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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032884
Receipt No. R000037475
Official scientific title of the study 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

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Basic information
Official scientific title of the study Efficacy of Low Frequency Therapy Equipment for Temporomandibular Disorder Patients
Title of the study (Brief title) 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 Eiji Tanaka
Organization Institute of Biomedical Sciences,
Tokushima University Graduate School
Division name Department of Orthodontics
Address 3-18-15 Kuramoto-cho Tokushima-City, Tokushima
TEL 088-633-7357
Email etanaka@tokushima-u.ac.jp

Public contact
Name of contact person Susumu Abe
Organization Tokushima University Graduate School
Division name Department of Comprehensive Dentistry
Address 3-18-15 Kuramoto-cho Tokushima-City, Tokushima
TEL 088-633-9181
Homepage URL
Email susumu.abe@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 05 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037475

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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