Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)
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Purpose
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
- Pain reduction [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
| 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) |
-
Drug: duloxetine HCL
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- primary knee osteoarthritis
Exclusion Criteria:
- inflammatory conditions
- autoimmune disorders
- psychiatric illness
- morbid obesity
Contacts and Locations| Egypt | |
| Faculty of Medicine, University of Alexandria | |
| Alexandria, Egypt, 00203 | |
| Principal Investigator: | Anna Abou-Raya, MD | Faculty of Medicine, University of Alexandria |
More Information
No publications provided by Faculty of Medicine, University of Alexandria
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anna Abou-Raya, Professor of Rheumatology, Faculty of Medicine, University of Alexandria |
| ClinicalTrials.gov Identifier: | NCT01425827 History of Changes |
| Other Study ID Numbers: | alexmed116619163 |
| Study First Received: | August 19, 2011 |
| Last Updated: | August 27, 2011 |
| Health Authority: | Egypt: Institutional Review Board |
Keywords provided by Faculty of Medicine, University of Alexandria:
|
duloxetine osteoarthritis pain function |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013