Condition category
Musculoskeletal Diseases
Date applied
09/12/2019
Date assigned
30/12/2019
Last edited
16/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Musculoskeletal disorders (health problems related to bones, muscles, joints etc) that have been caused by work are a common reason for sick leave from work. Musculoskeletal disorders of all causes were responsible for between 2 and 3 of every 10 days absent from work in 2017/2018 in the Netherlands, Germany and the UK. Long-term work-related overloading and stressing of the body can cause problems with posture, pain, imbalance between the two legs and changes to gait (walking pattern). This study aims to investigate whether certain musculoskeletal disorders are more common in certain jobs.

Who can participate?
Women and men in selected professions (orchestra musicians, office workers, fitness instructors, physiotherapists, nurses, midwives, dentists, hairdressers, teachers and IT specialists), who have been working in the profession for at least 5 years.

What does the study involve?
Each person will visit the research team once only. They will have certain physical measurements taken to assess the symmetry of their spine and body and the way they walk (gait). They will also fill in questionnaires about their level of physical activity, pain, the effect of low back pain on their life and their quality of life.

What are the possible benefits and risks of participating?
Participants might benefit from learning about their posture, causes of pain and ways to prevent problems. This is an observational study, which means the study is not assigning a treatment to the participants, so there is no risk associated with the study treatment.

Where is the study run from?
University of Opole (Poland)

When is the study starting and how long is it expected to run for?
November 2018 to December 2021

Who is funding the study?
University of Opole (Poland)

Who is the main contact?
1. Dr Antonina Kaczorowska, antonina.kaczorowska@uni.opole.pl
2. Dr Agata Mroczek, agata.mroczek@uni.opole.pl
3. Dr Ewelina Lepsy, ewelina.lepsy@uni.opole.pl

Trial website

https://uni.opole.pl/

Contact information

Type

Public

Primary contact

Dr Antonina Kaczorowska

ORCID ID

https://orcid.org/0000-0002-0488-8583

Contact details

University of Opole
Kopernika Square 11a
Opole
45-040
Poland
+48 (0)774423546
antonina.kaczorowska@uni.opole.pl

Type

Scientific

Additional contact

Dr Agata Mroczek

ORCID ID

https://orcid.org/0000-0002-5246-0792

Contact details

University of Opole
Kopernika Square 11a
Opole
45-040
Poland
+48 (0)774423546
agata.mroczek@uni.opole.pl

Type

Scientific

Additional contact

Dr Ewelina Lepsy

ORCID ID

https://orcid.org/0000-0003-3663-9888

Contact details

University of Opole
Kopernika Square 11a
Opole
45-040
Poland
+48 (0)774423546
ewelina.lepsy@uni.opole.pl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

KB/130/FI/2018

Study information

Scientific title

The analysis of work-related musculoskeletal disorders in selected occupations.

Acronym

Study hypothesis

1. Long-term work with heavy load causes pain and overloading of the musculoskeletal system.
2. Long-term work in an occupation with asymmetric load causes posture defects and scoliosis and the differences in load of lower limbs.
3. Long-lasting work in an occupation with asymmetrical load causes asymmetry of gait.
4. Properly conducted physical activity improves posture and gait and reduces pain.

Ethics approval

Current ethics approval as of 06/02/2020:
1. Approved 04/12/2018, Opole Medical School Research Ethics Committee (68 Katowicka Street; Opole 45-065, Poland; +48 774410882; biurorektora@wsm.opole.pl), ref: KB/130/FI/2018
2. Extended by 06/02/2020 to include other professions as well as musicians, Opole Medical School Research Ethics Committee (68 Katowicka Street; Opole 45-065, Poland; +48 774410882; biurorektora@wsm.opole.pl), ref: KB/240/FI/2020


Previous ethics approval:
Approved 04/12/2018, Opole Medical School Research Ethics Committee (68 Katowicka Street; Opole 45-065, Poland; +48 774410882; biurorektora@wsm.opole.pl), ref: KB/130/FI/2018

Study design

Cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Screening

Patient information sheet

Information for participants can be found on the following website: https://wnoz.uni.opole.pl/projekty-badawcze/

Condition

Musculoskeletal disorders

Intervention

The research is observational and cross-sectional. Each person will be examined only once. There will be no remeasurements or follow up.

There will be no randomization. The representatives of selected jobs - 12 groups of 30 people each - will be examined: musicians (violinists, cellists and musicians playing symmetrical instruments), office workers, fitness instructors, physiotherapists, nurses, midwives, dentists, hairdressers, academic teachers, IT (computer) specialists.

Each person will be measured: torso rotation angle measured using a Bunnell scoliometer, distribution of the body's centre of gravity assessed using a posturography platform , difference between the load of lower limbs assessed using the two weight test, gait parameters using a gait track for gait analysis, physical activity assessed using the International Physical Activity Questionnaire (IPAQ) questionnaire, quality of life assessed using the WHOQOL-BREF scale, disability related to low back pain assessed using the Oswestry Disability Index, effect of low back pain on daily functioning assessed using the Roland–Morris Disability Questionnaire. In addition, the participants will assess their pain using a visual analogue scale and a self-reported questionnaire.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Pain assessed using a visual analogue scale
2. Duration of pain assessed using a self-reported questionnaire
3. Pain severity assessed using a self-reported questionnaire
4. Pain frequency assessed using a self-reported questionnaire
5. Pain location assessed using a self-reported questionnaire
6. Quality of life assessed using the WHOQOL-BREF scale
7. Disability related to low back pain assessed using the Oswestry Disability Index
8. Effect of low back pain on daily functioning assessed using the Roland–Morris Disability Questionnaire

Secondary outcome measures

1. Torso rotation angle measured using a Bunnell scoliometer
2. Distribution of the body's centre of gravity assessed using a posturography platform
3. Difference between the load of lower limbs assessed using the two weight test
4. Gait parameters using a gait track for gait analysis
5. Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) questionnaire

Overall trial start date

05/11/2018

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Representatives of selected professions: musicians, office workers, fitness instructors, physiotherapists, nurses, midwifes, dentists, hairdressers, academic teachers, IT (computer) specialists.
2. Minimum 5 years of work experience

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Infections
2. Acute injuries
3. Balance system and motor control disorders
4. Cancer
5. Pregnancy
6. Chronic wounds

Recruitment start date

07/01/2020

Recruitment end date

31/08/2021

Locations

Countries of recruitment

Poland

Trial participating centre

University of Opole
Kopernika Square 11a
Opole
45-040
Poland

Sponsor information

Organisation

Opole University

Sponsor details

Kopernika Square 11a
Opole
45-040
Poland
+48(0)77 44 23 524
snw@wsm.opole.pl

Sponsor type

University/education

Website

https://uni.opole.pl/

Funders

Funder type

University/education

Funder name

Opole University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in peer-reviewed journals.

IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication.

Intention to publish date

15/04/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/11/2020: The trial website, participant information sheet link, trial participating centre, plain English summary, contact details, sponsor details and funder were all updated to change the institution from Opole Medical School to University of Opole. 09/04/2020: Due to current public health guidance, recruitment for this study has been paused. 06/02/2020: The ethics approval has been updated. 12/12/2019: Trial's existence confirmed by Opole Medical School Research Ethics Committee.