Personalized Analgesia Through Central Nervous System Engagement to Unlock Performance

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Benedict Alter
Study ID
NCT07759336
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Chronic Knee Pain
  • Chronic Pain
  • Knee Osteoarthritis (Knee OA)

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Duloxetine — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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 Dates

First listed
Aug 12, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
85 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Duloxetine, then placebo
    In Period A, participants will receive duloxetine. In Period B, participants will receive placebo.
  • Experimental: Placebo, then duloxetine
    In Period A, participants will receive placebo. In Period B, participants will receive duloxetine.

Primary Outcome Measure

Distance walked in the 6-minute walking test [ Time Frame: 6 minutes per measurement; measured several times from enrollment to last study visit for up to 16 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh - Center for Innovation in Pain Care (Research)PittsburghPennsylvania15206
Benedict Alter, MD, PhD
[email protected]
412-677-0575

Find similar trials in Pittsburgh, PA

By research site
University of Pittsburgh - Center for Innovation in Pain Care (Research)· Pittsburgh, PA

Related Studies