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

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Runi Blafoss, MSc, National Research Centre for the Working Environment, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

September 1, 2023

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 21, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IRMA21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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