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

NCT ID: NCT01918228

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 505 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-04-30

Brief Summary

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

Detailed Description

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.

Conditions

Non-specific Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Talks about what science says about LBP

Intervention Type: BEHAVIORAL

Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone

Control group

No intervention will be provided by the study team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Talks about what science says about LBP

Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Centre for the Working Environment, Denmark

OTHER_GOV

Sponsor Role: collaborator

University of Huddersfield

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Pernille Frederiksen

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tom Bendix, Professor

Role: STUDY_CHAIR

Copenhagen Center for Back Research

Locations

Copenhagen Center for Back Research

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

PF2013

Identifier Type: REGISTRY

Identifier Source: secondary_id

VRRPhDPF

Identifier Type: -

Identifier Source: org_study_id