Condition category
Musculoskeletal Diseases
Date applied
24/01/2013
Date assigned
21/02/2013
Last edited
22/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.arbejdstilsynet.dk

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24261985
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24885476

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes