Personalized pain relief for knee OA using central nervous system-based duloxetine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this double-blind, cross-over Phase 4 trial, adults with knee osteoarthritis will receive duloxetine or placebo for 16 weeks to see if the medication improves walking ability and physical activity. Participants will undergo surveys, physical function tasks, non-invasive brain imaging, and sensory testing at study visits. The trial aims to determine if addressing central nervous system sensitization with duloxetine can improve function and potentially slow joint degeneration. It is led by Benedict Alter with NINDS collaboration at the University of Pittsburgh.

Why it matters

Who can join: the full rules

Inclusion 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. 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.

Exclusion Criteria:

* 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. Stable use of treatments for greater than 1 month does not exclude the participant.
* 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).
* 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

Where it's running

• University of Pittsburgh - Center for Innovation in Pain Care (Research)
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Benedict Alter, MD, PhD — University of Pittsburgh
• Study coordinator: Benedict Alter, MD, PhD
• Email: bea51@pitt.edu
• Phone: 412-677-0575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.