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

NCT06834061 | Recruiting

• 1 other identifier: KFSIRB200-513
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Ultrasonography; Diagnosis; Management; Follow-Up; Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome

  Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome will be recorded.

  Intraoperatively

Study Arms (1)

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

Interventions

Ultrasound PROCEDURE

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.

Ultrasound group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Disease; Carpal Tunnel Syndrome

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Ahmed A Zahra, MD

CONTACT

00201004642184; a86anas@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: February 19, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)