Comparison of conventional and cooled radiofrequency treatment of the genicular nerves versus sham procedure for patients with chronic knee pain: protocol for a multicentre, double-blind, randomised controlled trial (COGENIUS).
chronic pain
knee
pain management
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
02 08 2023
02 08 2023
Historique:
medline:
4
8
2023
pubmed:
3
8
2023
entrez:
2
8
2023
Statut:
epublish
Résumé
The prevalence of chronic knee pain is increasing. Osteoarthritis (OA) and persistent postsurgical pain (PPSP) are two important causes of knee pain. Chronic knee pain is primarily treated with medications, physiotherapy, life-style changes and intra-articular infiltrations. A radiofrequency treatment (RF) of the genicular nerves is a therapeutical option for refractory knee pain. This study investigates the effectiveness and cost-effectiveness of conventional and cooled RF in patients suffering from chronic, therapy resistant, moderate to severe knee pain due to OA and PPSP. The COGENIUS trial is a double-blinded, randomised controlled trial with 2-year follow-up. Patients and outcome assessors are blinded. Patients will be recruited and treated in Belgium and the Netherlands. All PPSP after a total knee prothesis and OA patients (grades 2-4) will undergo a run-in period of 1-3 months where conservative treatment will be optimised. After the run-in period, 200 patient per group will be randomised to conventional RF, cooled RF or a sham procedure following a 2:2:1 ratio. The analysis will include a comparison of the effectiveness of each RF treatment with the sham procedure and secondarily between conventional and cooled RF. All comparisons will be made for each indication separately. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index score at 6 months. Other outcomes include knee pain, physical functionality, health-related quality of life, emotional health, medication use, healthcare and societal cost and adverse events up to 24 months postintervention. Ethics approval was obtained from the Ethics Committee of the University of Antwerp (Number Project ID 3069-Edge 002190-BUN B3002022000025), the Ethics committee of Maastricht University (Number NL80503.068.22-METC22-023) and the Ethics committee of all participating hospitals. Results of the study will be published in international peer-reviewed journals. NCT05407610.
Identifiants
pubmed: 37532482
pii: bmjopen-2023-073949
doi: 10.1136/bmjopen-2023-073949
pmc: PMC10401223
doi:
Banques de données
ClinicalTrials.gov
['NCT05407610']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e073949Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
Pain Res Manag. 2020 Sep 19;2020:2537075
pubmed: 33014212
Surg Radiol Anat. 2019 Dec;41(12):1461-1471
pubmed: 31338537
Pain. 2019 Jan;160(1):19-27
pubmed: 30586067
Pain. 2011 Mar;152(3):481-487
pubmed: 21055873
Contemp Clin Trials Commun. 2016 Aug 15;3:117-121
pubmed: 27822568
J Arthroplasty. 2017 Dec;32(12):3854-3860
pubmed: 28844632
Rev Panam Salud Publica. 2015 Dec;38(6):506-14
pubmed: 27440100
J Rheumatol. 2019 Aug;46(8):981-989
pubmed: 30647185
Cureus. 2021 Nov 11;13(11):e19489
pubmed: 34912630
Best Pract Res Clin Rheumatol. 2022 Dec;36(4):101810
pubmed: 36642619
Pharmacoeconomics. 1993 Nov;4(5):353-65
pubmed: 10146874
Pain Med. 2021 May 21;22(5):1019-1021
pubmed: 33538816
J Pain Res. 2022 Aug 31;15:2577-2586
pubmed: 36068792
Rheumatology (Oxford). 2015 Feb;54(2):270-7
pubmed: 25150513
Eur J Pain. 2020 Aug;24(7):1228-1241
pubmed: 32416018
Reg Anesth Pain Med. 2016 Jul-Aug;41(4):501-10
pubmed: 27281721
Pain Pract. 2008 Jan-Feb;8(1):1-4
pubmed: 18211588
Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589
pubmed: 31278997
Arthritis Care Res (Hoboken). 2020 Oct;72 Suppl 10:608-629
pubmed: 33091258
Pain. 2010 May;149(2):177-193
pubmed: 20207481
Eur Spine J. 2006 Jan;15 Suppl 1:S17-24
pubmed: 16320034
Arthritis Rheumatol. 2020 Feb;72(2):220-233
pubmed: 31908163
Control Clin Trials. 2004 Apr;25(2):143-56
pubmed: 15020033
Reg Anesth Pain Med. 2021 Apr;46(4):298-304
pubmed: 33558282
Lancet. 2019 Apr 27;393(10182):1745-1759
pubmed: 31034380
Pharmacoeconomics. 2020 Aug;38(8):785-807
pubmed: 32390067
Rheumatology (Oxford). 2014 May;53(5):937-47
pubmed: 24489012
Curr Pain Headache Rep. 2021 Apr 17;25(6):42
pubmed: 33864533
Pain Physician. 2018 Mar;21(2):169-177
pubmed: 29565947
Phys Ther. 2002 Feb;82(2):128-37
pubmed: 11856064
J Bone Joint Surg Am. 2013 Mar 6;95(5):385-92
pubmed: 23344005
Joint Bone Spine. 2016 Dec;83(6):657-663
pubmed: 27426445
Nat Rev Rheumatol. 2014 Jul;10(7):437-41
pubmed: 24662640
Maturitas. 2016 Jul;89:22-8
pubmed: 27180156
Int J Environ Res Public Health. 2021 Jul 12;18(14):
pubmed: 34299875
Reg Anesth Pain Med. 2023 May;48(5):197-204
pubmed: 36653065
Ann Rheum Dis. 2020 Jun;79(6):819-828
pubmed: 32398285
Reg Anesth Pain Med. 2021 Mar;46(3):210-216
pubmed: 33273065
Pain Med. 2018 Aug 1;19(8):1628-1638
pubmed: 29300971
Pain Med. 2021 May 21;22(5):1116-1126
pubmed: 33772285
Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S208-28
pubmed: 22588746
Caspian J Intern Med. 2011 Spring;2(2):205-12
pubmed: 24024017
Arthritis Care Res (Hoboken). 2013 Nov;65(11):1795-1803
pubmed: 23740860
J Am Acad Orthop Surg. 2021 May 1;29(9):387-396
pubmed: 32701684
Int J Rheum Dis. 2018 Oct;21(10):1772-1778
pubmed: 27515095
Curr Pain Headache Rep. 2001 Dec;5(6):517-25
pubmed: 11676886
Qual Life Res. 2018 Nov;27(11):2897-2908
pubmed: 29978346
Arthritis Rheum. 2012 Jun;64(6):1697-707
pubmed: 22392533
Rheum Dis Clin North Am. 2022 May;48(2):549-567
pubmed: 35400378
Pain Med. 2020 Feb 1;21(2):333-348
pubmed: 31578561
Pain Pract. 2017 Jun;17(5):578-588
pubmed: 27641918