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Venous leg ulcers (VLU) account for the majority of chronic wounds, with an estimated rise in prevalence due to demographic change. Care often does not comply with evidence, and patients remain passive and uninformed. To support general practice VLU care, the ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software-supported case management and standardised patient education. Experts from the medical community (physicians, nurses, association of medical assistants), health insurance and patient representatives provided their assessment of barriers in VLU care, requirements for intervention components and their expected effects. Semi-structured interviews and questionnaires were used at two measuring points. Qualitative data analysis was based on the Theoretical Domains Framework. Quantitative data were analysed descriptively. Ten experts named a lack of knowledge and application regarding compression therapy, reluctance to assume role as primary care provider, and inadequate remuneration as barriers for evidence-based VLU care. To effectively address these barriers, interventions are required to foster the use of compression therapy and patient education. A multimodal approach such as pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence-based treatment and supporting patient adherence.
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.
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.
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.
ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. Registered on 20 October 2023, first patient enrolled on 27 November 2023.
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