UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015693 |
|---|---|
| Receipt number | R000018239 |
| Scientific Title | A study for clinical effect of electrical stimulation |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2014/11/14 15:46:24 |
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Basic information
Public title
A study for clinical effect of electrical stimulation
Acronym
clinical effect of electrical stimulation
Scientific Title
A study for clinical effect of electrical stimulation
Scientific Title:Acronym
clinical effect of electrical stimulation
Region
| Japan |
Condition
Condition
locomotive syndrome
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check how many times we work for carring it out
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
five months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
for group of standard treatment
Interventions/Control_2
once a week of electrical stimulation
Interventions/Control_3
twice a week of electrical stimulation
Interventions/Control_4
three times a week of electrical stimulation
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients of locomotive syndrome
Key exclusion criteria
The person who corresponds to a taboo of elekitrical stimulation, person with the economic profit.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Oda |
Organization
Saitama Medical University
Division name
Orthopaedic surgery
Zip code
Address
moroyama iruma-gun Saitama
TEL
049-276-1238
tsnhm2005@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Miyajima |
Organization
Saitama Medical University
Division name
Orthopaedic surgery
Zip code
Address
moroyama iruma-gun Saitama
TEL
049-276-1238
Homepage URL
tsnhm2005@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University department of orthopaedic surgery
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University department of orthopaedic surgery
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
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
| 2014 | Year | 11 | Month | 17 | 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
| 2014 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 14 | Day |
Last modified on
| 2014 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018239
