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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018874
Receipt No. 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

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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
Email 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
Email j-shkkan@mbox.med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021827

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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