NCT00480038终止不适用
WHODAS-II for Patients With Symptomatic Lumbar Disc Herniation
Kovacs Foundation4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Measurement characteristics of WHODAS-II
研究概览
简要总结
The main purpose of this study is to determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with symptomatic lumbar disc herniation (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients seen for symptomatic lumbar disc herniation
- •Radiated pain concordant with nerve root
- •With or without motor restriction
- •Able to read and write
- •Signed the informed consent form
排除标准
- •Central nervous system pathology (with or without treatment)
- •Diagnosis of rheumatic inflammatory disease or fibromyalgia
- •Red flags for underlying systemic disease
- •Criteria for diagnosis of symptomatic spinal stenosis
- •Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
- •Motor deficit that progresses or does not improve in 6 weeks
结局指标
主要结局
Measurement characteristics of WHODAS-II
时间窗: At baseline and at 7 days
次要结局
- Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar herniated disc(At baseline and at 7 days)
研究者
研究点 (4)
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