RT Journal Article
SR Electronic
T1 Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study
JF International Journal of Spine Surgery
JO Int J Spine Surg
FD International Society for the Advancement of Spine Surgery
SP 110
OP 119
DO 10.14444/6015
VO 13
IS 2
A1 FISCHGRUND, JEFFREY S.
A1 RHYNE, ALFRED
A1 FRANKE, JÖRG
A1 SASSO, RICK
A1 KITCHEL, SCOTT
A1 BAE, HYUN
A1 YEUNG, CHRISTOPHER
A1 TRUUMEES, EERIC
A1 SCHAUFELE, MICHAEL
A1 YUAN, PHILIP
A1 VAJKOCZY, PETER
A1 DEPALMA, MICHAEL
A1 ANDERSON, DAVID G.
A1 THIBODEAU, LEE
A1 MEYER, BERNHARD
YR 2019
UL https://www.ijssurgery.com/content/13/2/110.abstract
AB Background: The purpose of the present study is to report the 2-year clinical outcomes for chronic low back pain (CLBP) patients treated with radiofrequency (RF) ablation of the basivertebral nerve (BVN) in a randomized controlled trial that previously reported 1-year follow up.Methods: A total of 147 patients were treated with RF ablation of the BVN in a randomized controlled trial designed to demonstrate safety and efficacy as part of a Food and Drug Administration-Investigational Device Exemption trial. Evaluations, including patient self-assessments, physical and neurological examinations, and safety assessments, were performed at 2 and 6 weeks, and 3, 6, 12, 18, and 24 months postoperatively. Participants randomized to the sham control arm were allowed to cross to RF ablation at 12 months. Due to a high rate of crossover, RF ablation treated participants acted as their own control in a comparison to baseline for the 24-month outcomes.Results: Clinical improvements in the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and the Medical Outcomes Trust Short-Form Health Survey Physical Component Summary were statistically significant compared to baseline at all follow-up time points through 2 years. The mean percent improvements in ODI and VAS compared to baseline at 2 years were 53.7 and 52.9%, respectively. Responder rates for ODI and VAS were also maintained through 2 years with patients showing clinically meaningful improvements in both: ODI ≥ 10-point improvement in 76.4% of patients and ODI ≥ 20-point improvement in 57.5%; VAS ≥ 1.5 cm improvement in 70.2% of patients.Conclusions: Patients treated with RF ablation of the BVN for CLBP exhibited sustained clinical benefits in ODI and VAS and maintained high responder rates at 2 years following treatment. Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of CLBP.