UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035260 |
|---|---|
| Receipt number | R000040171 |
| Scientific Title | Investigation of optimal jaw opening exercise for pain attributed temporomandibular disorders - randomized controlled trial |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2018/12/14 17:41:46 |
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Basic information
Public title
Investigation of optimal jaw opening exercise for pain attributed temporomandibular disorders - randomized controlled trial
Acronym
Jaw opening exercise for TMD pain
Scientific Title
Investigation of optimal jaw opening exercise for pain attributed temporomandibular disorders - randomized controlled trial
Scientific Title:Acronym
Jaw opening exercise for TMD pain
Region
| Japan |
Condition
Condition
temporomandibular disorders
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine optimal jaw opening exercise for pain attributed temporomandibular disorders.In this study, it is clarified which is effective jaw exercise with or without pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the limitation of daily life due to TMD
(first visit and after 2w, 4w, 8w)
Key secondary outcomes
mouth opening range
pain intensity
(first visit and after 2w, 4w, 8w)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
mouth opening execise with pain
Interventions/Control_2
mouth opening execise without pain
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who are classified with at least myalgia or arthralgia by the diagnostic criteria for temporomandibular disorder (DCTMD)
2.Patients whose symptom started more than a month ago and whose symptoms are not changing or becoming worse
3.Patients who cannot open their mouth over 40mm without pain and feel pain that scores over 30mm on a visual analog scale (VAS)
Key exclusion criteria
1.Patients who was classified as disc displacement without reduction by DCTMD
2.Patients who has received surgical operation on their temporomandibular joint or masticatory muscles
3.Patients who took analgesic drugs within the previous three days
4.Patients who have received any treatment for current pain
5.Patients who are diagnosed as degenerative joint disorder(erosion, atrophy, osteophyte)based on panoramic X-ray examination
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Nishiyama |
Organization
Tokyo Medical and Dental University
Division name
Orofacial Pain Management
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5713
anishi.tmj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Nishiyama |
Organization
Tokyo Medical and Dental University
Division name
Orofacial Pain Management
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5713
Homepage URL
anishi.tmj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
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
| 2018 | Year | 12 | Month | 17 | 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
| 2019 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | 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
| 2018 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040171
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
