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Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

Recruiting

Low-dose RADIOtherapy for Knee Osteoarthritis (RADIO-KO): Protocol for a Single-center, Sham-controlled, Randomized Clinical Trial

Who can join

Ages 50 to 100 · All sexes

Full eligibility criteria
Inclusion Criteria:

Age 50-100 years with a Mayo Clinic Rochester primary care provider At least moderate constant (ICOAP item A1) or intermittent (ICOAP item B6) pain Diagnosis of primary knee OA (ICD-10 M17.x) without recurrent acute inflammatory flares Joint-line tenderness on examination co-localizes with the reported pain and without a primary extra-articular pain generator Radiographic KL grade 2-3 within the preceding year Ability to complete electronic surveys

Exclusion Criteria:

Pregnancy or childbearing potential without surgical sterilization Recent knee trauma is causing the current pain History of inflammatory arthritis or hemarthrosis Symptomatic hip OA KL grade 1 or 4 Uncontrolled psychiatric illness Prior ipsilateral intra-articular knee surgery Corticosteroid injection within 3 months or hyaluronic acid injection within 6 months in the ipsilateral knee (or 1 month if no sustained improvement after either) Fibromyalgia Active malignancy requiring treatment Regular current use of opioids, platelet-rich plasma, or acupuncture use for the knee

About the study

The primary aim of this study is to investigate whether low-dose radiotherapy is an effective treatment to reduce the pain of knee osteoarthritis. A secondary aim is to determine whether patients experience any more measurable side effects than those receiving sham treatments.

What is being tested

Sponsor: Mayo Clinic · Participants: 128 · Started: Jun 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06887829

Locations in the U.S.

MinnesotaMayo Clinic, Rochester

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.