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Could a pill plus walking ease knee pain and lift mood in veterans?

NCT ID NCT07649291

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether combining the medication duloxetine with a structured walking program can improve physical function, reduce pain, and ease depressive symptoms in veterans with knee osteoarthritis. Participants will be assigned to either the drug-plus-exercise group or a physical therapy referral group. The goal is to find a practical treatment that addresses both pain and mood in this population.

What this could mean

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

Active substance
duloxetine
What this could lead to
If it works, this could point toward a practical treatment strategy that improves mobility and quality of life for veterans with chronic knee pain and depression.
What could go wrong
This is a mid-stage trial with 102 participants, so results may not apply to all patients. The combination may cause side effects like nausea or dizziness, and the exercise program may be hard to maintain.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 102 people

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

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Veterans aged ≥40 years * English-speaking * symptomatic KOA based on American College of Rheumatology (ACR) criteria * Patient Health Questionnaire-9 (PHQ-9) scores indicating mild to severe depressive symptoms * no planned knee surgery within the next 6 months * ability to participate in supervised aerobic exercise Exclusion Criteria: * current use of antidepressants, opioids, benzodiazepines, or antipsychotics * engaging in structured aerobic or resistance exercise ≥3 times per week * cognitive impairment defined as a Mini-Mental State Examination (MMSE) score \<20 * diagnosis of bipolar disorder, psychosis, recent substance use disorder, or suicidal ideation per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * medical conditions contraindicating exercise (e.g., recent myocardial infarction, unstable angina, peripheral arterial disease with ulcers, -uncontrolled hypertension \>190/110, or New York Heart Association class ≥3 cardiac or pulmonary disease) * pregnant or lactating individuals * active cancer that is currently undergoing treatment (receiving chemotherapy and/or radiation therapy * other conditions deemed by study team to endanger the health of the participant

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder Motor Activity osteoarthritis, knee Pain

As listed by the trial registrant

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

Depression Knee osteoarthritis Pain

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

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland, 21201, United States

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