Sudoscan in Patients With Autoimmune Disorders

NCT02434458 | Completed DMC

• 1 other identifier: HC15DISI0040
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 2

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).

Conditions

Autoimmune Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sudoscan values

  Small fiber function from sweat glands, using Sudoscan

  once at time of enrollment

Secondary Outcomes (1)

• NCS studies

  once at time of enrollment

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who meet the following diagnostic criteria for either 1. Fibromyalgia or 2. Rheumatoid arthritis

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (2)

Bucheon St Mary's Hospital, Catholic University of Korea

Bucheon-si, Gyenoggido, 420-717, South Korea

Location

Bucheon St Mary's Hospital

Bucheon-si, South Korea

Location

MeSH Terms

Conditions

Autoimmune Diseases; Fibromyalgia; Polyneuropathies; Small Fiber Neuropathy; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Arthritis; Joint Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Su-Jin Monn, M.D., PhD

  Catholic University of Korea, College of Medicine Bucheon St. Mary's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 5, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

KR (2)