UMIN-CTR Clinical Trial

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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