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Can a pain drug help you walk better with knee arthritis?

NCT ID NCT07759336

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether duloxetine, an FDA-approved osteoarthritis drug, can improve walking ability and physical activity in people with chronic knee osteoarthritis pain. Participants take duloxetine or a placebo for six weeks, then complete surveys, physical tasks, brain imaging, and sensory tests. The goal is to see if the drug helps with pain during movement and everyday function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Duloxetine, an FDA-approved drug for osteoarthritis, taken by mouth daily for 6 weeks.
What this could lead to
If effective, duloxetine could become a proven option to improve walking ability and daily activity in people with knee osteoarthritis.
What could go wrong
This is a relatively small trial, and duloxetine may not outperform placebo. Possible side effects include nausea, dizziness, and fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 85 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 weight-bearing knee X-rays as part of the Screening Visit. * Age: 45-80 years old * Gender: Males and females will be recruited. * Language: only English-speaking subjects will be included. Exclusion Criteria: * Inflammatory arthritis (e.g. rheumatoid arthritis). * More intense pain due to another chronic pain syndrome (e.g. fibromyalgia, hip osteoarthritis) * Significant pain or weakness in the lower extremities due to a neurological condition (e.g. lumbar radiculopathy, paresis due to stroke) * New, ongoing acute pain * Recent use of duloxetine defined as any use within the last 3 months * Current use of antidepressants or tramadol * Current routine use of more than 30 mg oral morphine equivalents per day (use of \<=30 mg OME does not exclude the participant). * New treatment that may help knee osteoarthritis (including medication, exercise, behavioral, or complementary and integrative treatments) started in the last month. Stable use of treatments for greater than 1 month does not exclude the participant. * Unwillingness to maintain current knee osteoarthritis treatments for the duration of the study. This means that eligible participants must plan for the following: medications and dietary supplements should not change substantially in frequency or dose; behavioral therapy, exercise therapy, and complementary and integrative therapies should be consistent; and there should be no interventional treatments planned for lower extremity musculoskeletal conditions (e.g. joint steroid injections, knee radiofrequency ablation, knee replacement surgery). * Recent knee intra-articular injection of steroid or other agent (greater than 1 month does not exclude the participant) * Recent knee radiofrequency ablation (greater than 3 months does not exclude the participant) * Recent knee arthroscopic surgery (greater than 3 months does not exclude the participant) * History of knee replacement or open knee surgery on the index knee, defined as the more painful knee on average over the last month. * Inability to walk or climb stairs without significant assistance (e.g. a one-person assist, use a wheelchair; use of a cane does not exclude the participant). * Inability to participate in study procedures (e.g. cognitive impairment limiting ability to understand directions, inability to understand and read English) * Uncontrolled or unstable medical disorder preventing participation in study procedures * History of brain surgery * Tattoos on sensory testing sites * Pregnancy * History of severe renal impairment defined by GFR \< 30 ml/min or, if renal function testing is not available on EMR review, patient-reported history of acute or chronic kidney disease of any severity * History of chronic liver disease or cirrhosis * History of angle-closure glaucoma

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Pittsburgh, Pennsylvania, 15206, United States

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