The Effectiveness of a Stratified Care Model for Non-specific Low Back Pain in Danish Primary Care Compared to Current Practice in a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 333
- 试验地点
- 4
- 主要终点
- Patient reported change measured by the Roland Morris Disability Questionnaire
研究概览
简要总结
Background Studies in the United Kingdom find the stratified care model of the STarT Back Tool (SBT) to be superior to usual care in primary care low back pain (LBP) patients. However, considerations on differences in health care and social systems across countries are required before taking steps towards any recommendations of implementing stratified care into other health care services.
Objective To investigate the effectiveness of the stratified care model of the SBT, when embedded into the regional disease management programs on LBP in primary care as compared to current best practice care.
详细描述
Methods The study is a two-armed randomized controlled trial in Danish primary health care setting. In total 700 patients are included in the study.
The patients are randomised automatically by a developed database to; 1) Stratified care (treatment matched to stratification according to SBT) or 2) Control treatment (treatment based solely on clinical reasoning).
All data including patient consent is collected and monitored using a web-based data management system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients found eligible for referral to physiotherapy by the general practitioner (GP)
- •18 years and above
- •understand Danish language.
排除标准
- •Serious pathology (malignancy, inflammatory arthritis, etc.),
- •serious nerve root compression (cauda equina, paresis <3),
- •influential comorbidity, psychiatric illness, personality disorder, spinal surgery during the last 6 months, pregnancy, or already receiving physiotherapy treatment.
研究组 & 干预措施
Stratified care
Patients are stratified into low, medium, high risk of poor outcome. Stratified care are delivered by special trained physiotherapists according to risk group
干预措施: Stratified care (Other)
Current care
Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.
干预措施: Current care (Other)
结局指标
主要结局
Patient reported change measured by the Roland Morris Disability Questionnaire
时间窗: 3 and 12 months
Change in disability measured by the Roland Morris Disability Questionnaire at 3 and 12 months (RMDQ)
次要结局
- Patient reported global change measured by the questionnaire "Global Impression of Change"(3 and 12 months)
- Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire(12 months)
- Change in pain intensity measured on a numeric range scale(3 and 12 months)
- Time off work assessed by the Danish National Register on Public Transfer Payments (DREAM)(3 and 12 months)
- Time off work monitored by standardized patient reported data(3 and 12 months)
研究者
Lars Morsoe
Ph.D.
Region of Southern Denmark