Effect of Limaprost in Combination With Transforaminal Epidural Steroid Injection for the Treatment of Lumbar Spinal Stenosis: a Prospective, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- ODI (Oswestry Disability Index) change
研究概览
简要总结
The purpose of this study was to compare the effects of limaprost(Opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (TFESI) was administered compared to the placebo group.
详细描述
This study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (TFESI) is performed.
The subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo TFESI for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (LSS).
All study subjects are presented with TFESI at the level appropriate for their symptoms in the operating room and then returned to the recovery room. All participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure.
Patients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving TFESI. Patients assigned to the trial group will take limaprost (Opalmon®) three times a day, one tablet once from the first day after receiving TFESI. In both groups, the drug was administered for 12 weeks.
In both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only Acetaminophen was allowed as a rescue drug.
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
- Double (Participant, Investigator)
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
- •Patients aged 18 to 85 years
- •Patients with a new or known diagnosis of lumbar spinal stenosis on Magnetic Resonance Imaging (MRI)
- •Patients scheduled to undergo TFESI due to low back pain or leg pain
排除标准
- •Refusal of a patient
- •Coagulopathy
- •Systemic infection or local infection at the needle injection site
- •Patients with lumbar instability
- •Neoplasms in the needle path
- •Allergy to amide-type local anesthetics
- •Decreased cognition to the extent that NRS is incomprehensible
- •Patients with peripheral vascular disease (including peripheral arterial disease)
- •Patients taking anticoagulant or antiplatelet drugs
- •Patients with severe cardiovascular disease or liver or kidney disease
- •Patinets with cerebral infarction
- •Patinets with a history of gastrointestinal bleeding
- •Patinets who have had lumbar spine surgery or are expected to receive it within 12 months
- •Patients who show positive in the straight leg elevation test
- •Patients who are allergic or sensitive to limaprost (Opalmon®) and placebo or their ingredients
结局指标
主要结局
ODI (Oswestry Disability Index) change
时间窗: 4 weeks after placebo or limaprost (Opalmon®)
The change in ODI compared to the baseline was measured at the outpatient visit.
次要结局
- ODI (Oswestry Disability Index) change(12 weeks after placebo or limaprost (Opalmon®))
- Euroqol-5 Dimensions Questionnaire (EQ-5D) change(12 weeks after placebo or limaprost (Opalmon®))
- Treadmill test change(12 weeks after placebo or limaprost (Opalmon®))
- Numeric Rating Scale (NRS) change(12 weeks after placebo or limaprost (Opalmon®))
- Beck Depression Inventory (BPI) change(12 weeks after placebo or limaprost (Opalmon®))
- Changes in analgesic drugs(12 weeks after placebo or limaprost (Opalmon®))
研究者
Jeeyoun Moon
Associate Professor
Seoul National University