Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year. (VRRPF)
Primary Purpose
Non-specific Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Talks about what science says about LBP
Sponsored by
About this trial
This is an interventional prevention trial for Non-specific Low Back Pain
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
Sites / Locations
- Copenhagen Center for Back Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
No intervention will be provided by the study team.
Outcomes
Primary Outcome Measures
Functional Level
item 2 & 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable
Sickness absence (analysed as work participation)
item 5 in the COMI (Deyo et al. 1998)
Secondary Outcome Measures
No. of monthly healthcare visits
Number of monthly visits to any kind of healthcare provider
Back beliefs
item 10 & 12-14 from the Back Beliefs Questionnaire
Full Information
NCT ID
NCT01918228
First Posted
April 25, 2013
Last Updated
August 22, 2017
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
National Research Centre for the Working Environment, Denmark, University of Huddersfield, University of Bergen
1. Study Identification
Unique Protocol Identification Number
NCT01918228
Brief Title
Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year.
Acronym
VRRPF
Official Title
Effect of an Educational Based Intervention on Danish Workers With Low Back Pain. A Randomized Controlled Single Blinded Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
National Research Centre for the Working Environment, Denmark, University of Huddersfield, University of Bergen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
505 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be provided by the study team.
Intervention Type
Behavioral
Intervention Name(s)
Talks about what science says about LBP
Intervention Description
Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
Primary Outcome Measure Information:
Title
Functional Level
Description
item 2 & 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable
Time Frame
12 months
Title
Sickness absence (analysed as work participation)
Description
item 5 in the COMI (Deyo et al. 1998)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
No. of monthly healthcare visits
Description
Number of monthly visits to any kind of healthcare provider
Time Frame
12 months
Title
Back beliefs
Description
item 10 & 12-14 from the Back Beliefs Questionnaire
Time Frame
5.5 months
Other Pre-specified Outcome Measures:
Title
Overall Workability
Description
single item from the Workability Index (WAI) numeric continuant variable,
Time Frame
12 months
Title
Bothersomeness last week
Description
item 2 from the COMI (Deyo et al. 1998)
Time Frame
12 months
Title
Restricted activity last week
Description
item 3 from the COMI (Deyo et al. 1998)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Bendix, Professor
Organizational Affiliation
Copenhagen Center for Back Research
Official's Role
Study Chair
Facility Information:
Facility Name
Copenhagen Center for Back Research
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year.
We'll reach out to this number within 24 hrs