Knee Osteoarthritis study: Duloxetine
Official title Personalized Analgesia Through Central Nervous System Engagement to Unlock Performance
ClinicalTrials.gov ID: NCT07759336
What this study is testing
What is Duloxetine?
This is an investigational medicine being studied to see if it helps with walking ability in people with knee osteoarthritis. It is designed to affect chemicals in the brain and spinal cord that help the body process pain signals.
Also referred to as Cymbalta.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether duloxetine improves walking ability and physical activity in people with knee osteoarthritis.
- Who it's for
- You may be able to join if you have knee osteoarthritis and chronic knee pain.
- What's involved
- You will take either duloxetine or a pretend treatment. You will fill out surveys, do walking tests, have brain scans, and feel how your body reacts to pain.
- Time commitment
- The study lasts several months and includes multiple visits for tests and surveys.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- 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...
- KL grade 2-4 (Kellgren and Lawrence 1957) indicating significant degenerative changes on knee X-ray.
- Age: 45-80 years old
- Gender: Males and females will be recruited.
You likely can't join if
- 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
See the full eligibility 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.
- Age: 45-80 years old
- Gender: Males and females will be recruited.
- Language: only English-speaking people will be included.
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.