Abstract
Introduction
Low back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking.
Methods and analysis
RADICAL is a double-blind, parallel group, superiority randomised controlled trial. A total of 250 adults listed for RFD will be recruited from approximately 20 National Health Service (NHS) pain and spinal clinics. Recruitment processes will be optimised through qualitative research during a 12-month internal pilot phase. Participants will be randomised in theatre using a 1:1 allocation ratio to RFD or placebo. RFD technique will follow best practice guidelines developed for the trial. Placebo RFD will follow the same protocol, but the electrode tip temperature will not be raised. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered the alternative intervention to the one provided at the outset without disclosing the original allocation. The primary clinical outcome will be pain severity, measured using a pain Numeric Rating Scale, at 3 months after randomisation. Secondary outcomes will be assessed up to 2 years after randomisation and include disability, health-related quality of life, psychological distress, time to pain recovery, satisfaction, adverse events, work outcomes and healthcare utilisation. The primary statistical analyses will be by intention-to-treat and will follow a pre-specified analysis plan. The primary economic evaluation will take an NHS and social services perspective and estimate the discounted cost per quality adjusted life year and incremental net benefit of RFD over the 2-year follow up period.
Ethics and dissemination
Ethics approval was obtained from the London - Fulham Research Ethics Committee (21/LO/0471). Results will be disseminated in open access publications and plain language summaries.
Registration: ISRCTN registration number: ISRCTN16473239
Low back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking.
Methods and analysis
RADICAL is a double-blind, parallel group, superiority randomised controlled trial. A total of 250 adults listed for RFD will be recruited from approximately 20 National Health Service (NHS) pain and spinal clinics. Recruitment processes will be optimised through qualitative research during a 12-month internal pilot phase. Participants will be randomised in theatre using a 1:1 allocation ratio to RFD or placebo. RFD technique will follow best practice guidelines developed for the trial. Placebo RFD will follow the same protocol, but the electrode tip temperature will not be raised. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered the alternative intervention to the one provided at the outset without disclosing the original allocation. The primary clinical outcome will be pain severity, measured using a pain Numeric Rating Scale, at 3 months after randomisation. Secondary outcomes will be assessed up to 2 years after randomisation and include disability, health-related quality of life, psychological distress, time to pain recovery, satisfaction, adverse events, work outcomes and healthcare utilisation. The primary statistical analyses will be by intention-to-treat and will follow a pre-specified analysis plan. The primary economic evaluation will take an NHS and social services perspective and estimate the discounted cost per quality adjusted life year and incremental net benefit of RFD over the 2-year follow up period.
Ethics and dissemination
Ethics approval was obtained from the London - Fulham Research Ethics Committee (21/LO/0471). Results will be disseminated in open access publications and plain language summaries.
Registration: ISRCTN registration number: ISRCTN16473239
Original language | English |
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Article number | e079173 |
Number of pages | 8 |
Journal | BMJ Open |
Volume | 14 |
Issue number | 7 |
DOIs | |
Publication status | Published - 27 Jul 2024 |
Bibliographical note
Publisher Copyright:© Author(s) (or their employer(s)) 2024.
Research Groups and Themes
- HEHP@Bristol