NCT06264297招募中不适用
High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial
Consorci Sanitari de Terrassa2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年2月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE
研究概览
简要总结
The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients over 18 years of age.
- •Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
- •Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
- •Radicular syndrome of three months or more of evolution.
- •Normal or pathological electromyogram (EMG).
- •Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire.
- •Patients with a previous positive block diagnosis.
- •Patients who have signed the informed consent document.
排除标准
- •Patients under 18 years of age.
- •Patients with non-radicular low back pain.
- •MRI not consistent with the patient's symptoms.
- •Patients with peripheral neuropathy of the lower extremities.
- •Patients with a history or current diagnosis of serious mental disorder.
- •Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome.
- •Infection at the puncture site.
- •Coagulation disorders.
- •Pregnant patients.
- •Patients who refuse to sign the informed consent document.
- •Patients allergic to radiological contrast.
结局指标
主要结局
OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE
时间窗: From enrollment to the end of treatment at 6 months
this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life
次要结局
- patient global impression of improvement (pgi-i) score(From enrollment to the end of treatment at 6 months)
- DN4 - QUESTIONNAIRE(From enrollment to the end of treatment at 6 months)
- Visual Numeric Scale(From enrollment to the end of treatment at 6 months)
- Categorical scale(From enrollment to the end of treatment at 6 months)
研究者
Maria Martinez
Anesthesiologist
Consorci Sanitari de Terrassa
研究点 (2)
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