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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fatih Sultan Mehmet Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ozgeilleez

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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