Musculoskeletal DisordersIRMA21NCT04240184
Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain
An observational study of Musculoskeletal Disorders and Stress, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
BACKGROUND: Musculoskeletal disorders, and in particular low-back pain (LBP), are common among blue collar workers. In the work environment, both physical- and psychosocial risk factors exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Disorders, Stress
- What is being tested?
- Physical workload
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Enrolled study participants will receive a baseline questionnaire by e-mail that will address various aspects of physical-, psychological and social work environment and health. The questionnaire will also comprise an invitation to participate in a text message survey. Participants recruited for the text message survey will receive a SMS text message before and after every workday for 3 full weeks (21 days) to rate the magnitude of pain in their low back, and to score their current level of perceived physical fatigue and mental stress. During the same 3-week study period, section leaders at the warehouses will provide company records about the workload of each participating warehouse worker (goods handled by each worker, weight of the goods) along with a working schedule for each worker. One year after responding to the baseline questionnaire, the participant will be receiving a follow-up questionnaire
Who may be able to join
- working ≥30 h per week in a registered retail industry warehouse
- ability to read and understand Danish or English,
- ≥18 years of age.
Who cannot join
- Hypertension > 160/100 mmHg
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
National Research Centre for the Working Environment
Copenhagen, 2100
Lars L Andersen, PhD, 39165319 ext. 0045, lla@nrcwe.dk
About this study
BACKGROUND:
Musculoskeletal disorders, and in particular low-back pain (LBP), are common among blue collar workers. In the work environment, both physical- and psychosocial risk factors exist. Working in warehouses in Denmark involve large quantities of occupational lifting, high work pace and a low degree of influence at work. This study investigates both acute and long-term associations between physical- and psychosocial work environmental factors and risk of LBP in warehouse workers. The specific study aims are to investigate 1) exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP, 2) the influence of accumulated workdays and rest days during a working week on LBP, 3) long-term association between occupational lifting exposure and LBP when assessed over 1 year, and 4) the role of psychological and social factors on the above associations.
Read more
METHODS:
The present study is designed as a 1-year prospective cohort study that will examine full-time warehouse workers from up to five retail chains in Denmark. Study aims 1 and 2 will be addressed using objective data based on company records with information on weight of all the goods handled by each warehouse worker during every single workday for 3 weeks. During this period, each worker will reply to text messages received before and after every workday (also on days off work) in which study participants will score their pain in the low back, bodily fatigue and perceived mental stress (scale 0-10). Long-term pain development is assessed using questionnaire surveys before and after 1 year. Further, pressure pain threshold (PPT) will be measured for selected trunk extensor muscles in approximately 50 workers using algometry along with measurements of maximal trunk extensor strength. Associations are modelled using linear mixed models with repeated measures between variables and LBP controlled for relevant confounders.
DISCUSSION:
This study provides knowledge about the acute and long-term associations between physical- and psychosocial work environmental factors and LBP. The obtained data will have the potential to provide recommendations on improved design of the working week to minimize the risk of LBP among warehouse workers, and may potentially enable to identify a reasonable maximum lifting threshold per day (ton lifted/day).
