UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029971 |
|---|---|
| Receipt number | R000034234 |
| Scientific Title | The relationship between neck stiffness and trunk, body posture, and oral behavior |
| Date of disclosure of the study information | 2017/11/15 |
| Last modified on | 2019/11/18 22:32:58 |
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Basic information
Public title
The relationship between neck stiffness and trunk, body posture, and oral behavior
Acronym
Neck stiffness and body posture & oral behavior
Scientific Title
The relationship between neck stiffness and trunk, body posture, and oral behavior
Scientific Title:Acronym
Neck stiffness and body posture & oral behavior
Region
| Japan |
Condition
Condition
Neck stiffness, tiredness, or pain
Classification by specialty
| Orthopedics | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clearfy if bado body posture and oral behavior lead to neck stiffness
Basic objectives2
Others
Basic objectives -Others
To investigate 1) if bad body posture is related to neck and masseter muscle activity, and 2) if masseter muscle activity influenced neck muscle activity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Trapetius muscle activity
Key secondary outcomes
Spinal alignment, Muscle hardness and pain threshold of trapetius and masseter muscle, Centroid mobility, Maximum bite force
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Desk work under four different conditions; two different posture (condition 1: upright sitting, condition 2: Bad posture sitting) and biting (condition 1: non-contacting teeth, condition 2: clenching)
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Faculty staff and students belonging to the University of Tokushima and their families and acquaintances
Key exclusion criteria
Those who have orthopedic diseases of the spine, spinal cord diseases, orthopedic diseases of the shoulder joints and other neurological diseases, those who show allergic reactions to the surface electrode, those who are pregnant, those using the cardiac pacemaker, those who are difficult to accomplish tasks due to have cognitive dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Suzuki |
Organization
Tokushima University Graduate School
Division name
Department of Stmatognathic function and Occlusal Reconstruction
Zip code
770-8504
Address
3-18-15 Kuramoto-Cho, Tokushima, Tokushima
TEL
0886337350
yosuzuki@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Suzuki |
Organization
Tokushima University Graduate School
Division name
Department of Stmatognathic function and Occlusal Reconstruction
Zip code
770-8504
Address
3-18-15 Kuramoto-Cho, Tokushima, Tokushima
TEL
0886337350
Homepage URL
yosuzuki@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Tokushima University Graduate School
Address
3-18-15 Kuramoto-Cho, Tokushima, Tokushima
Tel
0886337350
yosuzuki@tokushima-u.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
徳島大学病院（徳島）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 15 | 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
| 2017 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | 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
| 2017 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034234
