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Sudoscan in Patients With Autoimmune Disorders

Investigation of Sudoscan in the Evaluation of Small Fiber Dysfunction in Korean Patients With Autoimmune Disorders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02434458
Enrollment
85
Registered
2015-05-05
Start date
2015-05-31
Completion date
2015-09-30
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Disease

Keywords

fibromyalgia,, polyneuropathy, small fiber neuropathy, rheumatoid arthritis, sudomotor

Brief 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).

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.

Interventions

None listed

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

A. for healthy control group \- No previous diagnosis of peripheral polyneuropathy, fibromyalgia or rheumatoid arthritis B. For case group * Fibromyalgia diagnosed by the rheumatology department * Rheumatoid arthritis diagnosed by the the rheumatology department.

Exclusion criteria

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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Sudoscan valuesonce at time of enrollmentSmall fiber function from sweat glands, using Sudoscan

Secondary

MeasureTime frameDescription
NCS studiesonce at time of enrollmentNCS values of the upper and lower extremity sensory nerves performed by an electromyographer

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026