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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046554
Receipt No. R000053116
Scientific Title Effect of lumbar lordosis angle in adolescent baseball players on the development of lumbar spondylolysis
Date of disclosure of the study information 2022/01/05
Last modified on 2022/01/05

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Basic information
Public title Effect of lumbar flexion on the development of lower back injury in youth baseball players.
Acronym Effect of lumbar flexion on the development of lower back injury
Scientific Title Effect of lumbar lordosis angle in adolescent baseball players on the development of lumbar spondylolysis
Scientific Title:Acronym Effect of lumbar lordosis angle on the development of lumbar spondylolysis
Region
Japan

Condition
Condition Back pain, lumbar spondylolysis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the magnitude of lumbar kyphosis angle on the development of lumbar spondylolysis.
Basic objectives2 Others
Basic objectives -Others To investigate the effect of the magnitude of lumbar kyphosis angle on the development of lumbar spondylolysis in adolescent baseball players.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence of lumbar spondylolysis
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
11 years-old <=
Age-upper limit
18 years-old >=
Gender Male
Key inclusion criteria 1. Males between the ages of 11 and 18 who visited the clinic.
2. who play baseball as an athletic event.
3. who had an MRI scan with a chief complaint of lumbar pain lasting more than 2 weeks.
Key exclusion criteria Participants whose MRI images did not show the upper margin of the first lumbar vertebra and the upper margin of the sacrum.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Kitagawa
Organization Shinshu University
Division name Department of Physical Therapy, School of Health Sciences
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-2413
Email tkitagawa@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Onoda
Organization Hanamizuki Orthopedic Sports Clinic
Division name Department of Rehabilitation
Zip code 452-0942
Address 1-18-8 Kiyosu, Kiyosu City, Aichi
TEL 052-408-0087
Homepage URL
Email onodayuki.pt@gmail.com

Sponsor
Institute Hanamizuki Orthopedic Sports Clinic
Institute
Department

Funding Source
Organization self-financing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Medicine Medical Ethics Committee, Shinshu University
Address 3-1-1 Asahi, Matsumoto, Nagano
Tel 0263-37-2572
Email mdrinri@shinshu-u.ac.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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 05 Day

Related information
URL releasing protocol https://www.protocols.io/view/effect-of-lumbar-lordosis-angle-in-adolescent-base-b28iqhue
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 Enrolling by invitation
Date of protocol fixation
2021 Year 12 Month 29 Day
Date of IRB
2021 Year 12 Month 14 Day
Anticipated trial start date
2021 Year 12 Month 29 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No special notes

Management information
Registered date
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053116

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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