Vivek Mehta1, Kavita Poply1, Michael Husband2, Sibtain Anwar3, Richard Langford1. 1. Pain and Anaesthesia Research Centre, St. Bartholomew's Hospital, United Kingdom. 2. St. Richard's Hospital, Western Sussex Hospital NHS Trust, Spitafield Lane, Chicester, West Sussex. 3. Department of Perioperative Medicine, Barts Heart Centre, Barts Health NHS Trust, West Smithfield London.
Abstract
BACKGROUND:Radiofrequency neurotomy (RFN) is a therapy aimed at providing lasting back pain relief for sacroiliac joint (SIJ) pain. A recent advancement in RFN is a strip lesioning technique that involves placement of a single curved electrode and a 3-pole design that facilitates the creation of 5 overlapping 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, there is 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 a strip lesioning device for reduction of SIJ pain. STUDY DESIGN: Prospective, double-blind, randomized, sham-controlled trial with 6-month follow-up SETTING: A tertiary care interventional pain management center in the UK METHODS:Patients with SIJ pain with positive diagnostic local anesthetic blocks were randomly assigned (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 data were 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 had decreased significantly, from 8.1 (± 0.8) at baseline to 3.4 (± 2.0) (P < 0.001). The sham group did not 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 borderline anxiety 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 randomly assigned 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 lesioning device is an appropriate therapy to treat SIJ pain. KEY WORDS: Radiofrequency, sacroiliac joint pain, low back pain, neurotomy, randomized controlled trial, simplicity.
RCT Entities:
BACKGROUND: Radiofrequency neurotomy (RFN) is a therapy aimed at providing lasting back pain relief for sacroiliac joint (SIJ) pain. A recent advancement in RFN is a strip lesioning technique that involves placement of a single curved electrode and a 3-pole design that facilitates the creation of 5 overlapping 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, there is 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 a strip lesioning device for reduction of SIJ pain. STUDY DESIGN: Prospective, double-blind, randomized, sham-controlled trial with 6-month follow-up SETTING: A tertiary care interventional pain management center in the UK METHODS:Patients with SIJ pain with positive diagnostic local anesthetic blocks were randomly assigned (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 data were 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 had decreased significantly, from 8.1 (± 0.8) at baseline to 3.4 (± 2.0) (P < 0.001). The sham group did not 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 borderline anxiety 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 randomly assigned 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 lesioning device is an appropriate therapy to treat SIJ pain. KEY WORDS: Radiofrequency, sacroiliac joint pain, low back pain, neurotomy, randomized controlled trial, simplicity.
Authors: Rudolf Likar; Johann Auer; Albert Chavanne; Wilfried Ilias; Michael Kern; Petra Krepler; Hans-Georg Kress; Ulrike Lischnig; Gernot Maurer; Oliver Sommer; Martin C Spendel; Siegfried Thurnher; Karl Wohak; Andreas Wolf; Michael Wölkhart Journal: Schmerz Date: 2021-01-14 Impact factor: 1.107
Authors: Andy Kranenburg; Gabriel Garcia-Diaz; Judson H Cook; Michael Thambuswamy; Whitney James; David Stevens; Adam Bruggeman; Ying Chen; Robyn Capobianco; W Carlton Reckling; Joel D Siegal Journal: Med Devices (Auckl) Date: 2022-07-20