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Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year. (VRRPF)

2017年8月22日 更新者:Pernille Frederiksen、Glostrup University Hospital, Copenhagen

Effect of an Educational Based Intervention on Danish Workers With Low Back Pain. A Randomized Controlled Single Blinded Study.

RCT study of the effect of an educational-based intervention on low back pain-related outcomes concerning beliefs and behaviour.

研究概览

详细说明

Previous studies have strongly implied that information is a valuable means for people suffering from LBP in terms of coping appropriately. Most studies have tested the effect of information as part of a multimodal intervention.

Four Nordic studies testing the effect of 'reassuring information' based on the 'Functional Disturbance'-model (proposed by Indahl et al. 1999 - also called the 'non-injury'-model) have all been effective at positively altering the functional level and/or days of sickness absence - when provided in combination with other elements to people with subacute/chronic back pain. The present study set out to test the effect of this kind of resassuring information alone.

Between November 2012 and September 2013, we included app. 500 municipal workers perfoming either manual work, administrative work or a combination of the two. Participants worked in 5 different municipal workplaces. These workplaces were characterized by being devided into 'natural working unit', which had no or very little daily contact. All 5 workplaces participated with at least 2 units. Thus 11 units contributed to the data. Baseline assessment took place during right upon recruitment prior to randomization.

We cluster-randomized the 11 units into an intervention and a control group using a simple stepwise randomization-metod.

The intervention group received two 45-minute lectures at the workplace with an interval of 2 weeks. The lectures were coherent allthough different. They consisted of information on the scientific knowledge on the etiology of LBP, basic anatomy, common myths about LBP, a theory of non-specific LBP being caused by muscular functional disturbances (Indahl 1999), pain physiology, and scientific knowledge on seemingly appropriate coping strategies to prevent a prolonged course. Emphasis was made to reduce pain-related fear of movement and catastrophizing thoughts and beliefs. Instead, activity during pain episodes was promoted as well as a natural use of the back despite pain. A non-directive approach was used (non-imperativ wording and absence of giving advice). The purpose was to provide information but let the participant make their own conclusions on how and if to use the information in present/future coping with pain.

In addition to the lecture, the intervention group participants were provided with a leaflet showing various relevenat stretching exercises (back and related muscles) and they were offered the option to make a call to the primary investigator in case any questions would arise subsequently.

The control group was untreated by us. Both groups had access to all 'usual' help (workplace, general practitioner etc).

Upon completion of the lectures, twelve monthly assessments were conducted using Text Messaging (SMS). During each assessment, participants answered questions on no. of LBP days, no. of LBP-related cutdown days, no. of LBP-related sick days, no. of LBP-related healthcare visits, overall workability, bothersomeness last week, restricted activity last week, and use of pain medicine or degree of sadness/depression.

In addition, a separate assessment was performed at app. 5.5 monts to obtain responses on back beliefs.

The data collection was completed in 2014. Analysis are nearly finished. The sicentific paper on the study is anticipated to take place in the beginning of 2016.

研究类型

介入性

注册 (实际的)

505

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

      • Glostrup、丹麦、2600
        • Copenhagen Center for Back Research

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 72年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

-employed at one of the participating municipal workplaces

Exclusion Criteria:

  • pregnancy within the first 6 months of the study
  • physical or mental disease that has significant impact on the individual in terms of pain (eg. Rheumathoid disease, clinical depression)
  • present cancer disease (risk of metastasis)
  • planned stop at the workplace within the first 6 months of the study

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:预防
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention group
Talks on scientific status on back pain with the purpose of reducing LBP-related insecurity/fear, reducing the focus on the pain and providing participants with alternative explanation to their LBP. They were also provided with a folder (general stretching exercises) and had telephone access to health professional if they had questions about LBP during the follow-up year.
Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
无干预:Control group
No intervention will be provided by the study team.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional Level
大体时间:12 months
item 2 & 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable
12 months
Sickness absence (analysed as work participation)
大体时间:12 months
item 5 in the COMI (Deyo et al. 1998)
12 months

次要结果测量

结果测量
措施说明
大体时间
No. of monthly healthcare visits
大体时间:12 months
Number of monthly visits to any kind of healthcare provider
12 months
Back beliefs
大体时间:5.5 months
item 10 & 12-14 from the Back Beliefs Questionnaire
5.5 months

其他结果措施

结果测量
措施说明
大体时间
Overall Workability
大体时间:12 months
single item from the Workability Index (WAI) numeric continuant variable,
12 months
Bothersomeness last week
大体时间:12 months
item 2 from the COMI (Deyo et al. 1998)
12 months
Restricted activity last week
大体时间:12 months
item 3 from the COMI (Deyo et al. 1998)
12 months

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

  • 学习椅:Tom Bendix, Professor、Copenhagen Center for Back Research

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

2013年2月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2016年4月1日

研究注册日期

首次提交

2013年4月25日

首先提交符合 QC 标准的

2013年8月5日

首次发布 (估计)

2013年8月7日

研究记录更新

最后更新发布 (实际的)

2017年8月23日

上次提交的符合 QC 标准的更新

2017年8月22日

最后验证

2017年8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

  • VRRPhDPF
  • PF2013 (注册表标识符:Pernille Frederiksen)

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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