Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

Summary

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.

Detailed Description

This is a single-center, single-blinded, sham-controlled, superiority randomized controlled trial at Mayo Clinic, Rochester, Minnesota. A total of 128 adults aged 50-100 years with primary knee OA, Kellgren-Lawrence (KL) grade 2-3, and at least moderate pain will be randomized 1:1 to receive either low dose radiotherapy (LDRT) to the affected knee or an identical sham procedure. LDRT will be delivered at 0.5 Gray (Gy) per fraction x 6 fractions (3 Gy total, delivered over 2 weeks). Non-responders at 2 months will receive an identical second course according to the original allocation. The primary endpoint is the area under the curve (AUC) of the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale collected weekly for 6 months. Secondary and exploratory endpoints include analgesic use, durability of response at 9 and 12 months, and effect modification by age and body mass index. The trial has 80% power (two-sided alpha level of 0.05) to detect a half-standard-deviation difference in AUC between groups on the ICOAP scale over 6 months.

Eligibility Criteria

Interventions