UMIN-CTR Clinical Trial

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
Email	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
Email	seikei@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030515