EuroPainClinicsStudy XI (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Oswestry disability index (ODI) 12m
研究概览
简要总结
Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain
详细描述
Description of the clinical state:
Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome. A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint. Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches.
Description of interventional procedures:
Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •patients aged between 20 and 80
- •positive two medial branch nerve blocks with pain relief over 80% during the first 12hours after nerve block application
- •positive patient history for facet joint pain
- •patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS >=5)
- •those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form
排除标准
- •patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
- •women with positive a pregnancy test before the trial or who planned to become
- •pregnant within the following 3 years
- •other patients viewed as inappropriate by the staff
- •disagreement with participation in the study
结局指标
主要结局
Oswestry disability index (ODI) 12m
时间窗: 12 months follow-up
The ODI self-administered questionnaire measuring 0-100 scale
Change from baseline EuroQoL-5 dimension (EQ-5D) value 12m
时间窗: 12 months follow-up
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m
时间窗: 6 months follow-up
VAS 10 point measurement
Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m
时间窗: 6 months follow-up
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change from baseline Visual Analog Pain Scale (VAS) of back pain 12m
时间窗: 12 months follow-up
VAS 10 point measurement
Oswestry disability index (ODI) 6m
时间窗: 6 months follow-up
The ODI self-administered questionnaire measuring 0-100 scale
次要结局
- Appearance and rate of complications related to procedure(12 months follow-up)
- Dose of radiation exposure(12 months follow-up)
- Postprocedural drug usage(12 months follow-up)
- Before procedure drug usage(before procedure)