Radiofrequency denervation of the lumbar facet joints: guidelines for the RADICAL randomised controlled trial

Abstract

Background and aim: The RADICAL trial has been funded by the National Institute for Health Research (NIHR) to evaluate the clinical and cost-effectiveness of radiofrequency denervation (RFD) for low back pain. Recommendations have been published which aim to standardise selection of patients and RFD technique. However, it is important to ensure these recommendations are acceptable to clinicians within the context of the trial. The aim of this work was to develop standardised criteria for the trial entry and RFD technique for implementation within the RADICAL trial. Methods: Fourteen pain clinicians completed a survey, which involved reviewing the current recommendations and indicating whether they disagreed with any of the recommendations and if so why. Responses were collated and presented at a half-day workshop with 14 attendees. During the workshop, the National Low Back and Radicular Pain Pathway (NLBRPP) guidelines for patient selection and an article by Eldabe and colleagues presenting recommendations on the RFD technique were reviewed. Attendees discussed whether each component of the recommendations should be mandatory, mandatory with alteration or clarification or optional within the RADICAL trial. Results: Attendees agreed during the workshop that 5 of the 10 criteria for patient selection described in the NLBRPP should be mandatory within the RADICAL trial. Three were agreed as mandatory criteria but required further clarification, one of which involved defining a positive response to a diagnostic medial branch block as ⩾60% pain relief. Two criteria had optional components. After reviewing the recommendations on the RFD technique from Eldabe and colleagues, seven components were agreed as mandatory, three were mandatory with alterations and three were optional. Conclusion: When evaluating complex interventions, such as RFD, it is important to ensure agreement and clarity on the clinical protocol, so that the intervention can be reproduced, if found to be effective.

Effectiveness and cost-effectiveness of radiofrequency denervation versus placebo for chronic and moderate to severe low back pain: study protocol for the RADICAL randomised controlled trial

“…Findings from the RADICAL trial will contribute to shaping clinical guidelines and service provision for patients living with chronic LBP. Study training resources, developed in line with the consensus-based best practice guidelines for RFD produced by the RADICAL team, 23 have been positively received and taken up by clinicians across the country, demonstrating that the trial is already impacting on RFD provision by improving standards. The study opened to recruitment on 27 May 2022 and is currently recruiting across 17 centres.…”

“…Positive response to a single diagnostic MNBB with no steroids administered. Based on the outcome of a meeting of RADICAL clinicians, 23 a positive response is defined as ≥60% pain relief in the first 24 hours, based on patient-reported assessment. Final eligibility will be met if a patient’s pain returns to ≥5 on a 0–10 Numeric Rating Scale (NRS) after MNBB.…”

“… 27 To refine the RFD technique for the trial, a national consensus meeting was held with clinicians, patients and academics. 23 Components of the RFD procedure were classified as mandatory or recommended (see online supplemental file ), based on existing best practice recommendations.…”