Plain English Summary
Background and study aims
A high prevalence of work-related musculoskeletal disorders among elderly care workers has persisted over the years despite extensive efforts in primary prevention in Denmark. Thus, effective and feasible interventions for preventing low back pain (LBP) and reducing consequences of LBP remain to be found. Many single interventions have been carried out at workplaces to prevent and reduce LBP, but with a low success rate. This may be due to single interventions only addressing one aspect of the multi-factorial origin of LBP. Therefore, the main aim of this study is to examine whether a multifaceted worksite intervention among elderly care workers consisting of participatory ergonomics (applied science of equipment design, as for the workplace, intended to maximize productivity by reducing operator fatigue and discomfort.), physical exercise and cognitive behavioural training combined will prevent LBP and consequences of LBP such as pain-related influence on work and leisure activities and other long-term consequences of LBP (e.g. sickness absence and work ability).
Who can participate?
Both male and female elderly care workers will be invited to participate in the study if they are 18-65 years old. They may participate if they are currently working more than 20 hours a week. Elderly care workers with pain and elderly care workers without pain may participate.
What does the study involve?
The participants will be asked to answer questionnaires about work and health related factors as well as leisure time activities, perform a short health check, and participate in initiatives at their workplace consisting of participatory ergonomics, physical exercise and cognitive behavioural training. The participatory ergonomics will be carried out in small working groups in two workshops led by an ergonomist where they will discuss ergonomic problems and solutions. The working teams will participate in physical exercise one hour per week led by an instructor. The workers will also participate in two workshops consisting of cognitive behavioural training, where the main aim is to give tools to better cope with and to prevent pain. The participants will be divided into groups based on their working teams. Then they will be randomly assigned to one of four starting points 3 months apart, where they will begin the initiatives. Until they begin the initiatives, they will be considered a control group in order to better evaluate the results of the study. All participants will receive the same intervention initiatives.
What are the possible benefits and risks of participating?
The participants will gain knowledge about their own health and how to reduce the risk for LBP, prevent LBP and cope with LBP. Participation in the study involves no known risks.
Where is the study run from?
The study takes place in a municipality in Denmark, which is divided into nine geographical areas. In this study four of those areas will be participating. Each geographical area has between 1-5 nursing centers, giving a total of 13 participating centers. The nursing centers consist of approximately 53 working teams in total. The study is managed from The National Research Centre for the Working Environment in Copenhagen, Denmark.
When is the study starting and how long is it expected to run for?
The baseline testing began in November 2012 followed by a 3-month burn-in period. The intervention will begin in February 2013 and is anticipated to end in the spring of 2014. Recruiting of participants ended in November 2012. The participants will be involved in the initiatives at the worksite for the duration of approximately 18 months beginning in November 2012.
Who is funding the study?
The Danish Working Environment Research Fund.
Who is the main contact?
Miss Charlotte Diana Nørregaard Rasmussen
cnr@arbejdsmiljoforskning.dk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Charlotte Diana Nørregaard Rasmussen
ORCID ID
Contact details
Lersø Parkalle 105
Copenhagen
2100
Denmark
+45 3916 5466
cnr@arbejdsmiljoforskning.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A multifaceted intervention to prevent low back pain and its consequences among elderly care workers: A stepped-wedge cluster randomized controlled trial
Acronym
Study hypothesis
1. A 3-month multifaceted intervention among elderly care workers will reduce low back pain compared to a control group with no intervention.
2. A 3-month multifaceted intervention among elderly care workers pain-free at baseline will prevent low back pain compared to a control group with no intervention.
3. A 3-month multifaceted intervention among elderly care workers with pain at baseline will reduce consequences of low back pain compared to a control group with no intervention.
Ethics approval
Committees on Biomedical Research Ethics of the Capital Region of Denmark, 10/10/2012, ref: H-4-2012-115
Study design
Stepped-wedge cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Elderly care workers with and without low back pain
Intervention
Baseline testing will begin 01/11-2012, Intervention will begin 18/02/2013
The multifaceted intervention will consist of:
1. Participatory ergonomics
2. Physical exercise
3. Cognitive behavioural training
The intervention is an integrated intervention targeting pain and is tailored to the specific worksite through a modified intervention mapping approach, with participation from the organisation, leaders and employees.
The intervention consists of group activities with one hour of physical training per week, 2 workshops of participatory ergonomics and 2 workshops of cognitive behavioural training. The intervention lasts three months. Local instructors will conduct the intervention after training from researchers in the intervention activities and will follow a written manual. The intervention is followed by a sustainability phase where the activities are reduced to a maintenance level and without project funded instruction.
Control group/period:
While a group is in a control arm no other intervention is received.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. LBP is measured by days with and intensity of pain each month throughout the data collection period.
2. Consequences of pain among elderly care workers with pain at baseline measured by days with bothersomeness due to LBP each month throughout the data collection period. Because LBP is a fluctuating condition, monthly monitoring will be conducted by using mobile phone text messages. In addition to the frequent measuring of LBP, bothersomeness due to LBP will also be measured monthly by text messages.
Secondary outcome measures
1. Sickness absence due to LBP measured each month (Self-reported)
2. Work ability measured each 3 months
3. Occupational lifting and carrying measured each 3 months
4. Self-rated physical exertion measured each 3 months
5. Support from management measured each 3 months
Overall trial start date
18/02/2013
Overall trial end date
15/06/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female elderly care workers working more than 20 hours a week
2. Age 18 - 65 years old
3. Signed informed consent
4. Do not fulfill the exclusion criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The target number is 400 elderly care workers. Due to an expected drop-out of approximately 30 per cent, we plan to recruit approximately 560 workers.
Participant exclusion criteria
1. Unwilling to participate in the multifaceted intervention
2. Sick-listed (long-term)
Recruitment start date
18/02/2013
Recruitment end date
15/06/2015
Locations
Countries of recruitment
Denmark
Trial participating centre
Lersø Parkalle 105
Copenhagen
2100
Denmark
Sponsor information
Organisation
Danish Working Environment Research Fund (Denmark)
Sponsor details
Landskronagade 33
Copenhagen
2100
Denmark
+45 7012 1288
at@at.dk
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Danish Working Environment Research Fund (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Prevention Fund (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24261985
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24885476
Publication citations
-
Protocol
Rasmussen CD, Holtermann A, Mortensen OS, Søgaard K, Jørgensen MB, Prevention of low back pain and its consequences among nurses' aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial., BMC Public Health, 2013, 13, 1088, doi: 10.1186/1471-2458-13-1088.
-
Results
Rasmussen CD, Larsen AK, Holtermann A, Søgaard K, Jørgensen MB, Adoption of workplaces and reach of employees for a multi-faceted intervention targeting low back pain among nurses' aides, BMC Med Res Methodol, 2014, 14, 60, doi: 10.1186/1471-2288-14-60.