Efficacy and Long-term Effect of Radiofrequency Denervation in Patients with Clinically Diagnosed Cervical Facet Joint Pain A Double-blind Randomized Controlled Trial

Study Design. Multicenter double-blind randomized sham-controlled trial. Objective. To assess the efficacy of radiofrequency (RF) denervation of the cervical facet joints in chronic cervical facet joint pain. Summary of Background Data. One randomized controlled trial showed efficacy of RF denervation in whiplash-associated disease. There are no randomized controlled trials on RF denervation in patients with chronic cervical facet joint pain. Methods. Patients were randomized to receive RF denervation combined with bupivacaine (intervention group) or bupivacaine alone (control group). In the intervention group, an RF thermal lesion was made at the cervical medial branches after the injection of bupivacaine. The primary outcome was measured at 6 months and consisted of pain intensity, self-reported treatment effect, improvement on the Neck Disability Index, and the use of pain medication. Duration of effect was determined using telephone interviews. Results. We included 76 patients. In the intervention group, 55.6% showed > 30% pain decrease versus 51.3% in the control group (P = 0.711); 50.0% reported success on the Patients' Global Impression of Change in the intervention group versus 41.0% (P = 0.435); the Neck Disability Index was 15.0 +/- 8.7 in the intervention group compared with 16.5 +/- 7.2 (P = 0.432), the need for pain medication did not differ significantly between groups (P = 0.461). The median time to end of treatment success for patients in the RF group was 42 months, compared with 12 months in the bupivacaine group (P = 0.014). Conclusions. We did not observe significant differences between RF denervation combined with injection of local anesthesia compared with local anesthesia only at 6 months follow-up. We found a difference in the long-term effect after 6 months follow-up in favor of the RF treatment.