Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study
Bibliographic record
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: , 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).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".