Ultrasound Neuromodulation (Low‐Intensity Focused Ultrasound) to Treat Knee Osteoarthritis Pain A Randomized, Observer‐ and Participant‐Masked, Sham‐Controlled, Human‐Subjects Pilot Study

Low‐intensity focused ultrasound is a non‐invasive neuromodulation technique that delivers mechanical forces to a deep location within the body through acoustic pressure waves without affecting tissue between the transducer and focal target. Preliminary studies involving healthy volunteers suggest f...

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Published inJournal of ultrasound in medicine Vol. 44; no. 9; pp. 1713 - 1721
Main Authors Ilfeld, Brian M., Cao, Khoa N., Branson, Ruben, Bloom, Philip
Format Journal Article
LanguageEnglish
Published England John Wiley & Sons, Inc 01.09.2025
Subjects
Adult
Aged
Case Series
Female
Humans
Male
Middle Aged
Osteoarthritis, Knee - complications
Osteoarthritis, Knee - therapy
Pain Management - methods
Pain Measurement
Pilot Projects
Treatment Outcome
Ultrasonic Therapy - methods
chronic pain
pain management
analgesia
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Summary:Low‐intensity focused ultrasound is a non‐invasive neuromodulation technique that delivers mechanical forces to a deep location within the body through acoustic pressure waves without affecting tissue between the transducer and focal target. Preliminary studies involving healthy volunteers suggest focused ultrasound reversibly prevents action potential formation similar to a local anesthetic nerve block, but the modality has not been used in patients with existing pain. The current randomized pilot study was undertaken to 1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial; and 2) monitor for related complications of focused ultrasound when treating knee osteoarthritis pain.
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The authors appreciate the creation of Figures 4 and 5 by Elan Ilfeld and Jonathon Whitten. Funding for this project is provided by Pegasus Neurotechnology (Melbourne, Victoria, Australia). The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the funding entities. Dr. Ilfeld: The University of California San Diego has received funding and/or products from the following companies for other research studies of this author: Epimed International (Dallas, Texas, USA), SPR Therapeutics (Cleveland, Ohio, USA), Infutronix (Natick, Massachusetts, USA), Avanos Medical (Irvine, California, USA), Masimo (Irvine, CA, USA), and Varian Medical Systems (Palo Alto, California, USA). Dr. Cao: Chief Executive Officer of Pegasus Neurotechnology (Melbourne, Victoria, Australia). Drs. Branson and Bloom: Drs. Branson and Bloom's employer, SportsMedBiologic (Melbourne, Victoria, Australia), received funding from Pegasus Neurotechnology for the research described in this report.
ISSN:0278-4297
1550-9613
1550-9613
DOI:10.1002/jum.16706