UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044555 |
|---|---|
| Receipt number | R000050307 |
| Scientific Title | Influence of the stimulus intensity of radial extracorporeal shock wave on spinal excitability and peripheral tissues in healthy subjects |
| Date of disclosure of the study information | 2021/06/16 |
| Last modified on | 2021/06/16 09:57:18 |
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Basic information
Public title
Influence of the stimulus intensity of radial extracorporeal shock wave on spinal excitability and peripheral tissues in healthy subjects
Acronym
Influence of the stimulus intensity of radial extracorporeal shock wave on spinal excitability and peripheral tissues in healthy subjects
Scientific Title
Influence of the stimulus intensity of radial extracorporeal shock wave on spinal excitability and peripheral tissues in healthy subjects
Scientific Title:Acronym
Influence of the stimulus intensity of radial extracorporeal shock wave on spinal excitability and peripheral tissues in healthy subjects
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal stimulus intensity for radial extracorporeal shock wave on spinal excitability and peripheral tissue in healthy subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
H-reflex
ultrasonic echo
Key secondary outcomes
pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
radial extracorporeal shockwave: stimulus intensity 3Bar
Interventions/Control_2
radial extracorporeal shockwave: stimulus intensity 1Bar
Interventions/Control_3
radial extracorporeal shockwave: stimulus intensity sham
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy subjects
2. No medication
Key exclusion criteria
1.neurological disease
2.cardiac dysfunction
3.epilepsy
4. vestibular dysfunction
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Nakamura |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
6390218
Address
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
n.junji.0923@gmail.com
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Nakamura |
Organization
Nishiyamato Rehabilitaiton Hospital
Division name
Department of Rehabilitation Medicine
Zip code
6390218
Address
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
TEL
0745-71-6688
Homepage URL
n.junji.0923@gmail.com
Sponsor or person
Institute
Nishiyamato Rehabilitaiton Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishiyamato Rehabilitaiton Hospital
Address
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
Tel
0745-71-6688
reha.nishiyamato@fuga.ocn.ne.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
| 2021 | Year | 06 | Month | 16 | 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
21
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050307
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
