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

Alex Madzia, Chirag Agrawal, Paddy Jarit, Stephanie Petterson, Kevin Plancher, Ralph Ortiz, Alex Madzia, Chirag Agrawal, Paddy Jarit, Stephanie Petterson, Kevin Plancher, Ralph Ortiz

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

Conflict of interest statement

CONFLICT OF INTEREST The authors declare no conflict of interest, financial or otherwise.

Figures

Fig. (1).
Fig. (1).
Sustained Acoustic Medicine (SAM) ultrasound device applied to the medial and lateral articulation points of the knee with 1% diclofenac ultrasound coupling patch.
Fig. (2).
Fig. (2).
Flow chart illustrating study design: Participants screening, exclusion criteria, and data collection time points.
Fig. (3).
Fig. (3).
Numeric Rating Score: A) “All Subjects n=32” NRS pain showing significant decrease in pain from day 1 through day 7 of treatment. Pain was reduced by 50% from start to end of study (2.06 NRS, p<0.001). B) “Rapid Responder n=24” NRS showing significant decrease over 7 days of study. Pain was reduced by 70% from start to end of study (2.96 NRS, p<0.001).
Fig. (4).
Fig. (4).
WOMAC Functional Score: A) Significant 351-point (p<0.001) decrease in WOMAC score after 7 days of SAM with diclofenac treatment in all subjects n=32. B) Rapid Responders n=24 shows more robust 510-point (p<0.001) WOMAC decrease in response to the SAM with diclofenac treatment over 7 days.
Fig. (5).
Fig. (5).
Pain reduction of current study compared with Draper et al. (2018). One week of daily SAM with diclofenac patch treatment provides an additional 10% to 30% pain reduction for patients 5 weeks faster than prior reported literature for long-duration ultrasound treatment.

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