跳至主要内容
临床试验/NCT02015572
NCT02015572Unknown不适用

Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)

Frederiksberg University Hospital2 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2016年1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
302
试验地点
2
主要终点
Accumulated duration of self-assessed sick leave due to LBP

研究概览

简要总结

Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work.

This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice.

The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up.

The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.

The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.

详细描述

Eligible participants are: 1) 18-65 years of age; 2) current episode of 2-4 weeks of LBP; 3) self-reported physically demanding work; 4) express concerns about the ability to maintain their current job.

The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease

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 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 (current episode of 2-4 weeks)
  • Self-reported physically demanding work
  • Sick-listed or at risk
  • Speak, read and understand Danish
  • Accept workplace visit by the occupational physicians
  • Be in gainful employment for at last 30 hours/week

排除标准

  • Severe somatic or psychiatric comorbidity
  • Pregnancy
  • Cancer or metastatic disease
  • LBP treatment or referral to outside providers (e.g. back-surgery)
  • Contraindications for having a MRI.

结局指标

主要结局

Accumulated duration of self-assessed sick leave due to LBP

时间窗: 6 months

次要结局

  • Changes in pain level(6 months)
  • Change in Disability(6 months)
  • Changes in Fear Avoidance Beliefs scores(6 months)
  • Satisfaction with the intervention(6 months)

研究者

发起方
Frederiksberg University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjarke Brandt Hansen

MD

Frederiksberg University Hospital

研究点 (2)

Loading locations...

相似试验