Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study

Jordi Perez, Michael Gofeld, Suzanne Leblang, Arik Hananel, Ron Aginsky, Johnny Chen, Jean-Francois Aubry, Yoram Shir, Jordi Perez, Michael Gofeld, Suzanne Leblang, Arik Hananel, Ron Aginsky, Johnny Chen, Jean-Francois Aubry, Yoram Shir

Abstract

Objective: To investigate the safety and feasibility of a fluoroscopy-guided, high-intensity focused ultrasound system for zygapophyseal joint denervation as a treatment for chronic low back pain.

Methods: The clinical pilot study was performed on 10 participants diagnosed with lumbar zygapophyseal joint syndrome. Each participant had a documented positive response to a diagnostic block or a previous, clinically beneficial radiofrequency ablation. For a descriptive study, the primary outcome was the safety question. All device- or procedure-related adverse events were collected. Secondary outcome variables included the average numeric rating scale for pain, the Roland-Morris Disability Questionnaire, the Brief Pain Inventory, the Patient Global Impression of Change, the morphine equivalent dose, and the finding of the neurological examination.

Results: All participants tolerated the procedure well with no significant device- or procedure-related adverse events; there was one episode of transient pain during the procedure. The average numeric rating scale score for pain decreased from 6.2 at baseline to 2.1 (n = 10) after 1 month, 4.9 (n = 9) after 3 months, 3.0 (n = 8) after 6 months, and 3.0 (n = 6) after 12 months. The ratio of participants who were considered a treatment success was 90% at 1 month, 50% at 3 months, 60% at 6 months, and 40% at 12 months.

Conclusions: The first clinical pilot study using a noninvasive, fluoroscopy-guided, high-intensity focused ultrasound lumbar zygapophyseal neurotomy resulted in no significant device- or procedure-related adverse events and achieved clinical success comparable with that of routine radiofrequency ablation.

Trial registration: ClinicalTrials.gov NCT03321344.

Keywords: Ablation; High-Intensity Focused Ultrasound; Neurotomy; Zygapophyseal Pain.

© The Author(s) 2021. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.

Figures

Figure 1.
Figure 1.
The FUSMobile, Inc. Neurolyser XR, a Fluoroscopy-guided, 1-MHz HIFU Device. (A) Power unit, (B) fluoroscopic image display, and (C) transducer placed over target location .
Figure 2.
Figure 2.
Targeting alignment. (A) Placement of the two radio-opaque markers, with the imaginary line starting at the center of the image field of view and ending at the target. (B) The colinear laser markers aligned to the center of each of the radio-opaque markers.
Figure 3.
Figure 3.
Targeting procedure. (A) X-ray image of the lumbar spine with an “X” marker (white arrow), attached to the C-arm image intensifier, positioned over the target area over the MB nerve along the lateral L4 pedicle. (B) X-ray image with an opaque rod denoting the skin site over the target area (white arrow), which is then marked with a permanent marker. (C) With the use of colinear lasers, the center of translucent mockup cradle is aligned to the mark on the skin, and the center of the “X” marker is aligned on the intensifier (white arrow). For accurate targeting, the laser spot position should be <6 mm from the center of the “X” from the image intensifier marker and <2 mm from the center of the skin marker. (D) Central mockup cradle is replaced with the more opaque Neurolyser Transducer, including an x-ray aimed at the center of the transducer (white arrow). The final targeting accuracy confirms the target in the center of the concentric circles.
Figure 4.
Figure 4.
NRS scores over 1 year. (A) The average NRS for pain severity decreased from a mean of 6.2 at baseline to 2.1 (n = 10) at 1 month, 4.9 (n = 9) at 3 months, 3.0 (n = 8) at 6 months, and 3.0 (n = 6) at the 12-month follow-up period. (B) The average NRS assuming last observation carried forward (LOCF). With this method, pain severity decreased from a mean of 6.2 at baseline to 2.0 at 1 month, 5.0 at 3 months, 3.8 at 6 months, and 4.7 at the 12-month follow-up period.
Figure 5.
Figure 5.
Time plot for each individual NRS score.
Figure 6.
Figure 6.
Clinical success ratio over time. Clinical success rates at the 1-, 3-, 6-, and 12-month follow-up periods were 90% (n = 10), 50% (n = 10), 60% (n = 10), and 40% (n = 10), respectively.
Figure 7.
Figure 7.
Roland-Morris Disability Questionnaire scores over time.
Figure 8.
Figure 8.
Patient Global Impression of Change scores over time.

