NCT04532684

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Oct 2016

Longer than P75 for phase_4 knee-osteoarthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 25, 2021

Status Verified

May 1, 2020

Enrollment Period

3.8 years

First QC Date

August 23, 2020

Last Update Submit

January 21, 2021

Conditions

Knee Osteoarthritis

Keywords

Knee osteoartrhritisDuloxetinePregabalinPain

Outcome Measures

Primary Outcomes (3)

  • 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).

    0.,4., and 12. weeks

  • 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.

    0.,4, and 12. weeks

  • 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.

    0., 4. and 12. weeks

Secondary Outcomes (4)

  • Assessing Beck Depression Inventory Score Change in Patients

    0., 4. and 12. weeks

  • Assesing Beck Anxiety Inventory Score Change in Patients

    0.,4.,and 12. weeks

  • Assessing Pittsburgh Sleep Quality Index Score Change in Patients

    0.,4.,and 12. weeks

  • Assessing Short Form-36 (SF-36) Questionnaire Score Change in Patients

    0.,4.,and 12. weeks

Study Arms (2)

Duloxetine

ACTIVE COMPARATOR

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

Drug: Duloxetine

Pregabalin

ACTIVE COMPARATOR

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

Drug: Pregabalin

Interventions

DuloxetineDRUG
Duloxetine
PregabalinDRUG
Pregabalin

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36269595DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Duloxetine HydrochloridePregabalin

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compoundsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Özge Gülsüm İlleez, M.D

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcome Assesor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized prospective clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2020

First Posted

August 31, 2020

Study Start

October 1, 2016

Primary Completion

July 15, 2020

Study Completion

December 15, 2020

Last Updated

January 25, 2021

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share