- Conditions
- Musculoskeletal Disorders, Stress
- Being tested
- Physical workload
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical workloadOther
Cohort study - The specific study aims are to investigate 1) exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP, 2) the influence of accumulated workdays and rest days during a working week on LBP, 3) long-term association between occupational lifting exposure and LBP when assessed over 1 year, and 4) the role of psychological and social factors on the above associations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term LBP
exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP
Measured: 21 days
Accumulated workdays and LBP
the influence of accumulated workdays and rest days during a working week on LBP
Measured: 21 days
Long-term LBP
Long-term association between occupational lifting exposure and LBP when assessed over 1 year
Measured: 1 year
Secondary outcomes (1)
Psychosocial influence on LBP
The role of psychological and social factors on outcome 1, 2 and 3
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Sep 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Lars L Andersen, PhD, Study director, National Research Centre for the Working Environment, DenmarkRuni Blafoss, MSc, Principal investigator, National Research Centre for the Working Environment, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240184
- Sponsor's protocol ID
- IRMA21
- Acronym
- IRMA21
- Status last verified
- Oct 2022
- First submitted
- 21 Jan 2020
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain
- ClinicalTrials.gov ID
- NCT04240184
- Acronym / sponsor ID
- IRMA21 / IRMA21
- Conditions
- Musculoskeletal Disorders, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- University of Southern Denmark
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND:
Musculoskeletal disorders, and in particular low-back pain (LBP), are common among blue collar workers. In the work environment, both physical- and psychosocial risk factors exist. Working in warehouses in Denmark involve large quantities of occupational lifting, high work pace and a low degree of influence at work. This study investigates both acute and long-term associations between physical- and psychosocial work environmental factors and risk of LBP in warehouse workers. The specific study aims are to investigate 1) exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP, 2) the influence of accumulated workdays and rest days during a working week on LBP, 3) long-term association between occupational lifting exposure and LBP when assessed over 1 year, and 4) the role of psychological and social factors on the above associations.
METHODS:
The present study is designed as a 1-year prospective cohort study that will examine full-time warehouse workers from up to five retail chains in Denmark. Study aims 1 and 2 will be addressed using objective data based on company records with information on weight of all the goods handled by each warehouse worker during every single workday for 3 weeks. During this period, each worker will reply to text messages received before and after every workday (also on days off work) in which study participants will score their pain in the low back, bodily fatigue and perceived mental stress (scale 0-10). Long-term pain development is assessed using questionnaire surveys before and after 1 year. Further, pressure pain threshold (PPT) will be measured for selected trunk extensor muscles in approximately 50 workers using algometry along with measurements of maximal trunk extensor strength. Associations are modelled using linear mixed models with repeated measures between variables and LBP controlled for relevant confounders.
DISCUSSION:
This study provides knowledge about the acute and long-term associations between physical- and psychosocial work environmental factors and LBP. The obtained data will have the potential to provide recommendations on improved design of the working week to minimize the risk of LBP among warehouse workers, and may potentially enable to identify a reasonable maximum lifting threshold per day (ton lifted/day).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Enrolled study participants will receive a baseline questionnaire by e-mail that will address various aspects of physical-, psychological and social work environment and health. The questionnaire will also comprise an invitation to participate in a text message survey. Participants recruited for the text message survey will receive a SMS text message before and after every workday for 3 full weeks (21 days) to rate the magnitude of pain in their low back, and to score their current level of perceived physical fatigue and mental stress. During the same 3-week study period, section leaders at the warehouses will provide company records about the workload of each participating warehouse worker (goods handled by each worker, weight of the goods) along with a working schedule for each worker. One year after responding to the baseline questionnaire, the participant will be receiving a follow-up questionnaire
Key inclusion criteria (3 listed)
- working ≥30 h per week in a registered retail industry warehouse
- ability to read and understand Danish or English,
- ≥18 years of age.
Key exclusion criteria (1 listed)
- Hypertension > 160/100 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical workloadCohort study - The specific study aims are to investigate 1) exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP, 2) the influence of accumulated workdays and rest days during a working week on LBP, 3) long-term association between occupational lifting exposure and LBP when assessed over 1 year, and 4) the role of psychological and social factors on the above associations. | Other | – |
Primary outcome
Short-term LBP
Time frame: 21 days
exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP
Accumulated workdays and LBP
Time frame: 21 days
the influence of accumulated workdays and rest days during a working week on LBP
Long-term LBP
Time frame: 1 year
Long-term association between occupational lifting exposure and LBP when assessed over 1 year
1 secondary outcome
Psychosocial influence on LBP
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars L Andersen, PhD study director
National Research Centre for the Working Environment, Denmark
Runi Blafoss, MSc principal investigator
National Research Centre for the Working Environment, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Disorders and Stress, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Runi Blafoss, MSc (39165200 ext. 0045, rub@nfa.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term LBP (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.