Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients

August 22, 2023 updated by: Burak Tayyip Dede

Ultrasound Evaluation of the Median Nerve in Patients With Rheumatoid Arthritis and Its Relationship With Disease Activity

In rheumatoid arthritis (RA) patients, the diagnosis of Carpal tunnel syndrome (CTS) was made based on clinical findings and physical examinations. Then, the cross-sectional areas of the participants' median nerves from different levels were measured. Meidolateral and anteroposterior diameter were measured at the level of the carpal tunnel inlet. Flattening ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated. The obtained data were compared between RA with CTS, RA without CTS and healthy control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

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
      • Istanbul, Turkey
        • Istanbul Training and Resarch Hospital

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria healthy controls (HC) with no history of rheumatic diseases and CTS.

Description

Inclusion Criteria:

  • RA patients identified according to the 2010 American College of Rheumatology/Europan Leage Against Rheumatism classification criteria
  • healthy controls (HC) with no history of rheumatic diseases and CTS.
  • Individuals aged 18-65 years.

Exclusion Criteria:

  • thoese with hypothyroidism,
  • gout,
  • diabetes mellitus,
  • history of CTS surgery,
  • upper extremity plexopathy,
  • polinöropathy,
  • uncontrollable fibromyalgia,
  • steroid injection for CTS
  • For the HC group, those with phalen or tinnel detected in at least one wrist and those with bifid median nerve detected during US evaluation were not included in the study.

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
Intervention / Treatment
group 1: RA without CTS
Rheumatoid arthritis patients without a diagnosis of CTS based on clinical findings and physical examination
Diagnostic test: Ultarsound
Median nerve evaluation of participants with ultrasound
group 2: RA with CTS
Rheumatoid arthritis patients with a diagnosis of CTS based on clinical findings and physical examination
Diagnostic test: Ultarsound
Median nerve evaluation of participants with ultrasound
group:3 Healthy Control
Healthy Control without rheumatologic disease and Carpal tunnel syndrome
Diagnostic test: Ultarsound
Median nerve evaluation of participants with ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of US findings among participants
Time Frame: 6 months
Comparison of US findings among participants
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between US findings and disease activity in the patient group
Time Frame: 6 months
The correlation between the US findings of the participants in the patient group and the CDA, which evaluates disease activity, was examined.
6 months

Collaborators and Investigators

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

Sponsor

Burak Tayyip Dede

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)

January 15, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/04/2022; 2011-KAEK-50;126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

Clinical Trials on Median Nerve Entrapment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe