Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome

NCT ID: NCT06368505

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2024-07-16

Brief Summary

The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:

• Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome
• Asses safety profile of both methods

Participants will:

• Randomized to one of the two arms
• Visit the clinic 1 and 3 months after intervention
• Assessed for efficacy and safety of the intervention

Detailed Description

The medical records of patients diagnosed with carpal tunnel syndrome will be reviewed using a computerized carpal tunnel syndrome sheet including all variables for each patient assessing the symptoms and the functional condition by assessing changes in the usual daily routines. The assessment of the patients was done before and after the intervention (1 and 3 months later).

The CSA is obtained (in mm² at distal wrist crease) using ultrasound. Then the CTS grading was determined via US staging 9-13, 13-15, >15 as mild, moderate and severe respectively.

Ultrasound-Guided Intracarpal Injection. High-resolution US examination will be done by using a GE Logiq E9 with ML6-15-D Matrix linear array probe (USA). Under sterile conditions, a 25-gauge needle will be used using ulnar approach and under real time visualization the needle will be guided to the superficial ulnar aspect of the median nerve. The patients will be randomized into two groups

PRP group:

whole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach

Hydrodissection group:

5ml will be injected to detach the median nerve from the TCL (2ml saline, 2ml dexamethasone and 1ml lidocaine), the injectate will be delivered via the in-plane ulnar approach, and the median nerve will be hydrodissected from its undersurface while advancing the needle among the superficial surface of the median nerve and the TCL.

All patients will be observed for 30-min post-injection for possible side effects before discharge.

Outcome Measurements: All outcome assessments will be measured at 1 and 3 months after intervention.

Primary Outcome Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and The visual analog scale (VAS) to assess the efficacy of interventions Secondary Outcome The cross-sectional area (CSA) of the Median nerve will be measured by the same US machine, Measurements were repeated 3 times and averaged for further

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet rich plasma

3 ml PRP injection

Group Type: EXPERIMENTAL

ultrasound guided PRP injection

Intervention Type: OTHER

whole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach

hydrodissection

5ml injectate

Group Type: EXPERIMENTAL

ultrasound guided hydrodissection

Intervention Type: OTHER

5ml will be injected to detach the median nerve from the TCL (2ml saline, 2ml dexamethasone and 1ml lidocaine), the injectate will be delivered via the in-plane ulnar approach, and the median nerve will be hydrodissected from its undersurface while advancing the needle among the superficial surface of the median nerve and the TCL

Interventions

ultrasound guided PRP injection

whole blood is initially collected in tubes that contain anticoagulants, such as citrate dextrose A to prevent platelet activation prior to its use. Then PRP is prepared by a differential centrifugation. Then 3ml of PRP will be delivered via the in-plane ulnar approach

Intervention Type: OTHER

ultrasound guided hydrodissection

5ml will be injected to detach the median nerve from the TCL (2ml saline, 2ml dexamethasone and 1ml lidocaine), the injectate will be delivered via the in-plane ulnar approach, and the median nerve will be hydrodissected from its undersurface while advancing the needle among the superficial surface of the median nerve and the TCL

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed clinically as carpal tunnel syndrome with at least 3 months of symptoms and confirmed electro-physiologically as carpal tunnel syndrome

Exclusion Criteria

• Onset of carpal tunnel syndrome during pregnancy
• Co-existence of brachial plexopathy or thoracic outlet syndrome by clinical examination
• Previous carpal tunnel decompressive surgery or corticosteroid injection in carpal tunnel
• Patients with infection or local edema at the site of injection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osama Ahmed Elshafei

OTHER

Sponsor Role: lead

Responsible Party

Osama Ahmed Elshafei

lecturer of neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mansoura University

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

osama elshafei, MD, PHD

Role: CONTACT

osama_elshafei@mans.edu.eg

+201211182182

Facility Contacts

osama elshafei, MD PHD

Role: primary

osama_elshafei@mans.edu.eg

Dena El-Ghzzawy

Role: backup

Profdr_os@yahoo.com

Other Identifiers

R.24.02.2506.R1

Identifier Type: -

Identifier Source: org_study_id