- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04240184
Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain (IRMA21)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Runi Blafoss, MSc
- Phone Number: 0045 39165200
- Email: rub@nfa.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Recruiting
- National Research Centre for the Working Environment
-
Contact:
- Lars L Andersen, PhD
- Phone Number: 0045 39165319
- Email: lla@nrcwe.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- working ≥30 h per week in a registered retail industry warehouse
- ability to read and understand Danish or English,
- ≥18 years of age.
Exclusion Criteria:
- Hypertension > 160/100 mmHg
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short-term LBP
Time Frame: 21 days
|
exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP
|
21 days
|
Accumulated workdays and LBP
Time Frame: 21 days
|
the influence of accumulated workdays and rest days during a working week on LBP
|
21 days
|
Long-term LBP
Time Frame: 1 year
|
Long-term association between occupational lifting exposure and LBP when assessed over 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial influence on LBP
Time Frame: 21 days
|
The role of psychological and social factors on outcome 1, 2 and 3
|
21 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Runi Blafoss, MSc, National Research Centre for the Working Environment, Denmark
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRMA21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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