Clinical trial NCT04240184: Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain
Official title: Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Disorders
Stress
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: University of Southern Denmark
First posted: 2020-01-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).


Eligibility criteria: 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

Primary outcomes:
measure: Short-term LBP
timeFrame: 21 days
measure: Accumulated workdays and LBP
timeFrame: 21 days
measure: Long-term LBP
timeFrame: 1 year
Secondary outcomes:
measure: Psychosocial influence on LBP
timeFrame: 21 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Research Centre for the Working Environment
Study officials:
affiliation: National Research Centre for the Working Environment, Denmark
name: Lars L Andersen, PhD
role: STUDY_DIRECTOR
affiliation: National Research Centre for the Working Environment, Denmark
name: Runi Blafoss, MSc
role: PRINCIPAL_INVESTIGATOR
References: