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

Ultrasound Guided Activated and Non-activated Platelet Rich Plasma Injection Versus Hydro Dissection for Treatment of Carpal Tunnel Syndrome

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

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound
• Intervention / Treatment: Drug: platelet rich plasma

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mona S kamel, MS; Phone Number: 01005404022; Email: mona.sa.kamel@gmail.com
• Study Contact Backup: Name: Eman M Abushady, MD; Phone Number: 01114156464; Email: emanmones@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Recruiting
    • Ain Shams University Hospitals
    • Contact: R
    • Contact: Eman M Abushady, MD; Email: emymones@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Activated PRP; PRP is activated by adding 200μl of 0.025 calcium chloride and used in hydrodissection.	Drug: 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.; Other Names: PRP; steroids
Active Comparator: Non-Activated PRP; PRP is used directly in hydrodissection.	Drug: 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.; Other Names: PRP; steroids
Active Comparator: Steroid group; Hydro dissection using a combination of steroid (Triamcinolone 40mg), local anesthetics and dextrose.	Drug: 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.; Other Names: PRP; steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Syndrome Questionnaire	questionnaire formed of 11 questions each question give grading from 1 to 5 where is 1 means normal and 5 means sever pain and in between different grades	2 weeks, 1,3 and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
cross sectional area	change of cross sectional area of median nerve when measuring cross sectional area in millimeter by ultrasound	3 months
Nerve conduction study for median nerve	distal Latency in milliseconds of motor and sensory fibers of median nerve	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mona S Kamel, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: PRP, CTS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: FMASU MD 154 2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No