Evidence map›Paper›PMID 33408796›Full record

ArticleThe open orthopaedics journal2020

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

3 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in The open orthopaedics journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.0field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04391842 phase1completednot on this map

Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis

TypeinterventionalSponsorZetrOZ, Inc.Ran2019 to 2019Enrolled34ConditionsOsteo Arthritis Knee, ArthritisArmsSustained Acoustic Device with 1% Diclofenac patch
NCT05254470 completednot on this map

Customer Survey of Athletic Trainers Who Utilize SAM Ultrasound Device in Routine Care

TypeobservationalSponsorZetrOZ, Inc.Ran2020 to 2022Enrolled135ConditionsMusculoskeletal Injury, Pain, Chronic, Pain, Acute, Sport InjuryArmsContinuous Ultrasound
NCT05254574 phase1recruitingnot on this mapstarted 2022, after this paper: background citation

Sustained Acoustic Medicine for Osteoarthritis Pain

TypeinterventionalSponsorZetrOZ, Inc.Ran2022 to 2026Enrolled200ConditionsOsteoarthritisArmsSustained Acoustic Device with 2.5% Diclofenac Patch, 2.5% Diclofenac Patches
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Long Duration Ultrasound: Recent Advancements and Clinical Applications.International journal on physical medication & rehabilitation · 2025
    Article
  3. Article
  4. Long Duration Continuous Ultrasound with Diclofenac Sodium Enhances Recovery from Sprains and Strains.International journal on physical medication & rehabilitation · 2025
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Alex MadziaDepartment of Biomedical Engineering, University of Cincinnati, Cincinnati, OH 45219, USA.
Chirag AgrawalDepartment of Biomedical Engineering, University of Cincinnati, Cincinnati, OH 45219, USA.
Paddy JaritSport and Orthopaedic Physical Therapy, Fairfield, CT 06824, USA.
Stephanie PettersonThe Orthopaedic Foundation, Stamford, CT 06824, USA.
Kevin PlancherAlbert Einstein College of Medicine, Bronx, NY, New York, USA.
Ralph OrtizMedical Pain Consultants, Dryden, NY 13053, USA.
University of Cincinnati · USAmerican Physical Therapy Association · USCornell University · USPain Management Institute · US

Funding

Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee OsteoarthritisR44AG061985 · NIA · ZETROZ SYSTEMS, LLC · PI George Kenneth Lewis · 2020 to 2026
$11.0M
NIA NIH HHS R44 AG061985
6 · The paper itself

Abstract

backgroundSustained 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.

methodsThe 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/cm

resultsThe 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.

conclusionSustained 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).

Indexed as

Anti-steroidal anti-inflammatory drugsDiclofenacLong-duration continuous ultrasoundLow-intensity continuous ultrasoundPain managementSonophoresisSustained acoustic medicine

Identifiers

PMID33408796
PMCPMC7784557
OpenAlexW3106408735

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.