UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018874 |
|---|---|
| Receipt number | R000021827 |
| Scientific Title | Prevention of low back pain by physical exercise before work and training of local muscles |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2017/09/05 10:06:05 |
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Basic information
Public title
Prevention of low back pain by physical exercise before work and training of local muscles
Acronym
Prevention of low back pain by local muscles training
Scientific Title
Prevention of low back pain by physical exercise before work and training of local muscles
Scientific Title:Acronym
Prevention of low back pain by local muscles training
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of low back pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
result of physical fitness test (before, 40 days after, and 80 days after the initiation of the study)
Key secondary outcomes
subjective symptoms, muscle weight measured by body composition monitor, muscle thickness measured by ultrasonography(before, 40 days after, and 80 days after the initiation of the study)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
physical exercise before work (40days) -> no intervention (40days)
Interventions/Control_2
no intervention (40days)->physical exercise before work (40days)
Interventions/Control_3
training of local muscles (40days)->no intervention (40days)
Interventions/Control_4
no intervention (40days)->training of local muscles (40days)
Interventions/Control_5
no intervention (40days)->no intervention (40days)
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
workers at maunufacturing factory engaged in 3 shift work
Key exclusion criteria
those with dysesthesia or radiation pain in their lower limb, those with operation history of spine, those within 3 months after discharge from hopital
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seichi Horie |
Organization
University of Occupational and Environmental Health, Japan
Division name
Health Policy and Management
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL
+81-93-691-7407
horie@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seichi Horie |
Organization
University of Occupational and Environmental Health, Japan
Division name
Health Policy and Management
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Japan
TEL
+81-93-691-7407
Homepage URL
j-shkkan@mbox.med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
The Occupational Health Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2015 | Year | 09 | 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
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
| 2014 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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 | 09 | Month | 01 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021827
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
