UMIN-CTR Clinical Trial

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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