Neuropathic PainNCT05581836
The Effect of Central Sensitization and Neuropathic Pain After Total Knee Arthroplasty
An observational study of Neuropathic Pain, run by The Catholic University of Korea at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neuropathic Pain
- How many people
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- Primary knee degenerative osteoarthritis
- Patients for total knee arthroplasty over the age of 60
- Patients with 2 year postoperative medical records
Who cannot join
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
- Allergy or intolerance to study medications
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic Univerisity of Korea Seoul St Mary's hospital
Seoul
About this study
Official title: The Effect of Central Sensitization and Neuropathic Pain on Patients Reported Outcomes Following 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.
Read the 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.
- Conditions
- Neuropathic Pain
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581836
- Sponsor's protocol ID
- KC22RASI0362
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Central Sensitization and Neuropathic Pain on Patients Reported Outcomes Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05581836
- Acronym / sponsor ID
- KC22RASI0362
- Conditions
- Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Primary knee degenerative osteoarthritis
- Patients for total knee arthroplasty over the age of 60
- Patients with 2 year postoperative medical records
Key exclusion criteria (10 listed)
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score (time frame: 2 years after TKA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.