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Completed

NCT Number: NCT06249503

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

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

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Key information

Conditions

Carpal Tunnel Syndrome Compare Steroids Versus PRP in Dissection of Median Nerve by Ultrasound Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11566, Egypt

About this study

  • 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)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet rich plasma

Drug

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

Primary outcomes

  1. Pain visual analogue scale

    Time frame: 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 outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire

    Time frame: 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

Other outcomes

  1. cross sectional area

    Time frame: 3 months

    change of cross sectional area of median nerve when measuring cross sectional area in millimeter by ultrasound

  2. Nerve conduction study for median nerve

    Time frame: 3 months

    distal Latency in milliseconds of motor and sensory fibers of median nerve

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: PRP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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