Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain

Study Overview
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Brief Summary
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Osteoarthritis (OA) is a common degenerative joint disorder associated with chronic pain at older age.It is known that patients with osteoarthritis experience nociceptive and neuropathic pain to varying degrees. Addition of molecules targeting neuropathic pain to conventional therapy has been shown to improve treatment response in the management of osteoarthritis.The aim of our study is to evaluate the effect of duloxetine and pregabalin on pain, functional capacity, quality of life, depression, anxiety and sleep patterns in knee osteoarthritis.

Detailed Description
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A total of 66 patients (aged 40-69) with knee osteoarthritis were randomized into two treatment groups to receive either duloxetine 60mg/day or pregabalin 300mg/day. The patients were evaluated before and one month after treatment and three months after treatment using the visual analog scale (VAS-pain), Neuropathic Pain Diagnostic Questionnaire (DN4), Short Form-36 (SF-36) Questionnaire, Western Ontario and McMaster University Osteoarthritis İndeks (WOMAC), Beck Depression Scale (BDS), Beck Anxiety Akalası (BAS), Pittsburg Sleep Quality Index (PSQI).

Official Title
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Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40-69 Diagnosed with knee osteoarthritis according to the American College of Rheumatology (ACR) criteria Grade 2-3 knee osteoarthritis according to Kellgren-Lawrence grading system VAS-pain score: 4 and above Neuropathic Pain Diagnostic Questionnaire (DN4) score: 4 and above Body mass index value: 40 and below Exclusion Criteria: A history of trauma or surgical operation in the knee region Diabetes mellitus Fibromyalgia Inflammatory rheumatic disease Central or peripheral neurological disorder Severe cardiac, pulmonary, or malignant disease Invasive treatment for knee last 3 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duloxetine<br>33 patients received 60 mg/day of duloxetine HCL orally for 12 weeks | Drug: Duloxetine<br> <br> |
| Active Comparator: Pregabalin<br>33 patients received 300 mg/day of pregabalin orally for 12 weeks | Drug: Pregabalin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing Visual Analog Scale Score Change in Patients | All patients were asked to score the severity of their current knee pain on a 10-cm visual analogue scale (VAS). | 0.,4., and 12. weeks | 
| Neuropthic Pain Diagnostic Questionnaire (DN4) | There are 10 questions in the DN-4 including 7 questions related to pain quality and 3 questions that investigate the presence of tactile sensation, pinprick sensation, and allodynia. A total score 4/10 indicates neuropathic pain. | 0.,4, and 12. weeks | 
| Assessing Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score Change in Patients | The WOMAC consists of 24 questions that assess pain, stiffness, and problems with physical activities. The patient answers all questions on a 5-point Likert-type scale, and the total score ranges from 0 and 96. | 0., 4. and 12. weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing Beck Depression Inventory Score Change in Patients | Symptoms of depression were evaluated by means of the Beck Depression Inventory | 0., 4. and 12. weeks | 
| Assesing Beck Anxiety Inventory Score Change in Patients | Current anxiete state of patients was assessed by means of the Beck Anxiety Inventory | 0.,4.,and 12. weeks | 
| Assessing Pittsburgh Sleep Quality Index Score Change in Patients | Sleep quality assessments were performed by means of the Pittsburgh Sleep Quality Index | 0.,4.,and 12. weeks | 
| Assessing Short Form-36 (SF-36) Questionnaire Score Change in Patients | The SF-36 has eight subscales and consists of a total of 36 questions. The subscales are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. A score of 0 is equivalent to maximum disability (poor quality of life), and a score of 100 is equivalent to no disability (good quality of life). | 0.,4.,and 12. weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee osteoartrhritis, Duloxetine, Pregabalin, Pain