IRMA21: Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain

Sponsor
National Research Centre for the Working Environment, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04240184
Collaborator
University of Southern Denmark (Other)
400
1
24
16.7

Study Details

Study Description

Brief 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. 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Physical workload

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Short-term LBP [21 days]

    exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP

  2. Accumulated workdays and LBP [21 days]

    the influence of accumulated workdays and rest days during a working week on LBP

  3. Long-term LBP [1 year]

    Long-term association between occupational lifting exposure and LBP when assessed over 1 year

Secondary Outcome Measures

  1. Psychosocial influence on LBP [21 days]

    The role of psychological and social factors on outcome 1, 2 and 3

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Research Centre for the Working Environment Copenhagen Denmark 2100

Sponsors and Collaborators

  • National Research Centre for the Working Environment, Denmark
  • University of Southern Denmark

Investigators

  • Study Director: Lars L Andersen, PhD, National Research Centre for the Working Environment, Denmark
  • Principal Investigator: Runi Blafoss, MSc, National Research Centre for the Working Environment, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier:
NCT04240184
Other Study ID Numbers:
  • IRMA21
First Posted:
Jan 27, 2020
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021