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

NCT06249503 | Completed Phase 4 DMC

• 1 other identifier: FMASU MD 154 2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

PRP, CTS

Outcome Measures

Primary Outcomes (1)

• Pain visual analogue scale

  Ruler with number on it and the scale by measuring the distance in millimeter from 0 to 10 where is 0 means no pain and 10 means sever disabling pain and in between the different degrees of pain

  2 weeks,1,3 and 6 months

Secondary Outcomes (1)

• Boston Carpal Tunnel Syndrome Questionnaire

  2 weeks, 1,3 and 6 months

Other Outcomes (2)

• cross sectional area

  3 months

• Nerve conduction study for median nerve

  3 months

Study Arms (3)

Activated PRP

ACTIVE COMPARATOR

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

Drug: platelet rich plasma

Non-Activated PRP

ACTIVE COMPARATOR

PRP is used directly in hydrodissection.

Drug: platelet rich plasma

Steroid group

ACTIVE COMPARATOR

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

Drug: platelet rich plasma

Interventions

platelet rich plasma 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.

Also known as: PRP, steroids

Activated PRP; Non-Activated PRP; Steroid group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11566, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Steroids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mona S Kamel

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: February 8, 2024
• Study Start: February 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 16, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)