Jad G Khalil1, Matthew Smuck2, Theodore Koreckij3, John Keel4, Douglas Beall5, Bradly Goodman6, Paul Kalapos7, Dan Nguyen8, Steven Garfin9. 1. William Beaumont Hospital, Department of Orthopaedic Surgery, 3811 West 13 Mile Rd, Royal Oak, MI 48073, USA. Electronic address: jadkhalil@gmail.com. 2. Stanford Orthopedic Surgery, 450 Broadway St, Pavillion C, Redwood City, CA 94063, USA. 3. Saint Luke's Hospital, Medical Plaza Bldg 1, Ste. 610, 4320 Wornall Rd, Kansas City, MO 64111, USA. 4. Emory Orthopedics/Spine Center, 59 Executive Park South NE, Atlanta, GA 30329, USA. 5. Clinical Investigations, LLC, 1800 S. Renaissance Blvd, Ste 110, Edmond, OK 73013, USA. 6. Alabama Clinical Therapeutics, LLC, 52 Medical Park East Drive, Suite 203, Birmingham, Alabama 35235, USA. 7. Penn State Hershey Medical Center, 500 University Drive, H066, Hershey, PA 17033, USA. 8. Oklahoma Spine Hospital, 14100 Parkway Commons Drive, Ste 103, Oklahoma City, OK 73134, USA. 9. University of California San Diego, 9500 Gilman Drive, #0602, La Jolla, CA 92093-0602, USA.
Abstract
BACKGROUND CONTEXT: Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN). PURPOSE: The purpose of this RCT was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology. STUDY DESIGN/ SETTING: A prospective, parallel, open label RCT was conducted at 20 U.S. sites. PATIENT SAMPLE: A total of 140 patients with chronic LBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized 1:1 to undergo either RF ablation of the BVN or continue standard care. OUTCOME MEASURES: Oswestry Disability Index (ODI) was collected at baseline, 3, 6, 9, and 12-months postprocedure. Secondary outcome measures included a 10-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment. METHODS: Patients were randomized 1:1 to receive RF ablation or to continue standard care. Self-reported patient outcomes were collected using validated questionnaires at each study visit. An interim analysis to assess for superiority was prespecified and overseen by an independent data management committee when a minimum of 60% of patients had completed their 3-month primary endpoint visit. RESULTS: The interim analysis showed clear statistical superiority (p<.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared with the standard care arm. This resulted in a data management committee recommendation to halt enrollment in the study and offer early cross-over to the control arm. These results are comprised of the outcomes of the 104 patients included in the intent-to-treat analysis of the 3-month primary endpoint, which included 51 patients in the RF ablation arm and 53 patients in the standard care arm. Baseline ODI was 46.1, VAS was 6.67, and mean age was 50 years. The percentage of patients with LBP symptoms ≥5 years was 67.3%. Comparing the RF ablation arm to the standard care arm, the mean changes in ODI at 3 months were -25.3 points versus -4.4 points, respectively, resulting in an adjusted difference of 20.9 points (p<.001). Mean changes in VAS were -3.46 versus -1.02, respectively, an adjusted difference of 2.44 cm (p<.001). In the RF ablation arm, 74.5% of patients achieved a ≥10-point improvement in ODI, compared with 32.7% in the standard care arm (p<0.001). CONCLUSIONS: Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP.
RCT Entities:
BACKGROUND CONTEXT: Current literature suggests that degenerated or damaged vertebral endplates are a significant cause of chronic low back pain (LBP) that is not adequately addressed by standard care. Prior 2-year data from the treatment arm of a sham-controlled randomized controlled trial (RCT) showed maintenance of clinical improvements at 2 years following radiofrequency (RF) ablation of the basivertebral nerve (BVN). PURPOSE: The purpose of this RCT was to compare the effectiveness of intraosseous RF ablation of the BVN to standard care for the treatment of chronic LBP in a specific subgroup of patients suspected to have vertebrogenic related symptomatology. STUDY DESIGN/ SETTING: A prospective, parallel, open label RCT was conducted at 20 U.S. sites. PATIENT SAMPLE: A total of 140 patients with chronic LBP of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized 1:1 to undergo either RF ablation of the BVN or continue standard care. OUTCOME MEASURES: Oswestry Disability Index (ODI) was collected at baseline, 3, 6, 9, and 12-months postprocedure. Secondary outcome measures included a 10-point Visual Analog Scale (VAS) for LBP, ODI and VAS responder rates, SF-36, and EQ-5D-5L. The primary endpoint was a between-arm comparison of the mean change in ODI from baseline to 3 months post-treatment. METHODS:Patients were randomized 1:1 to receive RF ablation or to continue standard care. Self-reported patient outcomes were collected using validated questionnaires at each study visit. An interim analysis to assess for superiority was prespecified and overseen by an independent data management committee when a minimum of 60% of patients had completed their 3-month primary endpoint visit. RESULTS: The interim analysis showed clear statistical superiority (p<.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared with the standard care arm. This resulted in a data management committee recommendation to halt enrollment in the study and offer early cross-over to the control arm. These results are comprised of the outcomes of the 104 patients included in the intent-to-treat analysis of the 3-month primary endpoint, which included 51 patients in the RF ablation arm and 53 patients in the standard care arm. Baseline ODI was 46.1, VAS was 6.67, and mean age was 50 years. The percentage of patients with LBP symptoms ≥5 years was 67.3%. Comparing the RF ablation arm to the standard care arm, the mean changes in ODI at 3 months were -25.3 points versus -4.4 points, respectively, resulting in an adjusted difference of 20.9 points (p<.001). Mean changes in VAS were -3.46 versus -1.02, respectively, an adjusted difference of 2.44 cm (p<.001). In the RF ablation arm, 74.5% of patients achieved a ≥10-point improvement in ODI, compared with 32.7% in the standard care arm (p<0.001). CONCLUSIONS: Minimally invasive RF ablation of the BVN led to significant improvement of pain and function at 3-months in patients with chronic vertebrogenic related LBP.
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