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

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).

Applications of Wearable Technology in a Real-Life Setting in People with Knee Osteoarthritis: A Systematic Scoping Review

“…Of these, 2219 records did not meet the inclusion criteria. Subsequently, 266 full-text articles were assessed for eligibility, and 68 studies [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 ...…”

“…Low cost of wearable technology or subsidization of costs by health insurance was another facilitator. Only two studies reported the price of wearable technology used in their studies with a reported price of $4400 to $6800 for ultrasound devices [ 26 , 33 ]. Sliepen et al reported that the financial burden varies widely between activity monitors for knee and hip OA patients, ranging from €25 to €4500 [ 15 ], demonstrating a difference in the price of wearables depending on their applications (data collection vs. treatment).…”

Sustained acoustic medicine for the treatment of musculoskeletal injuries: a systematic review and meta-analysis

“…The study characteristics and participants for knee joint conditions treated by SAM are reported in Table 2 . The four eligible studies comprised two randomized controlled trials (RCTs) [ 51 , 52 ] one prospective multi-site non-randomized study [ 66 ] and two combined pilot studies [ 67 ]. Three of the four studies compared an intervention group (SAM) with a placebo control group (Non-Functioning Device) in the treatment of mild to moderate grade knee Osteoarthritis on clinically validated scales (Kellgren and Lawrence system for classification of osteoarthritis or Osteoarthritis Research Society International Scale).…”

“…Three of the four studies compared an intervention group (SAM) with a placebo control group (Non-Functioning Device) in the treatment of mild to moderate grade knee Osteoarthritis on clinically validated scales (Kellgren and Lawrence system for classification of osteoarthritis or Osteoarthritis Research Society International Scale). Among the included studies, three were single center [ 51 , 52 , 67 ] and one was a multicenter trial [ 66 ] all conducted in the United States. The included studies involved a total of 156 subjects who received SAM treatment in additional to usual care for knee joint pain.…”

Low-Intensity Continuous Ultrasound Therapies—A Systematic Review of Current State-of-the-Art and Future Perspectives

“…Similarly, Masterson et al investigated diclofenac sodium penetration through a hydrogel stack using long-duration LICUS at 3 MHz, 0.132 W/cm 2 for 4 h. They reported a 3.8-fold higher drug penetration through a hydrogel stack mimicking the ex vivo transdermal model [ 141 ]. In a recent multicenter clinical study, Madzia et al reported treating 32 patients with moderate to severe knee OA with sam ® (LICUS at 3 MHz, 0.132 W/cm 2 , 1.3 W) for 4 h/day for one week in conjunction with sodium diclofenac patches [ 142 ]. After seven days of treatment, patients showed a 2.06- to 2.96-point decrease in pain on the NRS pain scale and 351- to 510-point functional improvement on the WOMAC scale.…”