Efficacy of temporary work modifications on disability related to musculoskeletal pain and depressive symptoms

ISRCTN ISRCTN74743666
DOI https://doi.org/10.1186/ISRCTN74743666
Secondary identifying numbers 33713
Submission date
11/10/2013
Registration date
25/10/2013
Last edited
27/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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?
Finnish Institute of Occupational Health (Finland)

When is the study starting and how long is it expected to run for?
October 2013 to December 2017

Who is funding the study?
1. Finnish Work Environment Fund (Finland)
2. Academy of Finland (Finland)

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

Contact information

Prof Eira Viikari-Juntura
Scientific

Finnish Institute of Occupational Health
PL 40
Helsinki
00251
Finland

Email eira.viikari-juntura@ttl.fi

Study information

Study designSingle-center controlled trial stepped-wedge design
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeQuality of life
Participant information sheet Patient information in Finnish: http://www.ttl.fi/tyojarjestelyt
Scientific titleEfficacy of temporary work modifications on disability related to musculoskeletal pain and depressive symptoms: a non-randomised controlled trial
Study objectivesOur 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(s)Coordinating Ethics Committee of Hospital District of Helsinki and Uusimaa, 19/03/2013, ref: 35/13/03/2013
Health condition(s) or problem(s) studiedMusculoskeletal pain, depressive symptoms
InterventionWe 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date28/10/2013
Completion date31/12/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants600
Key inclusion criteriaEmployees 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
Key exclusion criteria1. 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)
Date of first enrolment28/10/2013
Date of final enrolment30/11/2016

Locations

Countries of recruitment

  • Finland

Study participating centre

Finnish Institute of Occupational Health
PL 40
Helsinki
00251
Finland

Sponsor information

The Finnish Work Environment Fund (Finland)
Government

Annankatu 34-36 B
Helsinki
FI-00100
Finland

Email info@tsr.fi
Website http://www.tsr.fi
ROR logo "ROR" https://ror.org/02v046k89

Funders

Funder type

Government

Finnish Work Environment Fund (Finland) (ref. 112257)
Government organisation / National government
Alternative name(s)
Finnish Work Environment Fund, Työsuojelurahasto Arbetarskyddsfonden, Työsuojelurahasto | Helsinki
Location
Finland
Academy of Finland (Finland) (ref. 267589)
Government organisation / Universities (academic only)
Alternative name(s)
Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
Location
Finland

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planOne international peer-reviewed paper will be published on the main results.

27/04/2018: 2017 results in https://www.tsr.fi/documents/20181/478409/112257-loppuraportti-Tilap+Ty%C3%B6j%C3%A4rj+TSR+Loppuraportti+21.12.2017+FINAL.pdf
IPD sharing planThe datasets generated will not be made publicly available due to sensitivity of the data and the small number of participants.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 18/05/2015 Yes No

Editorial Notes

27/04/2018: Online report added to publication and dissemination plan.
08/12/2016: The overall trial end date has been updated from 31/12/2015 to 31/12/2017 and the recruitment end date has been updated from 31/12/2015 to 30/11/2016. In addition, the availability of participant level data and publication and dissemination plan has been added.