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.
2 other identifiers
interventional
505
1 country
1
Brief Summary
RCT study of the effect of an educational-based intervention on low back pain-related outcomes concerning beliefs and behaviour.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 25, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedAugust 23, 2017
August 1, 2017
1.6 years
April 25, 2013
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
No. of monthly healthcare visits
12 months
Back beliefs
5.5 months
Other Outcomes (3)
Overall Workability
12 months
Bothersomeness last week
12 months
Restricted activity last week
12 months
Study Arms (2)
Intervention group
EXPERIMENTALTalks 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.
Control group
NO INTERVENTIONNo intervention will be provided by the study team.
Interventions
Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
Eligibility Criteria
You may qualify if:
- employed at one of the participating municipal workplaces
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glostrup University Hospital, Copenhagenlead
- National Research Centre for the Working Environment, Denmarkcollaborator
- University of Huddersfieldcollaborator
- University of Bergencollaborator
Study Sites (1)
Copenhagen Center for Back Research
Glostrup Municipality, 2600, Denmark
Study Officials
- STUDY CHAIR
Tom Bendix, Professor
Copenhagen Center for Back Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
April 25, 2013
First Posted
August 7, 2013
Study Start
February 1, 2013
Primary Completion
September 1, 2014
Study Completion
April 1, 2016
Last Updated
August 23, 2017
Record last verified: 2017-08