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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Catholic Univerisity of Korea Seoul St Mary's hospital

Seoul, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Oct 17, 2022
Registry last updated: Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed