Carpal Tunnel Syndrome Evaluation With Ultrasound in Rheumatoid Arthritis Patients

Sponsor

Burak Tayyip Dede (Other)

Overall Status

Completed

CT.gov ID

NCT06012630

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Median Nerve Entrapment	Diagnostic Test: Ultarsound

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 15, 2023

Actual Primary Completion Date :

Jul 1, 2023

Actual Study Completion Date :

Aug 15, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Comparison of US findings among participants [6 months]
Comparison of US findings among participants

Secondary Outcome Measures

Relationship between US findings and disease activity in the patient group [6 months]
The correlation between the US findings of the participants in the patient group and the CDA, which evaluates disease activity, was examined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.