Clinical trial NCT01918228: Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year.
Official title: Effect of an Educational Based Intervention on Danish Workers With Low Back Pain. A Randomized Controlled Single Blinded Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Low Back Pain
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: National Research Centre for the Working Environment, Denmark
name: University of Huddersfield
name: University of Bergen
First posted: 2013-08-07
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Functional Level
timeFrame: 12 months
measure: Sickness absence (analysed as work participation)
timeFrame: 12 months
Secondary outcomes:
measure: No. of monthly healthcare visits
timeFrame: 12 months
measure: Back beliefs
timeFrame: 5.5 months
Other outcomes:
measure: Overall Workability
timeFrame: 12 months
measure: Bothersomeness last week
timeFrame: 12 months
measure: Restricted activity last week
timeFrame: 12 months
Locations:
city: Glostrup
country: Denmark
facility: Copenhagen Center for Back Research
Study officials:
affiliation: Copenhagen Center for Back Research
name: Tom Bendix, Professor
role: STUDY_CHAIR
References: