The Effect of Local Corticosteroid Injection in Carpal Tunnel Syndrome Patients With Type 2 Diabetes

Официальное название

The Effect of Local Corticosteroid Injection on Electrophysiological and Ultrasonographic Findings in Carpal Tunnel Syndrome Patients With Type 2 Diabetes

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride
  Both groups will receive an injection containing 1 mL of 40 mg \[40 mg/mL\] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride, administered using the 'ulnar in-plane' technique under ultrasound guidance.

Первичные конечные точки

• Visual Analog Scale (VAS) [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]
• Tinel Sign [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]
• Phalen Test [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]
• Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]
• Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]
• Hand Grip Strength [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]
• Pinch Strength [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]

Вторичные конечные точки (7)

• Median Nerve Cross-Sectional Area (MNCSA) [Срок оценки: before treatment, 4 weeks after treatment, 12 weeks after treatment]
• Median Nerve Sensory Distal Latency [Срок оценки: before treatment, 12 weeks after treatment]
• Median Sensory Nerve Action Potential Amplitude [Срок оценки: before treatment, 12 weeks after treatment]
• Median Nerve Sensory Conduction Velocity [Срок оценки: before treatment, 12 weeks after treatment]
• Median Nerve Motor Distal Latency [Срок оценки: before treatment, 12 weeks after treatment]
• Median Nerve Compound Muscle Action Potential Amplitude [Срок оценки: before treatment, 12 weeks after treatment]
• Median Nerve Motor Conduction Velocity [Срок оценки: before treatment, 12 weeks after treatment]

Критерии участия

Критерии включения

• Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1):

• Age between 18 and 75 years
• Presence of clinical symptoms compatible with carpal tunnel syndrome (e.g., pain, paresthesia, numbness) for at least 3 months
• Patients diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings
• Diagnosis of type 2 diabetes mellitus
• Regulated blood glucose levels, defined as hemoglobin A1c (HbA1c) < 7%
• Idiopathic Carpal Tunnel Syndrome Group (Group 2):

• Age between 18 and 75 years
• Presence of clinical symptoms consistent with carpal tunnel syndrome (e.g., pain, paresthesia, numbness) for at least 3 months
• Patients diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings
• No diagnosis of diabetes mellitus

Критерии исключения

• Severe carpal tunnel syndrome based on electrophysiological findings
• Presence of polyneuropathy, cervical radiculopathy, brachial plexopathy, or thoracic outlet syndrome
• Uncontrolled blood glucose levels in the diabetic group (hemoglobin A1c ≥ 7%)
• Presence of another systemic disease, other than diabetes mellitus, that may cause carpal tunnel syndrome
• Presence of a rheumatological disease
• History of wrist surgery
• Less than 6 months since a local corticosteroid injection for carpal tunnel syndrome
• Less than 3 months since completion of a physical therapy program for carpal tunnel syndrome
• Infection at the intended injection site
• Presence of malignancy
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Haydarpasa Numune Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07433257 · HNEAH-GOEK 2024/130

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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