Spine Centre of Southern Denmark, Sygehus Lillebalt Middelfart Sygehus, Middelfart, Denmark.
Department of Regional Health Research, Faculty of Health Services, University of Southern Denmark, Odense, Denmark.
BMJ Open. 2018 Dec 19;8(12):e024949. doi: 10.1136/bmjopen-2018-024949.
Lumbar spinal stenosis is a common cause of low back and leg pain in the elderly and affects both physical activity and quality of life. First-line treatments are non-surgical options but if unsuccessful, surgery is advocated. The literature is not clear as to the outcome of surgery compared with non-surgical treatment, and the optimal time for surgery is not explicit. This observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical management 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. Outcomes are assessed at baseline and 6 and 12 months. Outcomes at 12 months will be compared for patients who undergo surgery for lumbar spinal stenosis and patients managed non-surgically, using different analytical approaches. Prespecified prognostic factors of interest at baseline include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pretreatment function, self-rated health, income, general self-efficacy and MRI-graded severity of central stenosis.
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 (18/22336). All participants provide consent. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences according to the Strengthening the Reporting of Observational Studies in Epidemiology and Prognosis Research Strategy statements. Potential sources of bias will be addressed using Risk of Bias in Non-randomised Studies of Interventions.
NCT03548441; Pre-results.
腰椎管狭窄症是老年人腰背疼痛和下肢疼痛的常见原因，会影响到身体活动和生活质量。一线治疗是非手术选择，但如果不成功，就提倡手术。文献对于手术与非手术治疗的结果并不明确，手术的最佳时机也不明确。本观察性研究旨在调查治疗过程，比较腰椎管狭窄症患者手术和非手术治疗的效果，并在当前临床实践的背景下确定预后因素。
从全国健康和社会问题登记处、慢性背痛临床登记处和医院病历中收集关于治疗、结局和患者特征的前瞻性登记数据。主要结局是苏黎世跛行问卷测量的身体功能变化。次要结局是症状严重程度、疼痛相关功能、健康相关生活质量和一般自我效能的变化。在基线、6 个月和 12 个月时进行评估。将在 12 个月时对接受腰椎管狭窄症手术的患者和非手术治疗的患者进行比较，使用不同的分析方法。基线时感兴趣的预设预后因素包括治疗分配、腰背疼痛强度、合并症、症状持续时间、治疗前功能、自我评估健康状况、收入、一般自我效能和 MRI 分级的中央狭窄严重程度。
该研究已由南丹麦地区卫生研究委员会（S-20172000-200）进行评估，并向丹麦数据保护局（18/22336）报告。所有参与者均提供同意。研究结果将在同行评议的出版物中发表，并根据《观察性研究和预后研究中的加强报告策略》在国家和国际会议上进行报告。将使用干预措施的非随机研究中的偏倚风险来解决潜在的偏倚来源。
NCT03548441；预结果。
