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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name