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NOT YET RECRUITING
NCT07759336
PHASE4

Personalized Analgesia Through Central Nervous System Engagement to Unlock Performance

Sponsor: Benedict Alter

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2026-08

Completion Date

2028-08

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DRUG

Duloxetine

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.

DRUG

Placebo

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.

Locations (1)

University of Pittsburgh - Center for Innovation in Pain Care (Research)

Pittsburgh, Pennsylvania, United States