UMIN-CTR Clinical Trial

Public title

Mechanism of Persistent Postoperative Pain Following Total Knee Arthroplasty

Acronym

Mechanism of Persistent Postoperative Pain Following TKA

Scientific Title

Mechanism of Persistent Postoperative Pain Following Total Knee Arthroplasty

Scientific Title:Acronym

Mechanism of Persistent Postoperative Pain Following TKA

Region

Japan

Condition

Knee Osteoarthritis, Rheumatoid Arthritis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the mechanism of persistent postoperative pain following total knee arthroplasty.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Study1 Resting pain, Movement-evoked Pain, Kinesiophobia, Mean velocity, Maximum knee flexion angle, Number of stagnations, Mean information entropy
Study2 Resting pain, Movement-evoked Pain, Sense of body ownership, Sense of agency, Motor dysfunction, Kinesiophobia

Key secondary outcomes

short-form McGill pain questionnaire-2
central sensitization inventory-9
painDETECT questionnaire
Fremantle Knee Awareness Questionnaire
Tampa scale for kinesiophobia-11
Knee Injury and Osteoarthritis Outcome Score

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Osteoarthritis and Rheumatoid Arthritis undergoing Total Knee Arthroplasty

Key exclusion criteria

Individuals with a history of dementia or central nervous system diseases, those who have difficulty responding to questionnaires, and those undergoing revision total knee arthroplasty

Target sample size

100

Name of lead principal investigator

1st name	Tomoya
Middle name
Last name	Tanaka

Organization

Kio University

Division name

Graduare school of health sciences

Zip code

6350832

Address

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

TEL

0745-54-1603

Email

f3983386@kio.ac.jp

Name of contact person

1st name	Tomoya
Middle name
Last name	Tanaka

Organization

Kio University

Division name

Graduare school of health sciences

Zip code

6350832

Address

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

TEL

0745-54-1603

Homepage URL

Email

f3983386@kio.ac.jp

Institute

Kio University

Institute

Department

Personal name

Organization

Kio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kio University

Address

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

Tel

0745541601

Email

f3983386@kio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

12

Month

10

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

10

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Measurement Items in the First Study

Both the questionnaire and video analysis will be conducted a total of four times: preoperatively, and at 1 week, 2 weeks, and 3 weeks postoperatively.

Questionnaire
For pain and movement-related factors, the following parameters will be evaluated using a visual analog scale (VAS):
1. Pain while at rest (resting pain),
2. Pain during knee movement (pain during activity),
3. Fear of movement (kinesiophobia).

Video Analysis
As movement parameters, the maximum flexion and maximum extension of the knee will be recorded using a digital camera in the sagittal plane. From the video recordings, the following parameters will be calculated:
1. Mean velocity (temporal factor),
2. Maximum flexion angle (spatial factor),
3. Number of stagnations (movement hesitation),
4. Mean information entropy (awkwardness of movement).

Measurement Items in the Second Study

A simplified questionnaire will be completed twice a day, at 7:00 AM and 7:00 PM (with a one-hour window before or after the designated time), from postoperative day 1 to at least day 11, for a total of 21 measurements. Participants will respond on paper.

The simplified questionnaire consists of the following six items:
1. Resting pain,
2. Pain during walking,
3. Sense of body ownership,
4. Sense of agency in movement,
5. Motor dysfunction,
6. Kinesiophobia.

Each item will be rated using an 11-point numerical rating scale (NRS).

Registered date

2024

Year

11

Month

29

Day

Last modified on

2024

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064347