NCT06012630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 17, 2023

Last Update Submit

August 22, 2023

Conditions

Keywords

Rheumatoid arthritisUltrasoundCarpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Comparison of US findings among participants

    Comparison of US findings among participants

    6 months

Secondary Outcomes (1)

  • Relationship between US findings and disease activity in the patient group

    6 months

Study Arms (3)

group 1: RA without CTS

Rheumatoid arthritis patients without a diagnosis of CTS based on clinical findings and physical examination

Diagnostic Test: Ultarsound

group 2: RA with CTS

Rheumatoid arthritis patients with a diagnosis of CTS based on clinical findings and physical examination

Diagnostic Test: Ultarsound

group:3 Healthy Control

Healthy Control without rheumatologic disease and Carpal tunnel syndrome

Diagnostic Test: Ultarsound

Interventions

UltarsoundDIAGNOSTIC_TEST

Median nerve evaluation of participants with ultrasound

group 1: RA without CTSgroup 2: RA with CTSgroup:3 Healthy Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Resarch Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Median NeuropathyArthritis, RheumatoidCarpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
8 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 25, 2023

Study Start

January 15, 2023

Primary Completion

July 1, 2023

Study Completion

August 15, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Locations