PT  - JOURNAL ARTICLE
AU  - Fischgrund, Jeffrey S.
AU  - Rhyne, Alfred
AU  - Franke, Jörg
AU  - Sasso, Rick
AU  - Kitchel, Scott
AU  - Bae, Hyun
AU  - Yeung, Christopher
AU  - Truumees, Eeric
AU  - Schaufele, Michael
AU  - Yuan, Philip
AU  - Vajkoczy, Peter
AU  - Depalma, Michael
AU  - Anderson, David G.
AU  - Thibodeau, Lee
AU  - Meyer, Bernhard
TI  - 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
AID  - 10.14444/6015
DP  - 2019 Apr 01
TA  - International Journal of Spine Surgery
PG  - 6015
4099  - https://www.ijssurgery.com/content/early/2019/04/03/6015.short
4100  - https://www.ijssurgery.com/content/early/2019/04/03/6015.full
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.