NCT06730724

Brief Summary

This study will include 20 patients aged 18-75 years who have been diagnosed with carpal tunnel syndrome (CTS) based on electrophysiological examinations performed within the last three months, as well as 20 healthy volunteers without a CTS diagnosis. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. Pinch grip strength will be evaluated using a Jamar pinch meter, and hand grip strength will be assessed using a Jamar dynamometer. Ultrasound will be used to measure the cross-sectional area and thickness of the thenar muscles as well as the cross-sectional area of the median nerve. Additionally, previous electrophysiological examination results will be recorded for the CTS patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 9, 2024

Last Update Submit

December 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thenar Muscle Cross-Sectional Area (Ultrasound)

    Measurement of the cross-sectional area of the thenar muscles using ultrasound to determine muscle atrophy or changes associated with carpal tunnel syndrome.

    0 day

Secondary Outcomes (4)

  • Thenar Muscle Thickness (Ultrasound)

    0 day

  • Median Nerve Cross-Sectional Area (Ultrasound)

    0 day

  • Pinch Grip Strength

    0 day

  • Hand Grip Strength

    0 day

Study Arms (2)

Carpal tunnel syndrome

Patients with carpal tunnel syndrome

Other: No intervention

Control group

Healthy controls without carpal tunnel syndrome

Other: No intervention

Interventions

No intervention

Carpal tunnel syndromeControl group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Carpal tunnel syndrome and healthy controls

You may qualify if:

  • Patients aged 18-75 years.
  • Diagnosed with carpal tunnel syndrome based on electrophysiological examination within the last 3 months.
  • Healthy volunteers without a diagnosis of carpal tunnel syndrome.
  • Volunteered to participate in the study.

You may not qualify if:

  • Refusal to participate in the study.
  • History of surgery due to carpal tunnel syndrome.
  • Presence of neuromuscular diseases.
  • Presence of advanced osteoarthritis.
  • Presence of psychiatric disorders.
  • Presence of cognitive impairments that may hinder study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Büşra Şirin Ahısha

    Beylikdüzü State Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Büşra Şirin Ahısha, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

December 10, 2024

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations