A Randomized Controlled Multicentre Trial of a Brief Intervention (BI) Versus a BI Plus Cognitive Behavioural Treatment (CBT) Versus Nutritional Supplementation for Patients With Long-lasting Back Pain.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 414
- 试验地点
- 3
- 主要终点
- Sickness leave
研究概览
简要总结
CINS is a large multicentre study which aims to test out the effect of 4 different interventions, namely a brief cognitive intervention (BI), a more extensive cognitive behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.
详细描述
The treatment principles for low back pain, and also other types of non-specific muscle pain, have changed dramatically over the last 10 to 15 years; from traditional treatment like bed rest and inactivity to more active treatment strategies ("the back pain revolution"; Waddell et al 1997). Norwegian research has been in the forefront, particularly in demonstrating the clinical and cost effective brief interventions (BI) (Indahl et al., 1995, 1998; Hagen et al 2000, 2004, Brox et al 2003, Storheim et al 2003). However, about 30% of the patients do not recover or return to normal social and working life. The aim of this study is therefore to see if a longer cognitive behavioural intervention (CBT) has an additional benefit to BI, and to compare this with a potentially beneficial dietary supplement.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients sicklisted 2-10 months for low back pain
- •The following diagnosis are included: L02, L03, L84 and L86
排除标准
- •Being off the sick list
- •Pregnancy
- •Osteoporosis
- •L diagnoses suggesting recent low back pain trauma
- •Specific spinal or other injuries which may account for the current back pain
- •Serious psychiatric pathology
结局指标
主要结局
Sickness leave
时间窗: 2008-2020
次要结局
- Cortisol curves(2008-2010)
- Function(2008-2010)
- Health complaints(2008-2010)
- Psychopathology(2008-2010)
