Low-dose RaDiation therapy for patients with KNee osteoArthritis (LoRD-KNeA): a protocol for a sham-controlled randomised trial

被引：3

作者：

Kim, Byoung Hyuck ^{[1
,2
]}

Shin, Kichul ^{[3
,4
]}

Kim, Min Jung ^{[3
]}

Kim, Hak Jae ^{[5
]}

Ro, Du Hyun ^{[6
]}

Wang, Joon Ho ^{[7
]}

Lee, Dae-Hee ^{[7
]}

Kim, Dong Hyun ^{[8
]}

Sun, Jiyu ^{[9
]}

Lee, Ji Hyun ^{[10
]}

Kim, Ji Young ^{[11
]}

Hong, Eun-Hee ^{[11
]}

Cho, Seong-Jun ^{[11
]}

Han, Hyuk-Soo ^{[6
]}

Park, Won ^{[12
]}

机构：

[1] Seoul Natl Univ, Radiat Oncol, Coll Med, Seoul, South Korea

[2] Seoul Natl Univ, Radiat Oncol, Seoul Metropolitan Govt, Boramae Med Ctr, Seoul, South Korea

[3] Seoul Natl Univ, Dept Internal Med, Seoul Metropolitan Govt, Boramae Med Ctr, Seoul, South Korea

[4] Seoul Natl Univ, Dept Internal Med, Div Rheumatol, Coll Med, Seoul, South Korea

[5] Seoul Natl Univ, Dept Radiat Oncol, Coll Med, Seoul, South Korea

[6] Seoul Natl Univ, Dept Orthopaed Surg, Coll Med, Seoul, South Korea

[7] Sungkyunkwan Univ, Dept Orthoped Surg, Sch Med, Seoul, South Korea

[8] Seoul Natl Univ, Dept Radiol, Seoul Metropolitan Govt, Boramae Med Ctr, Seoul, South Korea

[9] Seoul Natl Univ, Med Res Collaborating Ctr, Seoul Metropolitan Govt, Boramae Med Ctr, Seoul, South Korea

[10] Sungkyunkwan Univ, Dept Radiol, Sch Med, Seoul, South Korea

[11] Korea Hydro & Nucl Power Co Ltd, Radiat Hlth Res Inst, Seoul, South Korea

[12] Sungkyunkwan Univ, Dept Radiat Oncol, Sch Med, Suwon, South Korea

来源：

BMJ OPEN | 2023年 / 13卷 / 02期

关键词：

Knee; RADIOTHERAPY; Pain management; DISEASES;

D O I：

10.1136/bmjopen-2022-069691

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：7

共 15 条

[1] OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis [J].

Bannuru, R. R. ;

Osani, M. C. ;

Vaysbrot, E. E. ;

Arden, N. K. ;

Bennell, K. ;

Bierma-Zeinstra, S. M. A. ;

Kraus, V. B. ;

Lohmander, L. S. ;

Abbott, J. H. ;

Bhandari, M. ;

Blanco, F. J. ;

Espinosa, R. ;

Haugen, I. K. ;

Lin, J. ;

Mandl, L. A. ;

Moilanen, E. ;

Nakamura, N. ;

Snyder-Mackler, L. ;

Trojian, T. ;

Underwood, M. ;

McAlindon, T. E. .

OSTEOARTHRITIS AND CARTILAGE, 2019, 27 (11) :1578-1589

[2] Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials [J].

Bhala, N. ;

Emberson, J. ;

Merhi, A. ;

Abramson, S. ;

Arber, N. ;

Baron, J. A. ;

Bombardier, C. ;

Cannon, C. ;

Farkouh, M. E. ;

FitzGerald, G. A. ;

Goss, P. ;

Halls, H. ;

Hawk, E. ;

Hawkey, C. ;

Hennekens, C. ;

Hochberg, M. ;

Holland, L. E. ;

Kearney, P. M. ;

Laine, L. ;

Lanas, A. ;

Lance, P. ;

Laupacis, A. ;

Oates, J. ;

Patrono, C. ;

Schnitzer, T. J. ;

Solomon, S. ;

Tugwell, P. ;

Wilson, K. ;

Wittes, J. ;

Baigent, C. ;

Adelowo, O. ;

Aisen, P. ;

Al-Quorain, A. ;

Altman, R. ;

Bakris, G. ;

Baumgartner, H. ;

Bresee, C. ;

Carducci, M. ;

Chang, D-M. ;

Chou, C-T. ;

Clegg, D. ;

Cudkowicz, M. ;

Doody, L. ;

El Miedany, Y. ;

Falandry, C. ;

Farley, J. ;

Ford, L. ;

GarciLosa, M. ;

Gonzalez-Ortiz, M. ;

Haghighi, M. .

