UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051939 |
|---|---|
| Receipt number | R000059279 |
| Scientific Title | Is the organizational intervention approach effective in preventing low back pain in nursing care homes? A cluster randomized controlled trial |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/12/14 14:15:55 |
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Basic information
Public title
Is the organizational intervention approach effective in preventing low back pain in nursing care homes? A cluster randomized controlled trial
Acronym
Is the organizational intervention approach effective in preventing low back pain in nursing care homes? A cluster randomized controlled trial
Scientific Title
Is the organizational intervention approach effective in preventing low back pain in nursing care homes? A cluster randomized controlled trial
Scientific Title:Acronym
Is the organizational intervention approach effective in preventing low back pain in nursing care homes? A cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to devise a new organizational intervention program to test its effectiveness in preventing care workers low back pain in nursing care home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UWES (Utrecht Work Engagement Scale)
Key secondary outcomes
Unidentified complaint (low back pain)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Groups of participatory approach. (Baseline-12weeks)
Interventions/Control_2
Active control. (Baseline-6 month)
Interventions/Control_3
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
| 64 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a) Workers in nursing care homes.
b) Age: working-age population (18-64y).
c) Gender: any gender.
Key exclusion criteria
a) Persons attending a hospital for low back pain at the start of the survey.
b) Length of service: Less than 3 months.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naomichi |
| Middle name | |
| Last name | Tani |
Organization
Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Division name
Department of Ergonomics
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, Japan
TEL
093-691-7458
n-tani@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Naomichi |
| Middle name | |
| Last name | Tani |
Organization
Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health
Division name
Department of Ergonomics
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, Japan
TEL
093-691-7458
Homepage URL
n-tani@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee of Medical Research, University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, Japan
Tel
093-691-7205
daigakukanri@mbox.pub.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
| 2023 | Year | 10 | Month | 01 | 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
50
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
| 2023 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059279
