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临床试验/NCT00459433
NCT00459433已完成不适用

The Right Intervention for the Right Patient

The Back Research Center, Denmark2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
2
主要终点
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire

研究概览

简要总结

Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention.

We would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.

详细描述

Two quality assurance investigations are performed in the The Back Research Center Clinic, where one is published in The Spine. The systematics of Health Technology Assessment was used to throw light on important indicators in relation to Health Technology aspects, patient aspects, organisational aspects and economical aspects. At 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory.

A Norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. Conversely the mono disciplinary intervention had best effect on the least severe patient group.

Therefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs.

Even though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity.

  • mainly biological
  • both biological and psychological
  • both biological and social
  • both biological, psychological and social It is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. It is important to take into account all three elements, the severity of the elements, and the combination of elements. To be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.

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 (Participant)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Unspecific low back pain
  • Level of low back pain must be at least equal to leg pain
  • Patients must have been sick listed during the past 12 months
  • Age > 17 years and < than 60

排除标准

  • Modic changes as seen on MRI
  • Direct or progressive paresis or Cauda equina syndrome
  • Known MB Bechterew or Sacroiliitis
  • Suspicion of other serious malignancy
  • Alcohol or medicine abuse
  • A screening result of more than 30 in the Beck Depression Inventory

结局指标

主要结局

Days on sick leave and days with low back pain problems measured every week by SMS questionnaire

时间窗: 12 months

次要结局

  • Pain level(12 months)
  • Activity of daily living(12 months)

研究者

发起方
The Back Research Center, Denmark
申办方类型
Other

研究点 (2)

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