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.

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

Study Overview

• Status: Completed
• Conditions: Non-specific Low Back Pain
• Intervention / Treatment: Behavioral: Talks about what science says about LBP

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.

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Copenhagen Center for Back Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Talks about what science says about LBP; Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
No Intervention: Control group; No intervention will be provided by the study team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Level	item 2 & 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable	12 months
Sickness absence (analysed as work participation)	item 5 in the COMI (Deyo et al. 1998)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No. of monthly healthcare visits	Number of monthly visits to any kind of healthcare provider	12 months
Back beliefs	item 10 & 12-14 from the Back Beliefs Questionnaire	5.5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Workability	single item from the Workability Index (WAI) numeric continuant variable,	12 months
Bothersomeness last week	item 2 from the COMI (Deyo et al. 1998)	12 months
Restricted activity last week	item 3 from the COMI (Deyo et al. 1998)	12 months

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Collaborators: University of Bergen; National Research Centre for the Working Environment, Denmark; University of Huddersfield
• Investigators: Study Chair: Tom Bendix, Professor, Copenhagen Center for Back Research

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: VRRPhDPF; PF2013 (Registry Identifier: Pernille Frederiksen)