EuroPainClinicsStudy X (Minimally Invasive Spinal Surgical Approaches)
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Fat degeneration of muscles
研究概览
简要总结
Non-interventional, retrospective-prospective cohort study based on the collection of data and their evaluation after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.
详细描述
The aim of this clinical study is to compare the benefits and complications after minimally invasive spinal procedures in patients with acute lumbosacral radicular syndrome caused by a herniated disc compressing the spinal neural structures.
The study only works with patient data provided by the outpatient clinic for research analysis in the EPCS IV clinical study. All patient data are encrypted during collection and evaluation during the study, and stored in an encrypted database. The data will be evaluated by an independent institution - The Institute of Measurement of the Slovak Academy of Sciences.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient age 18-60 years
- •first spinal surgery in the areas L1-S1
- •signed informed consent for the participation in the study
排除标准
- •patients with a history of other back problems (compression fracture, spondylitis, tumour)
- •patients after repeated spinal surgeries
- •patients with a systemic disease affecting the muscles elite athletes
- •patients who disagree to participate in the study
- •women with a positive pregnancy test or women planning on becoming pregnant
结局指标
主要结局
Fat degeneration of muscles
时间窗: 24 months after procedure
Fat degeneration of musculus erector spinae and multifidus muscles evaluated by comparing the pre-operative current MRI of the lumbosacral spine using the 2-point Dixon Technique and Goutallier classification in each group
Oswestry disability index (ODI)
时间窗: 24 months after procedure
ODI is based on a questionnaire, which includes 10 items, each one has 6 possible answers. Each item is rated from 0 to 5 and the sum of all answers is evaluated on a scale from 0-100, with higher scores meaning more serious symptoms.
EQ-5D-5L
时间窗: 24 months after procedure
EQ-5D is a standardized questionnaire tool developed by the EuroQol group as a measure of the quality of life linked to health, that can be used in a wide spectrum of health conditions and their treatment. The system has 5 dimensions: mobility, being able to take care of oneself, every-day activities, pain/discomfort and anxiety/depression. Each system can be graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems. T Changes in the visual analogue scale (VAS) of lower limb pain evaluated on a scale of 0 to 10
次要结局
- Occurrence of early and late post-surgery complications(24 months after procedure)
- Usage of painkillers before and after the procedures(24 months after procedure)
研究者
MUDr. Miroslav Buriánek MBA, MUDr. Robert Rapčan FIPP
Clinical Research Manager
R-CLINIC s.r.o.