Abstract
Background and aim
The RADICAL trial has been funded by the 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 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 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 five 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 RFD technique from Eldabe and colleagues, seven components were agreed as mandatory, three were mandatory with alterations and three were optional.
Conclusions
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.
The RADICAL trial has been funded by the 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 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 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 five 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 RFD technique from Eldabe and colleagues, seven components were agreed as mandatory, three were mandatory with alterations and three were optional.
Conclusions
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.
| Original language | English |
|---|---|
| Pages (from-to) | 251-258 |
| Number of pages | 8 |
| Journal | British Journal of Pain |
| Volume | 15 |
| Issue number | 3 |
| Early online date | 17 Jul 2020 |
| DOIs | |
| Publication status | Published - 2021 |
Bibliographical note
Funding Information:The authors disclosed receipt of the following financial support for the research, authorship and/or publication of this article: This project was funded by the National Institute for Health Research (NIHR) (Health Technology Assessment programme (project reference NIHR127457)). The study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© The British Pain Society 2020.
Keywords
- low back pain
- pain clinics
- pain management
- radiofrequency denervation
- chronic pain