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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532684
• Other study ID #: ozgeilleez
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: December 15, 2020

Study information

• Verified date: May 2020
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Duloxetine

• Pregabalin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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