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NCT Number: NCT04532684

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

Pregabalin

Drug

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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).

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2020
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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