UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024117 |
|---|---|
| Receipt number | R000026788 |
| Scientific Title | The countermeasures against non-specific low back pain with our developed exercise program |
| Date of disclosure of the study information | 2016/09/21 |
| Last modified on | 2020/11/09 14:31:26 |
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Basic information
Public title
The countermeasures against non-specific low back pain with our developed exercise program
Acronym
Countermeasures against non-specific LBP
Scientific Title
The countermeasures against non-specific low back pain with our developed exercise program
Scientific Title:Acronym
Countermeasures against non-specific LBP
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to analyse the clinical outcome after novel comprehensive exercise program with respect to low back pain (LBP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of LBP(Grade), Numerical Rating Scale(NRS) for LBP
[Time Frame: baseline, 3 months]
Key secondary outcomes
Fear Avoidance Beliefs Questionnaire(FABQ), The Kneels STarT Back Screening Tool (SBST), Kessler Psychological Distress (K6) scale, EuroQual(EQ)-5D, Work ability
[Time Frame: 3 months]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The conventional management, and the novel comprehensive exercise program(combined exercises including the trunk rotation) against LBP.
Interventions/Control_2
The conventional management, and the conventional exercise program against LBP.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Workers
Key exclusion criteria
1.Workers having specific low back pain, and who were presently receiving medical treatment.
2.Workes having mental disease, and who were presently receiving medical treatment.
3.Other conditions that resulted in the workers being considered to be ineligible by the researcher.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fuminari |
| Middle name | |
| Last name | Asada |
Organization
Osaka Rosai Hospital
Division name
Research Center for the Promotion of Health and Employment Support
Zip code
591-8025
Address
3-1179,Nagasone-Cho, Sakai-City, Osaka 591-8025, Japan
TEL
072-255-7520(4255)
f-asada@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Fuminari |
| Middle name | |
| Last name | Asada |
Organization
Osaka Rosai Hospital
Division name
Research Center for the Promotion of Health and Employment Support
Zip code
591-8025
Address
3-1179,Nagasone-Cho, Sakai-City, Osaka 591-8025, Japan
TEL
072-255-7520
Homepage URL
f-asada@osakah.johas.go.jp
Sponsor or person
Institute
Japan Organization of Occupational Health and Safety
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Rosai Hospital
Address
3-1179, Nagasone-Cho, Sakai-City, Osaka 591-8025, Japan
Tel
072-252-3561
f-asada@osakah.johas.go.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
大阪労災病院（大阪府），神戸ろうさい病院(兵庫県)，和歌山労災病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 21 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026788
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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