UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032884 |
|---|---|
| Receipt number | R000037475 |
| Scientific Title | Efficacy of Low Frequency Therapy Equipment for Temporomandibular Disorder Patients |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2018/06/05 23:36:15 |
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Basic information
Public title
Efficacy of Low Frequency Therapy Equipment for Temporomandibular Disorder Patients
Acronym
Effectiveness of Low Frequency Therapy Equipment
Scientific Title
Efficacy of Low Frequency Therapy Equipment for Temporomandibular Disorder Patients
Scientific Title:Acronym
Effectiveness of Low Frequency Therapy Equipment
Region
| Japan |
Condition
Condition
Temporomandibular Disorder
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the therapeutic effect of a newly developed low frequency therapy device for temporomandibular disorder patients by comparing pain relief immediately or duration of pain relief effect before and after treetment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using Visual Analog Scale (VAS) as a numerical value representing pain and discomfort
Key secondary outcomes
Occlusal force
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
one time per one day (at arrival)
2 week or more, half of year or less
20 minutes at arrival
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Myalgia or Myofacial pain
Arthralgia without deformation of condyle
no Rheumatoid arthritis
Key exclusion criteria
Patient who can not communicate at inquiry
Diseases judged not to be TMD
Patients wearing specific implantable electronic devices such as pacemakers
Patients with unknown acute (painful) disease
Patients with heart problems
Patients with high hemorrhagic diathesis
Patients with malignant tumors
Maternal mothers
Heat diseases patients
Infectious disease patients
Patients who are at risk of vascular disorders such as thrombosis, venous thrombosis, varicose veins
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Tanaka |
Organization
Institute of Biomedical Sciences,
Tokushima University Graduate School
Division name
Department of Orthodontics
Zip code
Address
3-18-15 Kuramoto-cho Tokushima-City, Tokushima
TEL
088-633-7357
etanaka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Abe |
Organization
Tokushima University Graduate School
Division name
Department of Comprehensive Dentistry
Zip code
Address
3-18-15 Kuramoto-cho Tokushima-City, Tokushima
TEL
088-633-9181
Homepage URL
susumu.abe@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima 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 | 06 | Month | 07 | 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
| 2018 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 15 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037475
