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

NCT ID: NCT06249503

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-09-01

Brief Summary

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

Detailed Description

1. 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)

2. 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 anesthesia) and dextrose.

Conditions

Carpal Tunnel Syndrome; Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Activated PRP

PRP is activated by adding 200μl of 0.025 calcium chloride and used in hydrodissection.

Group Type: ACTIVE_COMPARATOR

platelet rich plasma

Intervention Type: DRUG

The patients hand will be facing upwards and slightly extended, the Median nerve will be identified at the inlet of the carpal tunnel. Ultrasound guided injection will be done with the use of the ulnar in-plane technique. with a 25-gage needle will be introduced from the ulnar side of the wrist between carpal tunnel and median nerve.

Non-Activated PRP

PRP is used directly in hydrodissection.

Group Type: ACTIVE_COMPARATOR

platelet rich plasma

Intervention Type: DRUG

The patients hand will be facing upwards and slightly extended, the Median nerve will be identified at the inlet of the carpal tunnel. Ultrasound guided injection will be done with the use of the ulnar in-plane technique. with a 25-gage needle will be introduced from the ulnar side of the wrist between carpal tunnel and median nerve.

Steroid group

Hydro dissection using a combination of steroid (Triamcinolone 40mg), local anesthetics and dextrose.

Group Type: ACTIVE_COMPARATOR

platelet rich plasma

Intervention Type: DRUG

The patients hand will be facing upwards and slightly extended, the Median nerve will be identified at the inlet of the carpal tunnel. Ultrasound guided injection will be done with the use of the ulnar in-plane technique. with a 25-gage needle will be introduced from the ulnar side of the wrist between carpal tunnel and median nerve.

Interventions

platelet rich plasma

The patients hand will be facing upwards and slightly extended, the Median nerve will be identified at the inlet of the carpal tunnel. Ultrasound guided injection will be done with the use of the ulnar in-plane technique. with a 25-gage needle will be introduced from the ulnar side of the wrist between carpal tunnel and median nerve.

Intervention Type: DRUG

Other Intervention Names

PRP; steroids

Eligibility Criteria

Inclusion Criteria

• Patients with mild to moderate idiopathic Carpal 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona S Kamel

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU MD 154 2022

Identifier Type: -

Identifier Source: org_study_id