Comparing the effectiveness of pulsed radiofrequency treatment to lumbar dorsal root ganglion according to application times in patients with lumbar radicular pain: protocol for a randomised controlled trial

• Published in: BMJ open Vol. 14; no. 2; p. e077847
• Main Authors: Park, Soyoon, Jang, Jae Ni, Park, Ji-Hoon, Song, Yumin, Sooil, Choi, Kim, Young Uk, Park, Sukhee
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 22.02.2024; BMJ Publishing Group LTD; BMJ Publishing Group
• Subjects: Anaesthesia; Back pain; Consent; Epidural; Ganglia, Spinal; Humans; Low Back Pain; Lumbosacral Region; Pain; Pain management; Patients; Pulsed Radiofrequency Treatment - methods; Quality of Life; Randomized Controlled Trials as Topic; Spinal stenosis; Spine; Steroids; Treatment Outcome; Spine; Back pain; Pain management
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-077847

IntroductionLumbar radicular pain (LRP) is a common symptom characterised by a sharp, shooting or lancinating sensation localised to one or more dermatomes of the lumbar spine. Despite its high prevalence and significant impact on quality of life, the most effective conservative treatment for patients with LRP remains uncertain. When conventional treatment methods do not provide satisfactory results, the option of using epidural steroids and/or pulsed radiofrequency (PRF) treatment may be considered as a secondary approach for managing the condition. Ongoing advances in the field have led to a wide range of PRF parameters being investigated and extensively documented. Therefore, this study will aim to evaluate the treatment efficacy, sustainability and adverse effects of PRF application for different durations in patients with LRP.Methods and analysisThis study will be a double-blind, randomised, controlled trial. Eligible patients with LRP who visit the International St. Mary’s Hospital pain clinic in Korea will be assigned to three groups (1:1:1 ratio) based on the duration of PRF application: 240, 360 and 480 s. Outcome measures will include an assessment of radicular pain intensity, physical function, global improvement, treatment satisfaction and adverse events. The primary outcome will be a Numeric Rating Scale (NRS) score 3 months after the procedure. The secondary outcomes will be the number of subjects in each group reporting successful treatment defined as a significant decrease of NRS or improved physical function score or high satisfaction at the 3 and 6 months follow-up. X2 or Fisher’s exact test and one-way analysis of variance will be used to compare the outcomes.Ethics and disseminationThis trial was approved by the Ethics Committee of Catholic Kwandong University International St. Mary’s Hospital (IS23EISE0018). The findings will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberKCT0008612.