Comparative Effectiveness and Prognostic Factors for Outcome of Surgical and Non-surgical Management of Lumbar Spinal Stenosis in an Elderly Population: Protocol for an Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Physical function
研究概览
简要总结
Introduction: Lumbar spinal stenosis is a common cause of low back and leg pain in elderly impacting physical activity and quality of life. Initial treatments are non-surgical options. If unsuccessful, surgery is advocated. The literature is not clear as to the outcome of surgery when compared to non-surgical treatment, and the optimal time for surgery is not explicit.
Materials and analysis: This observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical treatment in patients with lumbar spinal stenosis, and identify prognostic factors for outcome in the context of current clinical practice. Prospectively registered data on treatment, outcome and patient characteristics are collected from nationwide registers on health and social issues, a clinical registry of people with chronic back pain and hospital medical records. Primary outcome is change in physical function measured by the Zurich Claudication Questionnaire. Secondary outcomes are changes in symptom severity, pain-related function, health-related quality of life, and general self-efficacy. All outcomes are measured at baseline, 6 months and 12 months follow up. Comparisons on these variables will be made between those who undergo surgery for lumbar spinal stenosis and those not receiving surgery at 12 months follow up according to different analysis populations. Prognostic factors include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pre-treatment function, self-rated health, income, general self-efficacy and magnetic resonance imaging graded compression of central stenosis.
Ethics and dissemination: The study has been evaluated by The Regional Committees on Health Research for Southern Denmark (S-20172000-200) and notified to the Danish Data Protection Agency (17/30636). All participants provide consent. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences following the guidance from the STROBE and PROGRESS statement. Potential sources of bias will be addressed using ROBINS-I.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>60 years.
- •ICD-10 diagnosis of degenerative lumbar spinal stenosis registered in the nationwide patient registry between January 1st - December 31st
- •Included in the SpineData registry.
- •Give consent to use patient-reported data for research purposes
排除标准
- 未提供
结局指标
主要结局
Physical function
时间窗: Between baseline and 12 months follow up
Change in physical function score in the Zurich Claudication Questionnaire (ZCQ) collected through a clinical registry of people with chronic back pain (SpineData). The ZCQ is a condition-specific self-reported measure of symptom severity, physical function and satisfaction with treatment in patients with lumbar spinal stenosis. The questionnaire is composed of three domains (subscales) with a Likert-type scale. The physical function subscale includes 6 items addressing walking distance and walking ability. All but one item have Likert response scales with 4 categories. The physical function subscale score is calculated from the unweighted mean of all answered items. The possible range of the score is 1 to 4. Lower scores indicate less disability.
次要结局
- Pain related physical function(Between baseline and 12 months follow up)
- Health related quality of life(Between baseline and 12 months follow up)
- General self-efficacy(Between baseline and 12 months follow up)
- Symptom severity(Between baseline and 12 months follow up)