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

2017年2月10日 更新者:Bjarke Brandt Hansen、Frederiksberg University Hospital

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.

研究概览

详细说明

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

研究类型

介入性

注册 (实际的)

302

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Frederiksberg
      • Copenhagen、Frederiksberg、丹麦、2000 F
        • The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Occupational intervention
Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist.
Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
有源比较器:Usual care
Intervention from the patient's general physician.
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Accumulated duration of self-assessed sick leave due to LBP
大体时间:6 months
6 months

次要结果测量

结果测量
措施说明
大体时间
Changes in pain level
大体时间:6 months
Pain will be evaluated by using the 13 items Pain-Detect questionnaire, which includes measurements of LBP on an ordinal, 11-point numerical rating scale (NRS: 0 = no LBP; 10 = worst LBP possible).
6 months
Changes in Fear Avoidance Beliefs scores
大体时间:6 months
Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured.
6 months
Change in Disability
大体时间:6 months
The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability.
6 months
Satisfaction with the intervention
大体时间:6 months
Measured on an 11-point NRS with the anchors "not at all satisfied" to "extremely satisfied".
6 months

其他结果措施

结果测量
措施说明
大体时间
Accumulated duration of self-assessed sick leave due to LBP
大体时间:12 months
12 months
MRI findings
大体时间:Baseline
Degree of degenerative MRI findings in the lumbar spine predicts outcome (sick leave)
Baseline
Predictors of outcome
大体时间:Baseline
Baseline questionnaires scores (Pain categorization (PainDETECT®), Numeric Pain Rating Scale (NPRS), Fear Avoidance Beliefs, 36-item short-form health-survey (SF36) and Roland Morris Disability) are associated with outcome (sick leave).
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ann Kryger, MD, PhD、University Hospital Frederiksberg and Bispebjerg

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年1月1日

初级完成 (实际的)

2016年6月1日

研究完成 (预期的)

2018年12月1日

研究注册日期

首次提交

2013年11月29日

首先提交符合 QC 标准的

2013年12月13日

首次发布 (估计)

2013年12月19日

研究记录更新

最后更新发布 (实际的)

2017年2月13日

上次提交的符合 QC 标准的更新

2017年2月10日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GoBack-001

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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