UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026574 |
|---|---|
| Receipt number | R000030515 |
| Scientific Title | Study of orthopedic extracorporeal shockwave therapy |
| Date of disclosure of the study information | 2017/03/17 |
| Last modified on | 2019/07/13 13:17:27 |
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Basic information
Public title
Study of orthopedic extracorporeal shockwave therapy
Acronym
Study of orthopedic extracorporeal shockwave therapy
Scientific Title
Study of orthopedic extracorporeal shockwave therapy
Scientific Title:Acronym
Study of orthopedic extracorporeal shockwave therapy
Region
| Japan |
Condition
Condition
plantar fasciitis, peritendinitis, enthesitis, epiphyseal disease, fatigue fracture, arthropathy, pseudoarthrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct use results survey of approved products, extracorporeal shockwave therapy system for orthopedic use, Dornier Epos Ultra
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the change of Visual Analogue Scale(VAS) and JSSF ankle/hindfoot scale before and after the therapy
Key secondary outcomes
Adverse event
Changes in the imaging findings(X-ray,MRI,US)
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
Extracorporeal shockwave therapy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are eligible only if they meet all of the following criteria:
1.The patients aged 16 and over
2.The patients who are fully informed and understand about this study, and then provide the written voluntary consent to participation
3.The patients who are diagnosed as the orthopedic diseases or trauma in need of treatment
Key exclusion criteria
Patients are excluded from the study if they meet any of the following criteria:
1.The patients who have contraindications
2.The patients who are judged inappropriate for this study by researcher
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki Hospital
Division name
Department of Orthopaedic Surgery
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
seikei@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuo |
| Middle name | |
| Last name | Chosa |
Organization
University of Miyazaki Hospital
Division name
Department of Orthopaedic Surgery
Zip code
889-1692
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
Homepage URL
seikei@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki 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
University of Miyazaki Research Support Center
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
Tel
0985-85-9403
igakubu_kenkyu@med.miyazaki-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 | 03 | 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
130
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 | 11 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 03 | Month | 16 | Day |
Last modified on
| 2019 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030515
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
