UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000365 |
|---|---|
| Receipt number | 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 16:02:36 |
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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
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
ishigaki-s@umin.net
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000335