References

    1. Deyo RA, Tsui-Wu YJ. Descriptive epidemiology of low-back pain and its related medical care in the United States. Spine 1987;12(3):264–8.
    1. MacVicar J, MacVicar AM, Bogduk N. The prevalence of “pure” lumbar zygapophysial joint pain in patients with chronic low back pain. Pain Med 2021;22(1):41–8.
    1. Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology 2007;106(3):591–614.
    1. Manchikanti L, Hirsch JA, Pampati V. Chronic low back pain of facet (zygapophysial) joint origin: Is there a difference based on involvement of single or multiple spinal regions? Pain Physician 2003;6(4):399–405.
    1. McCormick ZL, Marshall B, Walker J, McCarthy R, Walega DR. Long-term function, pain and medication use outcomes of radiofrequency ablation for lumbar facet syndrome. Int J Anesth Anesthesiol 2015;2(2):028. doi:10.23937/2377-4630/2/2/1028.
    1. Cohen SP, Bhaskar A, Bhatia A, et al. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med 2020;45(6):424–67.
    1. Miele F. Ultrasound Physics and Instrumentation, 5th edition. Forney, TX: Pegasus Lectures; 2013.
    1. Ter Haar G, Coussios C. High intensity focused ultrasound: Physical principles and devices. Int J Hyperthermia 2007;23(2):89–104.
    1. Focus Feature: 2020 State of the Field Report. Focused Ultrasound Foundation. Available at: (accessed February 28, 2021).
    1. Weeks EM, Platt MW, Gedroyc W. MRI-guided focused ultrasound (MRgFUS) to treat facet joint osteoarthritis low back pain—Case series of an innovative new technique. Eur Radiol 2012;22(12):2822–35.
    1. Kaye EA, Monette S, Srimathveeravalli G, et al. MRI-guided focused ultrasound ablation of lumbar medial branch nerve: Feasibility and safety study in a swine model. Int J Hyperthermia 2016;32(7):786–94.
    1. Aginsky R, LeBlang S, Hananel A, et al. Tolerability and feasibility of x-ray guided non-invasive ablation of the medial branch nerve with focused ultrasound: Preliminary proof of concept in a pre-clinical model. Ultrasound Med Biol 2021;47(3):640–50.
    1. Gofeld M, Jitendra J, Faclier G. Radiofrequency denervation of the lumbar zygapophysial joints: 10-year prospective clinical audit. Pain Physician 2007;10(2):291–300.
    1. Chen J, LeBlang S, Hananel A, et al. An incoherent HIFU transducer for treatment of the medial branch nerve: Numerical study and in vivo validation. Int J Hyperthermia 2020;37(1):1219–28.
    1. Goodman BS, House LM, Vallabhaneni S, et al. Anticoagulant and antiplatelet management for spinal procedures: A prospective, descriptive study and interpretation of guidelines. Pain Med 2017;18(7):1218–24.
    1. Narouze S, Benzon HT, Provenzano D, et al. Interventional spine and pain procedures in patients on antiplatelet and anticoagulant medications (second edition): Guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain. Reg Anesth Pain Med 2018;43(3):225–62.
    1. Bogduk N. Diagnosing lumbar zygapophysial joint pain. Pain Med 2005;6(2):139–42.
    1. Zwiebel H, Aginsky R, Hananel A, et al. In vivo measurements of medial branch nerve depth and adjacent osseous structures for ablation of facet-related back pain: Predictors for patient candidacy. North Am Spine Soc J 2020;3:100018.

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