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

April 4, 2022 updated by: Yong In, The Catholic University of Korea

The Clinical Effect of Pregabalin on Neuropathic Pain in Central Sensitized Patients Who Are Treated With Duloxetine After Total Knee Arthroplasty: Randomized Controlled Trial.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Screening for central sensitization and neuropathic pain will be performed two weeks in advance of surgery for patients scheduled to undergo total knee arthroplasty, and is performed through a central sensitization questionnaire and neuropathic pain survey. Through the Central Sensitization Inventory, if the score is 40 or higher out of 100 points, it is considered as the subject of central sensitization. And 13 or higher based on 38 points are considered as the subject of neuropathic pain.

Among the patients who meet these two criteria, only those who agree to the study are targeted. The same probability is assigned by a randomized table two weeks before surgery to a group taking duloxetine and pregabalin and a group taking only duloxetine.

In the case of patients with central sensitization and neuropathic pain, both the experimental group and the control group will take medicine for 10 weeks from 2 weeks before surgery to 8 weeks after surgery. The experimental group takes one pill of duloxetine 30 mg, one pill of pregabalin 150mg after breakfast and one pill of pregabalin 150 mg after dinner. The control group takes only one pill of duloxetine 30 mg after breakfast.

A total of 10 weeks' worth of drugs will be provided two weeks before surgery, and medication compliance will be evaluated based on the number of unused drugs returned by the test subject when the drug is returned. In order to evaluate medication compliance, clinical trials should record the number of drugs provided and returned at each visit and the discontinuation date. Subjects must receive medication guidance on the drug-taking schedule. When the clinical trial is completed or terminated in the middle, the unused or partially used drugs must be returned to the clinical examiner and discarded after confirmation.

Relief drugs can also be taken up to six tablets a day, up to two tablets of 650 mg of Tylenol ER Tablets(acetaminophen) once in both groups.

Anthropological information (gender, age, weight, height, body mass index) and outcome variables (VAS scale for checking the degree of pain) are analyzed for the subjects of the study among patients with central sensitization and neuropathic pain.

The subjects will be collected for three months after surgery in both the experimental group and the control group, and the data will be organized and the results will be derived after the last subject's three-month collection.

From immediately after surgery to three months after surgery, we will evaluate the side effects complaining in the subject group. Side effects will be evaluated through interviews with patients during outpatient visits. The above clinical evaluation is observed during the daily treatment process, and the method performed in this clinical trial is judged to have no unpredictable side effects during the current clinical process.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • the Catholic Univerisity of Korea Seoul St Mary's hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yong In, MD, PhD
        • Sub-Investigator:
          • Mansoo Kim, MD, PhD
        • Sub-Investigator:
          • Jae Jung Kim, MD
        • Sub-Investigator:
          • Ki Ho Kang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Duloxetine and Pregabalin
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
Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.
Other Names:
  • Cymbalta 30mg
Drug: Pregabalin 150mg
Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.
Other Names:
  • Lyrica 150mg
Active Comparator: Active Comparator: Duloxetine
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
Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.
Other Names:
  • Cymbalta 30mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Pain Scale change
Time Frame: Changes from preoperative Visual pain scale at postoperative 1,2,6,18 weeks and 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster University Arthritis Index Scale change
Time Frame: Changes from preoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scale at postoperative 1, 2, 6, 18 weeks and 1 year
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.
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
Time Frame: Changes from preoperative knee range of motion at postoperative 1, 2, 6, 18 weeks and 1 year
Knee range of motion
Changes from preoperative knee range of motion at postoperative 1, 2, 6, 18 weeks and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Yong In, MD, PhD, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC22MISV0096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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