Percutaneous Intradiscal Radiofrequency as A Treatment for Radicular Pain From Lumbar Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change from baseline radicular pain score at 2 weeks
研究概览
简要总结
The goal of this clinical trial is to demonstrate the efficacy of percutaneous intradiscal radiofrequency as a treatment for radicular pain from lumbar disc herniation.
The main question it aims to answer is:
• Can percutaneous intradiscal radiofrequency lower the severity of radicular pain from lumbar disc herniation Participants will be treated with percutaneous intradiscal radiofrequency and evaluated for radicular pain severity before and 3 months after the procedure.
There is no comparison group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 year-old patients with radicular pain from lumbar disc herniation for ≥ 3 months
- •Lumbar disc herniation ≤ 2 locations evidenced by MRI, with ≥ 50% remaining disc height, without disc sequestration
- •Previously treated with epidural steroid injection (ESI) and achieved ≥ 50 % pain relief from local anesthetic effect, confirming radicular pain from lumbar disc herniation, but did not respond to ESI (< 50 % Pain relief or pain relief < 3 months)
排除标准
- •Patient refusal
- •Previous lumbar spine surgery
- •Progressive neurological deficit and/or cauda equina syndrome
- •Coagulopathy
- •Allergic to any medication in study protocols
- •Unable to rate the pain
- •Pain in any area worse than the radicular pain
研究组 & 干预措施
Percutaneous intradiscal radiofrequency
Standard monitoring ,prone position, sterile prepped and draped No sedation, Fentanyl 0.5-2 mcg/kg IV as needed ATB prophylaxis: ceftriaxone 1 g IV Performed by interventional pain physician, under fluoroscopic guidance 2% lidocaine 5 ml LA using Flextrode introducer kit, Boston Scientific Corporation Using an extrapedicular approach ipsilateral to the prolapse, the Flextrode cannula is advanced to the posterior disc.
The Flextrode electrode is inserted through the cannula. Sensory (50Hz) and motor (2Hz) stimulation, 3 Volts amplitude and 1msec pulse width. Confirm no sensory/motor response.
Lateral, AP, and oblique x-ray views are used to confirm the active tips are fully within the disc Thermal RF: temp 80 ◦C, 4 min Ceftriaxone 75 mg intradiscal injection via the cannula
干预措施: Percutaneous intradiscal radiofrequency treatment (Device)
结局指标
主要结局
Change from baseline radicular pain score at 2 weeks
时间窗: pre-treatment and 2 week post-treatment
Radicular pain severity using numerical rating scale (0-10) Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
Change from baseline radicular pain score at 3 months
时间窗: pre-treatment and 3 months post-treatment
Radicular pain severity using numerical rating scale (0-10) Zero represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'.
次要结局
- Oswestry Disability Index (ODI) at 3 months(3 month post-treatment)
- WHOQOL-Brief total score at baseline(pre-treatment)
- WHOQOL-Brief total score at 2 weeks(2 week post-treatment)
- WHOQOL-Brief total score at 3 months(3 month post-treatment)
- Oswestry Disability Index (ODI) at baseline(pre-treatment)
- Oswestry Disability Index (ODI) at 2 weeks(2 week post-treatment)
研究者
Rarinthorn Choomsai Na Ayuthaya, MD
Principal Investigator
Chulalongkorn University