UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029971
Receipt No. 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 2017/11/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Yoshitaka Suzuki
Organization Tokushima University Graduate School
Division name Department of Stmatognathic function and Occlusal Reconstruction
Zip code
Address 3-18-15 Kuramoto-Cho, Tokushima, Tokushima
TEL 0886337350
Email yosuzuki@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Suzuki
Organization Tokushima University Graduate School
Division name Department of Stmatognathic function and Occlusal Reconstruction
Zip code
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
Address
Tel
Email

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
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
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034234

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.