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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040313
Receipt No. R000045995
Scientific Title The effect of self SNAGs on the range of motion of the lumbar spine in asymptomatic subjects
Date of disclosure of the study information 2020/05/05
Last modified on 2020/12/10

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Basic information
Public title The effect of self SNAGs on the range of motion of the lumbar spine in asymptomatic subjects
Acronym The effect of self SNAGs on the range of motion of the lumbar spine in asymptomatic subjects
Scientific Title The effect of self SNAGs on the range of motion of the lumbar spine in asymptomatic subjects
Scientific Title:Acronym The effect of self SNAGs on the range of motion of the lumbar spine in asymptomatic subjects
Region
Japan

Condition
Condition healthy individuals
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the immediate effect of self-SNAGs using the Mulligan strap and the change in the range of motion of the lumbar spine with a 1-week intervention. Also, the lumbar range of motion is compared with physical characteristics.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Lumbar range of motion
flex,extension,lateral flex,rotation
Key secondary outcomes FFD
SLR
Thomas test
VAS
HBD
sports career
BMI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) 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 In the intervention group, self-SNAGs are performed by applying a string-shaped Mulligan strap to the waist. Apply the strap to the Jacoby line (L4) and bend it vertically while pulling it vertically. The principle of this exercise is to be painless, so the pull strength of the strap should be painless. At that time, the knee joint should be flexed. The intervention period is one week and the number of times is 6 times x 3 sets. Allow 1 minute between interventions and self-exercise for about 5 minutes.

Interventions/Control_2 In the sham group, trunk flexion is performed in a standing position. Exercise should be painless. 6 times x 3 sets, 1 week. Leave one minute between exercises and a total of about five minutes of self-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
20 years-old <=
Age-upper limit
24 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adult
Faculty of Health Sciences, Saitama Medical University
Key exclusion criteria Those who do not have written consent for participation in this study.
Those who cannot start at the measurement start time.
Those who have a history of low back pain within the past 2 years.
Those who have a history of spine. (Spondylolisthesis, scoliosis, etc.)
Those who have difficulty continuing self-exercise.
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
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
Institute Saitama Medical University Ethics Review Committee
Institute
Department

Funding Source
Organization Saitama Medical University Ethics Review Committee
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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 05 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 08 Day
Last follow-up date
2021 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
2020 Year 05 Month 05 Day
Last modified on
2020 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045995

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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