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NCT04240184: IRMA21
Physical and Psychosocial Work Environmental Risk Factors of Low-back Pain
trial testing Physical workload in Musculoskeletal Disorders in 400 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | National Research Centre for the Working Environment, Denmark |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 400 |
| Start date | 1 September 2021 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Physical workload
Conditions studied
- Musculoskeletal Disorders — all drugs for Musculoskeletal Disorders →
- Stress — all drugs for Stress →
Sponsor
National Research Centre for the Working Environment, Denmark
Who can join
18 and older, any sex, with Musculoskeletal Disorders or Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Other National Research Centre for the Working Environment, Denmark trials
Trials by the same sponsor.
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- NCT03634410 — SeniorWorkingLife (Danish Title: SeniorArbejdsLiv) · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04240184 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Centre for the Working Environment, Denmark
- Last refreshed: 31 October 2022
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