Personalized Analgesia Through Central Nervous System Engagement to Unlock Performance
Benedict Alter
Summary
The goal of this clinical trial is to examine the effects of duloxetine on walking ability and physical activity in patients with knee osteoarthritis. Researchers will compare duloxetine to a placebo (a look-alike substance that contains no drug) to see if duloxetine works to improve walking ability in patients with knee osteoarthritis. At study visits, participants will complete surveys, perform physical function tasks, undergo non-invasive brain imaging, and undergo sensory testing.
Description
Using a double-blind, cross-over, 16-week randomized clinical trial of duloxetine versus placebo, this study will investigate whether duloxetine improves walking ability and physical activity in knee osteoarthritis patients (N=85). Aerobic exercise such as walking is important in preventing joint deterioration and is a first-line treatment for knee osteoarthritis, despite being painful. Indeed, many patients are limited in their ability to walk due to pain. Prior literature and preliminary data from our group indicate that central nervous system (CNS) pain processing contributes to pain-relate…
Eligibility
- Age range
- 45–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Knee pain for greater than 6 months. * Moderate-to-severe knee pain (\>3/10) due to osteoarthritis, as defined by American College of Rheumatology and EULAR diagnostic criteria (Zhang 2010, Altman 1986) on \>50% of days in the past month. * KL grade 2-4 (Kellgren and Lawrence 1957) indicating significant degenerative changes on knee X-ray. This will be determined on evaluation of weight-bearing clinical X-rays on review of medical records. In the infrequent situation that the patient does not have an X-ray on review of their medical records, then the patient will obtain…
Interventions
- DrugDuloxetine
Duloxetine is an FDA-approved treatment for osteoarthritis. The drug will be prescribed for subjects with knee osteoarthritis pain to improve pain during mobility. The treatment consists of 30 mg of encapsulated duloxetine by mouth once daily for one week followed by 60 mg of encapsulated duloxetine by mouth once daily for 4 weeks. Then, patients will taper back down to 30 mg of encapsulated duloxetine by mouth once daily for one week.
- DrugPlacebo
The placebo is a capsule that has been filled with an inactive filler, microcrystalline cellulose (Avicel). It will match in look to the overencapsulated duloxetine capsules but not contain the duloxetine itself. Participants will take 1 week of the placebo pill identical in appearance to encapsulated duloxetine 30 mg followed by 4 weeks of the placebo pill identical in appearance to encapsulated duloxetine 60 mg. Then, patients will take one week of the placebo pill identical in appearance to encapsulated duloxetine 30 mg.
Location
- University of Pittsburgh - Center for Innovation in Pain Care (Research)Pittsburgh, Pennsylvania