UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044538
Receipt number R000050883
Scientific Title Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey
Date of disclosure of the study information 2021/06/15
Last modified on 2023/12/18 09:26:23

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Basic information

Public title

Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey

Acronym

Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey

Scientific Title

Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey

Scientific Title:Acronym

Prevalence of Chronic post surgical pain after total Knee Arthroplasty and examination of factor. Multicenter survey

Region

Japan


Condition

Condition

Total knee arthroplasty (TKA)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this multicenter study is to investigate the incidence of CPSP in patients with TKA, and the factors involved.

Basic objectives2

Others

Basic objectives -Others

epidemiology, pathophysiology and prognosis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain intensity
Tampa Scale of Kinesiophobia
Fremantle Knee Awareness Questionnaire
Western Ontario McMaster Universities Osteoarthritis Index
Central Sensitization Inventory

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

After TkA

Key exclusion criteria

severe chronic uncontrolled pain at a site other than the surgical knee before the surgery
a stroke or other central nervous system disorder
another recent surgery
rheumatoid arthritis
dementia

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Ryota
Middle name
Last name Imai

Organization

Osaka Kawasaki Rehabilitation University

Division name

School of Rehabilitation

Zip code

597-0104

Address

158 Mizuma, Kaizuka City, Osaka, Japan

TEL

072-446-6700

Email

imair@kawasakigakuen.ac.jp


Public contact

Name of contact person

1st name Ryota
Middle name
Last name Imai

Organization

Osaka Kawasaki Rehabilitation University

Division name

School of Rehabilitation

Zip code

597-0104

Address

158 Mizuma, Kaizuka City, Osaka, Japan

TEL

072-446-6700

Homepage URL


Email

imair@kawasakigakuen.ac.jp


Sponsor or person

Institute

Osaka Kawasaki Rehabilitation University

Institute

Department

Personal name



Funding Source

Organization

NO

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Faculty of Health and Welfare, Prefectural
University of Hiroshima,
Fukuoka Orthopaedic Hospital
Shion Hospital
Anshin hospital
Kashiba Asahigaoka Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka Kawasaki Rehabilitation University

Address

158 Mizuma, Kaizuka City, Osaka, Japan

Tel

072-446-6700

Email

imair@kawasakigakuen.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

2021 Year 06 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

650

Results

The one-year incidence of chronic postsurgical pain (CPSP) stood at 9.5% among the postoperative cohort, comprising 56 patients. Age and BMI did not exhibit any statistically significant differences. females demonstrated a significantly higher propensity for developing CPSP. Furthermore, significant distinctions were observed in the trajectory slope of the pain experienced by the study participants.

Results date posted

2023 Year 12 Month 18 Day

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

Open public recruiting

Date of protocol fixation

2021 Year 04 Month 01 Day

Date of IRB

2021 Year 05 Month 01 Day

Anticipated trial start date

2021 Year 06 Month 15 Day

Last follow-up date

2024 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The purpose of this multicenter study is to investigate the incidence of CPSP in patients with TKA, and the factors involved.


Management information

Registered date

2021 Year 06 Month 15 Day

Last modified on

2023 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name