UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033090
Receipt number R000037718
Scientific Title Evaluation of brain activity in patients with chronic low back pain using a non-contact brain activity detection sensor
Date of disclosure of the study information 2018/07/01
Last modified on 2023/12/25 20:45:13

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Basic information

Public title

Evaluation of brain activity in patients with chronic low back pain using
a non-contact brain activity detection sensor

Acronym

Evaluation of brain activity in patients with chronic low back pain using
a non-contact brain activity detection sensor

Scientific Title

Evaluation of brain activity in patients with chronic low back pain using
a non-contact brain activity detection sensor

Scientific Title:Acronym

Evaluation of brain activity in patients with chronic low back pain using
a non-contact brain activity detection sensor

Region

Japan


Condition

Condition

Chronic low back pain
Healthy control

Classification by specialty

Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To detect brain activity of patients with chronic low back pain using with Non contact brain activity detection sensor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between RGB data and various pain assessment

Key secondary outcomes

Correlation between RGB data and cause of low back pain


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

89 years-old >=

Gender

Male and Female

Key inclusion criteria

Chronic low back pain group
1 Patients between the ages from 20 to 89.
2 Chronic low back pain who defined as a patient that lasted for longer than three months with a score of 5 or higher on the Numerical Rating Scal
Healty control
1 Healthy subjects between the ages from 20 to 89.
2 Subjects do not have low back pain

Key exclusion criteria

1 Patients who suffer from infection,malignant disease,Rheumatoid arthritis and other Inflammatory joint disease.
2 Patients who have audiovisual failure
3 Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Tanishima

Organization

Tottori University Faculry of Medicine

Division name

Department of Orthopedic Surgery

Zip code


Address

36-1 Nishi-cho,Yonago,Tottori

TEL

0859-38-6587

Email

shinjit@tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinji Tanishima

Organization

Tottori University Faculry of Medicine

Division name

Department of Orthopedic Surgery

Zip code


Address

36-1 Nishi-cho,Yonago,Tottori

TEL

0859-38-6587

Homepage URL


Email

shinjit@tottori-u.ac.jp


Sponsor or person

Institute

Tottori University Faculry of Medicine

Institute

Department

Personal name



Funding Source

Organization

Tottori University Faculry of Medicine

Organization

Division

Category of Funding Organization

Other

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

鳥取大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 01 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

We registered some cases under investigation

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

Completed

Date of protocol fixation

2018 Year 04 Month 20 Day

Date of IRB

2018 Year 04 Month 20 Day

Anticipated trial start date

2018 Year 07 Month 01 Day

Last follow-up date

2020 Year 07 Month 01 Day

Date of closure to data entry

2020 Year 07 Month 01 Day

Date trial data considered complete

2020 Year 07 Month 01 Day

Date analysis concluded

2020 Year 07 Month 01 Day


Other

Other related information

We investigate patients who have chronic low back pain at our clinic between July 2018 and July 2020.
We also investigate subjects who have no low back pain as a control.


Management information

Registered date

2018 Year 06 Month 21 Day

Last modified on

2023 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name