Table 2.
Three-Year Aggregate Cohort Baseline Clinical Characteristics
Demographic features, low back pain treatment history, and clinical characteristics at baseline for BVNA study participants in the aggregate 3-year cohort are reported for the pooled and individual study results.
| INTRACEPT BVNA Treatment Arm (N = 53) | CLBP Single Arm Cohort (N = 42) |
P-Valuea | BVNA Aggregate Cohort (N = 95) | |
|---|---|---|---|---|
| Mean Age in Years (range) | 50.6 (30–68) | 45.4 (30–66) | 0.0070 | 48.3 (30–68) |
| Female, n (%) | 27 (50.9%) | 24 (57.1%) | 0.6790 | 51 (53.7%) |
| Duration LBP ≥ 5 years, n (%) | 36 (67.9%) | 31 (73.8%) | 0.1170 | 67 (70.5%) |
| Mean ODI (range) | 45.2 (30–76) | 47.3 (30–72) | 0.3430 | 46.1 (30–76) |
| Mean VAS (range) | 6.6 (4–9) | 6.8 (4–9) | 0.2614 | 6.7 (4–9) |
| Mean SF-36 (PCS) (range) | 32.2 (18–46) | 32.4 (19–48) | 0.8632 | 32.3 (18–48) |
| Mean SF-36 (MCS) (range) | 54.1 (33–70) | 53.7 (20–68) | 0.8518 | 53.9 (20–70) |
| Mean EQ-5D-5L (range) | 0.6 (0–1) | 0.6 (0–1) | 0.5458 | 0.6 (0–1) |
| Mean Beck Depression Index (range) | 5.8 (0–16) | 4.6 (0–13) | 0.1653 | 5.3 (0–16) |
| Opioid Use at Baseline, n (%) | 20 (37.7%) | 7 (16.7%) | 0.0382 | 27 (28.4%) |
| Spinal Injection Treatment(s) (12 month prior to enrollment), n (%) | 20 (37.7%) | 12 (28.6%) | 0.3883 | 32 (33.7%) |
| Pain Interventions (i.e., medial branch RFA), n (%) | 9 (17.0%) | 3 (7.1%) | 0.2166 | 12 (12.6%) |
| Prior lumbar surgery (discectomy/laminectomy) | 7 (13.2%) | 6 (14.3%) | 1.0000 | 13 (13.7%) |
aP-values using Fisher’s Exact test for categorical data and independent sample t-test for continuous data.
Abbreviations: BVNA - basivertebral nerve ablation; N - number; ODI - Oswestry disability index; VAS - visual analog scale; PCS - physical component score; MCS - mental component score.