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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019207
Receipt No. 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

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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
Email 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
Email kentatanaka@tsukuba-seikei.jp

Sponsor
Institute University of Tsukuba hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022203

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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