UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029529 |
|---|---|
| Receipt number | R000033742 |
| Scientific Title | Establishment of effective muscular strength training method for Arthrogenic muscle inhibition |
| Date of disclosure of the study information | 2017/10/12 |
| Last modified on | 2020/10/14 18:53:36 |
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Basic information
Public title
Establishment of effective muscular strength training method for Arthrogenic muscle inhibition
Acronym
Establishment of effective muscular strength training method for Arthrogenic muscle inhibition
Scientific Title
Establishment of effective muscular strength training method for Arthrogenic muscle inhibition
Scientific Title:Acronym
Establishment of effective muscular strength training method for Arthrogenic muscle inhibition
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Establish effective muscle strength training for Arthrogenic muscle inhibition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pre- and post-treatment assessment by H/M ratio under the pain condition.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Hypertonic saline injection
Continue administration at 0.15ml/min for 20 minutes
Interventions/Control_2
Isotoni saline injection for control
Continue administration at 0.15ml/min for 20 minutes
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
A volunteer aged between 20 and 50 without muskloskeletal pain.
Key exclusion criteria
1) chronic muskloskeletal pain
2) Oral administration of anti-inflammatory analgesic
3) mental illness
4) abnormality blood pressure
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Oda |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
7838505
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
TEL
088-880-2490
jm-s.oda@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Oda |
Organization
Kochi Medical School Hospital
Division name
Department of Rehabilitation Center
Zip code
7838505
Address
Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
TEL
088-880-2490
Homepage URL
jm-s.oda@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Kochi Medical School Hospital
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 783-8505
Tel
088-880-2490
jm-s.oda@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
| 2017 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000033742
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000033742
Number of participants that the trial has enrolled
14
Results
In response to pain, there were significant decreases in the H/M ratio.After the imagery using the ankle movie, H/M ratio was significantly improved.
Results date posted
| 2020 | Year | 10 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy volunteers
Participant flow
Subjects were given a detailed written and verbal explanation of the experimental procedures.
Adverse events
None
Outcome measures
H/M ratio
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033742
