Carpal Tunnel Syndrome in Patients With Psoriatic Arthritis; Ultrasonography and Magnetic Resonance Imaging Findings

October 7, 2021 updated by: Ezgi AKYILDIZ TEZCAN, Selcuk University
This study aimed to investigate relationship between CTS diagnosis with electrodiagnostic studies and median nerve's cross-sectional area measered by US and MRI in PsA patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Carpal tunnel syndrome (CTS) is a type of entrapment neuropathy, caused by compression of the median nerve in the carpal tunnel at the wrist1. It accounts for about 90% of all entrapment neuropathies. But there is no gold standard technique for diagnosing CTS. Electrodiagnostic studies (EDS) are generally used in differential diagnosis because the symptoms may be difficult to interpret. Unfortunetely EDS has some limitations. The factors can limit EDS are that it is not comfortable for patients and physicians, may require interventional procedures, need patient cooperation, provide limited information on the etiology of CTS, time consuming, and can not be used in some patient groups such as patients with dermatological contraindications. Recent years, magnetic resonance imaging (MRI) and ultrasonography (US) have facilitated the diagnosis of CTS. The median nerve cross-sectional area (CSA) measured by US or MRI has been found to be associated with CTS. However, there are studies with conflicting results regarding the median nerve CSA in patients with rheumatic diseases. Psoriatic arthritis (PsA), a kind of rheumatic disease, occurs in up to 30% of people with psoriasis and can have serious debilitating effects on the peripheral joints, spine, tendon insertions, and fingers. To our knowlage, any study didn't assess MRI measurements of median nerve CSA in PsA patients. In this study we aimed to assess CTS's US and MRI findings in patients with PsA and compare them healty controls.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Selçuk University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 excluded from the study if they had history of conditions associated with an increased incidence of CTS except PsA (diabetes mellitus, pregnancy, hypothyroidism, renal failure or other severe systemic diseases); history or clinical/electrophyscologic finding of radiculopathy, plexopathy, polyneuropathy or any nervous system diseases; history of fractures, severe trauma or surgical interventions involving the wrist; bifid median nerve on wrist imaging and under the age of 18, over the age of 65. There was no history of rheumatic disease in the healthy volunteer group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
healthy volunteers
Diagnostic test: Ultrasonography, Magnetic resonance imaging
The cross-sectional area of the median nerve was measured with US and MRI.
Psoriatic arthritis patients
Diagnostic test: Ultrasonography, Magnetic resonance imaging
The cross-sectional area of the median nerve was measured with US and MRI.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The cross-sectional area of the median nerve measured by US and MRI
Time Frame: 12 months
The measurement will be made at the pisiform bone level and with the continuous trace method.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTSINPSAUSMRI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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