Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome

This study aims to assess the ultrasound (US) and nerve conduction studies (NCS) as a tool for diagnosis, treatment planning and follow-up of patients with carpal tunnel syndrome (CTS).

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Ultrasonography; Diagnosis; Follow-Up; Management
• Intervention / Treatment: Procedure: Ultrasound

Detailed Description

Carpal tunnel syndrome (CTS) is one of the most common upper extremity compression neuropathies and is caused by compression of the median nerve in the carpal tunnel at the wrist.

The ultrasound (US) is a follow-up option as a diagnostic tool in CTS. It is a readily available non-invasive tool which has a shorter examination time. It can measure a number of median nerve parameters, including size, vascularity (using power Doppler) and mobility (using dynamic imaging). In addition,the US provides information on anatomical variations of the median nerve and surrounding structures that may be a causative factor in CTS.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Ahmed A Zahra, MD; Phone Number: 00201004642184; Email: a86anas@gmail.com

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Recruiting
      • Kafrelsheikh University
      • Contact: Ahmed A Zahra, MD; Phone Number: 00201004642184; Email: a86anas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This retrospective study will be carried out on 60 patients with CTS admitted in KafrElsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of KafrElsheikh Faculty of Medicine and all the included patients will provide written informed consent.

Description

Inclusion Criteria:

• Age ≥18 years old.
• Both sexes.
• Patients with carpal tunnel syndrome.

Exclusion Criteria:

• History of wrist surgery (including carpal tunnel injection) or fracture.
• Clinical or electrophysiological evidence of an accompanying condition that mimics carpal tunnel syndrome or interferes with its evaluation, such as proximal median neuropathy, cervical radiculopathy or polyneuropathy.
• History of underlying disorders associated with carpal tunnel syndrome such as diabetes mellitus, rheumatoid arthritis, pregnancy, acromegaly or hypothyroidism.
• Electrodiagnostic findings suggestive of co-existing neurological disorders.
• Subclinical sensory polyneuropathy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound group; All patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery.	Procedure: Ultrasound; All patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome	Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome will be recorded.	Intraoperatively

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Disease; Carpal Tunnel Syndrome
• Other Study ID Numbers: KFSIRB200-513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No