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Completed

NCT Number: NCT06852131

Carpal Tunnel Syndrome Treatment: Surgery Vs. Injections

This prospective randomized controlled study included 68 patients (aged 18-70) with mild to moderate carpal tunnel syndrome (CTS), randomized into three groups: surgical treatment (25 patients, 25 wrists), corticosteroid (CS) treatment (20 patients, 32 wrists), and platelet-rich plasma (PRP) treatment (23 patients, 35 wrists). Diagnosis was confirmed through clinical evaluation and electrodiagnostic (EDX) testing, with assessments including the Visual Analog Scale (VAS), Boston Carpal Tunnel Questionnaire (BCTQ), ultrasonographic median nerve cross-sectional area (CSA) and flattening ratio (FR), and sensory/motor conduction parameters. Treatments were ultrasound-guided CS (1 mL triamcinolone, 40 mg/mL) or PRP (1 mL extracted from centrifuged venous blood) injections, while surgical treatment involved standard open carpal tunnel release using the WALANT (Wide Awake Local Anesthesia No Tourniquet) technique. Follow-ups were conducted at 1, 3, and 6 months, and the study was ethically approved with informed patient consent.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

minimum of 3 months duration of symptoms and mild to moderate CTS

Exclusion criteria

  • 1) Patients with severe CTS diagnosed with EMG or the presence of thenar atrophy, 2) Polyneuropathy, 3) Previous injection therapy for CTS, 4) Previous CTS surgery, 5) Pregnancy or lactation.

Treatment and study plan

open carpal tunnel surgery

Procedure

open carpal tunnel surgery

Steroid injection

Procedure

triamsinolon injection

PRP injection

Procedure

PRP injection

Primary outcomes

  1. Electrophysiological studies

    Time frame: 1-3-6 months

    All EDX were performed using the Medtronic Key-Point EMG device (Denmark) by a neurology expert. Sensory and motor conduction studies of the median nerve and sensory conduction studies of the ulnar nerve were performed using standard techniques of supramaximal stimulation. Stimulation intensity was increased (3 mA for sensory or motor studies) each time until supramaximal stimulation was reached and maximal action potential was achieved. Sensory nerve conduction studies were performed with an antidromic method. Median nerve sensory nerve conduction velocity (SNCV) and sensory nerve action potential (SNAP) amplitude were calculated by recording from thumb and ulnar nerve from the 5th finger. Median nerve compound muscle action potential (CMAP) amplitude and distal motor latency (DML) were recorded from the abductor pollicis brevis Comparing with our clinical neurophysiology laboratory's normal values, the patients with only abnormal SNCVs (small or slow) with normal motor conduction we

  2. ultrasonography

    Time frame: 1-3-6 months

    In both measurements and injections, the patients were positioned as follows: shoulder in a neutral position, elbow at 90º flexion, forearm supinated, wrist in slight extension, and fingers in semi-flexion. For examination, a linear array probe portable US device (Clarius, L7 HD3 Linear Scanner) was used. Median nerve CSA was measured using the manual trace method in axial view in the proximal carpal tunnel (at the scaphoid-pisiform level), where the median nerve's largest enlargement was found. The mean of cross-sectional area (CSA) was calculated using three consecutive measurements (mm²) and recorded. Flattening ratio (FR) was calculated by dividing the transverse diameter of the nerve by its anteroposterior diameter.

  3. Boston carpal tunnel Questionnaire

    Time frame: 1-3-6 months

  4. Visual Analog Scale

    Time frame: 1-3-6 months

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Comparison of Surgical Treatment for Carpal Tunnel Syndrome with Corticosteroid Injection and Platelet-Rich Plasma Injection

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2025
Registry last updated
Feb 28, 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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