UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018087 |
|---|---|
| Receipt number | R000020933 |
| Scientific Title | Prevention of low back pain in nurses. |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2017/08/02 16:30:50 |
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Basic information
Public title
Prevention of low back pain in nurses.
Acronym
12ROSAI-Study
Scientific Title
Prevention of low back pain in nurses.
Scientific Title:Acronym
12ROSAI-Study
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A high prevalence of low back pain has persisted over the years among nurses. This study investigates the effectiveness and feasibility of simple exercise intervention and education for nurses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in subjective evaluations before and after the interventions (NRS:Numerical Rating Scale).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Simple exercise
Interventions/Control_2
Simple exercise + education
Interventions/Control_3
Control
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nurses in 12 ROSAI hospitals.
Key exclusion criteria
Pregnancy
Lumbar Spinal Stenosis
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ko Matsudaira |
Organization
22nd Century Medical & Research Center, Faculty of Medicine, University of Tokyo, Tokyo, Japan
Division name
Department of Medical Research and Management for Musculoskeletal Pain
Zip code
Address
7-3-1, Bunkyo-ku, Hongo, Tokyo
TEL
03-5800-9545
kohart801@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Takano |
Organization
Japan Labour Health and Welfare Organization KANSAI ROSAI Hospital
Division name
Center for Preventive Medicine
Zip code
Address
3-1-69 Inabaso, Amagasaki
TEL
06-6416-1221
Homepage URL
stop@kanrou.net
Sponsor or person
Institute
22nd Century Medical & Research Center, Faculty of Medicine, University of Tokyo, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
MHLW(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
Address
Tel
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
| 2016 | Year | 06 | Month | 30 | 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
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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020933
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
