Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year. (VRRPF)
Effect of an Educational Based Intervention on Danish Workers With Low Back Pain. A Randomized Controlled Single Blinded Study.
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Glostrup、丹麦、2600
- Copenhagen Center for Back Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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.
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Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
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无干预:Control group
No intervention will be provided by the study team.
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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
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item 2 & 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable
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12 months
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Sickness absence (analysed as work participation)
大体时间:12 months
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item 5 in the COMI (Deyo et al. 1998)
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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No. of monthly healthcare visits
大体时间:12 months
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Number of monthly visits to any kind of healthcare provider
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12 months
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Back beliefs
大体时间:5.5 months
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item 10 & 12-14 from the Back Beliefs Questionnaire
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5.5 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Workability
大体时间:12 months
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single item from the Workability Index (WAI) numeric continuant variable,
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12 months
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Bothersomeness last week
大体时间:12 months
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item 2 from the COMI (Deyo et al. 1998)
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12 months
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Restricted activity last week
大体时间:12 months
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item 3 from the COMI (Deyo et al. 1998)
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12 months
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合作者和调查者
合作者
调查人员
- 学习椅:Tom Bendix, Professor、Copenhagen Center for Back Research
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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