NCT02598232已完成2 期
A 24-week, Single-center, Open-label, Clinical Study to Evaluate the Efficacy and Safety of the 1,414nm Nd:YAG Laser System Added to PEN to Further Alleviate Back Pain in a Lumbar Herniated Intervertebral Disc Patient
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change in the Oswestry Disability Index
研究概览
简要总结
This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 19-79 years old
- •Patients with moderate disability based on the Oswestry Disability Index (ODI), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks
- •Patients who have language skills enough to answer questionnaires
- •Patients who agree to voluntarily participate in this study and to sign the Informed Consent Form, and who are able to participate for the entire period of this study
排除标准
- •Patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc
- •Patients who use an electronic medical device for their cardiovascular system
- •Patients who have spondylolisthesis in the relevant lesion
- •Patients with neurological defects
- •Patients who had undergone surgery on the relevant lumbar vertebra
- •Patients with cauda equina syndrome
- •Patients with congenital spinal deformity
- •Patients with spinal fracture
- •Patients with spinal infection, tumor, or other form of inflammatory spondylopathy
- •Patients with coagulation disorder
- •Patients with a history of malignant tumor (except those with a cured tumor and no re- occurrence for the last five years)
- •Patients who had participated in another clinical study within 30 days from their screening visit
- •Female patients with child-bearing potential who do not agree to use a medically acceptable contraceptive method* for up to 24 weeks after the use of the investigational medical device during this study
- •Medically acceptable contraceptive method: Condom, oral contraceptive pills taken continuously for more than three months, contraceptive injection or implants, intra- uterine contraceptive device, etc.
- •Patients who are pregnant or breastfeeding
- •Other patients who are considered unfit to participate in this study with clinically significant findings based on the investigator's judgment
结局指标
主要结局
Change in the Oswestry Disability Index
时间窗: Day 0, 24 weeks
次要结局
- Change in the Visual Analogue Scale(Day 0, 4 weeks, 12 weeks, 24 weeks)
- Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria(Day 0, 4 weeks, 12 weeks, 24 weeks)
- Change in the Oswestry Disability Index(Day 0, 4 weeks, 12 weeks)
- 12-Item Short-form Health Survey(Day 0, 4 weeks, 12 weeks, 24 weeks)
研究者
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