Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06368505
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome
Sponsor:
Osama Ahmed Elshafei
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: