36-Month prospective multicenter randomized controlled trial comparing endoscopic facet denervation and cryoneurolysis for chronic lumbar facet joint pain.
Abstract
Background
Cryoneurolysis and endoscopic facet denervation are established minimally invasive treatment options for lumbar facet joint-mediated pain; however, comparative evidence regarding their long-term effectiveness remains limited. This study compared the 36-month clinical outcomes of both procedures in a prospective multicenter randomized clinical trial.
Methods
Eighty patients with lumbar facet joint-mediated pain confirmed by dual controlled medial branch blocks (≥ 70% pain relief) were randomized to undergo cryoneurolysis (n = 40) or endoscopic facet denervation (n = 40). The primary endpoint was low back pain intensity measured using the Numeric Rating Scale (NRS) at the predefined 36-month follow-up. Secondary outcomes included disability, health-related quality of life, and reintervention rates. Longitudinal mixed-effects modelling and conservative sensitivity analyses were performed.
Results
Both treatment groups demonstrated significant and sustained improvements in pain, disability, and health-related quality of life compared with baseline. No statistically significant between-group difference was observed for the primary endpoint at 36 months. Longitudinal mixed-effects modelling demonstrated no significant treatment-by-time interaction (p = 0.74), with an adjusted between-group difference of 0.01 NRS points (95% CI -1.07 to 1.10; p = 0.98). Sensitivity analyses yielded findings consistent with the primary mixed-effects analysis. Reintervention was required in 8 of 40 patients (20.0%) in the cryoneurolysis group and 12 of 40 patients (30.0%) in the endoscopic denervation group (p = 0.44).
Conclusion
Both cryoneurolysis and endoscopic facet denervation were associated with sustained improvements in pain, disability, and health-related quality of life in carefully selected patients with lumbar facet joint-mediated pain. No statistically significant differences in long-term pain trajectories were observed between treatment groups. Although some secondary analyses numerically favored cryoneurolysis, the study was not designed or powered to establish superiority, equivalence, or non-inferiority between treatment modalities. Larger prospective studies are warranted to confirm these findings.