UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060152 |
|---|---|
| Receipt number | R000068797 |
| Scientific Title | Effectiveness of a Multicomponent Intervention Approach for the Prevention of Low Back Pain in the Land Freight Transportation Industry |
| Date of disclosure of the study information | 2025/12/21 |
| Last modified on | 2025/12/21 15:02:09 |
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Basic information
Public title
Effectiveness of a Multicomponent Intervention Approach for the Prevention of Low Back Pain in the Land Freight Transportation Industry
Acronym
Effectiveness of a Multicomponent Intervention Approach for the Prevention of Low Back Pain in the Land Freight Transportation Industry
Scientific Title
Effectiveness of a Multicomponent Intervention Approach for the Prevention of Low Back Pain in the Land Freight Transportation Industry
Scientific Title:Acronym
Effectiveness of a Multicomponent Intervention Approach for the Prevention of Low Back Pain in the Land Freight Transportation Industry
Region
| Japan |
Condition
Condition
Low Back Pain
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The point prevalence of low back pain among participants will be assessed at four time points using the Nordic Musculoskeletal Questionnaire (four items with dichotomous yes/no responses addressing pain during the past 12 months, activity limitation, history of medical consultation, and pain during the past 7 days): (1) baseline, (2) 12 weeks, (3) 24 weeks, and (4) 48 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Workplace Improvement Approach Using Digital Health Technologies (DHTs)
Interventions/Control_2
Tailor-Made Interventions Incorporating Personal Indicators (PI)
Interventions/Control_3
On-the-Job Exercise and Assistive Suits
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ebara |
Organization
University of Occupational and Environmental Health, Japan
Division name
Dept. of Ergonomics
Zip code
807-8555
Address
Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan.
TEL
0936917458
j-ninko@mbox.med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomichi |
| Middle name | |
| Last name | Tani |
Organization
University of Occupational and Environmental Health, Japan
Division name
Dept. of Ergonomics
Zip code
807-8555
Address
Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan.
TEL
0936917458
Homepage URL
n-tani@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Takeshi Ebara
Funding Source
Organization
Ministry of Health, Labour and Welfare, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health, Japan
Address
Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu, Fukuoka, Japan.
Tel
0936917458
j-ninko@mbox.med.uoeh-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
236
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068797
