Personalized Analgesia Through Central Nervous System Engagement to Unlock Performance

A vizsgálat adatai

Ki végzi

Benedict Alter

Azonosító

NCT07759336

A regiszteradat frissítve

2026. október 21.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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; Recent knee intra-articular injection of steroid or other agent (greater than 1 month does not exclude the participant); Recent knee arthroscopic surgery (greater than 3 months does not exclude the participant); 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); 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); 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 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; History of chronic liver disease or cirrhosis; History of angle-closure glaucoma; 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; Inflammatory arthritis (e.g. rheumatoid arthritis); 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); Recent knee radiofrequency ablation (greater than 3 months does not exclude the participant); 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); Tattoos on sensory testing sites; Pregnancy.

ClinicalTrials.gov NCT07759336