OsteoarthritisNCT05254652
The Clinical Effect of Pregabalin on Neuropathic Pain in Central Sensitized Patients After Total Knee Arthroplasty
A study testing Duloxetine 30mg and Pregabalin 150mg in people with Osteoarthritis, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Duloxetine 30mg and Pregabalin 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2022to May 2023
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Rheumatoid arthritis
- Other inflammatory arthritis
- Neuropsychiatric patients
- Hepatic insufficiency
- Renal insufficiency
- Allergy or intolerance to study medications
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
the Catholic Univerisity of Korea Seoul St Mary's hospital
Seoul
Jae Jung Kim, MD, 82-10-3388-2689, jaejung343@hanmail.net
Mansoo Kim, MD, PhD, 82-10-7233-3875, kms3779@naver.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Duloxetine 30mg, Pregabalin 150mg
- Keywords
- Pregabalin, neuropathic pain
- Medical subject headings
- Osteoarthritis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 30mgDrug
Also called Cymbalta 30mg
Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.
Pregabalin 150mgDrug
Also called Lyrica 150mg
Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Duloxetine 30mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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: 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
Knee range of motion
Measured: Changes from preoperative knee range of motion at postoperative 1, 2, 6, 18 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study startMay 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
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
- Investigators
- Yong In, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254652
- Sponsor's protocol ID
- KC22MISV0096
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of Pregabalin on Neuropathic Pain in Central Sensitized Patients Who Are Treated With Duloxetine After Total Knee Arthroplasty: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05254652
- Acronym / sponsor ID
- KC22MISV0096
- Conditions
- Osteoarthritis
- Keywords
- Pregabalin, neuropathic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 24 Feb 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Duloxetine and Pregabalin | Experimental | Drug: Duloxetine 30mg, Drug: Pregabalin 150mgExperimental 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. |
| Active Comparator: Duloxetine | Active comparator | Drug: Duloxetine 30mgActive 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine 30mgAlso: Cymbalta 30mgCase management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance. | Drug | Active Comparator: Duloxetine, Experimental: Duloxetine and Pregabalin |
| Pregabalin 150mgAlso: Lyrica 150mgCase management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance. | Drug | Experimental: Duloxetine and Pregabalin |
Primary outcome
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.
2 secondary outcomes
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
Knee range of motion change
Time frame: Changes from preoperative knee range of motion at postoperative 1, 2, 6, 18 weeks and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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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.
Yong In, MD, PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine 30mg and Pregabalin 150mg in people with Osteoarthritis, 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong In, MD, PhD (82-10-9044-5228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Scale change (time frame: Changes from preoperative Visual pain scale at postoperative 1,2,6,18 weeks and 1 year). 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 12 Apr 2022.