Diagnostic Screening Tool for Lumbar Spinal Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 1
- 主要终点
- Accuracy of the screening questionnaire for lumbar spinal stenosis (LLS screen)
研究概览
简要总结
The aim of this project is to develop a questionnaire that should distinguish patients with lumbar spinal stenosis (LSS) from other patients. LSS can cause significant pain and disability leading to dramatically reduced quality of life, immobility and functional limitation.
The number of people with pain and disability due to LSS is expected to increase with age due to the degenerative nature of the disease. With an aging population this could potentially become a major health economic challenge.
One of the challenges to estimate the true prevalence is the lack of a valid and reliable gold standard for LSS. To our knowledge, no diagnostic screening tool designed to estimate the prevalence of LSS in a clinical population of Danish patients with chronic low back pain (LBP) and leg pain has been developed.
The objective of this project is to develop a diagnostic screening tool for LSS - the LLS Screen. This should consist of a set of items useable in a self-administered questionnaire, a rule to compute the probability of having LSS, and a cutpoint to be used to obtain a sensitivity of 95%. The rule should be applicable in patient populations suffering from low back pain and with increased suspicion to suffer from LSS due to failure of non-surgical treatment
详细描述
The specific objectives are:
A. To identify items with high content validity for diagnosing LLS B. To investigate the preliminary value of items included in the LLS screen C. To investigate the performance of the included items in the LLS screen D. To decide on the content of the final version of the LLS Screen
This project consists of four parts. Part I addresses objective A based on a literature search and qualitative semi-structured interviews. Part II addresses objective B by conducting a case-control study concurrent with a cohort study and performing a series of analyses to investigate the preliminary value and performance of the items. Part III describes the performance of the items by combining them in various ways to obtain an optimal diagnostic rule (objective C). Finally, part IV is a decision of the content of the final version of the LSS Screen based on information from Part I, II and III (objective D).
Part II:
A case-control study with cases and controls identified within a prospective clinical population based cohort study that will be boosted with cases of LSS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and write Danish
- •Age above 50
- •Low back pain and/or leg pain
排除标准
- 未提供
结局指标
主要结局
Accuracy of the screening questionnaire for lumbar spinal stenosis (LLS screen)
时间窗: Baseline
To estimate the accuracy of the questionnaire LSS Screens ability to identify patients with clinical symptoms of LSS in terms of sensitivity, specificity and diagnostic odds ratio.
次要结局
未报告次要终点