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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030707
Receipt No. R000035049
Scientific Title Verification of clinical effect of pressure waves (diffusion shock wave) treatment for Achilles / patellar tendinopathy
Date of disclosure of the study information 2018/01/11
Last modified on 2018/01/05

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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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 04 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
2018 Year 01 Month 05 Day
Last modified on
2018 Year 01 Month 05 Day


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

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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