UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041783 |
|---|---|
| Receipt number | R000045644 |
| Scientific Title | The influence of experimental pain on swallowing function |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/12/29 19:18:39 |
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Basic information
Public title
The influence of experimental pain on swallowing function
Acronym
The influence of experimental pain on swallowing function
Scientific Title
The influence of experimental pain on swallowing function
Scientific Title:Acronym
The influence of experimental pain on swallowing function
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of effect on swallowing function due to pain
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity on water swallowing and tongue pressure motion
Key secondary outcomes
Muscle onset
Muscle strength
Visual analogue scale
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Painful condition
Applying capsaicin cream (3 grams)
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who are willing to participate in the recruitment poster
Key exclusion criteria
1) Oral administration of anti-inflammatory analgesic
2)Mental illness
3)Abnormality blood pressure
4)Disease of the head and neck
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Yanogawa |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
783-8505
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
TEL
088-880-2490
jm-t.yanogawa@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Yanogawa |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
783-8505
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
TEL
088-880-2490
Homepage URL
jm-t.yanogawa@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kochi Medical School Hospital
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan
Tel
088-880-2490
jm-t.yanogawa@kochi-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045644
