UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025971 |
|---|---|
| Receipt number | R000019227 |
| Scientific Title | Development of the Japanese version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-J) and relathionship between kinesiophobia and temporomandibular disorders |
| Date of disclosure of the study information | 2017/02/02 |
| Last modified on | 2023/02/13 10:12:03 |
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Basic information
Public title
Development of the Japanese version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-J) and relathionship between kinesiophobia and temporomandibular disorders
Acronym
Development of TSK-TMD-J and relathionship between kinesiophobia and TMD
Scientific Title
Development of the Japanese version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-J) and relathionship between kinesiophobia and temporomandibular disorders
Scientific Title:Acronym
Development of TSK-TMD-J and relathionship between kinesiophobia and TMD
Region
| Japan |
Condition
Condition
Temporomandibular Disorders
Classification by specialty
| Oral surgery | Rehabilitation medicine | Dental medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study were to develop the Japanese version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-J) and to investigate the cross-sectional and longitudinal relathionships between kinesiophobia and temporomandibular disorders
Basic objectives2
Others
Basic objectives -Others
Development a new examination questionnaire
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total score of TSK-TMD-J at baseline, 2weeks after, 1 month after, 3 month after and 6 month after.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Temporomandibular disorders
Key exclusion criteria
People who have the current and past his tory of the stomatognathic disease other than the temporomandibular disorders
Psychiatric disease patients
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakayama |
Organization
Kio University
Division name
Department of general affairs
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
h.nakayama@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nara Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@kio.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
奈良県立医科大学（奈良県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The association between symptom of participants and answers of questionnaire is investigated
Management information
Registered date
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019227
