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 | 2026/06/22 10:33:13 |
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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
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
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
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
https://pubmed.ncbi.nlm.nih.gov/34509825/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34509825/
Number of participants that the trial has enrolled
221
Results
TThe mean preoperative walking pain intensity measured using the Visual Analog Scale was 48.4 mm. Postoperative walking pain intensity was 66.8 mm on postoperative day 1, 54.3 mm on postoperative day 3, 48.1 mm on postoperative day 5, 44.2 mm on postoperative day 7, and 10.6 mm at 1 year after surgery. The mean pain curve slope was minus 7.6, and the mean intercept was 72.7 .
Results date posted
| 2023 | Year | 12 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 221 patients who underwent total knee arthroplasty for knee osteoarthritis were included in the analysis. The mean age was 70.7 years (standard deviation, 7.4), and 108 participants (48.9%) were female. The affected limb was the right side in 98 participants (44.0%). The mean height was 153.8 cm (standard deviation, 7.9), and mean body weight was 62.2 kg (standard deviation, 10.8).
Participant flow
A total of 287 patients scheduled to undergo total knee arthroplasty for knee osteoarthritis were assessed for eligibility. Of these, 50 patients were excluded: 10 had severe uncontrolled chronic pain at a site other than the surgical knee before surgery, 4 had stroke or another central nervous system disorder, 15 had undergone another surgery within the prior 3 months, 15 had rheumatoid arthritis, and 6 had dementia. Consequently, 237 patients were enrolled in the study. After enrollment, 16 patients did not complete the evaluations, and the final analysis included 221 patients.
Adverse events
This was an observational study designed to assess walking pain and postoperative pain trajectories after total knee arthroplasty, and no additional invasive intervention beyond usual clinical care was performed for research purposes. No serious adverse events related to the study procedures were reported in the published article.
Outcome measures
The primary outcome measure was walking pain intensity at 1 year after total knee arthroplasty. Walking pain intensity was assessed using the Visual Analog Scale, with 0 mm indicating no pain and 100 mm indicating the highest possible degree of pain. Pain intensity was assessed preoperatively, on postoperative days 1, 3, 5, and 7, and at 1 year after surgery. Chronic postsurgical pain was defined as a Visual Analog Scale score greater than 30 mm for walking pain intensity at 1 year after surgery.To evaluate changes in acute postoperative pain, individual pain trajectories were calculated using walking pain intensity scores obtained on postoperative days 1, 3, 5, and 7. The pain trajectory was represented by a simple linear regression line with postoperative day on the x axis and pain intensity on the y-axis, and both the pain curve slope and intercept were calculated. Structural equation modeling was used to compare models for predicting pain intensity at 1 year after surgery. In addition, Classification and Regression Tree analysis using the CHAID method was performed to calculate clinically useful values for predicting chronic postsurgical pain. The predictor variables were pain curve slope, intercept, age, sex, body mass index, and preoperative pain intensity.Structural equation modeling showed that the pain trajectory model including both the pain curve slope and intercept had the best fit for predicting pain intensity at 1 year after surgery. In the CHAID analysis, when the pain curve slope was less than minus9.5, the probability of a Visual Analog Scale score greater than 30 mm at 1 year after surgery was 2.4%. When the pain curve slope was between minus9.5 and 2.8, the probability was 14.3%. When the pain curve slope was greater than 2.8, the probability was 33.3%. Furthermore, when the pain curve slope was between minus9.5 and 2.8 and the patient was older than 77 years, the probability was 36.0%. The cross-validated misclassification risk estimate for the decision tree model was 0.114, with a standard error of 0.022, indicating that the model predicted reduced pain intensity at 1 year after surgery with an accuracy of 88.6%.
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
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050883
