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The Effect of Central Sensitization and Neuropathic Pain After Total Knee Arthroplasty

Sponsor
The Catholic University of Korea (Other)
Overall Status
Completed
CT.gov ID
NCT05581836
Collaborator
(none)
312
Enrollment
1
Location
36
Actual Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A total of 312 patients who underwent primary TKA for end stage knee OA were enrolled. CS was defined as a patient with a score of 40 or higher using central sensitization inventory (CSI). NP was defined as a patient with a score of 12 or more using pain detect questionnaire (PDQ). PROMs were also evaluated based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score preoperatively and at postoperative 1 year. The patients were divided into 4 groups, group 1 with CS and NP positive, group 2 with only CS positive, group 3 with only NP positive, and group 4 with CS and NP negative, and PROM was compared between the groups.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    312 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Effect of Central Sensitization and Neuropathic Pain on Patients Reported Outcomes Following Total Knee Arthroplasty
    Actual Study Start Date :
    Jan 1, 2019
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score [2 years after TKA]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Primary knee degenerative osteoarthritis

    • Patients for total knee arthroplasty over the age of 60

    • Patients with 2 year postoperative medical records

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic Univerisity of Korea Seoul St Mary's hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • The Catholic University of Korea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yong In, Professor, The Catholic University of Korea
    ClinicalTrials.gov Identifier:
    NCT05581836
    Other Study ID Numbers:
    • KC22RASI0362
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuralgia

    Study Results

    No Results Posted as of Oct 19, 2022