Hyaluronic Acid Injection in Idiopathic Carpal Tunnel Syndrome; is it Effective as Local Corticosteroids? A Comparative Follow up Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Scores
研究概览
简要总结
This study compares the effectiveness of two types of local injections-Hyaluronic Acid (HA) and corticosteroids-for treating mild to moderate idiopathic Carpal Tunnel Syndrome (CTS). Sixty adult patients will be assigned to receive one of the two injections under ultrasound guidance. The goal is to see if HA is as effective as the standard corticosteroid treatment in improving symptoms and nerve function over a 3-month follow-up period.
详细描述
This is a prospective comparative 3-month follow-up study. Sixty adult patients diagnosed with mild or moderate idiopathic CTS by electro-diagnostic studies will be recruited from the Rheumatology and rehabilitation clinic at Minia University Hospitals, Egypt. Participants will be divided into two groups of 30: one receiving low molecular weight hyaluronic acid and the other receiving corticosteroids, both administered via ultrasound-guided perineural injection. Baseline and follow-up assessments at 1- and 3-months post-injection will include the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) scores, electro-diagnostic parameters (sensory and motor latencies, CMAP, etc.), and neuromuscular ultrasound examination (median nerve cross-sectional area, flattening ratio, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Numbness or pain in the Median Nerve (MN) distribution.
- •Nerve conduction studies (NCS) consistent with CTS as per the AANEM guidelines.
- •An MN cross-sectional area (CSA) at the wrist >12 mm²
排除标准
- •Patients with severe symptoms (indication for surgery).
- •Patients who show improvement on medical treatment.
- •Patients with previous surgical or injectional CTS treatment.
- •Coexistence of brachial plexopathy, or thoracic outlet syndrome.
- •Patients with infection at the site of injection.
研究组 & 干预措施
Hyaluronic Acid Group
Arm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of low molecular weight Hyaluronic Acid.
干预措施: Low Molecular Weight Hyaluronic Acid (Drug)
Corticosteroid Group
Arm Description 30 adult patients with mild to moderate idiopathic CTS receiving ultrasound-guided perineural injection of corticosteroids.
干预措施: corticosteroid (Drug)
结局指标
主要结局
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Scores
时间窗: Baseline, 1 month, and 3 months post-injection
Comparison of the BCTQ scores (symptom severity and functional status) between the Hyaluronic Acid and Corticosteroid groups.
Change in Electro-diagnostic Parameters
时间窗: Time Frame Baseline, 1 month, and 3 months post-injection
Comparison of sensory and motor electrodiagnostic parameters between the two groups, including peak sensory latency (ms), sensory nerve action potential - SNAP (µV), sensory conduction velocity - SCV (m/s), distal motor latency (ms), compound muscle action potential - CMAP (mV), and motor conduction velocity - MCV (m/s).
Change in Neuromuscular Ultrasound Examination Parameters
时间窗: Baseline, 1 month, and 3 months post-injection
Comparison of neuromuscular ultrasound parameters between the two groups, including the median nerve cross-sectional area (CSA) measured in mm², fascicular pattern, flattening ratio, and mobility of the median nerve.
次要结局
未报告次要终点
研究者
Yara Assem
Lecturer of Rheumatology, Rehabilitation and Physical medicine
Minia University Hospital