Ultrasound Guided Activated and Non Activated Platelet Rich Plasma Injection Versus Hydro Dissection by Steroids.
- Conditions
- Compare Steroids Versus PRP in Dissection of Median Nerve by UltrasoundCarpal Tunnel Syndrome
- Interventions
- Drug: platelet rich plasma
- Registration Number
- NCT06249503
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
-
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)
-
• 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Activated PRP platelet rich plasma PRP is activated by adding 200μl of 0.025 calcium chloride and used in hydrodissection. Non-Activated PRP platelet rich plasma PRP is used directly in hydrodissection. Steroid group platelet rich plasma Hydro dissection using a combination of steroid (Triamcinolone 40mg), local anesthetics and dextrose.
- Primary Outcome Measures
Name Time Method Pain visual analogue scale 2 weeks,1,3 and 6 months 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
- Secondary Outcome Measures
Name Time Method Boston Carpal Tunnel Syndrome Questionnaire 2 weeks, 1,3 and 6 months 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
Trial Locations
- Locations (1)
Ain Shams University Hospitals
🇪🇬Cairo, Egypt