Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT02434458
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02434458
Study Brief:
Protocol Section:
NCT02434458