Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060152) titled 'Effectiveness of a Multicomponent Intervention Approach for the Prevention of Low Back Pain in the Land Freight Transportation Industry' on Dec. 21.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - University of Occupational and Environmental Health, Japan
Condition:
Condition - Low Back Pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In occupational health practice, preventive measures have predominantly focused on individual-level interventions, while insufficient attention has been paid to physical and social factors that require organizational-level responses. In many other countries, low back pain risk assessment tools such as ISO 11228-1 have been widely adopted, and systematic management of manual material handling tasks has been promoted.
In Japan, we have played a central role in the development of the corresponding Japanese Industrial Standard (JIS Z 8505-1) based on ISO 11228-1, which was officially promulgated by ministerial notification in January 2025. However, research on organizational-level intervention approaches in the transportation industry is still at an early stage, and evidence from intervention studies remains limited.
Therefore, the present study aims to evaluate the effectiveness of an organizationally implemented multicomponent intervention approach targeting the transportation industry by conducting a cluster non-randomized controlled trial (CNRCT) involving workers from multiple worksites.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Workplace Improvement Approach Using Digital Health Technologies (DHTs)
Interventions/Control_2 - Tailor-Made Interventions Incorporating Personal Indicators (PI)
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Workers (full-time employees, dispatched workers, and hourly paid staff) employed at private transportation company worksites participating in an industry -government- academia collaborative consortium.
2. Age: adults of working age (18 to 64 years).
3. Sex: no restriction.
Key exclusion criteria - 1. Individuals who are receiving medical treatment for low back pain at the start of the study.
2. Individuals with a tenure of less than three months.
Target Size - 220
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 08 Month 06 Day
Date of IRB - 2025 Year 09 Month 03 Day
Anticipated trial start date - 2025 Year 10 Month 17 Day
Last follow-up date - 2026 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068797
Disclaimer: Curated by HT Syndication.