EuroPainClinicsStudy XIr-Zj (Cryoablation vs Radiofrequency Ablation of Medial Nerve Branches of Dorsal Roots Crossing Z Joints)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m
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
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
sealed envelope, random software
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 12 hours after nerve block application
- •positive patient history of 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 tests 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
研究组 & 干预措施
Lumbar medial branch RF neurotomy
Lumbar medial branch RF neurotomy Procedure lumbar medial branch RF neurotomy: Raising the temperature of the tip of the electrode to 85 C for 120 seconds. RF generator. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure. Repeated cryoablation ablation procedures are allowed (when VAS will be > 4 )
干预措施: Lumbar medial branch radiofrequency ablation neurotomy (Procedure)
Lumbar fazet joint decapsulation
Lumbar facet joint decapsulation through an endoscopic approach
干预措施: Endoscopic denervation of fazet joint (Procedure)
Lumbar medial branch cryoablation
Lumbar medial branch cryoablation Procedure lumbar medial branch cryoablation Decreasing the electrode temperature to - 85 C for 120 seconds in two cycles. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure Repeated cryoablation ablation procedures are allowed (when VAS will be =/> 4 ) Procedure/Surgery: Lumbar medial branch cryo ablation neurotomy A procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
干预措施: Lumbar medial branch cryo ablation neurotomy (Procedure)
结局指标
主要结局
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 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: 12 months follow-up
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement
Oswestry Disability Index (ODI) 12m
时间窗: 12 months follow-up
The ODI self-administered questionnaire measuring 0-100 scale
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
未报告次要终点