Duloxetine and aeRobic Exercise to Improve Function in VEterans With Knee Osteoarthritis (DRIVE)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorVA Office of Research and Development

About this trial

Knee osteoarthritis (KOA) is one of the most common causes of chronic pain, mobility problems, and disability among United States Veterans. Many Veterans with KOA also experience depressive symptoms, which can worsen pain, reduce motivation to exercise, and make recovery more difficult. This study will test whether a structured hybrid aerobic exercise program that combines supervised and home-based walking with the medication duloxetine can improve physical function, reduce pain, lessen depressive symptoms, and improve overall health-related outcomes in Veterans with KOA. The goal of this research is to develop a practical and scalable treatment strategy that could improve rehabilitation and quality of life for Veterans with chronic knee pain and depressive symptoms and potentially be adapted for other chronic musculoskeletal conditions treated within the VA healthcare system.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Exercise
  • Duloxetine
  • Placebo
  • PT referral

Treatment groups

102 Participants
are divided into 3 treatment groups

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

Baltimore VA Medical Center

Collaborator