Effectiveness of Percutaneous Foraminotomy in Patients With Lumbar Foraminal Stenosis: A Prospective, Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- NRS score
研究概览
简要总结
Percutaneous Extraforaminotomy using BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea), was performed in patients who did not show improvement lasting more than 1 month after diagnostic conventional fluoroscopically guided transforaminal epidural block with local anesthetic and steroid.
Numeric rating scale(NRS) pain score, Oswestry disability index (ODI), Roland-Morris Disability Questionnaire (RDQ), claudication distance(CD) was checked before and after the procedure.
详细描述
Percutaneous Extraforaminotomy with Transforaminal Adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radicular pain with positive provocation factors > 3 months
- •Radicular pain at L4 or L5
- •Presence of dominant side when bilateral symptom present
- •Positive provocation factors: leg symptoms elicited or aggravated by walking but relieved by sitting down
- •Not appropriate relief of pain routinely conservative treatment (physiotherapy, exercise, analgesic medication, epidural steroid injection) > 3 months
- •Magnetic resonance imaging(MRI) : Foraminal stenosis of Grade 1-3 (foraminal herniated intervertebral disc(HIVD) with mild to severe degree of foraminal stenosis according to AJR:194, April 2010 by Lee, et. Al)
- •Subjects who signed for the consent form
排除标准
- •Acute back or leg pain
- •Sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes
- •Patients with a history of prior spine surgery
- •Allergic response to steroid or contrast dye
- •Bleeding diathesis or over coagulopathy
- •Patients with bilateral radiculopathy or spinal stenosis at more than 3 levels
结局指标
主要结局
NRS score
时间窗: 4 weeks after intervention
A comparison of the mean difference in the change of NRS scores of their leg pain from entry to the scores at 4-week
次要结局
- 5-point satisfaction scale(4, 8 and 12 weeks)
- NRS score(8, 12 weeks after intervention)
- Oswestry disability index(ODI)(4, 8 and 12 weeks after intervention)
- Any adverse events(Throughout the study period (up to 12 weeks))
- Roland-Morris Disability Questionnaire(RDQ)(4, 8 and 12 weeks after intervention)
研究者
Sangchul Lee
professor
Seoul National University Hospital