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

Stress Clinical Trial

— IRMA21  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240184
• Other study ID #: IRMA21
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2022
• Source: National Research Centre for the Working Environment, Denmark
• Contact: Runi Blafoss, MSc
• Phone: 39165200
• Email: rub[@]nfa.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 1, 2023
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Musculoskeletal Diseases
• Musculoskeletal Disorders
• Stress

Intervention

Other:
• Physical workload
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.

Locations

Country	Name	City	State
Denmark	National Research Centre for the Working Environment	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
National Research Centre for the Working Environment, Denmark	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term LBP	exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP	21 days
Primary	Accumulated workdays and LBP	the influence of accumulated workdays and rest days during a working week on LBP	21 days
Primary	Long-term LBP	Long-term association between occupational lifting exposure and LBP when assessed over 1 year	1 year
Secondary	Psychosocial influence on LBP	The role of psychological and social factors on outcome 1, 2 and 3	21 days