UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019207 |
|---|---|
| Receipt number | R000022203 |
| Scientific Title | An Exploratory Study on the effect on sports injuries of extracorporeal shock wave therapy |
| Date of disclosure of the study information | 2015/10/10 |
| Last modified on | 2015/10/26 14:02:09 |
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Basic information
Public title
An Exploratory Study on the effect on sports injuries of extracorporeal shock wave therapy
Acronym
An Exploratory Study on the effect on sports injuries of extracorporeal shock wave therapy
Scientific Title
An Exploratory Study on the effect on sports injuries of extracorporeal shock wave therapy
Scientific Title:Acronym
An Exploratory Study on the effect on sports injuries of extracorporeal shock wave therapy
Region
| Japan |
Condition
Condition
1. tendinitis, enthesitis
2. joint and fatigue fracture
3. greater trochanter part pain, bursitis
4. ligament damage, ligament, tendon attachment avulsion fracture
5. Other (painful outside the tibia, split patella, epiphyseal disease early avascular necrosis fracture, early osteochondritis dissecans)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove in Japanese effect on sports injuries of ESWT, which have been shown abroad
To verify the effect on similar pathologies and diseases that are currently adapted
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Pain-relieving effect
Changes in the imaging findings
Period of up to competition return
Key secondary outcomes
Adverse event
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who does not improve pain after 3 months or more competition discontinued diseases that are considered to be due to sports
Key exclusion criteria
Patients with trauma in the irradiation spot
Patients with a disease exacerbated by pain stimulus
Pregnant woman
Patients with malignant tumors in the irradiation spot
Patients can not be decision-making on their own
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Kanamori |
Organization
Tsukuba university
Division name
medicine
Zip code
Address
2-1-1, Amakubo, Tsukuba city, Ibaraki pref.
TEL
029-853-3219
kanamori@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Tanaka |
Organization
Tsukuba university
Division name
medicine
Zip code
Address
2-1-1, Amakubo, Tsukuba city, Ibaraki pref.
TEL
029-853-3219
Homepage URL
kentatanaka@tsukuba-seikei.jp
Sponsor or person
Institute
University of Tsukuba hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 10 | 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
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 17 | 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
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2015 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022203
