The Effects of Radiofrequency Neurotomy Using a Strip-Lesioning Device on Patients with Sacroiliac Joint Pain: Results from a Single-Center, Randomized, Sham-Controlled Trial

Background: Radiofrequency neurotomy (RFN) is a therapy aimed at providing lasting back painrelief for sacroiliac joint (SIJ) pain. A recent advancement in RFN is a strip lesioning technique thatinvolves placement of a single curved electrode and a 3-pole design that facilitates the creation of 5overlapping lesions. These lesions form one long strip lesion accessible through a single entry point,without the need for multiple punctures. Although the early case series data looks promising, thereis lack of long-term, randomized, controlled study evaluating the strip-lesioning system for SIJ pain.Objectives: The purpose of this study was to examine the safety and effectiveness of RFN using astrip lesioning device for reduction of SIJ pain.Study Design: Prospective, double-blind, randomized, sham-controlled trial with 6-monthfollow-upSetting: A tertiary care interventional pain management center in the UKMethods: Patients with SIJ pain with positive diagnostic local anesthetic blocks were randomlyassigned (2:1) to either the sham (no RF lesions performed) or the active group (RF lesions performed).The primary endpoint was improvement of pain using the Numeric Rating Scale (NRS-11) at 3 months.Results were analyzed using nonparametric tests. Safety, secondary, and long-term outcome datawere also collected.Results: Seventeen of 30 enrolled patients were randomly assigned to active treatment (n =11) or sham treatment (n = 6). At 3 months, the mean NRS-11 score for the active group haddecreased significantly, from 8.1 (± 0.8) at baseline to 3.4 (± 2.0) (P < 0.001). The sham group didnot experience a statistically or clinically meaningful decrease in mean NRS-11 score from baseline(7.3 ± 0.8) to 3 months (7.0 ± 1.7). On average, patients in the active group moved from borderlineanxiety at baseline (9.4 ± 5.9) to no anxiety (6.6 ± 6.3) at 3 months. Results were similar at 6 months.Limitations: Recruitment was stopped at 30 enrolled patients, only 17 of whom were randomlyassigned to active or sham treatment, after the interim analysis indicated a statistically significant (P< 0.001) difference in the pain outcome between the treatment and the sham groups.Conclusions: This study demonstrated that radiofrequency neurotomy using a strip lesioningdevice is an appropriate therapy to treat SIJ pain.Key words: Radiofrequency, sacroiliac joint pain, low back pain, neurotomy, randomized controlledtrial, simplicity