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

Neuropathic Pain Clinical Trial

Official title:

The Effect of Central Sensitization and Neuropathic Pain on Patients Reported Outcomes Following Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581836
• Other study ID #: KC22RASI0362
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Locations

Country	Name	City	State
Korea, Republic of	The Catholic Univerisity of Korea Seoul St Mary's hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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