UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010649 |
|---|---|
| Receipt number | R000012454 |
| Scientific Title | Treatment result of low intensity pulsed ultrasound for lumbar spondylolysis in adolescent |
| Date of disclosure of the study information | 2013/05/06 |
| Last modified on | 2017/05/08 09:07:27 |
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Basic information
Public title
Treatment result of low intensity pulsed ultrasound for lumbar spondylolysis in adolescent
Acronym
Treatment result of low intensity pulsed ultrasound for lumbar spondylolysis
Scientific Title
Treatment result of low intensity pulsed ultrasound for lumbar spondylolysis in adolescent
Scientific Title:Acronym
Treatment result of low intensity pulsed ultrasound for lumbar spondylolysis
Region
| Japan |
Condition
Condition
lumbar spondylolysis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of low intensity pulsed ultrasound for lumbar spondylolysis in adolescent
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone union rate, bone union period
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Low intensity pulsed ultrasound
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
| 10 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
lumbar spondylolysis patients diagnosed by MRI
Key exclusion criteria
Patients with malignant tumor
Patients who do not understand the purpose of research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiji Suzuki |
Organization
Kikugawa General Hospital
Division name
Department of Orthopedic surgery
Zip code
Address
1632, Higashiyokoji, Kikugawa-city, Shizuoka
TEL
0537352135
arihidee@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIdeyuki Arima |
Organization
Hamamatsu University School of Medicine
Division name
Department of orthopedic surgery
Zip code
Address
1-20-1 Handayama HIgaashi-ku Hamamatsu city Shizuoka
TEL
0534352299
Homepage URL
arihidee@yahoo.co.jp
Sponsor or person
Institute
Kikugawa General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kikugawa General Hospital
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
| 2013 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 05 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012454
