Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study



Alex Madzia1, Chirag Agrawal1, Paddy Jarit2, Stephanie Petterson3, Kevin Plancher4, 5, 6, Ralph Ortiz7, *
1 Department of Biomedical Engineering, University of Cincinnati, Cincinnati, OH 45219, USA
2 Sport and Orthopaedic Physical Therapy, Fairfield, CT 06824, USA
3 The Orthopaedic Foundation, Stamford, CT 06824, USA
4 Albert Einstein College of Medicine, Bronx, NY, New York, USA
5 Weill Cornell Medical College, New York, NY 13053, USA
6 Plancher Orthopaedics & Sports Medicine, New York, NY 13053, USA
7 Medical Pain Consultants, Dryden, NY 13053, USA


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Creative Commons License
© 2020 Madzia et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Medical Pain Consultants, 2127 Dryden Rd Dryden, New York, NY, USA; Tel: 607 844 9979; E-mail: ralph0tirz@gmail.com


Abstract

Background:

Sustained Acoustic Medicine (SAM) is an emerging, non-invasive, non-narcotic, home-use ultrasound therapy for the daily treatment of joint pain. The aim of this multi-site clinical study was to examine the efficacy of long-duration continuous ultrasound combined with a 1% diclofenac ultrasound gel patch in treating pain and improving function in patients with knee osteoarthritis.

Methods:

The Consolidated Standards of Reporting Trials (CONSORT) were followed. Thirty-two (32) patients (18-males, 14-females) 54 years of average age with moderate to severe knee pain and radiographically confirmed knee osteoarthritis (Kellgren-Lawrence (KL) grade II/III) were enrolled for treatment with the SAM device and diclofenac patch applied daily to the treated knee. SAM ultrasound (3 MHz, 0.132 W/cm2, 1.3 W) and 6 grams of 1% diclofenac were applied with a wearable device for 4 hours daily for 1 week, delivering 18,720 Joules of ultrasound energy per treatment. The primary outcome was the daily change in pain intensity using a numeric rating scale (NRS 0-10), which was assessed prior to intervention (baseline, day 1), before and after each daily treatment, and after 1 week of daily treatment (day 7). Rapid responders were classified as those patients exhibiting greater than a 1-point reduction in pain following the first treatment. Change in Western Ontario McMaster Osteoarthritis Questionnaire (WOMAC) score from baseline to day 7 was the secondary functional outcome measure. Additionally, a series of daily usability and user experience questions related to devising ease of use, functionality, safety, and effectiveness, were collected. Data were analyzed using t-tests and repeated measure ANOVAs.

Results:

The study had a 94% retention rate, and there were no adverse events or study-related complaints across 224 unique treatment sessions. Rapid responders included 75% of the study population. Patients exhibited a significant mean NRS pain reduction over the 7-day study of 2.06-points (50%) for all subjects (n=32, p<0.001) and 2.96-points (70%) for rapid responders (n=24, p<0.001). The WOMAC functional score significantly improved by 351 points for all subjects (n=32, p<0.001), and 510 points for rapid responders (n=24, p<0.001). Over 95% of patients found the device safe, effective and easy to use, and would continue treatment for their knee OA symptoms.

Conclusion:

Sustained Acoustic Medicine combined with 1% topical diclofenac rapidly reduced pain and improved function in patients with moderate to severe osteoarthritis-related knee pain. The clinical findings suggest that this treatment approach may be used as a conservative, non-invasive treatment option for patients with knee osteoarthritis. Additional research is warranted on non-weight bearing joints of the musculoskeletal system as well as different topical drugs that could benefit from improved localized delivery.

Clinical Trial Registry Number: (NCT04391842).

Keywords: Sustained acoustic medicine, Sonophoresis, Diclofenac, Anti-steroidal anti-inflammatory drugs, Long-duration continuous ultrasound, Low-intensity continuous ultrasound, Pain management.