI0040
- Status last verified
- Sep 2015
- First submitted
- 27 Apr 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sudoscan in the Evaluation of Small Fiber Dysfunction in Korean Patients With Autoimmune Disorders
- ClinicalTrials.gov ID
- NCT02434458
- Acronym / sponsor ID
- HC15DISI0040
- Conditions
- Autoimmune Disease
- Keywords
- fibromyalgia,, polyneuropathy, small fiber neuropathy, rheumatoid arthritis, sudomotor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 May 2015 (estimated)
- 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.
The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small fiber nerve function, specifically those of the sudomotor, in patients with autoimmune disorders (i.e fibromyalgia and rheumatoid arthritis).
Detailed description
Small fiber neuropathy can manifest in different autonomic and painful symptoms, but current diagnostic tools are confined to nerve conduction studies and quantitative sensory testing.
The former can only asses the large nerve fibers and fail to reflect sudomotor function, the latter tool can be subject to technical error. Pain and autonomic dysfunction, which reflect small fiber dysfunction has recently gained much interest in disorders with polyneuropathy but current studies have been confined mostly to diabetic polyneuropathies. There has been growing evidence that autoimmune disorders such as fibromyalgia can also manifest in small fiber dysfunction. Because of the complexity of diagnosing small fiber dysfunction, there are yet no standard protocols on how to assess and treat these patients. Sudoscan uses reverse iontophoresis to assess the function of the sweat glands. The tool is easy to use, non-invasive with quantitative results that are objective.
The objective of this study is to assess the small fiber function; that is the sudomotor function; using Sudoscan in patients diagnosed with fibromyalgia and rheumatoid arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia case group | – | –Patients diagnosed with fibromyalgia from the department of rheumatology will be subject to sudoscan evaluation and NCS studies. |
| Control | – | –Healthy control subjects |
| Rheumatoid arthritis group | – | –Patients diagnosed with rheumatoid arthritis at the department of rheumatology will be subject to sudoscan evaluation and NCS studies. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who meet the following diagnostic criteria for either 1. Fibromyalgia or 2. Rheumatoid arthritis
Key inclusion criteria (5 listed)
- for healthy control group
- No previous diagnosis of peripheral polyneuropathy, fibromyalgia or rheumatoid arthritis
- For case group
- Fibromyalgia diagnosed by the rheumatology department
- Rheumatoid arthritis diagnosed by the the rheumatology department.
Key exclusion criteria (16 listed)
- For control group
- -Participants with previously diagnosed with medical conditions that are known to cause peripheral polyneuropathy (i.e. diabetes mellitus, chronic renal failure, hepatitis, malnutrition), or participants taking medications related to peripheral polyneuropathy(chemoagents, anti Tbc medication) or manifest with symptoms and signs of tingling sensation and gait disturbance that indicate presence of underlying peripheral polyneuropathy.
- For both control and case groups
- Severe skin deficits or swelling that may impede nerve conduction study
- Concomitant presence of mononeuropathy of the extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sudoscan values
Time frame: once at time of enrollment
Small fiber function from sweat glands, using Sudoscan
1 secondary outcome
NCS studies
Time frame: once at time of enrollment
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 15 Sep 2015.
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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.
Su-Jin Monn, M.D., PhD study director
Catholic University of Korea, College of Medicine Bucheon St. Mary's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Disease, run by The Catholic University of Korea at 2 sites in South Korea.
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 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
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?
Sudoscan values (time frame: once at time of enrollment). 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 15 Sep 2015.