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A multi-site clinical trial was carried to determine the efficacy of the combination of long-duration continuous ultrasound and 1% diclofenac ultrasound gel patch in individuals suffering from moderate to severe knee pain due to knee osteoarthritis
In patients suffering from moderate to severe
knee osteoarthritis, the combination of sustained acoustic medicine and 1%
topical diclofenac led to rapid pain alleviation and functional improvement.
A multi-site clinical trial was
carried to determine the efficacy of the
combination of long-duration continuous ultrasound and 1% diclofenac ultrasound
gel patch in individuals suffering from moderate to severe knee pain due to
knee osteoarthritis
The study recruited 32 subjects (mean age 54 years) suffering from osteoarthritis of the knee. Participants were treated with the sustained acoustic medicine device and daily application of diclofenac patch on the knee. For four hours daily for one week, the sustained acoustic medicine ultrasound and 6 grams of 1% diclofenac were applied via a wearable device.
The primary endpoint was the daily alteration in the intensity of pain. Utilizing a numeric rating scale, the pain intensity was analyzed before the intervention (baseline, day 1), prior to and after each daily therapy, and after one week of everyday therapy (day 7). The rapid responders were classified as those individuals displaying more than a 1-point decline in pain after the first therapy.
Alteration (from baseline to day
7) in Western Ontario McMaster Osteoarthritis Questionnaire (WOMAC) score was
the secondary endpoint. Furthermore, a series of daily usability and user
experience questions linked with efficacy, devising usage ease, functionality,
and safety were gathered.
This analysis had a retention rate of 94%. No adverse events or study-associated complaints across 224 unique therapy sessions were witnessed. The rapid responders incorporated about 75% of the trial population. Participants displayed a vital mean numeric rating scale pain decline over the seven-day study of 2.06-points (50%) for all participants (n=32) and 2.96-points (70%) for rapid responders (n=24).
For rapid responders (n=24), the
WOMAC functional score substantially improved by 510 points and for all the
participants (n=32), the score improved by 351 points. About 95% of subjects
found the device easy to use, safe, and effective and would continue therapy
for their symptoms of knee osteoarthritis.
The combination of sustained acoustic medicine
and 1% topical diclofenac
may be used as a conservative, non-invasive therapeutic choice for knee
osteoarthritis-related pain.
The Open Orthopaedics Journal
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 et al.
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