UMIN-CTR Clinical Trial

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
Email	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
Email	yosuzuki@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034234