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

Carpal Tunnel Syndrome Clinical Trial

Official title:

A Prospective Comparative Study on the Efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368505
• Other study ID #: R.24.02.2506.R1
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: July 16, 2024

Study information

• Verified date: April 2024
• Source: Mansoura University
• Contact: osama elshafei, MD, PHD
• Phone: +201211182182
• Email: osama_elshafei[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 16, 2024
• Est. primary completion date: June 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Osama Ahmed Elshafei

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)	Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a patient-based questionnaire, consists of two main scales: Symptom Severity Scale (SSS): Measures the severity of symptoms related to CTS. Functional Status Scale (FSS): Assesses functional limitations caused by CTS. Each scale contains several items, and patients rate their symptoms or functional difficulties on a scale from 1 to 5.; A score of 1 indicates no symptoms or functional difficulty. A score of 5 represents maximum symptoms or inability to perform the task1.; Interpretation: Higher scores on both scales indicate worse symptoms or greater functional impairment due to CTS.	before the intervention,1 and 3 months after intervention
Primary	The visual analog scale (VAS)	The Visual Analogue Scale (VAS) is a simple assessment tool used to measure pain intensity.; The VAS consists of a straight horizontal line, usually 10 centimetres (cm) in length.; One end of the line represents "no pain," while the other end represents "the worst pain ever experienced." Patients are asked to rate their current level of pain by placing a mark on the line.; Using a ruler, the score is determined by measuring the distance (in millimetres) from the "no pain" anchor to the patient's mark.; The resulting score ranges from 0 to 100, with a higher score indicating greater pain intensity.	before the intervention,1 and 3 months after intervention
Secondary	The cross-sectional area (CSA) of the Median nerve	Using the ultrasound, the CSA is obtained (in mm² at distal wrist crease) by utilizing the tracing function on the US machine by direct tracing around the inner margin of the epineurium but with no weaving in between each fascicle. Measurements were repeated three times and average value was used for statistical evaluation.	before the intervention and 3 months after intervention