Condition category
Musculoskeletal Diseases
Date applied
11/10/2013
Date assigned
25/10/2013
Last edited
20/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Previous research suggests that continuing to work with a suitable workload is beneficial for people with muscular aches or depressive symptoms with regard to health, return to work and work retention in the long run. We will carry out a study to find out whether temporary work modifications are effective in helping workers with muscular pain or depressive symptoms to return to work or stay at work. The study's findings will give new knowledge about the possibilities of work modifications in enhancing recovery from musculoskeletal pain and depressive symptoms and the possibilities of enhancing return to work.

Who can participate?
Workers aged 18 to 60 who have sought medical advice in their occupational health service due to musculoskeletal pain or depressive symptoms will be invited to participate.

What does the study involve?
At the first stage of the study we will recruit workers and follow their symptoms and work disability for one year. At the second stage (intervention phase) seminars will be given to the participating occupational physicians about initiating temporary work modifications at the workplace. The physicians will then look carefully at the potential of temporary work modifications for eligible workers and initiate them when considered as beneficial.

What are the possible benefits and risks of participating?
Participating at the first stage does not involve benefits or risks to the worker. Participating at the second stage may improve recovery from pain or depressive symptoms. There is a possibility that the symptoms worsen if the work modifications are not adequate or you resume ordinary duties too early. In that case we will provide you a possibility to meet your doctor without delay.

Where is the study run from?
The study is from the Finnish Institute of Occupational Health, Finland.

When is the study starting and how long is it expected to run for?
The study starts in October 2013. Participants will be recruited until December 2015. However, we will follow the health and work disability of the participants over a one-year period.

Who is funding the study?
Funding has been provided by the Finnish Work Environment Fund (Finland) and the Academy of Finland (Finland).

Who is the main contact?
Professor Eira Viikari-Juntura
eira.viikari-juntura@ttl.fi

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eira Viikari-Juntura

ORCID ID

Contact details

Topeiuksenkatu 41 a A
Helsinki
00250
Finland
-
eira.viikari-juntura@ttl.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33713

Study information

Scientific title

Efficacy of temporary work modifications on disability related to musculoskeletal pain and depressive symptoms: a non-randomised controlled trial

Acronym

Study hypothesis

Our hypothesis is that continuing to work with a suitable workload is beneficial for subjects with musculoskeletal or depressive symptoms with regard to health outcomes, return to work and work retention at a longer perspective. Moreover, temporary modification of workload will enhance return to work and work retention in subjects with musculoskeletal or depressive symptoms.

Ethics approval

Coordinating Ethics Committee of Hospital District of Helsinki and Uusimaa, 19/03/2013, ref: 35/13/03/2013

Study design

Single-center controlled trial stepped-wedge design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Patient information in Finnish: http://www.ttl.fi/tyojarjestelyt

Condition

Musculoskeletal pain, depressive symptoms

Intervention

We will apply the stepped wedge design, in which a group of participating occupational physicians recruits patients first to the control group and then starts to recruit patients to the intervention. Participating occupational physicians are enrolled to the study in small groups, who are first taught about the principles of the study (when starting to enrol controls) and will later participate in interactive seminars about how to initiate workplace modifications and discuss them with the workplace (when starting to recruit subjects to the intervention). This design enables the recruitment of cases and controls with a short time interval and we can thereby minimise the effects of changes in the work or societal environment on the results of the intervention.

Temporary work modifications prescribed by the occupational physician, e.g. workplace adaptations, amended duties, altered work hours or a phased RTW. Work modifications can be prescribed for a maximum of 1 month per visit and for a maximum of 3 months per disease spell.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Sustained return to work (>4 weeks at work without a new sickness absence spell)
2. Total number of sickness absence days during 12 months following recruitment to the study

Secondary outcome measures

1. Intensity of musculoskeletal pain (VAS 0-10)
2. Interference of work (VAS 0-10) and sleep (VAS 0-10) by the pain and depressive symptoms (PHQ-9, http://www.terveysportti.fi), inquired via internet-based questionnaires at 0, 3, 6, 9 and 12 months after recruitment.

Overall trial start date

28/10/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Employees who seek medical advice in the occupational health service primarily due to musculoskeletal pain or depressive symptoms.
Specific inclusion criteria:
1. Age 18-60 years, male and female
2. Working full-time or nearly full-time (>30 hours per week)
3. Employed in current job for at least 4 months and employment likely to continue the following 12 months
4. Musculoskeletal pain (>4 on a scale of 0-10) or depressive symptoms (>1 positive response to two screening questions on depression (Arroll et al. BMJ. 2003 Nov 15;327(7424):1144-6)
5. Functional ability is not sufficient to perform current work tasks
6. Previous sickness absence <6 weeks during preceding 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Anticipated long absence from work during the following 12 months due to other reasons, e.g. pregnancy, studies, military service, alternation leave, absence due to other illness or its treatment (e.g. surgery, cytostatic therapy or radiation therapy)
2. Serious or acute disease requiring full sickness absence, e.g. febrile infection, active stage of inflammatory joint disease; serious mental disorder)
3. Other factors having significant effect on disability (e.g. serious conflict at the workplace, difficult personal life situation, current problem is due to a work accident, current insurance or workmen's compensation dispute, severe alcohol or drug dependency)

Recruitment start date

28/10/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Finland

Trial participating centre

Topeiuksenkatu 41 a A
Helsinki
00250
Finland

Sponsor information

Organisation

The Finnish Work Environment Fund (Finland)

Sponsor details

Annankatu 34-36 B
Helsinki
FI-00100
Finland
-
info@tsr.fi

Sponsor type

Government

Website

http://www.tsr.fi

Funders

Funder type

Government

Funder name

Finnish Work Environment Fund (Finland) (ref. 112257)

Alternative name(s)

Finnish Work Environment Fund

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Finland

Funder name

Academy of Finland (Finland) (ref. 267589)

Alternative name(s)

Academy of Finland

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Finland

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25986643

Publication citations

Additional files

Editorial Notes