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

Ain Shams University

Status and phase: Completed; Phase 4

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

Treatments: Drug: platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT06249503

FMASU MD 154 2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Activated PRP

Active Comparator group

Description:

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

Treatment:

Drug: platelet rich plasma

Non-Activated PRP

Active Comparator group

Description:

PRP is used directly in hydrodissection.

Treatment:

Drug: platelet rich plasma

Steroid group

Active Comparator group

Description:

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

Treatment:

Drug: platelet rich plasma