UMIN-CTR Clinical Trial

Basic information
Public title	Verification of clinical effect of pressure waves (diffusion shock wave) treatment for Achilles / patellar tendinopathy
Acronym	Verification of clinical effect of pressure waves (diffusion shock wave) treatment for Achilles / patellar tendinopathy
Scientific Title	Verification of clinical effect of pressure waves (diffusion shock wave) treatment for Achilles / patellar tendinopathy
Scientific Title:Acronym	Verification of clinical effect of pressure waves (diffusion shock wave) treatment for Achilles / patellar tendinopathy
Region	Japan

Condition
Condition	Achilles tendinopathy patellar tendinopathy
Classification by specialty	Gastroenterology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is to confirm the effect of diffusion type Shockwave on tendonopathy of patellar and Achilles by comparison result of single blind comparison. By showing its effectiveness of it, evaluate the possibility as a new treatment for athletes who can not perform surgery to avoid interruption.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate IKDC questionnaire, VAS, physical remarks in 3 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intervention of extracorporeal shock wave 4 times a week.Output 2-4 bar, 12 Hz, 2000 shot
Interventions/Control_2	Intervention of placebo 4 times a week. 2000shot
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	12 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	Pain continues for 1 month or more after onset. Subjects who do not wish to conduct medication treatment such as corticosteroid injection or surgery.
Key exclusion criteria	Those who have undergone major operation of the knee in the past.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Ikeda
Organization	Juntendo University School of Medicine
Division name	Orthopedics
Zip code
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	hi-ikeda@juntendo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Keiji Kobayashi
Organization	Juntendo University nerima hospital
Division name	Orthopedics
Zip code
Address	3-1-10 Takanodai, Nerima-ku, Tokyo
TEL	03-5923-3111
Homepage URL
Email	kobakei44@gmail.com

Sponsor
Institute	Juntendo university School of Medicine
Institute
Department

Funding Source
Organization	Sakai medical
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 11 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	Terminated
Date of protocol fixation	2017 Year 12 Month 04 Day
Date of IRB	2017 Year 07 Month 25 Day
Anticipated trial start date	2017 Year 12 Month 04 Day
Last follow-up date	2018 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	2018 Year 01 Month 05 Day
Last modified on	2020 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035049