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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Duloxetine
Pregabalin
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoartrhritis, Duloxetine, Pregabalin, Pain

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Duloxetine

    Pregabalin

    Arm Description

    33 patients received 60 mg/day of duloxetine HCL orally for 12 weeks

    33 patients received 300 mg/day of pregabalin orally for 12 weeks

    Outcomes

    Primary Outcome Measures

    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).
    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.
    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.

    Secondary Outcome Measures

    Assessing Beck Depression Inventory Score Change in Patients
    Symptoms of depression were evaluated by means of the Beck Depression Inventory
    Assesing Beck Anxiety Inventory Score Change in Patients
    Current anxiete state of patients was assessed by means of the Beck Anxiety Inventory
    Assessing Pittsburgh Sleep Quality Index Score Change in Patients
    Sleep quality assessments were performed by means of the Pittsburgh Sleep Quality Index
    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).

    Full Information

    First Posted
    August 23, 2020
    Last Updated
    January 21, 2021
    Sponsor
    Fatih Sultan Mehmet Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04532684
    Brief Title
    Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain
    Official Title
    Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    July 15, 2020 (Actual)
    Study Completion Date
    December 15, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fatih Sultan Mehmet Training and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Knee osteoartrhritis, Duloxetine, Pregabalin, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized prospective clinical trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double (Participant, Outcome Assesor)
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Duloxetine
    Arm Type
    Active Comparator
    Arm Description
    33 patients received 60 mg/day of duloxetine HCL orally for 12 weeks
    Arm Title
    Pregabalin
    Arm Type
    Active Comparator
    Arm Description
    33 patients received 300 mg/day of pregabalin orally for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine
    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin
    Primary Outcome Measure Information:
    Title
    Assessing Visual Analog Scale Score Change in Patients
    Description
    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
    Title
    Neuropthic Pain Diagnostic Questionnaire (DN4)
    Description
    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
    Title
    Assessing Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score Change in Patients
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Assessing Beck Depression Inventory Score Change in Patients
    Description
    Symptoms of depression were evaluated by means of the Beck Depression Inventory
    Time Frame
    0., 4. and 12. weeks
    Title
    Assesing Beck Anxiety Inventory Score Change in Patients
    Description
    Current anxiete state of patients was assessed by means of the Beck Anxiety Inventory
    Time Frame
    0.,4.,and 12. weeks
    Title
    Assessing Pittsburgh Sleep Quality Index Score Change in Patients
    Description
    Sleep quality assessments were performed by means of the Pittsburgh Sleep Quality Index
    Time Frame
    0.,4.,and 12. weeks
    Title
    Assessing Short Form-36 (SF-36) Questionnaire Score Change in Patients
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Özge Gülsüm İlleez, M.D
    Organizational Affiliation
    Fatih Sultan Mehmet Training and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    36269595
    Citation
    Leaney AA, Lyttle JR, Segan J, Urquhart DM, Cicuttini FM, Chou L, Wluka AE. Antidepressants for hip and knee osteoarthritis. Cochrane Database Syst Rev. 2022 Oct 21;10(10):CD012157. doi: 10.1002/14651858.CD012157.pub2.
    Results Reference
    derived

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

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