The Effect of Local Corticosteroid Injection on Electrophysiological and Ultrasonographic Findings in Carpal Tunnel Syndrome Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1)
Patients with mild-to-moderate carpal tunnel syndrome diagnosed by electrophysiological findings who also have a diagnosis of type 2 diabetes mellitus.
Treatment consists of an injection containing 1 mL of 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride.
干预措施: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride (Drug)
Idiopathic Carpal Tunnel Syndrome Group (Group 2)
Patients with mild-to-moderate idiopathic carpal tunnel syndrome diagnosed by electrophysiological findings, without a diagnosis of diabetes mellitus. Treatment consists of an injection containing 1 mL of 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride.
干预措施: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: before treatment, 4 weeks after treatment, 12 weeks after treatment
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Higher scores correspond to greater pain severity.
Tinel Sign
时间窗: before treatment, 4 weeks after treatment, 12 weeks after treatment
The Tinel sign will be conducted by a physician by percussing over the median nerve at the wrist. A positive sign is identified by the occurrence of tingling or "pins and needles" sensations in the palm, thumb, index finger, or middle finger. Findings will be documented as positive or negative.
Phalen Test
时间窗: before treatment, 4 weeks after treatment, 12 weeks after treatment
The Phalen test will be performed by a physician to assess median nerve compression. A positive test is defined as the reproduction of pain or paresthesia in the palmar region, thumb, index finger, or middle finger during sustained wrist flexion. Test results will be recorded as positive or negative.
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
时间窗: before treatment, 4 weeks after treatment, 12 weeks after treatment
The Boston Carpal Tunnel Syndrome Questionnaire is a patient-reported outcome measure with two subscales: the Symptom Severity Scale and the Functional Status Scale. The Symptom Severity Scale includes 11 items assessing symptoms such as pain, paresthesia, numbness, weakness, nocturnal complaints, and difficulty grasping objects. The Functional Status Scale consists of 8 items evaluating hand-related functional abilities, including writing, buttoning clothes, holding a book while reading, gripping a telephone, opening jars, performing household activities, carrying shopping bags, and personal care tasks. Each item is scored on a 5-point Likert scale from 1 (no symptoms or no difficulty) to 5 (very severe symptoms or inability to perform the activity). Mean scores are calculated separately for each subscale, ranging from 1 to 5, with higher scores indicating greater symptom severity or poorer hand function. The validated Turkish version of the questionnaire was used.
Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
时间窗: before treatment, 4 weeks after treatment, 12 weeks after treatment
The Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) is a self-reported questionnaire used to evaluate neuropathic pain. Total scores range from 0 to 24, with higher scores indicating greater neuropathic pain severity. A score of 12 or higher is considered indicative of neuropathic pain. The validated Turkish version of the questionnaire will be used in this study
Hand Grip Strength
时间窗: before treatment, 4 weeks after treatment, 12 weeks after treatment
Hand grip strength will be measured using a hand-held dynamometer . Three measurements will be obtained, and the mean value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.
Pinch Strength
时间窗: before treatment, 4 weeks after treatment, 12 weeks after treatment
Pinch strength will be assessed using a pinchmeter , including tip pinch, lateral pinch, and palmar pinch. Each measurement will be repeated three times, and the average value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.
次要结局
- Median Nerve Sensory Distal Latency(before treatment, 12 weeks after treatment)
- Median Nerve Cross-Sectional Area (MNCSA)(before treatment, 4 weeks after treatment, 12 weeks after treatment)
- Median Sensory Nerve Action Potential Amplitude(before treatment, 12 weeks after treatment)
- Median Nerve Sensory Conduction Velocity(before treatment, 12 weeks after treatment)
- Median Nerve Motor Distal Latency(before treatment, 12 weeks after treatment)
- Median Nerve Compound Muscle Action Potential Amplitude(before treatment, 12 weeks after treatment)
- Median Nerve Motor Conduction Velocity(before treatment, 12 weeks after treatment)
研究者
Talha Çelik
Medical Doctor
Haydarpasa Numune Training and Research Hospital