The Effect of Central Sensitization and Neuropathic Pain After Total Knee Arthroplasty
1 other identifier
observational
312
1 country
1
Brief Summary
It has been well known that central sensitization (CS) is a risk factor for inferior outcomes following total knee arthroplasty (TKA). However, there are still insufficient studies on the relationship between CS and neuropathic pain (NP), and the effects of CS and NP on the patient-reported outcome measures (PROMs) of patients who underwent TKA. The purpose of this study was to investigate the relationship between CS and NP and whether CS and NP were associated with PROM in patients undergoing TKA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
October 12, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedOctober 19, 2022
October 1, 2022
3 years
October 12, 2022
October 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Western Ontario and McMaster University Arthritis Index (WOMAC) scale is a validated questionnarie for evaluation of patients who underwent knee operation. The questionnaire consists of 24 tiems, with five pain-related categories (score range 0-20), two stiffness categories (score range 0-8), and 17 physical functional categories (score range 0-68). All items were scored on a 5-point Likert scale (0 = none, 1 = slightly, 2 = moderate, 3 = serious, 4 = extreme). Total score range is 0-96. The lower the score, the better the result.
2 years after TKA
Eligibility Criteria
This study was approved by the Institutional Review Board of our hospital. Between May 2019 and February 2020, a total of 332 primary TKAs were performed at our institution by a single surgeon. Only patients with a follow-up period of more than two years were included in the study. The remaining 316 patients with primary TKAs were enrolled in this study.
You may qualify if:
- Primary knee degenerative osteoarthritis
- Patients for total knee arthroplasty over the age of 60
- Patients with 2 year postoperative medical records
You may not qualify if:
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
- Allergy or intolerance to study medications
- Patients with an acetylsalicylic acid of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
- Chronic opioid use (taking opioids for longer than 3 months)
- Alcohol, drug abuser
- Narcotics addiction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic Univerisity of Korea Seoul St Mary's hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2022
First Posted
October 17, 2022
Study Start
January 1, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
October 19, 2022
Record last verified: 2022-10