NCT05562271

Clinical Trial of Low-dose Radiation Therapy in Patients With Knee Osteoarthritis (LoRD-KNeA Trial)

A Multi-center, Randomized, Single-blinded, Exploratory Clinical Trial to Evaluate Safety and Efficacy of Alleviating Symptom of Low-dose RaDiation Therapy in Patients With KNee osteoArthritis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Clinical verification of knee osteoarthritis pain relief and functional improvement using low-dose radiation therapy

Detailed description

This clinical trial is a multicenter, randomized, single-blinded, exploratory clinical trial to evaluate the efficacy and safety of low-dose radiation for knee osteoarthritis patients. The experimental group is treated with low-dose irradiation 6 times for 3 weeks according to the dose determined for each group, and the control group is treated with sham irradiation. Both the experimental group and the control group visit the hospital 4 weeks after irradiation and at 4, 8, and 12 months to evaluate the efficacy and safety.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
RADIATION	low-dose radiation therapy	low-dose radiation therapy to involved knee joint
RADIATION	sham radiation therapy	sham radiation therapy to involved knee joint

Timeline

• Start date: 2022-10-28
• Primary completion: 2024-07-25
• Completion: 2025-09-30
• First posted: 2022-09-30
• Last updated: 2025-05-15

Locations

3 sites across 1 country: South Korea

Regulatory

• FDA-regulated device study