UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033074 |
|---|---|
| Receipt number | R000037710 |
| Scientific Title | Effects of habit and exercise of stomatognathic system on pain sensitivity |
| Date of disclosure of the study information | 2018/06/22 |
| Last modified on | 2020/12/21 12:09:01 |
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Basic information
Public title
Effects of habit and exercise of stomatognathic system on pain sensitivity
Acronym
Effect of habit and exercise on orofacial pain
Scientific Title
Effects of habit and exercise of stomatognathic system on pain sensitivity
Scientific Title:Acronym
Effect of habit and exercise on orofacial pain
Region
| Japan |
Condition
Condition
orofacial pain
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of habit and/or exercise of the stomatognathic system on the pain sensitivity of orofacial region
Basic objectives2
Others
Basic objectives -Others
modulation of pain
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain sensitivity to electrical stimulation
measuring point
1) baseline, 2) 2 days after exercise load, 3) 1 week after exercise load
Key secondary outcomes
1) muscle activity
2) VAS values of pain and fatigue
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
eccentric exercise
Interventions/Control_2
gum chewing
Interventions/Control_3
low level jaw clenching
Interventions/Control_4
control (no exercise)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subject who are free from any signs and symptoms of craniomandibular, neck and shoulder disorders.
Key exclusion criteria
Person with habit of stomatognathic region, chronic pain, using pacemaker.
Person that informed consent was not obtained. Person who is hard to adapt itself to exercise-load and/or stimulation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Torisu |
| Middle name | |
| Last name | Tetsurou |
Organization
Nagasaki university hospital
Division name
Department of Prosthetic Dentistry
Zip code
8528588
Address
Nagasaki, Sakamoto 1-7-1
TEL
095-819-7692
torisu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsurou |
| Middle name | |
| Last name | Torisu |
Organization
Nagasaki university hospital
Division name
Department of Prosthetic Dentistry
Zip code
8528588
Address
Nagasaki, Sakamoto 1-7-1
TEL
095-819-7692
Homepage URL
torisu@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital,
Department of Prosthetic Dentistry
Institute
Department
Personal name
Funding Source
Organization
JSPS Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki
Tel
0958197692
torisu@nagasaki-u.ac.jp
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
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 22 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 20 | Day |
Last modified on
| 2020 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037710
