Low-dose radiation treatment for knee osteoarthritis

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

This single-center, single-blinded, randomized, sham-controlled trial at Mayo Clinic will compare low-dose radiotherapy (0.5 Gy given three times per week for two weeks, total 3 Gy) with an identical sham procedure in patients with symptomatic knee osteoarthritis. Participants who do not respond to the initial course may receive a second identical course (active or sham) according to their randomization. Pain outcomes are measured with the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale collected weekly for six months. The study ends after all participants complete six months of follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Stephen P. Merry, M.D. — Mayo Clinic
• Study coordinator: Family Medicine Research Study Coordinators
• Email: RSTFMSC@mayo.edu
• Phone: 507-422-6823

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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.