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Subjects (12 males, 13 females), between the ages of 27 and 75 (M = 49.63 ± 11.35) had an average BMI of 25.38 (± 4.59). There were more epicondylitis conditions (n=16) than Achilles (n=5) or patellar (n=1) tendinopathy, and 68.2% of the injuries were in the dominant limb. Injury durations ranged from 2-6 weeks (n=2), 6-12 weeks (n=1), 3-6 months (n=4), and greater than 6 months (n=13). Two participants did not report their injury duration. A quarter of participants were taking NSAID medications during the study (27.2%), and 100% of the sample had previously used another form of treatment for their injury prior to the study, including heating pads, icing, TENS, massage therapy, physical therapy, cold laser therapy, traditional ultrasound, acupuncture, stretching, or NSAIDS without effective outcomes.
Participants reported significant (4.28 point decrease, p<0.001) decreases in pain from the start to conclusion for the study (Figure 3, Top), and 94% of patients reported at least a 50% decrease in pain from baseline. Critically, a review and recommendation from the Initiative on Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) suggests that a decrease of 2/10 points on a VAS scale is clinically meaningful (35), and the sam® Professional System met that threshold. Additionally, data was analyzed to investigate sex, injury location, and injury duration differences in reported pain, but no significant differences were found. In addition to providing pain reduction over the course of the entire study, participants also reported reductions in pain over the course of each daily treatment (Figure 3, Bottom). For weeks 1-2, there was a reduction in pain of 0.64 points during the first 2 weeks of treatment, with a change from 3.35 pre-treatment to 2.71 after 4-hour treatment (p<0.001).
Across the full study daily pain decreased 0.60 points, from pre-treatment (M = 2.67 ± 1.32), 30 minutes (M = 2.44 ± 1.31), 2 hours (M = 2.21 ± 1.29), and 4 hours into treatment (M = 2.06 ±1.30), which trended levels of significance (Figure 3, Bottom). The data for any differences due to sex, injury location, or injury duration, but found no significant effects. Strength measurement for epicondylitis group with the sample size (n=16) was analyzed for changes. For elbow tendinopathy, strength significantly increased between baseline (week 0) and week 2 in the treated arm by 3 kg (p <0.05), and at trending levels of significance between baseline and weeks 4 through 6 (4-5kg increase, p<0.10) (Figure 4). There were no significant increases in strength over time in the untreated arm of subjects.
Figure 3: (Top) Average pre-treatment pain scores decreased significantly (p<0.001) from baseline over six weeks of treatment. (Bottom) Average pain scores significantly decreased over the course of each daily 4 hour treatments during the first two weeks (*p<0.001), and at trending levels of significance over weeks 3-4 (†p=0.08) and weeks 5-6 (†p=0.08).
Clinical Trial Demonstrating Pragmatic use of
sam® Professional for the Treatment of
Tendonopathy:
Figure 4: Increases in strength (kgs) in the treated arm compared to baseline at weeks 2, 4, and 6. Changes were significant at 2 weeks (*p<0.05) and trending levels of significance at 4 weeks (†p<0.10).
In addition to clinical outcomes, device satisfaction and patient compliance with sam® Professional was analyzed. All respondents reported that the device was “overall easy to use” and that the “user manual and application instructions were easy to understand.” The majority of the sample (73.6%) reported experiencing less pain after treatment. Patient compliance was assessed as the percentage of days participants wore the device. On average, patients wore the device 91.65% (± 9.96%) of possible days. Given that participants were asked to wear the device at least 5 times per week, compliance rates above 76.2% (i.e., wearing 5 days per week over 6 weeks) met acceptable study compliance levels. The sam® Professional provides pain relief and accelerated recovery for both acute and chronic tendinopathy of the elbow, knee and ankle. Over six weeks of outpatient, self-applied intervention, patients reported a 4.28 point decrease in pain on a 10 pt VAS scale (p<0.001), 94% of patients reported at least a 50% decrease in pain from baseline, and hand-grip strength was significantly improved in the injured limb by 3-5 kg. The sam® Professional System is a safe and effective intervention for delivering therapeutic ultrasound to reduce pain, increase local circulation and accelerate the recovery of tendinopathy.
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