Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-05 @ 10:26 PM
Study NCT ID:
NCT07433257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Local Corticosteroid Injection in Carpal Tunnel Syndrome Patients With Type 2 Diabetes
Sponsor:
Haydarpasa Numune Training and Research Hospital
Organization:
Study Overview
Official Title:
The Effect of Local Corticosteroid Injection on Electrophysiological and Ultrasonographic Findings in Carpal Tunnel Syndrome Patients With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our study was planned as a prospective observational study aiming to compare the post-intervention recovery process between patients with carpal tunnel syndrome (CTS) and diabetes mellitus and patients with idiopathic carpal tunnel syndrome without diabetes mellitus. Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and who were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological findings and who received corticosteroid + local anesthetic injection will be included in the study. Data from patients who meet the inclusion and exclusion criteria will be included in the study. Patients' demographic and clinical data will be recorded. Records will be taken before treatment and at 4 and 12 weeks after treatment.
Detailed Description:
Our study was planned as a prospective observational study aiming to compare the post-intervention recovery process between patients with carpal tunnel syndrome (CTS) and diabetes mellitus and patients with idiopathic carpal tunnel syndrome without diabetes mellitus. Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and were diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings, and who were indicated for interventional procedures and received corticosteroid + local anesthetic injections. Data from patients meeting the inclusion and exclusion criteria will be included in the study. Demographic and clinical data such as age, gender, height, weight, occupation, and dominant hand, as recorded in the patients' follow-up documents, will be recorded. In addition, the VAS (Visual Analog Scale), Tinel sign and Phalen test, Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), Median Nerve Cross-Sectional Area (MNCSA) measured by ultrasound, MNCSA measurement at the pisiform-scaphoid level, and electromyography (EMG)-nerve conduction study results will be noted. Patients will be divided into two groups: Group 1 (patients with Type 2 Diabetes Mellitus diagnosed with Carpal Tunnel Syndrome) and Group 2 (patients with Idiopathic Carpal Tunnel Syndrome). Details of the treatment administered before patients are included in the study will be as follows: Both groups will receive an injection containing corticosteroid + local anesthetic in the form of 1 milliliter (mL) of 40 milligrams (mg) \[40 mg/mL\] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride using the 'ulnar in-plane' technique guided by ultrasonography. All evaluation parameters (except electrophysiological evaluations) will be obtained from data recorded before treatment, at week 4 after treatment, and at week 12 after treatment. Electrophysiological parameters will be obtained from data recorded before treatment and at week 12 after treatment. Intra-group and inter-group differences will be statistically analyzed.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: