A Phase 4 interventional study of Duloxetine and Pregabalin in Knee Osteoarthritis, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed. Open to participants aged 40 Years to 69 Years. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Phase 4, Interventional, and Treatment
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.
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).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Fatih Sultan Mehmet Training and Research Hospital is the lead sponsor of 118 studies on the registry; 34 are open to participants now.
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33 patients received 60 mg/day of duloxetine HCL orally for 12 weeks
Drug: Duloxetine
33 patients received 300 mg/day of pregabalin orally for 12 weeks
Drug: Pregabalin
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).
Time frame: 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.
Time frame: 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.
Time frame: 0., 4. and 12. weeks
Assessing Beck Depression Inventory Score Change in Patients
Symptoms of depression were evaluated by means of the Beck Depression Inventory
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 0.,4.,and 12. weeks
No study locations are listed for this record.
Plan to share: No
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Fatih Sultan Mehmet Training and Research Hospital