Duloxetine Plus Exercise to Improve Physical Function in Veterans With Knee Osteoarthritis, Pain, and Psychological Comorbidity
VA Office of Research and Development
Summary
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.
Description
Knee osteoarthritis (KOA) and depressive symptoms are both common among older adults and Veterans and are major contributors to chronic pain, reduced mobility, declines in physical function, disability, and poorer overall health outcomes. Veterans with KOA frequently experience co-occurring depressive symptoms, which can worsen pain, interfere with rehabilitation, and reduce adherence to exercise and other self-management strategies. Existing VA care guidelines generally treat KOA and depressive symptoms separately, and there remains limited evidence supporting integrated interventions that ta…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- BehavioralExercise
Participants will be asked to participate in a 1x/week center-based exercise session and 2x/week walking session conducted on their own for \~12 weeks.
- DrugDuloxetine
Participants will receive study medication - duloxetine - and take medication as directed.
- DrugPlacebo
Participants will receive study medication - matched placebo- and take as directed.
- BehavioralPT referral
Participants will be referred to physical therapy with treatment as part of usual care and individualized to the Veteran's needs.
Location
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, Maryland