Carpal Tunnel Syndrome Treatment: Surgery Vs. Injections

NCT06852131 | Completed

• 1 other identifier: İ02-82-22
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Outcome Measures

Primary Outcomes (4)

• Electrophysiological studies

  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

  1-3-6 months

• ultrasonography

  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.

  1-3-6 months

• Boston carpal tunnel Questionnaire

  1-3-6 months

• Visual Analog Scale

  1-3-6 months

Study Arms (3)

surgery group

ACTIVE COMPARATOR

Procedure: open carpal tunnel surgery

steroid injection group

ACTIVE COMPARATOR

Procedure: Steroid Injection

prp injection group

ACTIVE COMPARATOR

Procedure: PRP injection

Interventions

open carpal tunnel surgery PROCEDURE

open carpal tunnel surgery

surgery group

Steroid Injection PROCEDURE

triamsinolon injection

steroid injection group

PRP injection PROCEDURE

PRP injection

prp injection group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Steroids

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ankara university

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 28, 2025
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 28, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)