The Long-term Effect for Perineural Injection Therapy for Ulnar Neuropathy at Elbow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from pain on 1st, 3rd, 6th month after injection
研究概览
简要总结
Ulnar neuropathy at elbow (UNE) is the second common peripheral entrapment neuropathy. Although many conservative managements of UNE, the effectiveness of these methods are unsatisfied especial the moderate degree of UNE. Recently, ultrasound-guided perineural injection therapy (PIT) with 5% dextrose is progressively applicated for clinical treatment for entrapment neuropathy. However, current studies have not proved the effects of PIT on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. We design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PIT with 5% dextrose in patients with mild and moderate UNE.
详细描述
After obtaining written informed consent, 40 patients, clinically diagnosed with mild or moderate UNE were randomized into intervention or control group. Participants in intervention group received one-session of ultrasound-guided PIT injection with 5cc. 5% dextrose and control group received 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (total 5 cc) ultrasound-guided PIT injection. The primary outcome is Disabilities of the Arm, Shoulder and Hand (DASH) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity of the ulnar nerve, and strength of palmer finger pinch and grasp. The evaluation was performed pretreatment as well as on the 1st, 3rd and 6th month after the treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20-80 year-old.
- •Diagnosis was confirmed using an electrophysiological study
排除标准
- •Coagulopathy
- •Pregnancy
- •Inflammation status
- •Cervical radiculopathy
- •Polyneuropathy, brachial plexopathy
- •Thoracic outlet syndrome
- •Previously undergone wrist surgery or steroid injection for ulnar neuropathy
研究组 & 干预措施
2cc 0.9% normal saline+3cc Triamcinolone (30mg)
The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
干预措施: Ultrasound (Device)
5% dextrose
The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy
干预措施: 5% dextrose (Drug)
5% dextrose
The perineural injection with 5% dextrose is a new and potential treatment for peripheral entrapment neuropathy
干预措施: Ultrasound (Device)
2cc 0.9% normal saline+3cc Triamcinolone (30mg)
The Ultrasound-guided injection with 2cc 0.9% normal saline+3cc Triamcinolone (30mg)
干预措施: 2cc 0.9% normal saline+3cc Triamcinolone (30mg) (Drug)
结局指标
主要结局
Change from pain on 1st, 3rd, 6th month after injection
时间窗: Pre-treatment, 1st, 3rd, 6th month after injection
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
次要结局
- Change from severity of symptoms and functional status on 1st, 3rd, 6th month after injection(Pre-treatment, 1st, 3rd, 6th month after injection)
- Change from nerve conduction velocity on 1st, 3rd, 6th month after injection(Pre-treatment, 1st, 3rd, 6th month after injection)
- Change from cross-sectional area on 1st, 3rd, 6th month after injection(Pre-treatment, 1st, 3rd, 6th month after injection)
- Change from palmer finger pinch and grasp on 1st, 3rd, 6th month after injection(Pre-treatment, 1st, 3rd, 6th month after injection)
研究者
Yung-Tsan Wu
Attending Physician of Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital