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临床试验/NCT01690234
NCT01690234Unknown不适用

Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial

Back and Rehabilitation Center, Copenhagen2 个研究点 分布在 1 个国家目标入组 770 人开始时间: 2009年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
770
试验地点
2
主要终点
Number of days off work

研究概览

简要总结

In Denmark the number of patients, sick listed for more than four weeks is increasing, and patients suffering from musculoskeletal disorders make one third of the total amount of long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal diseases, including low back pain, are less likely to return to work after a period of sick leave. It seems that a multidisciplinary intervention, including cooperation between the health sector, the social sector and in the work place, has a positive effect on days off work due to musculoskeletal disorders and particularly low back pain. The aim of this study is to evaluate the effect of a work oriented multidisciplinary intervention.

A randomized controlled trial will include 770 patients with low back pain. The study population consists of patients, who are sick listed or at risk of sick leave due to LBP.

The control group is treated with usual care in a team with participation of a physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The Intervention group is treated with usual care and in addition intervention of a psychologist, an occupational physician, an ergonomist and a social worker from the local sickness benefit office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of days of work. Secondary outcomes are disability, pain, and quality of life.

This large RCT study is testing the effectiveness of a preventive intervention targeting patients on short term sick leave or at risk being sick listed because of low back pain. We have developed a novel multidisciplinary team structure using the treating physiotherapist as the return to work coordinator, and having the case manager from the sickness benefit office participating in team meetings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Working age adults 18-65
  • Low back pain (longer than 2 weeks)
  • Sicklisted or at risk
  • Employed or unemployed

排除标准

  • Severe comorbidity
  • Pregnancy
  • Difficulties in reading Danish language
  • Application for early retirement

结局指标

主要结局

Number of days off work

时间窗: 12 months

次要结局

  • Disability(12 months)

研究者

发起方
Back and Rehabilitation Center, Copenhagen
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tom Petersen

Physiotherapist

Back and Rehabilitation Center, Copenhagen

研究点 (2)

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