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

Non-specific Low Back Pain Clinical Trial

— VRRPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918228
• Other study ID #: VRRPhDPF
• Secondary ID: PF2013
• Status: Completed
• Phase: N/A
• First received: April 25, 2013
• Last updated: August 22, 2017
• Start date: February 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2017
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: April 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Low Back Pain

Intervention

Behavioral:
• Talks about what science says about LBP
Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone

Locations

Country	Name	City	State
Denmark	Copenhagen Center for Back Research	Glostrup

Sponsors (4)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	National Research Centre for the Working Environment, Denmark, University of Bergen, University of Huddersfield

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Workability	single item from the Workability Index (WAI) numeric continuant variable,	12 months
Other	Bothersomeness last week	item 2 from the COMI (Deyo et al. 1998)	12 months
Other	Restricted activity last week	item 3 from the COMI (Deyo et al. 1998)	12 months
Primary	Functional Level	item 2 & 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable	12 months
Primary	Sickness absence (analysed as work participation)	item 5 in the COMI (Deyo et al. 1998)	12 months
Secondary	No. of monthly healthcare visits	Number of monthly visits to any kind of healthcare provider	12 months
Secondary	Back beliefs	item 10 & 12-14 from the Back Beliefs Questionnaire	5.5 months