UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027554 |
|---|---|
| Receipt number | R000031585 |
| Scientific Title | A fundamental study with respect to incidence factor of low back pain and effects of the preventive training in high school volleyball players. |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2018/12/02 22:17:37 |
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Basic information
Public title
A fundamental study with respect to incidence factor of low back pain and effects of the preventive training in high school volleyball players.
Acronym
A fundamental study with respect to incidence factor of low back pain and effects of the preventive training in high school volleyball players.
Scientific Title
A fundamental study with respect to incidence factor of low back pain and effects of the preventive training in high school volleyball players.
Scientific Title:Acronym
A fundamental study with respect to incidence factor of low back pain and effects of the preventive training in high school volleyball players.
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence factor of low back pain and effects of the preventive training in high school volleyball players.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of low back pain and effects of the preventive training will be assessed with a self-reporting questionnaire and medical check including flexibility, agility, muscle strength, and muscular endurance.
Evaluation will be performed at the time of participant's inclusion and after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Prevention training of low back pain to corresponded to the medical check will be performed for 4 weeks.
Interventions/Control_2
A control group performs the usual practice.
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
| 15 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
High school volleyball players.
Key exclusion criteria
Those who has neuropathic pain in their lower extremity.
Those who have no problem with medical check.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyokazu Akasaka |
Organization
Medical Sciences, Graduate School of Medicine, Saitama Medical University
Division name
Depertment of Physical Therapy
Zip code
Address
350-0496 981 Kawakado Moroyamamachi, Irumagun, Saitama.
TEL
049-295-8246
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Mizoguchi |
Organization
Medical Sciences, Graduate School of Medicine, Saitama Medical University
Division name
Depertment of Physical Therapy
Zip code
Address
350-0496 981 Kawakado Moroyamamachi, Irumagun, Saitama
TEL
049-295-8246
Homepage URL
yassunnyassunn@gmail.com
Sponsor or person
Institute
Depertment of Physical Therapy, Medical Sciences, Graduate School of Medicine, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Depertment of Physical Therapy, Medical Sciences, Graduate School of Medicine, Saitama Medical University
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
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
| 2017 | Year | 05 | 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
| 2017 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 19 | 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
| 2017 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031585
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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