Efficacy of Ultrasound-Guided Deep Perineural Platelet Rich Plasma Versus Corticosteroid Injection in Patients With Ulnar Neuropathy at Elbow, a Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in ultrasound cross sectional area of ulnar nerve at elbow after injection
研究概览
简要总结
This study was be performed on 60 patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography selected from Physical medicine, Rheumatology & Rehabilitation Department, Faculty of Medicine, Tanta University.
Patients were be randomly divided into 2 groups:
Group I: will undergo a single ultrasound-guided deep perineural injection with 3ml PRP at the thickest part of the ulnar nerve. PRP will be prepared by PRP method.
Group II: will undergo a single ultrasound-guided deep perineural injection with 1ml corticosteroid (triamcinolone acetonide, 40mg/mL) mixed with 1ml lidocaine hydrochloride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with ulnar neuropathy at elbow diagnosed clinically and by electrophysiology and/or ultrasonography.
排除标准
- •Patients with severe ulnar neuropathy at elbow according to Gu's classification. 15
- •Brachial plexopathy, peripheral neuropathy, and cervical radiculopathy.
- •History of recent elbow trauma or operation.
- •Malignant neoplasm.
- •Bleeding Disorders.
- •Factors affecting nerve healing process e.g., tobacco use and systemic corticosteroid administration.
- •Contraindications for PRP injection:
- •Significant renal or hepatic dysfunction.
- •Critical thrombocytopenia.
- •Hemodynamic instability.
- •Septicemia.
- •Local infection at the site of the procedure.
- •Consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks.
- •Local injection at the suspected treatment site within the last month.
- •Recent fever or illness.
- •Hemoglobin level <10 g/dL.
- •Platelet dysfunction disorders.
研究组 & 干预措施
PRP group
3 cm of autologous platelet rich plasma injected once around the thickest part of ulnar nerve.
干预措施: PRP (Drug)
Corticosteroid group
Triamcinolone Acetonide 40mg/mL (1ml) mixed with 1ml lidocaine hydrochloride injected once around the thickest part of ulnar nerve.
干预措施: Triamcinolone Acetonide 40mg/mL (Drug)
结局指标
主要结局
Change in ultrasound cross sectional area of ulnar nerve at elbow after injection
时间窗: 1, and 3 months after injection
Change in nerve conduction parameters of ulnar nerve at elbow after injection
时间窗: 1 and 3 months after injection
Change in ulnar nerve conduction velocity and CMAP across elbow.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 month after injection)
研究者
Hajar Anwer Elnagar
Doctor
Tanta University