Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)

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

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-07-31

Brief Summary

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Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options have had limited symptomatic effect and are associated with significant side effects. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have, besides its antidepressant properties, a centrally acting analgesic effect.

The aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA.

288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary knee OA attending the outpatient clinic of our institution were enrolled in this study. All patients underwent a physical examination and where questioned about the number of flares. Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included improvements in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline and at monthly intervals for 4 months. All staff involved in data collection was blinded to the treatment assignment groups.

Detailed Description

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Conditions

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Pain Reduction Function Improvement

Keywords

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duloxetine osteoarthritis pain function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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duloxetine HCL

60 mg/day duloxetine for 16 weeks

Intervention Type DRUG

placebo

similar looking tablets to the active agent for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary knee osteoarthritis

Exclusion Criteria

* inflammatory conditions
* autoimmune disorders
* psychiatric illness
* morbid obesity

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Anna Abou-Raya

Professor of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Abou-Raya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

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Faculty of Medicine, University of Alexandria

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Abou-Raya S, Abou-Raya A, Helmii M. Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial. Age Ageing. 2012 Sep;41(5):646-52. doi: 10.1093/ageing/afs072. Epub 2012 Jun 27.

Reference Type DERIVED

PMID: 22743149 (View on PubMed)

Other Identifiers

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alexmed116619163

Identifier Type: -

Identifier Source: org_study_id