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

NCT ID: NCT04532684

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2020-12-15

Brief Summary

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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

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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).

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized prospective clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double (Participant, Outcome Assesor)

Study Groups

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Duloxetine

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

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Pregabalin

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

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Interventions

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Duloxetine

Intervention Type DRUG

Pregabalin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Özge Gülsüm İlleez, M.D

Role: PRINCIPAL_INVESTIGATOR

Fatih Sultan Mehmet Training and Research Hospital

References

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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.

Reference Type DERIVED
PMID: 36269595 (View on PubMed)

Other Identifiers

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ozgeilleez

Identifier Type: -

Identifier Source: org_study_id

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