← Explore

Ultrasound Neuromodulation (Low‐Intensity Focused Ultrasound) to Treat Knee Osteoarthritis Pain

Brian M. Ilfeld, Khoa N. Cao, Ruben Branson, Philip Bloom

Journal of Ultrasound in Medicine 2025 · 10.1002/jum.16706

human patientchronic painclinical scalebehaviour

Abstract

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.

Abstract via europepmc.

Specieshuman
Subjects5 participants
Sessions per subject1
Randomisedyes
Blindingdouble
Sham / controlundescribed
Auditory controlnot reported
Readout timingoffline
Anaesthesianot applicable
Readoutsclinical scale, behaviour — Dynamic numeric rating scale for knee pain; Brief Pain Inventory; WOMAC; light-touch sensation; quadriceps strength (Oxford scale)
Direction of effectmixed or unclearMean dynamic NRS fell in all groups including sham; the 225 W/cm2 group reported larger reductions than the 150 W/cm2 group, but the authors state no conclusions can be drawn with n=7.
Adverse eventsnone observedNo device-related cutaneous irritation, systemic side effects or other adverse events; sensation and quadriceps strength were not decreased.

Exposures

Exposure 1: Single 15 s sonication of the infrapatellar branch of the saphenous nerve at 150 or 225 W/cm2

Target: saphenous nerve — “infrapatellar branch of the saphenous nerve”
Device: other named manufacturer · Pegasus Neurotechnology, Melbourne, Victoria, Australia · Resonance (driven by a signal generator and power amplifier, Model H-107, Sonic Concepts)

Pulse timing
Waveformnot reported
Fundamental frequency (kHz)not reported⚑
Pulse duration (ms)not reported
Pulse repetition frequency (Hz)not reported
Duty cycle (%)not reported
Sonication duration (s)15✓✓✓⚑
Pressure and intensity, by domain
Free-field pressure (kPa)not reported
Free-field Isppa (W/cm²)not reported
Free-field Ispta (W/cm²)not reported
In-situ estimatenot reported
In-situ pressure (kPa)not reported
In-situ Isppa (W/cm²)not reported
In-situ Ispta (W/cm²)150, 225swept✓✓✓
Pressure, domain unspecified (kPa)2,200✓✓✓
Protocol, in the paper’s words

Participants received one 15 s focused ultrasound (or sham) treatment after which the transducer was removed; intensity was scaled for overlying fat and muscle attenuation. Cohorts were 0 (sham), 150 or 225 W/cm2 spatial-peak temporal-average, randomised 1:2:2.

Flags from extraction

  • exposures[0].timing.sonication_duration_s — The paper calls the 15 s a 'pulse duration'; recorded as sonication duration, pulse duration left not_reported.
  • exposures[0].unspecified_domain.ispta_w_cm2 — Spatial-peak temporal-average intensity given as 150 and 225 W/cm2 (18 W, 27 W); the text says it was scaled for attenuation but does not say whether it applies in water or at the nerve.
  • exposures[0].device.family — The device is Pegasus Resonance; the Sonic Concepts H-107 is named in the sentence as the driver but the transducer maker is not stated explicitly.
  • exposures[0].fundamental_frequency_khz — No frequency is stated in the text.
  • sham_type — Sham is 0 W/cm2 treatment; how it was produced is not described.
  • exposures[0].target.label — Peripheral nerve target, not brain.