UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039364
Receipt number R000044889
Scientific Title Preventive effects of low back pain by trunk flexibility exercise in high school rugby players
Date of disclosure of the study information 2020/02/02
Last modified on 2023/02/14 18:39:39

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Basic information

Public title

Preventive effects of low back pain by trunk flexibility exercise in high school rugby players

Acronym

Preventive effects of low back pain by trunk flexibility exercise in high school rugby players

Scientific Title

Preventive effects of low back pain by trunk flexibility exercise in high school rugby players

Scientific Title:Acronym

Preventive effects of low back pain by trunk flexibility exercise in high school rugby players

Region

Japan


Condition

Condition

healthy individuals

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the effects of back pain prevention training by trunk exercises on rugby players.To investigate the relationship between physical factors and back pain in high school rugby players.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Low back pain incidence
Six months after the start of the intervention

Key secondary outcomes

ROM flex ext rotation lateral flex
Back range of motion
FFD
SLR
Thomas test
Core Stability test
Standing long jump
30m dash


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Trunk flexibility gymnastics.
Intervention: Trunk exercise is performed by applying a strap on the waist. A strap is attached to the Jacoby line and bend the trunk forward while pulling it vertically. At this time, the knee joint is bent while performing. The intervention period is six months, and it is performed for each club activity as part of club activities such as preparing exercise and cool down. The number of this exercise is 10 times x 3 sets. There will be 1 minute between interventions and a total of 5 minutes of this flexible exercise.

Interventions/Control_2

control

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

16 years-old <=

Age-upper limit

18 years-old >=

Gender

Male

Key inclusion criteria

2019 national high school rugby football tournament Saitama prefecture qualifying best 16 or more teams

Key exclusion criteria

Those who cannot obtain written consent for participation in this study

Those who cannot start at the start of measurement

Patients who have undergone orthopedic surgery within one month due to trunk (including lumbar) symptoms

Those who have difficulty continuing self-exercise

Target sample size

70


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

Email

akasaka-smc@umin.ac.jp


Public contact

Name of contact person

1st name Yuto
Middle name
Last name Kikuchi

Organization

Saitama Medical University Graduate School of Medicine

Division name

Master and Doctoral Program in Physical Therapy

Zip code

350-0496

Address

981 Kawakado. Moroyama.Iruma.Saitama

TEL

049-295-1001

Homepage URL


Email

y.kikuike1009@gmail.com


Sponsor or person

Institute

Saitama Medical University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University Graduate School of Medicine

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

Email

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

埼玉医科大学大学院(埼玉県)


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 02 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


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

Terminated

Date of protocol fixation

2020 Year 03 Month 01 Day

Date of IRB

2014 Year 04 Month 14 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 02 Month 14 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 02 Day

Last modified on

2023 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044889


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name