跳至主要内容
临床试验/NCT00463970
NCT00463970已完成1 期

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.

NORCE Norwegian Research Centre AS3 个研究点 分布在 1 个国家目标入组 414 人开始时间: 2008年2月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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