UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046554 |
|---|---|
| Receipt number | 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 | 2024/01/09 07:59:36 |
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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
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
onodayuki.pt@gmail.com
Sponsor or person
Institute
Hanamizuki Orthopedic Sports Clinic
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000053116&flwp_key=1003x1CJN3k
Number of participants that the trial has enrolled
113
Results
Of the 112 subjects included, 79 were in the LS group and 33 in the non-LS group. The LLA was 45.42 (8.19) degree in the LS group and 36.68 (8.26) degree in the non-LS group, with significant differences between the groups. Logistic regression analysis showed that LLA significantly differed with an odds ratio of 1.14 (95% confidence interval: 1.07-1.21), even after adjusting for age and previous pitching experience.
Results date posted
| 2023 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were male baseball players aged 11-18 years who visited an orthopedic clinic with a chief complaint of lumbar pain and underwent a magnetic resonance imaging examination between January 1, 2018, and October 31, 2021.
Participant flow
Of the 112 subjects included, 79 were in the lumbar spondylolysis group and 33 in the non-LS group.
Adverse events
N/A.
Outcome measures
lumbar lordosis angle (LLA), age, previous pitching experience, and prevalence of LS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
No special notes
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053116
