UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018795
Receipt number R000021746
Scientific Title EEG recoring to quantitative evaluation on patients with complex regional pain syndrome.
Date of disclosure of the study information 2015/08/25
Last modified on 2015/08/29 10:58:44

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Basic information

Public title

EEG recoring to quantitative evaluation on patients with complex regional pain syndrome.

Acronym

quantitative evaluation of CRPS

Scientific Title

EEG recoring to quantitative evaluation on patients with complex regional pain syndrome.

Scientific Title:Acronym

quantitative evaluation of CRPS

Region

Japan


Condition

Condition

patients with fracture of the bone

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Quantitative evaluation of CRPS

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EEG data(eye open 3 min, eye close 3 min)
frequency analysis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

EEG recording

Interventions/Control_2


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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

patients with fracture of the bone

Key exclusion criteria

patients with not agreement of the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michihiro Osumi

Organization

Kio university

Division name

Neurorehabilitation Research Center

Zip code


Address

4-2-2 Umaminaka, Koryocho, Kitakatsuragigun, Nara

TEL

0745541601

Email

m.ohsumi@kio.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Michihiro Osumi

Organization

Kio university

Division name

Neurorehabilitation Research Center

Zip code


Address

4-2-2 Umaminaka, Koryocho, Kitakatsuragigun, Nara

TEL

0745541601

Homepage URL


Email

m.ohsumi@kio.ac.jp


Sponsor or person

Institute

Michihiro Osumi

Institute

Department

Personal name



Funding Source

Organization

Health, Labour and Welfare Scientific Research

Organization

Division

Category of Funding 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

2015 Year 08 Month 25 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 08 Month 21 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing especially


Management information

Registered date

2015 Year 08 Month 25 Day

Last modified on

2015 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021746