NCT05749185已完成不适用
Comparison Between the Effectiveness of Ultrasound-Guided High Voltage Pulsed Radiofrequency Versus Standard Voltage Pulsed Radiofrequency for Cervical Nerve Roots in Patients With Refractory Chronic Unilateral Cervical Radicular Pain
Minia University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- visual analogue score
研究概览
简要总结
The goal of this interventional study is to compare efficacy of either standard versus supra-voltage radiofrequency cervical epidural injection in pain alleviation in population with chronic cervical radiculopathy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 70 years, both genders.
- •American Society of Anesthesiologists (ASA) physical status grades I or II.
- •Unilateral cervical radicular pain secondary to cervical disc prolapse affecting single nerve root which was refractory to conventional conservative and physiotherapy measures for 12 weeks or more.
- •All candidates received 1 millilitre of 2% lidocaine via an ultrasound-guided diagnostic nerve block and informed at least 50% momentary reduction of their pain.
- •Diagnosis was confirmed by cervical MRI and nerve conduction tests.
排除标准
- •Refusal to participate.
- •Cervical radiculopathy pain recurrence after surgery.
- •Previous attempt of radiofrequency ablation.
- •Concomitant coagulopathic state ( decompensated liver disease, clopidogrel use) .
- •Metastatic lesion in the cervical vertebral column.
结局指标
主要结局
visual analogue score
时间窗: pre-treatment, 1,3, and 6 month after intervention
Number of patients with successful pain relief at 6 months post-intervention which is defined as more than or equal 50% reduction in VAS from pre-interventional level Vas score ranges from 0 to ten . 0= NO pain.... 1-3= mild pain .... 4-6 = moderate pain ... 6-10= severe untearable pain
次要结局
- Incidence of procedure related adverse events(6 hours after the procedure)
- Neck disability index(pre-treatment, 1,3 and 6 months after intervention)
研究者
Mina Maher
lecturer of anesthesia and pain medicine
Minia University
研究点 (2)
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