1- Guided Therapy Systems, Mesa, AZ, 2-The Core Institute, Phoenix, AZ INTERNATIONAL SOCIETY FOR THERAPEUTIC ULTRASOUND –TEL AVIV, ISRAEL-MARCH 14-16, 2016 Musculoskeletal Clinical Applications of Intense Therapy Ultrasound (ITU): Part 2. Initial Results of Clinical Study for Chronic Lateral Epicondylitis Michael H. Slayton, Ph.D.1, Richard C. Amodei, RDMS1, Keegan B. Compton1, and John A. Kearney, Jr., MD 2 1- Guided Therapy Systems, Mesa, AZ, 2-The Core Institute, Phoenix, AZ

Overview Objectives Background Protocol & Methods Results & Discussion Conclusion

Objectives Establish the feasibility of treatment by High Frequency ITU, a novel potential treatment for Lateral Epicondylitis Creates small thermal injuries noninvasively in and around a symptomatic Common Extensor Tendon (CET). Has been shown to initiate a tissue repair cascade and promote collagen generation in musculoskeletal tissue. Conduct a blinded, randomized, clinical study for ITU treatment of chronic Lateral Epicondylosis by IRB approved clinical protocol to access clinical efficacy of the procedure.

Background Acute and Chronic Epicondylitis Current Treatment Options Degenerative changes to Common Extensor Tendon (CET) affecting 1 – 3% of Total Population associated with: Lost Recreation time Decrease Quality of Life Work Related Disability Claims Current Treatment Options Conservative RICE: Rest, Ice, Compress and Elevate NSAIDS for Acute Pain and Inflammation Aggressive Treatments Cortisone Injections Plasma Rich Platelets Tenotomy ESWT Surgery

Technical Approach Custom 4.5  MHz high intensity (14  kw/cm²) ultrasound therapy system was designed and fabricated (GTS, Mesa, AZ, USA). Field simulations, testing and Schlieren images verified intensity, high focal pressure (37.9  MPa) and focal distance of 5.5 mm. Diagnostic ultrasound imaging performed by Spark System, 17 MHz linear array (Ardent Sound, Inc. Mesa, AZ USA)

Handheld 4.5 MHz, 5.5 mm probe and control system

Schlieren image: 4.5 MHz, 5.5 mm focal distance

Clinical Approach Treatment Treatment effects were assessed with Two Treatments, 4 weeks apart consisting of 80 14 msec pulses creating matrices of small ablative thermal lesions of 1 joule Manually targeted area mapped by diagnostic ultrasound imaging Each treatment time <10 minutes. Treatment effects were assessed with Diagnostic Ultrasound at 17 MHz Patient Reported outcomes at 2, 4, 8 at 12 weeks after initial treatment PRTEE: Patient Reported Tennis Elbow Evaluation VAS – Universal Pain Score for Elbow Pain

Protocol/Methods Treatment effects were assessed with Diagnostic ultrasound imaging at 17 MHz by a certified sonographer. Ultrasound images were analyzed to determine changes in the peri-tendon region, including hypoechoic areas, calcifications and dependent free fluid. Subject reported outcomes consisted of PRTEE survey, physical examination, Universal Analog Visual Pain Score and a Patient Reported Satisfaction Survey. Inclusion Criteria Clinical protocol includes 25 subjects diagnosed with chronic Tennis Elbow, or Lateral Epicondylosis (more than 3 months) and failed conventional therapy treatments. Subjects were subjected to standard therapy (stretching and strength exercises, hot and cold compresses and compression support) plus ITU. Principal investigator, sonographer and study coordinator administering the study were blinded to clinical assessments and diagnostic ultrasound results. P-values were calculated via 2-tailed paired T-tests for both treatment and control groups.

Results PRTEE: Patient Reported Tennis Elbow Evaluation Final Score is a weighted Pain Score based on 15 questions grouped into 3 categories: Overall Pain, Functional Disability and Usual Activities. Subjects respond to each question with a Pain Score of 0-10. Each category is then summed and weighted with a maximum score of 100 (Overall Pain 50%, Functional Disability 50% and Usual Activities (100%). * * Statistically significant difference from Visit 1 pain score (P <0.05)

* * Statistically significant difference from Visit 1 pain score (P <0.05)

Diagnostic Ultrasound Imaging

Ultrasound Images of Peri-tendon Fluid Visit 1 Week 0 Visit 4 Week 8 LE RH CET FL LE RH CET RFL LE=Lateral Epicondyle, RH=Radial Head, CET=Common Extensor Tendon, FL=Fluid, RFL=Resolving Fluid

Ultrasound Images of Peri-tendon Fluid Visit 1 Week 0 Visit 4 Week 8 LE RH CET FL LE RH CET RFL LE=Lateral Epicondyle, RH=Radial Head, CET=Common Extensor Tendon, FL=Fluid, RFL=Resolving Fluid

MC = Microcalcifications Ultrasound Images of Microcalcifications Visit 1 Week 0 Visit 4 Week 8 MC = Microcalcifications

MC = Microcalcifications Ultrasound Images of Microcalcifications Visit 1 Week 0 Visit 4 Week 8 MC = Microcalcifications

Discussion Diagnostic Ultrasound Images: Diagnostic Ultrasound Images show significant reduction in free fluid at 8 weeks, compared to baseline images in subjects with no to mild peri-tendon calcifications. These subjects correlated well with improving PRTEE survey scores (average, 46.8 down to 21.8). Subjects with little or no improvement in PRTEE scores consistently presented with moderate to severe peri-tendon calcifications. P-values calculated for the above reported outcomes were not statistically significant for Visits 2 (P>0.05) while results for Visits 3-5 demonstrated statistical significant difference (P<0.05).  

Conclusions Significant reduction of pain scores per activities (PRTEE) and Self- Reported Outcome Measures (73% improvement) with average Universal Pain Scores reduction from 5.2 to 2.4 were statistically significant (P<0.05) at 4, 8 and 12 weeks post treatment. Feasibility of Intense Therapeutic Ultrasound treatments of chronic Lateral Epicondylitis has been established with the initial results (n=17) of the ongoing clinical study.