Post-lesion Administration of Dexamethasone to Prevent the Development of Neuritis After Radiofrequency Ablation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of Lesions With Post-Ablation Neuritis
研究概览
简要总结
Chronic neck and back pain has become one of the leading causes of disability and loss of productivity. For many patients with facet or sacroiliac joint mediated pain who have responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the joints can provide long term relief. Radiofrequency ablation (RFA) is a relatively safe procedure with minimal risk of adverse events. However, with any procedure involving damage to the peripheral nervous system, there is risk of post-procedure neuropathic pain. The investigators will test the hypothesis that dexamethasone injection delivered at the time of lesion effectively prevents the development of post-ablation neuritis through a placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic, lumbar, and sacroiliac joint radiofrequency denervations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The patient, care providers, and principle investigator will be blinded.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac joint pain who have responded to medial branch blocks and are already scheduled for bilateral radiofrequency ablations
- •age greater than 18 years old
- •English speaking
排除标准
- •patient not previously scheduled for radiofrequency ablation of the cervical, thoracic, or lumbar facets, or sacroiliac joints
- •on anticoagulation
- •have a pacemaker
- •age less than 18 years old
- •non-English speaking
研究组 & 干预措施
Dexamethasone
Lesions where dexamethasone 4 milligram is administered post-radiofrequency ablation
干预措施: Dexamethasone 4 mg/ml (Drug)
Placebo
Lesions where 1 milliliter of normal saline is administered post-radiofrequency ablation
干预措施: Normal saline (Drug)
结局指标
主要结局
Number of Lesions With Post-Ablation Neuritis
时间窗: 4 weeks
Each patient had 2 lesions. One Lesion was treated with dexamethasone. The other lesion was treated with placebo. We then looked at the number of lesions that developed post-ablation neuritis.
次要结局
未报告次要终点