Table 2.
Supporting literature and evidence.
| Author and Year | Design | Study Size | Inclusion Criteria | Age of Participants, y | Participant Duration of Pain | Targeting Success | Adverse Events |
| Becker 201744 | SGOS | 16 | CLBP >6 mo Modic 1 or 2 changes L3 to S1 or positive discography | Mean 48.0 (range 34–66) |
Not reported | 91% | n = 4: lumbar pain, buttock pain, dysesthesia, and transient numbness resolved with pain medications. |
| Fischgrund 201838 | RCT | 225 randomized, 147 received BVNA, 128 PP (87%) at 12-mo of follow-up |
CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 46.9 (range 26–69) | 6–12 mo – 4%, 1–2 y – 10%, 2–3 y – 7%, 3–5 y – 12%, >5 y – 67% |
95% | 1 nerve root injury (sham group), 1 vertebral compression fracture (sham group), 1 retroperitoneal hemorrhage (sham group), 7 lumbar radiculitis, and transient motor or sensory deficits all resolved with supportive care. |
| Fischgrund 201931 | SGOS | 106 of 128 PP BVNA (83%) at 24 mo of follow-up | CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 47.4 (range 27–69) | 6–12 mo – 5%, 1–2 y – 11%, 2–3 y – 6%, 3–5 y – 14%, >5 y – 64% |
89% | Previously discussed. No additional serious or related adverse events reported through 24 mo of follow-up. |
| Fischgrund 202032 | SGOS | 100 of 117 PP BVNA US population (85%) at 5+ y of follow-up | CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 47.2 (range 26–69) | 6–12 mo – 4%, 1–2 y – 11%, 2–3 y – 4%, 3–5 y – 12%, >5 y – 69% |
89% | Previously discussed. No additional serious or related adverse events reported through a mean of 6.4 y of follow-up. |
| Khalil 201933 | RCT | 140 total randomized 51 of 66 randomized to BVNA treatment arm with a 3-mo primary endpoint visit completed (interim analysis population) |
CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 50.0 (range 26–70) | 6–12 mo – 8%, 1–2 y – 6%, 2–3 y – 10%, 3–5 y – 14%, >5 y – 63% |
96% | Interim analysis reported events; n = 15: incisional pain, leg pain/paresthesia, back pain in a new location, urinary retention, and lateral femoral cutaneous neurapraxia. All resolved. |
| Smuck 202134 | RCT | All BVNA treated (at 12 months): 61 of 66 BVNA treatment arm at 12 mo of follow-up (92%) 61 of 74 standard care controls that crossed to active treatment (82% crossover rate) |
CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | BVNA mean 49.4 (range 30–68); Crossover mean 49.5 (range 26–70) |
6–12 mo – 6%, 1–2 y – 6%, 2–3 y – 9%, 3–5 y – 15%, >5 y – 64% 6–12 mo – 3%, 1–2 y – 0%, 2–3 y – 10%, 3–5 y – 7%, >5 y – 80% |
97% | Full cohort events through 12 mo of follow-up; n = 21: 1 incisional pain, 1 nausea, and 1 inability to complete the procedure related to anesthesia, 1 urinary retention, 1 incision infection, 4 back pain related to procedure positioning, 13 leg pain/paresthesia (resolved median 43 d with oral medication). |
| Koreckij 202135 | SGOS | 58 of 66 BVNA treatment arm at 24 months of follow-up (88%) | CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 50.4 (range 30–68) | 6–12 mo – 3%, 1–2 y – 5%, 2–3 y – 9%, 3–5 y – 16%, >5 y – 67% |
98% | Previously discussed. No additional serious or related events through 24 mo of follow-up. |
| Truumees 201936 | SGOS | 28 of 48 BVNA single arm with 3-mo primary endpoint visit (interim analysis population) | CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 45.2 (SD 8.89) | 6–12 mo – 0%, 1–2 y – 11%, 2–3 y – 14%, 3–5 y – 0%, >5 y – 75% |
97% | n = 3: 1 aborted procedure due to inability to access and 2 leg pain events due to pedicle breach, resolved with oral medication. |
| Macadaeg 202037 | SGOS | 45 of 48 BVNA (full cohort) with 12-mo visit (94%) | CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Median 45.0 (range 25–66) | 1–2 y – 14.9%, 2–3 y – 10.6%, 3–5 y – 2.1%, >5 y – 72.3% |
96% | Full cohort through 12 mo of follow-up adverse events; n = 5: 1 aborted procedure due to inability to access, 3 radiculitis associated with potential pedicle breach resolved with oral medications, 1 corneal abrasion, 1 skin reaction to surgical prep. |
| DeVivo 2020 | SGOS | 56 | CLBP >6 mo despite >6 wk treatment, with Modic 1 or 2 changes L3 to S1 | Median 43.0 (range 38–52) | Not reported | 100% | None. |
| Fishchenko 202140 | SGOS | 19 | CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 52.6 (SD 6.9) | 1–2 y 73.7%, >5 y 26.3% | Not reported | n = 1: arterial injury of the “lumbalis sinistra” causing a hematoma within the iliopsoas with associated plexitis, treated with endovascular embolization. |
| Markman 201945 | PSA | 225 randomized, 147 received BVNA, 128 PP | CLBP >6 mo despite treatment with Modic 1 or 2 changes L3 to S1, minimum ODI 30, VAS 4 | Mean 46.9 (range 26–69) | 6–12 mo – 4%, 1–2 y – 10%, 2–3 y – 7%, 3–5 y – 12%, >5 y – 67% |
95% | Not reported. |
Abbreviations: BVNA, basivertebral nerve ablation; CLBP, chronic low back pain; ODI, Oswestry Disability Index; PP, per protocol; PSA, prospective single arm; RCT, randomized clinical trial; SGOS, single group observational study; VAS, visual analog scale.
a
Based on post-BVNA magnetic resonance imaging.