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

NCT06368505 | Recruiting

• 1 other identifier: R.24.02.2506.R1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel; ultrasound guided intervention

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The cross-sectional area (CSA) of the Median nerve

  before the intervention and 3 months after intervention

Study Arms (2)

Platelet rich plasma

EXPERIMENTAL

3 ml PRP injection

Other: ultrasound guided PRP injection

hydrodissection

EXPERIMENTAL

5ml injectate

Other: ultrasound guided hydrodissection

Interventions

ultrasound guided PRP injection 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

Platelet rich plasma

ultrasound guided hydrodissection 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

hydrodissection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osama Ahmed Elshafei: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35511, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

osama elshafei, MD, PHD

CONTACT

+201211182182; osama_elshafei@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of neurology

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 16, 2024
• Study Start: January 16, 2024
• Primary Completion: June 16, 2024
• Study Completion: July 16, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

EG (1)