UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051318 |
|---|---|
| Receipt number | R000058428 |
| Scientific Title | Effects of Prevention of LBP Program on Physical Function and Performance and incidence of low back pain in Adolescent Golf Athletes. |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2026/04/27 12:36:57 |
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Basic information
Public title
Effects of Prevention of LBP Program on Physical Function and Performance and incidence of low back pain in Adolescent Golf Athletes.
Acronym
Effects of Prevention of LBP Program on Physical Function and Performance and incidence of low back pain in Adolescent Golf Athletes.
Scientific Title
Effects of Prevention of LBP Program on Physical Function and Performance and incidence of low back pain in Adolescent Golf Athletes.
Scientific Title:Acronym
Effects of Prevention of LBP Program on Physical Function and Performance and incidence of low back pain in Adolescent Golf Athletes.
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effectiveness of a prevention of low back pain program in adolescent golf athletes as well as the physical functions and practices associated with low back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of low back pain over a 3-month period.
Key secondary outcomes
Exercise Compliance Rate
Practice content
Quality of low back pain
Range of motion of internal and external hip rotation
Fingerto-Floor Distance
Trunk lateral flexion and rotation range of motion
Hip Muscle Strength
Side bridge endurance
Golf Performance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Prevention of low back pain Program A.
Trail-side hip internal rotation exercise.
Cross-body stretching.
Shoulder joint flexion and extension exercises.
Shoulder joint abduction exercises.
Lunges and neck rotation exercises.
Continuous hop.
Perform at least two sets of each exercise.
Interventions/Control_2
Prevention of low back pain Program B.
Lead-side hip internal rotation exercise.
Trunk rotation exercise.
Trunk flexion-extension exercise.
Trunk lateral flexion exercise.
Lunges and trunk rotation exercises.
Squat jump.
Perform at least two sets of each exercise.
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
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Members of high school golf clubs in Saitama and Tokyo.
Key exclusion criteria
Those who do not consent to participate in this study
Those who have low back pain and have difficulty exercising
Those who are absent from club activities for some reason
Those who have played less than 5 rounds of golf
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kiyokazu |
| Middle name | |
| Last name | Akasaka |
Organization
Saitama Medical University
Division name
School of Physical Therapy
Zip code
350-0496
Address
981 Kawakado. Moroyama. Iruma. Saitama
TEL
049-295-1001
akasaka-smc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Hamada |
Organization
Saitama Medical University Graduate school
Division name
Doctoral Program in Physical Therapy
Zip code
350-0496
Address
981 Kawakado. Moroyama. Iruma. Saitama
TEL
049-295-1001
Homepage URL
y.hamada@ymail.ne.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
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
Saitama Medical University Ethics Review Committee
Address
38. Morohongou. Moroyama. Iruma. Saitama.
Tel
049-276-2143
ethics@saitama-med.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
協力が得られた高等学校（埼玉県・東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Not applicable.
Publication of results
Published
Result
URL related to results and publications
Not applicable.
Number of participants that the trial has enrolled
45
Results
There was no significant difference in the number of people with LBP between groups (GLEP: 5, Sham: 8; odds ratio = 0.486, 95% CI: 0.130 - 1.816, p = 0.279; Table 3). However, the number of LBP incidents was significantly lower in the GLEP group (GLEP: 16 incidents, Sham: 100 incidents; odds ratio = 0.157, 95% CI: 0.092 - 0.266, p < 0.001; Table 3). This corresponds to a reduction of about 84% in the number of LBP incidents in the GLEP group.
Results date posted
| 2026 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were recruited between August 2023 and March 2024. To ensure impartiality and account for variations in competition levels, we recruited the top performing high schools from two prefectures, resulting in a total of 3 schools participating.
Participant flow
Research documents were sent to the school principal and club activity advisor. Upon obtaining consent from the school principal and the club advisor, a study briefing was conducted for the participants. All participants provided written consent, and their rights were protected. Inclusion criteria were males and females who were on high school golf clubs and at least 5 rounds of golf experience.
Adverse events
Not applicable.
Outcome measures
A chi-square test was employed to compare the number of people with LBP between the two groups. Poisson regression analysis was performed to assess the relationship between the number of LBP incidents, trunk movement direction provoking LBP, and the swing phase associated with LBP.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058428
