Ultrasound Guided Activated and Non Activated Platelet Rich Plasma Injection Versus Hydro Dissection by Steroids.

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Description

PRP represents a promising, nonsurgical option for patients with carpal tunnel syndrome (CTS) with improvement in symptoms compared to placebo, conservative treatment, and local corticosteroid injections at 3-months postintervention. However, the lack of significant long-term results in pain and function demands the presence of future studies to further determine the long-term effect on a large group of homogeneous patients. More over to determine the clinical indications, effect on differing CTS severities, and the effects of preparation, concentration of the platelets and methods of activation of PRP

Study Overview

Start Date
February 1, 2023
Completion Date
June 1, 2024
Enrollment
90
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Ain Shams University Hospitals
Cairo 11566, Egypt

Eligibility

Eligibility Criteria
Inclusion Criteria:

Patients with mild to moderate idiopathic Carapal Tunnel Syndrome with clinical manifestations, diagnosed by electrophysiological study and ultrasound. CTS grading will be performed on basis of an electrophysiological study following Stevens classification (Stevens; 1997).

Early CTS: abnormal findings only in both comparative studies (≥0.5ms difference in peak latency)
Mild CTS: abnormal median sensory study (peak latency ≥3.5ms)
Moderate CTS: abnormal median sensory study and prolonged median distal motor latency (onset latency ≥4.5ms)
Sever CTS: any of the above mentioned abnormalities together with the evidence of axonal loss either by absent median sensory response, low amplitude, or absent median motor response (<2µV)

Exclusion Criteria:

• Patients suffering from diabetes, hypothyroidism, rheumatoid arthritis, , cervical radiculopathy, polyneuropathy, brachial plexopathy, traumatic nerve injury, thoracic outlet syndrome, coagulopathy

Pregnancy
Previous corticosteroid injection into the carpal tunnel.
Previous carpal tunnel decompressive surgery.

Study Contact Info

Study Contact Name
Mona S kamel, MS; Eman M Abushady, MD
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
The patients are blinded to the type of drug and the researchers are blinded to the randomization. Randomization will be done using a research randomization program (http://www.randomizer.org)
Patients will be randomly divided into three groups; each consists of 30 patients. Group 1 will include patients subjected to ultrasound guided activated PRP injection, group 2 will include patients subjected to ultrasound guided non-activated PRP injection, and group 3 patients will be subjected to ultrasound guided hydro dissection using a combination of steroid (Triamcinolone 40mg), LA (local anasthesi) and dextrose.
NCTid (if applicable)
NCT06249503