Clinical trial NCT06249503: Ultrasound Guided Activated and Non Activated Platelet Rich Plasma Injection Versus Hydro Dissection by Steroids.
Official title: Ultrasound Guided Activated and Non-activated Platelet Rich Plasma Injection Versus Hydro Dissection for Treatment of Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound
Keywords: PRP, CTS
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain visual analogue scale
timeFrame: 2 weeks,1,3 and 6 months
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 2 weeks, 1,3 and 6 months
Other outcomes:
measure: cross sectional area
timeFrame: 3 months
measure: Nerve conduction study for median nerve
timeFrame: 3 months
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Ain Shams University
name: Mona S Kamel
role: PRINCIPAL_INVESTIGATOR
References: