A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain


About this study

The purpose of this study is to determine the extent to which duloxetine and the combined effects of painTrainer and duloxetine improve pain and function in participants with knee osteoarthritis (KOA). Also, among those interested in additional treatment, including those following conservative treatment and those inappropriate for conservative care, determine whether nonsurgical procedural interventions improve pain and function. Additionally, to identify clinical and psychosocial phenotypes that predict short- and longer-term outcomes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Meets American College of Rheumatology Classification criteria for knee osteoarthritis.

Exclusion Criteria:

- Any inability to complete study procedures, including, but not limited to low English language literacy.

- Unstable medical condition that presents as an absolute or relative contraindication for participation (e.g., unstable angina, poorly controlled diabetes mellitus, end stage renal failure, automated implantable cardioverter-defibrillator that cannot be disabled before RFA).

- Severe untreated bleeding disorder (anticoagulants may be continued during phase II treatments in most patients).

- Severe vision or hearing impairment or serious cognitive impairment that could interfere with consent or outcome assessment.

- Poorly controlled serious psychiatric condition.

- Active substance abuse.

- Scheduled joint replacement on the affected knee.

- History of bilateral knee joint replacement arthroplasty (total knee arthroplasty [TKA]) or TKA in the affected knee; partial replacements may be eligible depending on physician judgment

-  Scheduled joint replacement

- History of unilateral total knee arthroplasty (TKA) and complaints of KOA pain limited to the operated knee

- Intra-articular viscosupplementation, steroid injection or arthroscopic surgery in the index knee within 12 weeks of baseline

- Ulcers or an open wound in the region of the index knee.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/18/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Paul Scholten, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information


Publications are currently not available

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