A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain

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 to 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 post-procedure. 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 pre-specified and overseen by an independent data management committee (DMC) when a minimum of 60% of patients had completed their 3-month primary endpoint visit.

RESULTS:

The interim analysis showed clear statistical superiority (p < 0.001) for all primary and secondary patient-reported outcome measures in the RF ablation arm compared to the standard care arm. This resulted in a DMC 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 (ITT) 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 three months were -25.3 points versus -4.4 points, respectively, resulting in an adjusted difference of 20.9 points (p<0.001). Mean changes in VAS were -3.46 versus -1.02, respectively, an adjusted difference of 2.44 cm (p<0.001). 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.