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

Carpal Tunnel Syndrome Clinical Trial

— PRP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249503
• Other study ID #: FMASU MD 154 2022
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: Mona S kamel, MS
• Phone: 01005404022
• Email: mona.sa.kamel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cross sectional area	change of cross sectional area of median nerve when measuring cross sectional area in millimeter by ultrasound	3 months
Other	Nerve conduction study for median nerve	distal Latency in milliseconds of motor and sensory fibers of median nerve	3 months
Primary	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	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