Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368505
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-07
Brief Title:
Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome
Sponsor:
Osama Ahmed Elshafei
Organization:
Mansoura University
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 gt15 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 gt15 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:
None
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?:
None