The Clinical Effect of Pregabalin on Neuropathic Pain in Central Sensitized Patients After Total Knee Arthroplasty

NCT05254652 | Unknown

• 1 other identifier: KC22MISV0096
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, patients scheduled to undergo total knee arthroplasty (TKA) will be screened through a survey for patients with central sensitivity and patients with neuropathic pain as preoperative evaluation. It is designed to evaluate the effectiveness of pregabalin with the decision to prescribe duloxetine by dividing patient groups according to central sensitization and neuropathic pain.

Conditions

Osteoarthritis

Keywords

Pregabalin; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Visual Pain Scale change

  Visual pain scale is a validated questionnaire for evaluation of patients who underwent knee operation. The score range is 0-10. The lower the score, the better the result.

  Changes from preoperative Visual pain scale at postoperative 1,2,6,18 weeks and 1 year

Secondary Outcomes (2)

• Western Ontario and McMaster University Arthritis Index Scale change

  Changes from preoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scale at postoperative 1, 2, 6, 18 weeks and 1 year

• Knee range of motion change

  Changes from preoperative knee range of motion at postoperative 1, 2, 6, 18 weeks and 1 year

Study Arms (2)

Experimental: Duloxetine and Pregabalin

EXPERIMENTAL

Experimental group will take medicine for 10 weeks from 2 weeks before surgery to 8 weeks after surgery. The group takes one pill of duloxetine 30 mg, one pill of pregabalin 150mg after breakfast and one pill of pregabalin 150 mg after dinner.

Drug: Duloxetine 30mg; Drug: Pregabalin 150mg

Active Comparator: Duloxetine

ACTIVE COMPARATOR

Active comparator group will take medicine for 10 weeks from 2 weeks before surgery to 8 weeks after surgery. The group takes only one pill of duloxetine 30 mg after breakfast.

Drug: Duloxetine 30mg

Interventions

Duloxetine 30mg DRUG

Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.

Also known as: Cymbalta 30mg

Active Comparator: Duloxetine; Experimental: Duloxetine and Pregabalin

Pregabalin 150mg DRUG

Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.

Also known as: Lyrica 150mg

Experimental: Duloxetine and Pregabalin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients for total knee arthroplasty over the age of 19
• Patients who have the will or ability to follow the doctor's instructions, including rehabilitation treatment such as joint exercise.
• Patients understand this study and agree in writing by the patient's own or by the patient's representative to participate in the study.
• Patients with central sensitization and neuropathic pain.

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 gabapentin or pregabalin use (regular use for longer than 3 months)
• Chronic opioid use (taking opioids for longer than 3 months)
• Alcohol, drug abuser
• Narcotics addiction

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

the Catholic Univerisity of Korea Seoul St Mary's hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis; Neuralgia

Interventions

Duloxetine Hydrochloride; Pregabalin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yong In, MD, PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong In, MD, PhD

CONTACT

82-10-9044-5228; iy1000@catholic.ac.kr

Mansoo Kim, MD, PhD

CONTACT

82-10-7233-3875; kms3779@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 24, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

KR (1)