Prospective Observational Cohort Study of Patients With Symptomatic Degenerative Spinal Stenosis With and Without Degenerative Spondylolisthesis Not Scheduled for Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index (ODI) version 2.0
研究概览
简要总结
The NORDSTEN- OS(Observational study) aim to study the natural course in patients with mild to moderate symptomatic lumbar spinal stenosis with and without degenerative spondylolisthesis. 10 years follow-up is planned.
The NORDSTEN-OS is one of three studies in The NORwegian Degenerative Spondylolisthesis and Spinal STENosis studies.
The two other studies are:
NORDSTEN-SST (Spinal stenosis trial) (NCT02007083); a randomized controlled trial comparing the clinical and radiological results in three different decompression techniques in patients with lumbar spinal stenosis. The NORDSTEN-DS (Degenerative spondylolisthesis) (NCT02051374); a randomized controlled trial comparing the outcome of surgery with decompression without fixation and decompression with fixation in patients with lumbar spinal stenosis and concurrent degenerative spondylolisthesis.
详细描述
Objectives:
- A longitudinal observation of clinical- and radiological development with 5- and 10 years follow-up. Variables predicting clinical deterioration or improvement, and outcome measurements including time from inclusion to time for surgery, will be analyzed. We will use predictive models appropriate to the type of data each prognostic outcome measure represents. For example the repeated pain and disability measures will be analysed using linear mixed models. Logistic regression models with no more than 1 variable per 10 events will be used to analyse associations between prognostic factors and disability. Multivariate analysis will identify the predictive prognostic factors in the demographic, physical, social and radiological domains. The number of factors that will be entered in the multivariate analysis will be condensed by univariate pre-testing and omitting highly correlated factors. The prognostic value of both single and combined variables will be addressed by calculating sensitivity, specificity, positive and negative likelihood ratios in a standard way.
Time to surgery will be modeled using Kaplan-Meier plot. Depending on number of treated patients the effect of selected covariates on time to surgery will be evaluated using the Cox model. 2. 1) To investigate differences between patients in the observational cohort and patients treated surgically in NORDSTEN-SST and NORDSTEN-DS, by comparing baseline demographic-, clinical-, and radiological data. Patients in the NORDSTEN-OS with lumbar spinal stenosis and a verified degenerative spondylolisthesis of ≥ 3mm will be compared to patients in the NORDSTEN-DS. Patients in the NORDSTEN-OS with lumbar spinal stenosis without degenerative spondylolisthesis will be compared to patients in the NORDSTEN-SST. We will use descriptive statistics to compare the patient groups. For each of the variables we will compare measures of central tendency such as mean and median, and measures of variability such as variance and quantiles. We will also plot distributions of certain variables using histograms or fitted densities, in order to easier compare and see similarities and differences between the groups.
Baseline data Demographical data: Age, gender, BMI, education and native language. Status regarding: marriage, smoking, work and disability benefits.
Clinical data: duration of symptoms (back pain and leg pain) and use of analgetics, Patient reported outcome measures: Oswestry Disability Index (ODI 2.0), Zurich Claudication Questionnaire, EQ-5D and Numeric Rating Scale for leg pain and back pain. Hopkins symptom check list (HSCL-25) HSCL-25 is a PROM for assessment of psychological variables. It covers emotional distress, scores range from 1 to 4, with lower scores indicating less severe symptoms.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of clinical symptoms of spinal stenosis. Neurogenic claudication or radiating pain to one or both lower limbs
- •Radiological findings corresponding to the clinical symptoms of LSS. Central stenosis or lateral recess stenosis with or without degenerative spondylolisthesis
- •Able to understand Norwegian language, both spoken and written
- •Able to give informed consent and to answer the questionnaires
- •Over 18 years of age
排除标准
- •Not willing to give written consent
- •Participation in other clinical trial that may interfere with this trial
- •American Society of Anesthesiologists (ASA) 4 or 5
- •Age older than 80 years
- •Not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physically)
- •Presence of cauda equina syndrome (bowel and bladder dysfunction) or complete motor deficit
- •Presence of an isthmic defect in pars interarticularis
- •Former fracture of the thoracolumbar region
- •Previous surgery in the lumbar region
- •Distinct symptoms in one or both legs due to other diseases, e.g. polyneuropathy, vascular claudication or osteoarthritis
- •Lumbosacral scoliosis of more than 20 degrees verified on standing x-ray AP-view
结局指标
主要结局
Oswestry Disability Index (ODI) version 2.0
时间窗: Baseline and follow-up at 2,5 and 10 years
ODI is a patient reported outcome measure (PROM) comprising 10 sections where the patient is supposed to mark the most appropriate item. ODI scores range from 0 to 100, with higher score indicating more severe pain and disability. ODI is recommended by international expert panels for the evaluation of disability in clinical trials and commonly used by physicians treating patients with back-related symptoms. It has been translated and validated for applications with Norwegian patients. The change in ODI from baseline to follow-up will be registered.
次要结局
- Zürich Claudication Questionnaire (ZCQ)(Baseline and follow-up at 2,5 and 10 years)
- Numeric Rating Scale (NRS) for back and leg pain.(Baseline. Follow-up at 2,5 and 10 years)
- Time from inclusion until time for to surgery.(10 years)
- EuroQol 5 dimensions questionnaire (EQ-5D).(Baseline and follow-up at 2,5 and 10 years)
- A questionnaire mapping subjective change of symptoms from baseline in a 6 point response scale, ranging from completely recovered to getting worse.(Follow-up at 2,5 and 10 years)
- A questionnaire mapping the satisfaction with living with the current state of symptoms for the rest of the life in a 5 point response scale, ranging from very satisfied to very dissatisfied.(Follow-up at 2,5 and 10 years)