Low-dose radiation therapy (LDRT) has been historically used as a non-pharmacologic option for osteoarthritis (OA), but solid evidence from randomized trials is still limited.
Materials/Methods: In this multicenter, randomized, sham-controlled trial, 114 patients with knee OA were allocated to receive sham irradiation, total 0.3 Gy/6 fractions, or total 3 Gy/6 fractions. The main inclusion criteria are primary knee OA classified as Kellgren-Lawrence grade 2–3 and a baseline walking pain score of 50–90/100. Use of concomitant analgesics, except for rescue drug, was restricted during the first 4 months. Re-irradiation was not allowed. The primary endpoint was the OMERACT-OARSI response rate at 4 months.
Results: All participants completed the treatment with perfect adherence. In the full analysis set, the responder rate at 4 months was significantly higher in the 3 Gy group (70.3%) than in the sham group (41.7%, p=0.014), whereas the 0.3 Gy group showed no significant difference compared to sham (58.3%, p=0.157). Similar results were observed in the per-protocol set. Clinically meaningful improvement (=16) in WOMAC total score at 4 months was observed more frequently in the 3 Gy group (56.8%) compared to sham (30.6%, p=0.024). However, there were no significant differences in the mean changes from baseline in other secondary outcomes, including VAS, PGA, serum inflammatory markers, and the amount of rescue drug use. No treatment-related toxicity was reported.
Conclusion:
A single course of 3 Gy LDRT led to significant improvement in clinical outcomes for patients with mild-to-moderate knee OA. These findings support its potential as a conservative treatment option. Long-term and imaging-based follow-up is ongoing.
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