Abstract
BackgroundLow-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome.Methods A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity ≥ 50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is the patients’ impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are a reduction in low-back pain intensity (numeric rating scale) and quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory).Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months (T6).DiscussionThis study will provide information on the effectiveness of cryoneurolysis vs. the effectiveness of radiofrequency ablation or placebo for patients with facet joint pain, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.Trial registrationThe trial is approved by the ethical committee of Central Jutland Denmark with registration number 1-10-72-27-19 and the Danish Data Protection Agency with registration number 666,852. The study is registered at Clinicaltrial.gov with the ID number NCT04786145.
Highlights
Low-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis
Known predictors for chronification of low-back pain from facet joint syndrome are high pain intensity, high level of generalized pain, low socio-economic status, weak social network, sick leave, co-morbidity, fear of movement and inadequate coping strategies, which underline the complexity of the condition [1]
Allocation and concealment The patients are allocated to the three study groups by random allocation based on computer generated random numbers
Summary
Low-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis. Facet joint syndrome can cause localized low-back pain and referred pain to adjacent structures in a pseudo-radicular pattern, making the underlying diagnosis difficult to confirm without the use of diagnostic blocks [2]. Neurologic symptoms, such as paresis, are usually absent despite 37 % of patients having a neuropathic pain component [3, 4], mainly presenting as radicular-like leg pain [5]. Known predictors for chronification of low-back pain from facet joint syndrome are high pain intensity, high level of generalized pain, low socio-economic status, weak social network, sick leave, co-morbidity, fear of movement and inadequate coping strategies, which underline the complexity of the condition [1]
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