UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015693
Receipt number R000018239
Scientific Title A study for clinical effect of electrical stimulation
Date of disclosure of the study information 2014/11/17
Last modified on 2014/11/14 15:46:24

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Basic information

Public title

A study for clinical effect of electrical stimulation

Acronym

clinical effect of electrical stimulation

Scientific Title

A study for clinical effect of electrical stimulation

Scientific Title:Acronym

clinical effect of electrical stimulation

Region

Japan


Condition

Condition

locomotive syndrome

Classification by specialty

Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To check how many times we work for carring it out

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

five months

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

for group of standard treatment

Interventions/Control_2

once a week of electrical stimulation

Interventions/Control_3

twice a week of electrical stimulation

Interventions/Control_4

three times a week of electrical stimulation

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

patients of locomotive syndrome

Key exclusion criteria

The person who corresponds to a taboo of elekitrical stimulation, person with the economic profit.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromi Oda

Organization

Saitama Medical University

Division name

Orthopaedic surgery

Zip code


Address

moroyama iruma-gun Saitama

TEL

049-276-1238

Email

tsnhm2005@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsuyoshi Miyajima

Organization

Saitama Medical University

Division name

Orthopaedic surgery

Zip code


Address

moroyama iruma-gun Saitama

TEL

049-276-1238

Homepage URL


Email

tsnhm2005@yahoo.co.jp


Sponsor or person

Institute

Saitama Medical University department of orthopaedic surgery

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University department of orthopaedic surgery

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


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

2014 Year 11 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

Preinitiation

Date of protocol fixation

2014 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 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

2014 Year 11 Month 14 Day

Last modified on

2014 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018239


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name