UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055436 |
|---|---|
| Receipt number | R000063343 |
| Scientific Title | Differences in Physical Characteristics of Cross-Country Skiers with and without Low Back Pain |
| Date of disclosure of the study information | 2024/09/06 |
| Last modified on | 2025/03/14 17:24:22 |
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Basic information
Public title
Differences in Physical Characteristics of Cross-Country Skiers with and without Low Back Pain
Acronym
Differences in Physical Characteristics of Cross-Country Skiers with and without Low Back Pain
Scientific Title
Differences in Physical Characteristics of Cross-Country Skiers with and without Low Back Pain
Scientific Title:Acronym
Differences in Physical Characteristics of Cross-Country Skiers with and without Low Back Pain
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although overseas cross-country skiing injury surveys indicate that low back pain occurs in approximately 60% of cross country skiers, the physical characteristics related to low back pain and the movement phases in skiing technique that tend to cause low back pain have not been clarified.
Therefore, the purpose of this study is to clarify the frequency of occurrence of back pain among Japanese high school cross-country skiers, the movement phases during which back pain occurs and the differences in physical characteristics in spine and pelvis alignment, range of motion of the spine, shoulder joint, and hip joint, trunk muscle strength and muscle endurance between those with and without low back pain by means of a questionnaire survey and physical examination.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the frequency of occurrence of back pain among Japanese high school cross-country skiers, the movement phases during which back pain occurs and the differences in physical characteristics in spine and pelvis alignment, range of motion of the spine, shoulder joint, and hip joint, lower extremity muscle tightness, and trunk muscle strength and muscle endurance between those with and without low back pain.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Spinal alignment (thoracic kyphosis angle, lumbar kyphosis angle)
Key secondary outcomes
Frequency of injury and low back pain in the past year, movement phases that tend to cause low back pain, pelvic tilt angle, range of motion of the spine, shoulder joint, and hip joint, lower limb muscle tightness (Thomas test, straight leg raising test, heel buttock distance), trunk muscle strength and muscle endurance.
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Male athletes who belong to high school cross-country skiing clubs in the Kanto-Koshinetsu region.
2) Athletes who are able to participate in regular practice.
3) Athletes who have read the explanatory document and have obtained consent from themselves and their guardians.
Key exclusion criteria
Athletes who meet any one of the following two conditions will be excluded.
1) Athletes who do not practice as usual during the measurement period due to injury or disability.
2) Athletes who have not read the instructions and cannot obtain consent from the athlete and his/her guardian.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tajika |
Organization
Gunma university Graduate School of Health Sciences
Division name
Rehabilitation Science Tajika Laboratory
Zip code
371-8511
Address
3-39-22 Showa-cho, Maebashi City, Gunma Prefecture
TEL
027-220-8945
tajika@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | HINATA |
| Middle name | |
| Last name | NAKAMATA |
Organization
Gunma university Graduate School of Health Sciences
Division name
Rehabilitation Science Tajika Laboratory
Zip code
371-8511
Address
3-39-22 Showa-cho, Maebashi City, Gunma Prefecture
TEL
027-220-8945
Homepage URL
h231c013@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Health Sciences, Department of Rehabilitation Sciences, Tajika Laboratory.
Institute
Department
Personal name
Funding Source
Organization
Gunma 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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15 Showa-cho, Maebashi City, Gunma Prefecture
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HS2024-033
Org. issuing International ID_1
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 06 | 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
21
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
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study. All athletes who belong to high school cross-country ski clubs in the Kanto-Koshinetsu region in 2024 and meet the selection criteria will be recruited. The recruitment period will be from approval by the ethical review committee until March 31, 2024. Measurement items will be the frequency of injury and low back pain in the past year, the movement phase when low back pain occurred, spinal alignment, pelvic tilt angle, range of motion of the spine, shoulder joint, and hip joint, lower limb muscle tightness, and trunk muscle strength and endurance.
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063343
