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Recruitment status
Unique ID issued by UMIN C000000365
Receipt No. R000000335
Scientific Title Randomized controlled clinical trial of cognitive behavioral therapy for chronic muscle pain in head, neck and shoulder regions.
Date of disclosure of the study information 2006/04/01
Last modified on 2009/11/02

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Basic information
Public title Randomized controlled clinical trial of cognitive behavioral therapy for chronic muscle pain in head, neck and shoulder regions.
Acronym Randomized controlled clinical trial of cognitive behavioral therapy for chronic muscle pain in head, neck and shoulder regions.
Scientific Title Randomized controlled clinical trial of cognitive behavioral therapy for chronic muscle pain in head, neck and shoulder regions.
Scientific Title:Acronym Randomized controlled clinical trial of cognitive behavioral therapy for chronic muscle pain in head, neck and shoulder regions.
Region
Japan

Condition
Condition Temporomandibular Disorders (TMD)
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the non-inferiority of cognitive behavioral therapy compared with stabilization splint therapy for masticatory muscle pain of temporomandibular disorders.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effective rate of visual analogue scale (VAS) for pain in masticatory muscle. (Effective: VAS decreased more than 50 % of the initial degree.)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive behavioral therapy only
Interventions/Control_2 Cognitive behavioral therapy and stabilization splint therapy
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
16 years-old <
Age-upper limit
55 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have had chronic pain in masticatory muscles more than 4 weeks.
Patients who have pain ranked more than 4 on Visual Analogue Scale over 4 weeks until starting trial.
Patients who are able to go to hospital during 26 weeks.
Key exclusion criteria Patients who had undergone treatment for TMD.
Patients who have pain caused by abnormal shape of bone, adhesion, disk displacement, and/or disk perforation in TMJ.
Patients who are unable to fit splint to jaw because of missing teeth.
Patients who are judged not to appropriate to this trial by dentists.
Target sample size 166

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emiko Morishige
Organization Osaka University Graduate School of Dentistry
Division name Department of Fixed Prosthodontics
Zip code
Address 1-8, Yamada-Oka, Suita, Osaka 565-0871, Japan
TEL 06-6879-2946
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi ISHIGAKI
Organization Osaka University Graduate School of Dentistry
Division name Department of Fixed Prosthodontics
Zip code
Address 1-8, Yamada-Oka, Suita, Osaka 565-0871, Japan
TEL 06-6879-2946
Homepage URL
Email ishigaki-s@umin.net

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2006 Year 04 Month 01 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
Date of protocol fixation
2005 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2007 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 03 Month 24 Day
Last modified on
2009 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000335

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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