Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups
Introduction Guidelines for symptomatic knee osteoarthritis (OA) dictate the initiation of conservative treatment (physical therapy, analgesics and intra-articular injections with corticosteroids) as a first line defence. When conservative treatment fails, the golden standard is invasive joint repla...
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BMJ Publishing Group
2025-07-01
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| author | Markus W Hollmann Johan Haumann Bram Thiel Marc B Godfried Jan-Willem Kallewaard Paul R de Wit Rienk van Beek Monique Schokker Carin Wensing Gezina Oei Derk A van Kampen Lars Elzinga Gijs Hendriks Jeroen van de Heiden Jan Willem Coumou |
| author_facet | Markus W Hollmann Johan Haumann Bram Thiel Marc B Godfried Jan-Willem Kallewaard Paul R de Wit Rienk van Beek Monique Schokker Carin Wensing Gezina Oei Derk A van Kampen Lars Elzinga Gijs Hendriks Jeroen van de Heiden Jan Willem Coumou |
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| description | Introduction Guidelines for symptomatic knee osteoarthritis (OA) dictate the initiation of conservative treatment (physical therapy, analgesics and intra-articular injections with corticosteroids) as a first line defence. When conservative treatment fails, the golden standard is invasive joint replacement surgery, but for a substantial group of patients who do not respond to the current conservative treatment, this is not (yet) indicated. The RADIOPHENOL study investigates if denervation of knee sensory (genicular) nerves can serve the gap between conservative and invasive treatment for younger patients and for patients who cannot undergo joint replacement surgery due to comorbid health conditions.Methods and analysis The RADIOPHENOL study is a multicentre unblinded randomised controlled trial with three parallel arms (1:1:1). In total, 192 patients with knee OA Kellgren-Lawrence grades 2–4 but not eligible for joint replacement according to the orthopaedic surgeon due to young age, old age and/or comorbidity or technical reasons are eligible and will be randomised to three groups of 64 patients. Group A: traditional radiofrequency ablation, group B: chemical neurolysis with phenol, group C: conservative medical management. Primary outcome is the Oxford Knee Score at 6 months. Secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis Index, knee pain by numeric rating scale, physical functionality, health-related quality of life, mental health, change in medication use, predictive value of a diagnostic block, procedure time, patient discomfort score during the intervention and adverse events.Ethics and dissemination The protocol (V.2.0, 15 May 2023), was approved by the Ethics Committee of Amsterdam UMC (NL83410.018.22 – METC2022.0890) on 31 July 2023. We aim to publish our results in international peer-reviewed journals.Trial registration details ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. Registered on 20 October 2023, first patient enrolled on 27 November 2023. |
| format | Article |
| id | doaj-art-c8367ffa1d6e457d8c5e76c2fff13e39 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-07-01 |
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| spelling | doaj-art-c8367ffa1d6e457d8c5e76c2fff13e392025-08-20T03:33:27ZengBMJ Publishing GroupBMJ Open2044-60552025-07-0115710.1136/bmjopen-2024-094576Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups Markus W Hollmann0Johan HaumannBram ThielMarc B GodfriedJan-Willem Kallewaard1Paul R de Wit2Rienk van Beek3Monique Schokker4Carin Wensing5Gezina Oei6Derk A van KampenLars ElzingaGijs HendriksJeroen van de HeidenJan Willem CoumouDepartment of Anesthesiology and Pain Medicine, Amsterdam UMC, Amsterdam, The NetherlandsDepartment of Anesthesiology and Pain Medicine, Amsterdam UMC, Amsterdam, The NetherlandsDepartment of Anesthesiology and Pain Medicine, Amsterdam UMC, Amsterdam, The NetherlandsDepartment of Anesthesiology and Pain Medicine, Dijklander Hospital, Hoorn, Purmerend and Volendam, The NetherlandsDijklander Research Centre, Dijklander Hospital, Hoorn, The NetherlandsDepartment of Anesthesiology and Pain Medicine, Amsterdam UMC, Amsterdam, The NetherlandsDepartment of Anesthesiology and Pain Medicine, Amsterdam UMC, Amsterdam, The NetherlandsIntroduction Guidelines for symptomatic knee osteoarthritis (OA) dictate the initiation of conservative treatment (physical therapy, analgesics and intra-articular injections with corticosteroids) as a first line defence. When conservative treatment fails, the golden standard is invasive joint replacement surgery, but for a substantial group of patients who do not respond to the current conservative treatment, this is not (yet) indicated. The RADIOPHENOL study investigates if denervation of knee sensory (genicular) nerves can serve the gap between conservative and invasive treatment for younger patients and for patients who cannot undergo joint replacement surgery due to comorbid health conditions.Methods and analysis The RADIOPHENOL study is a multicentre unblinded randomised controlled trial with three parallel arms (1:1:1). In total, 192 patients with knee OA Kellgren-Lawrence grades 2–4 but not eligible for joint replacement according to the orthopaedic surgeon due to young age, old age and/or comorbidity or technical reasons are eligible and will be randomised to three groups of 64 patients. Group A: traditional radiofrequency ablation, group B: chemical neurolysis with phenol, group C: conservative medical management. Primary outcome is the Oxford Knee Score at 6 months. Secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis Index, knee pain by numeric rating scale, physical functionality, health-related quality of life, mental health, change in medication use, predictive value of a diagnostic block, procedure time, patient discomfort score during the intervention and adverse events.Ethics and dissemination The protocol (V.2.0, 15 May 2023), was approved by the Ethics Committee of Amsterdam UMC (NL83410.018.22 – METC2022.0890) on 31 July 2023. We aim to publish our results in international peer-reviewed journals.Trial registration details ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. Registered on 20 October 2023, first patient enrolled on 27 November 2023.https://bmjopen.bmj.com/content/15/7/e094576.full |
| spellingShingle | Markus W Hollmann Johan Haumann Bram Thiel Marc B Godfried Jan-Willem Kallewaard Paul R de Wit Rienk van Beek Monique Schokker Carin Wensing Gezina Oei Derk A van Kampen Lars Elzinga Gijs Hendriks Jeroen van de Heiden Jan Willem Coumou Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups BMJ Open |
| title | Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups |
| title_full | Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups |
| title_fullStr | Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups |
| title_full_unstemmed | Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups |
| title_short | Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups |
| title_sort | genicular nerve radiofrequency ablation phenol neurolysis or conservative medical management in patients with knee osteoarthritis protocol for the radiophenol randomised controlled multicentre trial with three parallel groups |
| url | https://bmjopen.bmj.com/content/15/7/e094576.full |
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