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

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

Sponsors

Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Source Fatih Sultan Mehmet Training and Research Hospital
Brief 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.

Detailed Description

A total of 60 patients (aged 40-65) 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), 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).

Overall Status Completed
Start Date October 2016
Completion Date July 15, 2020
Primary Completion Date May 15, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Assessing Short Form-36 (SF-36) Questionnaire Score Change in Patients 0., 3. and 6. months
Assessing Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score Change in Patients 0., 3. and 6. months
Assessing Visual Analog Scale Score Change in Patients 0., 3. and 6. months
Secondary Outcome
Measure Time Frame
Assessing Beck Depression Inventory Score Change in Patients 0., 3. and 6. months
Assesing Beck Anxiety Inventory Score Change in Patients 0., 3. and 6. months
Assessing Pittsburgh Sleep Quality Index Score Change in Patients 0., 3. and 6. months
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Duloxetine

Arm Group Label: Duloxetine

Intervention Type: Drug

Intervention Name: Pregabalin

Arm Group Label: Pregabalin

Eligibility

Criteria:

Inclusion Criteria:

- Aged 40-65

- 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

Gender: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Özge Gülsüm İlleez, M.D Principal Investigator Fatih Sultan Mehmet Training and Research Hospital
Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Duloxetine

Type: Active Comparator

Description: 30 patients received 60 mg/day of duloxetine HCL orally for 12 weeks

Label: Pregabalin

Type: Active Comparator

Description: 30 patients received 300 mg/day of pregabalin orally for 12 weeks

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized prospective clinical trial

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Masking Description: Double (Participant, Outcome Assesor)

Source: ClinicalTrials.gov