Details

Autor(en) / Beteiligte

• Fischgrund, Jeffrey
• Sasso, Rick C.
• Bae, Hyun W.
• Rhyne, Alfred L.

Titel

Wednesday, September 26, 2018 1:00 PM – 2:00 PM Interventional Pain Management: 30. Two-year outcomes of patients treated with BVN ablation for the relief of chronic low back pain: results of the SMART trial

Ist Teil von

• The spine journal, 2018-08, Vol.18 (8), p.S15-S15

Ort / Verlag

Elsevier Inc

Erscheinungsjahr

2018

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Thirty percent of Americans have low back pain (LBP) at any given time, leading to approximately 50 million physician visits in the U.S. annually. For patients with chronic low back pain (CLBP), the etiology can be difficult to diagnose and then treat using either current nonsurgical therapies, with inherent patient adherence challenges, or surgical interventions, with associated long recovery times. Antonacci et al, following anatomic study, proposed that a portion of pain previously ascribed to the disc actually emanates from the vertebral body endplate nociceptors which communicate to the central nervous system (CNS) through the basivertebral nerve (BVN). We report on the two-year outcome data of the treatment arm patients in the SMART trial, which studied RF BVN ablation to treat CLBP. To determine the longer term efficacy of basivertebral nerve ablation, for the treatment of chronic low back pain. Prospective, randomized, double-blinded, sham control study that was an FDA approved clinical trial. Fifteen sites in the US and three in Germany participated. Skeletally mature patients with chronic (>6 months), isolated low back (lumbar) pain and no neurogenic leg pain, who had not responded to at least six months of nonoperative management (conservative care) were eligible for the SMART study.  Recent MRI had to demonstrate either Type 1 or 2 Modic changes at three or less contiguous vertebral bodies. ODI, Safety, VAS. A total of 128 patients, from the per-protocol treatment arm of the SMART trial, a double-blind sham-controlled randomized trial, were followed for up to 24 months. ODI and VAS instruments were used to collect patient reported outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. ODI and VAS data were available on 106 and 104 patients at 24 months respectively. The mean baseline ODI in the treatment arm was 42.4, decreasing to 22.6 at 12 months and 18.8 at 24 months. The mean baseline VAS in the treatment arm was 6.73, decreasing to 3.96 at 12 months and 3.13 at 24 months. Using a paired t-test comparing the 12 and 24-month VAS observations, the mean score at 24 months was significantly improved compared to 12 months (3.80 vs. 3.13, p=.004). The SMART trial demonstrates that BVN ablation is statistically and clinically superior to the sham intervention, and that the degree of ODI improvement is approximately one disability category. Longitudinal follow-up of these patients demonstrates that ablation of the BVN for the relief of CLBP is a durable procedure with continuing improvement in patient reported ODI and VAS scores at up to two years. Intracept System (Approved for this indication).