Low Back Pain 

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Focused Ultrasound Therapy

Focused ultrasound is a rapidly evolving, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with back pain, as a common cause is arthritis of the facet joints. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body with minimal damage to surrounding normal tissue.

How it Works
Where the beams converge, the ultrasound produces precise ablation (thermal destruction of tissue) enabling the nerves that carry painful signals from back arthritis to be treated without surgery.

Advantages
The primary treatment options for chronic low back pain caused by facet arthritis currently include medication, steroid injections, radiofrequency ablation of sensory nerves and invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.

Clinical Trials

A clinical trial in the US is recruiting patients for treatment of low back pain secondary to facet joint arthritis.

clinical trial in Taiwan is looking at treating facet arthritis causing low back pain with focused ultrasound. 

multi-center clinical trial in Canada is evaluating the safety and efficacy of a focused ultrasound device to treat back pain secondary to facet joint arthritis. This study is open to Canadian residents. Another arm of this same clinical trial has opened up in Israel as well.

See a list of back pain clinical trials > 
See a list of laboratory research sites >

Regulatory Approval and Reimbursement

The Insightec magnetic resonance guided focused ultrasound system has been approved in Europe and Russia for the treatment of facetogenic back pain.

Notable Papers

Bao J, Tangney T, Pilitsis JG. Focused Ultrasound for Chronic Pain. Neurosurg Clin N Am. 2022 Jul;33(3):331-338. doi: 10.1016/j.nec.2022.02.010. Epub 2022 May 25.

Perez J, Gofeld M, Leblang S, Hananel A, Aginsky R, Chen J, Aubry JF, Shir Y. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study. Pain Med. 2021 Sep 17:pnab275. doi: 10.1093/pm/pnab275.

Zhang W, Trivedi H, Adams M, Losey AD, Diederich CJ, Ozhinsky E, Rieke V, Bucknor MD. Anatomic thermochromic tissue-mimicking phantom of the lumbar spine for pre-clinical evaluation of MR-guided focused ultrasound (MRgFUS) ablation of the facet joint. Int J Hyperthermia. 2021;38(1):130-135. doi: 10.1080/02656736.2021.1880650.

Zwiebel H, Aginsky R, Hananel A, Baldor D, Gofeld M, Aubry JF, LeBlang SD. In vivo measurements of medial branch nerve depth and adjacent osseous structures for ablation of facet-related back pain: Predictors for patient candidacy. N Am Spine Soc J. 2020 Aug 7;3:100018. doi: 10.1016/j.xnsj.2020.100018.

Aginsky R, LeBlang S, Hananel A, Chen J, Gofeld M, Perez J, Shir Y, Aubry JF. 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 Mar;47(3):640-650. doi: 10.1016/j.ultrasmedbio.2020.10.019. Epub 2020 Nov 28.

Chen J, LeBlang S, Hananel A, Aginsky R, Perez J, Gofeld M, Shir Y, Aubry JF. An incoherent HIFU transducer for treatment of the medial branch nerve: Numerical study and in vivo validation. Int J Hyperthermia. 2020;37(1):1219-1228. doi: 10.1080/02656736.2020.1828628.

Browne JE, Tiegs-Heiden CA, Lehman VT, Long Z, Hangiandreou NJ, Watson RE, Hesley GK, Gorny KR. Magnetic Resonance Imaging-Guided Focused Ultrasound Ablation of Lumbar Facet Joints of a Patient With a Magnetic Resonance Image Non-Conditional Pacemaker at 1.5T. Mayo Clin Proc Innov Qual Outcomes. 2020 Aug 5;4(4):464-468. doi: 10.1016/j.mayocpiqo.2020.04.010. eCollection 2020 Aug.

Tiegs-Heiden CA, Lehman VT, Gorny KR, Boon AJ, Hesley GK. Improved Treatment Response Following Magnetic Resonance Imaging-Guided Focused Ultrasound for Lumbar Facet Joint Pain. Mayo Clin Proc Innov Qual Outcomes. 2019 Dec 28;4(1):109-113. doi: 10.1016/j.mayocpiqo.2019.10.003. eCollection 2020 Feb.

Scipione R, Anzidei M, Bazzocchi A, Gagliardo C, Catalano C, Napoli A. HIFU for Bone Metastases and other Musculoskeletal Applications. Semin Intervent Radiol. 2018 Oct;35(4):261-267. doi: 10.1055/s-0038-1673363. Epub 2018 Nov 5. Review.

Click here for additional references from PubMed.

International Approval
Clinical Trials