UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040313 |
|---|---|
| Receipt number | 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 | 2023/02/14 18:34:20 |
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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
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
y.kikuike1009@gmail.com
Sponsor or person
Institute
Saitama Medical University Ethics Review Committee
Institute
Department
Personal name
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
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
15
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
| 2020 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 30 | Day |
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
| 2021 | Year | 03 | Month | 31 | Day |
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
| 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=R000045995
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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