Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial
Introduction 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 pre...
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BMJ Publishing Group
2023-02-01
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| Online Access: | https://bmjopen.bmj.com/content/13/2/e069691.full |
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| author | Jiyu Sun Won Park Dong Hyun Kim Ji Hyun Lee Joon Ho Wang Hak Jae Kim Kichul Shin Min Jung Kim Ji Young Kim Byoung Hyuck Kim Du Hyun Ro Dae-Hee Lee Eun-Hee Hong Seong-Jun Cho Hyuk-Soo Han |
| author_facet | Jiyu Sun Won Park Dong Hyun Kim Ji Hyun Lee Joon Ho Wang Hak Jae Kim Kichul Shin Min Jung Kim Ji Young Kim Byoung Hyuck Kim Du Hyun Ro Dae-Hee Lee Eun-Hee Hong Seong-Jun Cho Hyuk-Soo Han |
| author_sort | Jiyu Sun |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05562271. |
| format | Article |
| id | doaj-art-d7941e4814a849a097e77cbfbbf85027 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-d7941e4814a849a097e77cbfbbf850272025-08-20T03:15:23ZengBMJ Publishing GroupBMJ Open2044-60552023-02-0113210.1136/bmjopen-2022-069691Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trialJiyu Sun0Won Park1Dong Hyun Kim2Ji Hyun Lee3Joon Ho Wang4Hak Jae Kim5Kichul Shin6Min Jung Kim7Ji Young Kim8Byoung Hyuck Kim9Du Hyun Ro10Dae-Hee Lee11Eun-Hee Hong12Seong-Jun Cho13Hyuk-Soo Han14Medical Research Collaborating Center, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of KoreaInha University Hospital, Incheon, Korea, Rep. of (South Korea)Department of Radiology, Seoul National University Seoul Metropolitan Government Boramae Medical Center, Seoul, Republic of KoreaYonsei University College of Medicine, Seoul, South KoreaDepartment of Orthopedic Surgery, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaDepartment of Radiation Oncology, Seoul National University College of Medicine, Seoul, Republic of KoreaDepartment of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of KoreaCollaborator (non-author)Radiation Health Research Institute, Korea Hydro & Nuclear Power Co Ltd, Seoul, Republic of KoreaRadiation Oncology, Seoul National University College of Medicine, Seoul, Republic of KoreaDepartment of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of KoreaDepartment of Orthopedic Surgery, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaRadiation Health Research Institute, Korea Hydro & Nuclear Power Co Ltd, Seoul, Republic of KoreaRadiation Health Research Institute, Korea Hydro & Nuclear Power Co Ltd, Seoul, Republic of KoreaDepartment of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of KoreaIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT05562271.https://bmjopen.bmj.com/content/13/2/e069691.full |
| spellingShingle | Jiyu Sun Won Park Dong Hyun Kim Ji Hyun Lee Joon Ho Wang Hak Jae Kim Kichul Shin Min Jung Kim Ji Young Kim Byoung Hyuck Kim Du Hyun Ro Dae-Hee Lee Eun-Hee Hong Seong-Jun Cho Hyuk-Soo Han Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial BMJ Open |
| title | Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial |
| title_full | Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial |
| title_fullStr | Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial |
| title_full_unstemmed | Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial |
| title_short | Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial |
| title_sort | low dose radiation therapy for patients with knee osteoarthritis lord knea a protocol for a sham controlled randomised trial |
| url | https://bmjopen.bmj.com/content/13/2/e069691.full |
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