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

January 21, 2021 updated by: Fatih Sultan Mehmet Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing Visual Analog Scale Score Change in Patients
Time Frame: 0.,4., and 12. weeks
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)
Time Frame: 0.,4, and 12. weeks
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
Time Frame: 0., 4. and 12. weeks
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
Time Frame: 0., 4. and 12. weeks
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
Time Frame: 0.,4.,and 12. weeks
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
Time Frame: 0.,4.,and 12. weeks
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
Time Frame: 0.,4.,and 12. weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Principal Investigator: Özge Gülsüm İlleez, M.D, Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

July 15, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

August 23, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ozgeilleez

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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