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

April 12, 2024 updated by: Osama Ahmed Elshafei

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Mansoura, Egypt, 35511
        • Recruiting
        • Mansoura University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dena El-Ghzzawy, MD
        • Principal Investigator:
          • OSAMA ELSHAFEI, MD PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet rich plasma
3 ml PRP injection
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
Experimental: hydrodissection
5ml injectate
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time Frame: before the intervention,1 and 3 months after intervention

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
The visual analog scale (VAS)
Time Frame: before the intervention,1 and 3 months after intervention

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cross-sectional area (CSA) of the Median nerve
Time Frame: before the intervention and 3 months after intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osama Ahmed Elshafei

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

June 16, 2024

Study Completion (Estimated)

July 16, 2024

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.24.02.2506.R1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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