- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06852131
Carpal Tunnel Syndrome Treatment: Surgery Vs. Injections
February 26, 2025 updated by: Yusuf Kıratlıoğlu, Ankara University
Comparison of Surgical Treatment for Carpal Tunnel Syndrome with Corticosteroid Injection and Platelet-Rich Plasma Injection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey
- Ankara University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: surgery group
|
open carpal tunnel surgery
|
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Active Comparator: steroid injection group
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triamsinolon injection
|
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Active Comparator: prp injection group
|
PRP injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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1-3-6 months
|
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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.
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1-3-6 months
|
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Boston carpal tunnel Questionnaire
Time Frame: 1-3-6 months
|
1-3-6 months
|
|
|
Visual Analog Scale
Time Frame: 1-3-6 months
|
1-3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
February 18, 2025
First Submitted That Met QC Criteria
February 26, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- İ02-82-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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