Radiation Oncology, Seoul National University College of Medicine, Seoul, Republic of Korea.
Radiation Oncology, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
BMJ Open. 2023 Feb 10;13(2):e069691. doi: 10.1136/bmjopen-2022-069691.
Low-dose radiation therapy (LDRT) for osteoarthritis (OA) has been performed for several decades. However, supporting evidence from randomised studies using modern methodologies is lacking, and a recently published randomised study failed to show the significant benefit of LDRT. The presented trial aims to evaluate the efficacy and safety of LDRT for patients with knee OA.
This prospective, multicentre, randomised trial will be conducted in the Republic of Korea. A total of 114 participants will be randomly assigned (1:1:1) to receive sham irradiation, 0.3 Gy/6 fractions of LDRT or 3 Gy/6 fractions of LDRT. Key inclusion criteria are primary knee OA with Kellgren-Lawrence grade 2-3 and visual analogue scale 50-90 when walking at the baseline. The primary endpoint is the rate of responders at 4 months after LDRT according to the OARSI-OMERACT criteria. Concomitant use of analgesics is prohibited until the primary efficacy evaluation is scheduled.
Currently, approval from the Ministry of Food and Drug Safety of the Republic of Korea and the institutional review board of each participating hospital has been obtained. Patient enrolment began in October 2022 and is ongoing at three participating sites. The results will be disseminated to academic audiences and the public via publication in an international peer-reviewed journal and presentation at conferences. This trial will provide valuable information on the safety and efficacy of LDRT for patients with knee OA.
NCT05562271.
低剂量辐射疗法（LDRT）治疗骨关节炎（OA）已经进行了几十年。然而，缺乏使用现代方法学的随机研究的支持证据，最近发表的一项随机研究未能显示 LDRT 的显著益处。本试验旨在评估 LDRT 治疗膝骨关节炎患者的疗效和安全性。
这是一项在韩国进行的前瞻性、多中心、随机试验。共有 114 名参与者将被随机分配（1:1:1）接受假照射、0.3 Gy/6 次 LDRT 或 3 Gy/6 次 LDRT。主要纳入标准是基线时膝关节 OA 为主，Kellgren-Lawrence 分级 2-3 级，行走时视觉模拟量表（VAS）50-90。主要终点是根据 OARSI-OMERACT 标准，LDRT 后 4 个月的应答率。在计划进行主要疗效评估之前，禁止同时使用镇痛药。
目前，已获得韩国食品药品安全部和每个参与医院的机构审查委员会的批准。患者招募于 2022 年 10 月开始，目前正在三个参与地点进行。研究结果将通过在国际同行评议期刊上发表和在会议上展示，向学术受众和公众传播。本试验将为膝骨关节炎患者 LDRT 的安全性和有效性提供有价值的信息。
NCT05562271。
