Chronic Pain, Osteoarthritis
Conditions
Keywords
Osteoarthritis, Chronic pain, Central pain
Brief summary
The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.
Detailed description
This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain. The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.
Interventions
OTHERPhenotype assessment
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria * Males and females age greater than 50 years at time of screening
Exclusion criteria
* History of chronic kidney disease or moderate to severe hepatic impairment * History of anemia * Allergy or intolerance of drug intervention * Inability to participate in outcome measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain | One month |
Countries
United States
Outcome results
None listed