UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030707
Receipt number 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 2020/01/23 08:06:56

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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 or person

Institute

Juntendo university School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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