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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05086029
Other study ID # CTSINPSASMI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2019
Est. completion date September 20, 2020

Study information

Verified date October 2021
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to investigate median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.


Description:

Carpal tunnel syndrome(CTS), a type of median nerve neuropathies, is the most common peripheral nerve entrapment syndrome. Most cases are idiopathic but CTS can be associated with rheumatologic disorders. There isn't any gold standard technique in diagnosis of CTS. Electrodiagnostic studies (EDS) are usually performed to confirm diagnose, to differentiate other diseases or to detect severity. But EDS have some disadvantages such as EDS are time consuming, uncomfortable, may require interventional procedures, can not directly assess the anatomy of the median nerve and its surrounding structures. For these reasons, the use of ultrasonography (US) in the diagnosis of carpal tunnel syndrome has been investigated for a long time. Most of them focused on the cross-sectional area(CSA) of median nerve. Fewer studies have investigated the vascularity of the median nerve. But there is conflict results because conventional Doppler techniques may fail to show small vessels or slow blood flow. Superb microvascular imaging (SMI) is a new ultrasound technology that can diferentiate blood flow signals from artifacts by using a new algorithm. In carpal tunnel syndrome hypervasularitation of median nerve has showed by SMI. To our best knowledge, there isn't any study assessing median nerve hypervascularity by using SMI in PsA. So we aimed to investigate median nerve hypervasculatitation in psoriatic arthritis (PsA) patients with CTS or without CTS by using SMI, then compare them with normal people.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date September 20, 2020
Est. primary completion date September 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - PsA patients according to the CASPAR criteria who consecutively applied to the FTR outpatient clinic for PsA follow-up and healthy volunteers who applied to the FTR outpatient clinic enrolled in the study. Exclusion Criteria: - Patients were not included in the study if they had a history of wrist or hand fracture, surgery, neurologic disorders such as radiculopathy, polyneuropathy or cerebrovas-cular disease, a history of conditions associated with an increased incidence of CTS such as diabetes mellitus, pregnancy, hypothyroidism or severe systemic diseases.

Study Design


Intervention

Diagnostic Test:
Superb Microvascular Imaging
Superb microvascular imaging (SMI) is a new ultrasound technology that can diferen-tiate blood flow signals from artifacts by using a new algorithm.

Locations

Country Name City State
Turkey Selcuk University Faculty of Medicine Konya

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The blood flow display ratio of SMI in the median nerve SMI signals will be graded from 0 to 3, in which 0 represented no signal, 1=one to two spot flow, 2= more than two spot flow or one to two strip blood flow (longer than 1 mm) and 3=more than two strip flow 18 months
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