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

This study has been completed.
Information provided by (Responsible Party):
Anna Abou-Raya, Faculty of Medicine, University of Alexandria Identifier:
First received: August 19, 2011
Last updated: August 27, 2011
Last verified: August 2011

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.

Condition Intervention
Pain Reduction Function Improvement Drug: duloxetine HCL Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Anna Abou-Raya, Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 16 weeks ]

Enrollment: 288
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: duloxetine HCL
    60 mg/day duloxetine for 16 weeks
    Drug: placebo
    similar looking tablets to the active agent for 16 weeks

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • primary knee osteoarthritis

Exclusion Criteria:

  • inflammatory conditions
  • autoimmune disorders
  • psychiatric illness
  • morbid obesity
  Contacts and Locations
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Please refer to this study by its identifier: NCT01425827

Faculty of Medicine, University of Alexandria
Alexandria, Egypt, 00203
Sponsors and Collaborators
Faculty of Medicine, University of Alexandria
Principal Investigator: Anna Abou-Raya, MD Faculty of Medicine, University of Alexandria
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anna Abou-Raya, Professor of Rheumatology, Faculty of Medicine, University of Alexandria Identifier: NCT01425827     History of Changes
Other Study ID Numbers: alexmed116619163
Study First Received: August 19, 2011
Last Updated: August 27, 2011

Keywords provided by Anna Abou-Raya, Faculty of Medicine, University of Alexandria:

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents processed this record on July 26, 2017