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Completed

NCT Number: NCT01918228

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

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

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Key information

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen Center for Back Research

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talks about what science says about LBP

Behavioral

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

Primary outcomes

  1. Functional Level

    Time frame: 12 months

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

  2. Sickness absence (analysed as work participation)

    Time frame: 12 months

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

Secondary outcomes

  1. No. of monthly healthcare visits

    Time frame: 12 months

    Number of monthly visits to any kind of healthcare provider

  2. Back beliefs

    Time frame: 5.5 months

    item 10 & 12-14 from the Back Beliefs Questionnaire

Other outcomes

  1. Overall Workability

    Time frame: 12 months

    single item from the Workability Index (WAI) numeric continuant variable,

  2. Bothersomeness last week

    Time frame: 12 months

    item 2 from the COMI (Deyo et al. 1998)

  3. Restricted activity last week

    Time frame: 12 months

    item 3 from the COMI (Deyo et al. 1998)

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • National Research Centre for the Working Environment, Denmark
  • University of Bergen
  • University of Huddersfield

Registry information

Official study title

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

Acronym: VRRPF

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Aug 7, 2013
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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