UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of optimal jaw opening exercise for pain attributed temporomandibular disorders - randomized controlled trial
Title of the study (Brief title)	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	Akira Nishiyama
Organization	Tokyo Medical and Dental University
Division name	Orofacial Pain Management
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5713
Email	anishi.tmj@tmd.ac.jp

Public contact
Name of contact person	Akira Nishiyama
Organization	Tokyo Medical and Dental University
Division name	Orofacial Pain Management
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5713
Homepage URL
Email	anishi.tmj@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040171