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临床试验/NCT01918228
NCT01918228已完成不适用

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

Glostrup University Hospital, Copenhagen2 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
505
试验地点
2
主要终点
Functional Level

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • employed at one of the participating municipal workplaces

排除标准

  • 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

研究组 & 干预措施

Intervention group

Experimental

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.

干预措施: Talks about what science says about LBP (Behavioral)

Control group

No Intervention

No intervention will be provided by the study team.

结局指标

主要结局

Functional Level

时间窗: 12 months

item 2 \& 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable

Sickness absence (analysed as work participation)

时间窗: 12 months

item 5 in the COMI (Deyo et al. 1998)

次要结局

  • No. of monthly healthcare visits(12 months)
  • Back beliefs(5.5 months)

研究者

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

Pernille Frederiksen

PhD Student

Glostrup University Hospital, Copenhagen

研究点 (2)

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