Efficacy and Safety of Percutaneous Transforaminal Endoscopic Discectomy Versus Radiofrequency Ablation in the Treatment of Lumbar Intervertebral Disc Herniation: a Case-control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes on the Visual Analogue Scale for Leg Pain
研究概览
简要总结
Lumbar disc herniation (LDH) is a common and frequently-occurring disease giving rise to low back pain and (or) leg pain. There are about 1.5 million people with LDH-related pain, accounting for 10% of outpatients each year in China. The mechanism of LDH-related pain is that the degeneration causes the protrusion of the intervertebral disc directly to the lower lumbar nerve root or spinal cord, and the chemical stimulation plays a key role in it. Currently, LDH treatments are mainly divided into conservative treatment, surgical treatment and minimally invasive treatment. The minimally invasive technique is a new technology that has been arising in recent years, with small wound, little bleeding and quick recovery. It mainly includes collagenase dissolving, laser decompression, radiofrequency ablation, etc. Intervertebral disc radiofrequency ablation is an early application of minimally invasive technique with a wide range of applications in a long time. The percutaneous transforaminal endoscopic discectomy (PTED) is a new technique, which is applied in clinics with shorter time, and the implementation and efficacy of the technique need to be further discussed. A case-control clinical trial is designed to compare the efficacy and safety of PTED with radiofrequency ablation in the treatment of LDH. Main outcome is Visual Analogue Scale for leg pain, secondary outcomes are Oswestry disability index, quality of life assessment, Burns Depression Checklist, recovery rate, complications, operation time and radiation exposure time, etc. The follow-up time points are 7 days, 1 month, 6 months and 12 months post-operation.
详细描述
Please see the Eligibility Criteria or Outcome Measures sections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor do not know all the information about the data origin and the group.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar intervertebral disc herniation has been treated with conservative treatment of > for 3 months, or can only temporarily improve symptoms to relieve pain, but can not be maintained for a long time, aged between 18 and 60;
- •The symptoms and signs of lumbar intervertebral disc herniation are obviously consistent with those of CT or MRI;
- •The protrusion size was < 8.0mm, and imaging examination showed the protrusion of intervertebral disc, mild or moderate protrusion, without calcification, dissociation, and osseous spinal stenosis;
- •Patients have a strong desire to treat, and understand radiofrequency thermal coagulation ablation and intervertebral endoscopic treatment of possible risk patients;
- •Conservative treatment is ineffective and the surgical treatment is rejected.
排除标准
- •The non-inclusion or prominent calcification, dissociation, dissociation and consolidation of vertebral canal stenosis or caudal syndrome in the rupture of the fibrous ring and posterior longitudinal ligament;
- •Patients with spinal fractures, tumors and intervertebral discs have skin infections that affect the puncture;
- •The combination of mental illness or cognitive dysfunction;
- •Patients with serious diseases such as active tuberculosis or heart, lung, liver and kidney;
- •Abnormal bleeding or coagulation function caused by various reasons;
- •Menstrual period and lactation period;
- •No informed consent is signed.
结局指标
主要结局
Changes on the Visual Analogue Scale for Leg Pain
时间窗: Baseline, 7 days, 1 month, 6 months and 12 months post-operation.
Draw a line of 100 mm on the paper, the end of the horizontal line is 0, indicating no pain; The other end is 10, which is a very serious pain; The middle section shows varying degrees of pain. Let the patient draw a mark on the horizontal line to indicate the extent of the pain.
次要结局
- Changes on the Visual Analogue Scale for Back Pain(Baseline, 7 days, 1 month, 6 months and 12 months post-operation.)
- Changes on Burns Depression Checklist(Baseline, 7 days, 1 month, 6 months and 12 months post-operation.)
- Changes on 36-Item Short-Form Quality of Life Questionnaire (SF-36)(Baseline, 7 days, 1 month, 6 months and 12 months post-operation.)
- Changes on the Oswestry Disability Index (ODI)(Baseline, 7 days, 1 month, 6 months and 12 months post-operation.)
- Complications(through study completion, up to 1year of follow-up.)
- Perceived recovery(Baseline, 7 days, 1 month, 6 months and 12 months post-operation.)