UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019213
Receipt number R000022210
Scientific Title Study of the effect due to the difference in the irradiation method of extracorporeal shock wave for refractory patellar tendinitis cases
Date of disclosure of the study information 2015/10/07
Last modified on 2015/10/26 14:45:00

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Basic information

Public title

Study of the effect due to the difference in the irradiation method of extracorporeal shock wave for refractory patellar tendinitis cases

Acronym

Study of the effect due to the difference in the irradiation method of extracorporeal shock wave for refractory patellar tendinitis cases

Scientific Title

Study of the effect due to the difference in the irradiation method of extracorporeal shock wave for refractory patellar tendinitis cases

Scientific Title:Acronym

Study of the effect due to the difference in the irradiation method of extracorporeal shock wave for refractory patellar tendinitis cases

Region

Japan


Condition

Condition

patella tendinitis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verifying the relationship between the illumination direction and the effect of the shock wave

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

pain score
Changes in the imaging findings

Key secondary outcomes

Adverse event


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

ESWT series 1: Irradiation methods 1
(8week to wash out)
ESWT series 2: Irradiation methods 2
(8week to wash out)
ESWT series 3: Irradiation methods 3

Interventions/Control_2

ESWT series 1: Irradiation methods 1
(8week to wash out)
ESWT series 2: Irradiation methods 3
(8week to wash out)
ESWT series 3: Irradiation methods 2

Interventions/Control_3

ESWT series 1: Irradiation methods 2
(8week to wash out)
ESWT series 2: Irradiation methods 1
(8week to wash out)
ESWT series 3: Irradiation methods 3

Interventions/Control_4

ESWT series 1: Irradiation methods 2
(8week to wash out)
ESWT series 2: Irradiation methods 3
(8week to wash out)
ESWT series 3: Irradiation methods 1

Interventions/Control_5

ESWT series 1: Irradiation methods 3
(8week to wash out)
ESWT series 2: Irradiation methods 1
(8week to wash out)
ESWT series 3: Irradiation methods 2

Interventions/Control_6

ESWT series 1: Irradiation methods 3
(8week to wash out)
ESWT series 2: Irradiation methods 2
(8week to wash out)
ESWT series 3: Irradiation methods 1

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

Patient who could not improve pain even after more than three months of competition discontinued patellar tendinitis, tendon disease cases that are considered to be due to Sports

Key exclusion criteria

Patients with trauma to the irradiated site
Patients with a malignant tumor in the irradiated site
Patients with a disease state is exacerbated by pain
Pregnant woman
Patients that can not determine the therapeutic intention itself

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiro Kanamori

Organization

Tsukuba university

Division name

medicine

Zip code


Address

2-1-1, Amakubbo, Tsukuba city, Ibaraki pref.

TEL

029-853-3219

Email

kanamori@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenta Tanaka

Organization

Tsukuba university

Division name

medicine

Zip code


Address

2-1-1, Amakubbo, Tsukuba city, Ibaraki pref.

TEL

029-853-3219

Homepage URL


Email

kentatanaka@tsukuba-seikei.jp


Sponsor or person

Institute

Tsukuba university

Institute

Department

Personal name



Funding Source

Organization

Ministry of education

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2015 Year 10 Month 07 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

Preinitiation

Date of protocol fixation

2015 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 17 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

2015 Year 10 Month 02 Day

Last modified on

2015 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022210


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name