UMIN-CTR Clinical Trial

Basic information
Public title	Extracorporeal shockwave therapy in musculoskeletal disorders
Acronym	Extracorporeal shockwave therapy in musculoskeletal disorders
Scientific Title	Extracorporeal shockwave therapy in musculoskeletal disorders
Scientific Title:Acronym	Extracorporeal shockwave therapy in musculoskeletal disorders
Region	Japan

Condition
Condition	enthesopathy stress fracture non union
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy of extracorporeal shock wave therapy in musculoskeletal disorders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of the pain after the extracorporeal shockwave therapy in enthesopathy, stress fracture and non union.
Key secondary outcomes	The period before making bone union after the extracorporeal shockwave therapy in enthesopathy, stress fracture and non union.

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	The extracorporeal shockwave was delivered to the tender area in enthesopathy or the fracture area.
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	We follow the adaptation disease that the International Society for Medical Shockwave Treatment make a recommendation.
Key exclusion criteria	anticoagulant medication, thrombotic disease, malignant disorder, pregnant woman, The patients who continue receiving cortisone treatment more than six months or the patient who does not pass from the last cortisone injection for six weeks.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Konno
Organization	Fukushima Medical University School
Division name	Department of Orthopedic Surgery
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL	024-547-1276
Email	fortho@fmu.ac.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Igari
Organization	Fukushima Medical University School
Division name	Department of Orthopedic Surgery
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL	024-547-1276
Homepage URL
Email	igataka@fmu.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery, Fukushima Medical University School
Institute
Department

Funding Source
Organization	Self funding
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	Fukushima Medical University School
Address	1 Hikarigaoka, Fukushima City, Fukushima, Japan
Tel	0245471276
Email	igataka@fmu.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 02 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
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	2017 Year 02 Month 01 Day
Date of IRB	2016 Year 12 Month 27 Day
Anticipated trial start date	2017 Year 02 Month 20 Day
Last follow-up date	2019 Year 03 Month 31 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 02 Month 16 Day
Last modified on	2019 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030076