LANCET, 2013, 382 (9894) :769-779

[3] SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials [J].

Chan, An-Wen ;

Tetzlaff, Jennifer M. ;

Gotzsche, Peter C. ;

Altman, Douglas G. ;

Mann, Howard ;

Berlin, Jesse A. ;

Dickersin, Kay ;

Hrobjartsson, Asbjorn ;

Schulz, Kenneth F. ;

Parulekar, Wendy R. ;

Krleza-Jeric, Karmela ;

Laupacis, Andreas ;

Moher, David .

BMJ-BRITISH MEDICAL JOURNAL, 2013, 346

[4] The Use of Low-Dose Radiation Therapy in Osteoarthritis: A Review [J].

Dove, Austin P. H. ;

Cmelak, Anthony ;

Darrow, Kaleb ;

McComas, Kyra N. ;

Chowdhary, Mudit ;

Beckta, Jason ;

Kirschner, Austin N. .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2022, 114 (02) :203-220

[5] Low-dose radiation therapy for osteoarthritis and enthesopathies: a review of current data [J].

Javadinia, Seyed Alireza ;

Nazeminezhad, Nooshin ;

Ghahramani-Asl, Ruhollah ;

Soroosh, Davood ;

Fazilat-Panah, Danial ;

PeyroShabany, Babak ;

Saberhosseini, Seyedeh Naeimeh ;

Mehrabian, Arezoo ;

Taghizadeh-Hesary, Farzad ;

Nematshahi, Mohammad ;

Dhawan, Gaurav ;

Welsh, James S. ;

Calabrese, Edward J. ;

Kapoor, Rachna .

INTERNATIONAL JOURNAL OF RADIATION BIOLOGY, 2021, 97 (10) :1352-1367

[6] Indications and treatment schedules for irradiation of benign diseases: a survey [J].

Leer, JWH ;

van Houtte, P ;

Davelaar, J .

RADIOTHERAPY AND ONCOLOGY, 1998, 48 (03) :249-257

[7] Effectiveness of low-dose radiation therapy on symptoms in patients with knee osteoarthritis: a randomised, double-blinded, sham-controlled trial [J].

Mahler, Elien A. M. ;

Minten, Michiel J. M. ;

Leseman-Hoogenboom, Mathilde M. ;

Poortmans, Philip M. P. ;

Leer, Jan Willem H. ;

Boks, Simone S. ;

van den Hoogen, Frank H. J. ;

den Broeder, Alfons A. ;

van den Ende, Cornelia H. M. .

ANNALS OF THE RHEUMATIC DISEASES, 2019, 78 (01) :83-90

[8] Risk of Upper Gastrointestinal Bleeding From Different Drug Combinations [J].

Masclee, Gwen M. C. ;

Valkhoff, Vera E. ;

Coloma, Preciosa M. ;

de Ridder, Maria ;

Romio, Silvana ;

Schuemie, Martijn J. ;

Herings, Ron ;

Gini, Rosa ;

Mazzaglia, Giampiero ;

Picelli, Gino ;

Scotti, Lorenza ;

Pedersen, Lars ;

Kuipers, Ernst J. ;

van der Lei, Johan ;

Sturkenboom, Miriam C. J. M. .

GASTROENTEROLOGY, 2014, 147 (04) :784-U128

[9] Low-Dose Radiation Therapy for Benign Painful Skeletal Disorders: The Typical Treatment for the Elderly Patient? [J].

Micke, Oliver ;

Seegenschmiedt, M. Heinrich ;

Adamietz, Irenaeus A. ;

Kundt, Guenter ;

Fakhrian, Khashayar ;

Schaefer, Ulrich ;

Muecke, Ralph .

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2017, 98 (04) :958-963

[10] Lack of beneficial effects of low-dose radiation therapy on hand osteoarthritis symptoms and inflammation: a randomised, blinded, sham-controlled trial [J].

Minten, M. J. M. ;

Leseman-Hoogenboom, M. M. ;

Kloppenburg, M. ;

Kortekaas, M. C. ;

Leer, J. W. ;

Poortmans, P. M. P. ;

van den Hoogen, F. H. J. ;

den Broeder, A. A. ;

van den Ende, C. H. M. .

OSTEOARTHRITIS AND CARTILAGE, 2018, 26 (10) :1283-1290

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