UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050962
Receipt number R000058089
Scientific Title Relationship between new knee integration and postoperative pain after total knee replacement: Using Moving Rubber "Knee" Illusion
Date of disclosure of the study information 2023/04/29
Last modified on 2023/04/29 17:55:42

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Basic information

Public title

Relationship between new knee integration and postoperative pain after total knee replacement: Using Moving Rubber "Knee" Illusion

Acronym

Is body illusion related to postoperative pain?

Scientific Title

Relationship between new knee integration and postoperative pain after total knee replacement: Using Moving Rubber "Knee" Illusion

Scientific Title:Acronym

Relationship between body illusion and postoperative pain

Region

Japan


Condition

Condition

healthy people, knee osteoarthritis patients

Classification by specialty

Orthopedics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify the effect of body illusion susceptibility on postoperative pain

Basic objectives2

Others

Basic objectives -Others

Development of rubber knee illusion

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body illusion susceptibility: questionnaire, proprioceptive drift
pain intensity, disability

Key secondary outcomes



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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

healthy people
Patients with knee osteoarthritis undergoing total knee arthroplasty

Key exclusion criteria

Persons with a history of dementia, central nervous system diseases, or those who are judged to have difficulty in performing the experiment.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Tomoya
Middle name
Last name Tanaka

Organization

Kio University

Division name

Graduate school of health sciences

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun

TEL

0745541601

Email

f3983386@kio.ac.jp


Public contact

Name of contact person

1st name Tomoya
Middle name
Last name Tanaka

Organization

Kio University

Division name

Graduate school of health sciences

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun

TEL

0745541601

Homepage URL


Email

f3983386@kio.ac.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio University

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

Kio University

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun

Tel

0745541601

Email

f3983386@kio.ac.jp


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

2023 Year 04 Month 29 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

2023 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2023 Year 04 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

non


Management information

Registered date

2023 Year 04 Month 29 Day

Last modified on

2023 Year 04 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058089