Document Type
Peer-Reviewed Article
Publication Date
2020
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
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.
DOI
10.2174/1874325002014010176
PMID
3408796
Recommended Citation
Madzia, A., Agrawal, C., Jarit, P., Petterson, S., Plancher, K., & Ortiz, R. (2020). Sustained acoustic medicine combined with a diclofenac ultrasound coupling patch for the rapid symptomatic relief of knee osteoarthritis: Multi-site clinical efficacy study. The Open Orthopaedics Journal, 14, 176-185. Doi: 10.2174/1874325002014010176
Publication
The Open Orthopaedics Journal
Volume
14
Publisher
Bentham Open
Pages
176-185
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Comments
Paddy Jarit is the owner of Sport & Orthopaedic Physical Therapy in Fairfield CT and a Clinical Partner in the Orthopaedic Physical Therapy Program at Sacred Heart University.
This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License CC-BY 4.0