Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Numerical Pain Rating scale for patient's pain during the procedure
研究概览
简要总结
Chronic neck pain is a common disorder for spine specialists. Radiofrequency ablation of medial branches has been proven effective in selected patients for relieving pain. A newer radiofrequency ablation cannula has been developed (multi-tined), allowing perpendicular access. It is proposed as an alternative to the more technically challenging traditional approach. This study aims to compared the technical and clinical aspects of both techniques.
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, Investigator, 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
- •18 years or older
- •Cervical neck pain at least 4/10 at rest or with activity
- •Neck pain lasting at least 6 months and refractory to conservative treatments
- •Neck pain is primarily axial (more than upper extremity)
- •Success to medial branch block protocol
排除标准
- •failure to medial branch block protocol (pain relief less than 75% on 2 occasions)
- •Cervical neck pain less than 4/10
- •Neurological deficits of upper extremity
- •neuropathic pain of upper extremity
- •pregnancy or breastfeeding
- •inflammatory or neoplastic lesion on x-ray
- •neck cortisone injection in last 3 months
- •any medical or psychiatric condition contra-indicated for radiofrequency ablation
研究组 & 干预措施
Traditional cannula
Cervical Medial Branch Radiofrequency Neurotomy using a conventional cannula, the patient lying prone with a posterior approach.
干预措施: Radiofrequency ablation of cervical medial branches (Device)
Multi-tined cannula
Cervical Medial Branch Radiofrequency Neurotomy using a Multi-Tined cannula, the patient lying in lateral decubitus with a lateral approach
干预措施: Radiofrequency ablation of cervical medial branches (Device)
结局指标
主要结局
Numerical Pain Rating scale for patient's pain during the procedure
时间窗: 1 day of the intervention
pain during radiofrequency procedure will be compared between the 2 groups as a principal hypothesis is that the new multi-tined cannula is better tolerated by patients Scale is from 0-10, 0/10 is no pain which is better than pain of 10/10
次要结局
- Fluoroscopy time(1 day of the intervention)
- Radiation dosage(1 day of the intervention)
- time of procedure(1 day of the intervention)
- Patient pain (Numerical Rating Scale - NRS score)(0, 3, 6 12 months)
- Patient function (Neck disability Index - NDI)(0, 3, 6, 12 months)