ISASS Policy Statement 2022: Literature Review of Intraosseous Basivertebral Nerve Ablation

Morgan Lorio; Olivier Clerk-Lamalice; Milaris Rivera; Kai-Uwe Lewandrowski

doi:10.14444/8362

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Figure 1
Modic change 1 (MC1) and Modic change 2 (MC2). Images A and B demonstrate decreased signal intensity of T1-weighted images and increased signal intensity on T2-weighted images, respectively (white arrows), corresponding to MC1 at the L5-S1 disc space. Images C and D correspond to L3-L4 MC2 characterized by increased endplate signal intensity on T1-weighted images and on T2-weighted images, respectively (white arrows). There are similar changes at the L4-L5 disc space (no arrows).
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Figure 2
Mean ODI and mean VAS over time. These graphs depict the mean ODI and mean VAS at each study follow-up for each arm. A statistically significant and clinically meaningful difference between arms in mean ODI and VAS improvement was demonstrated at 6 months as well as from baseline/re-baseline for each timepoint in patients treated with BVNA, including in control patients that crossed to active treatment. BVNA, basivertebral nerve ablation; ODI, Oswestry Disability Index; SC, standard care; VAS, visual analog scale.
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Figure 3
Multistudy comparison of functional improvement. Comparison of mean ODI over time for the 2 level I RCTs and the chronic low back pain single-arm study.33,34,36,38 *SMART RCT US per protocol treatment arm at mean of 6.4 years. **Standard arm re-baselined and offered active treatment at a median of 5.8 months. BVN, basivertebral nerve; ODI, Oswestry Disability Index; RCT, randomized clincial trial; SC, standard care.
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Figure 4
Comparison of proportion of patients by percent reduction in VAS for the 2 level I RCTs and the chronic low back pain single arm study.34,36,38 BVN, basivertebral nerve; VAS, visual analog scale.

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Table 1

Care management options often used for treating chronic low back pain.

1. Avoidance of activities that aggravate pain

2. Trial of chiropractic manipulation

3. Trial of physical therapy

4. Cognitive support and recovery reassurance

5. Spine biomechanics education

6. Specific lumbar exercise program

7. Home use of heat/cold modalities

8. Low-impact aerobic exercise as tolerated

9. Pharmacotherapy (eg, non-narcotic analgesics and nonsteroidal anti-inflammatory drugs)

10. Spinal injections (eg, epidural steroid injections, medial branch blocks, and facet injections) and/or facet ablations

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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.