INTERNATIONAL SOCIETY FOR THERAPEUTIC ULTRASOUND –TEL AVIV, ISRAEL-MARCH 14-16, 2016 Musculoskeletal Clinical Applications of Intense Therapy Ultrasound (ITU): Part 1. Clinical Study for Chronic Plantar Fasciitis Michael H. Slayton, Ph.D.1, Richard C. Amodei, RDMS1, Keegan B. Compton1, Ashley McNelly2 and L. Daniel Latt MD, Ph.D.2 1- Guided Therapy Systems, Mesa, AZ, 2-University of Arizona, School of Medicine, Tucson, AZ

Overview Objectives Background Protocol & Methods Results & Discussion Conclusion

Objectives Establish the feasibility of treatment by High Frequency ITU For Plantar Fasciitis/Fasciosis Creates small thermal injuries noninvasively in and around symptomatic Plantar Fascia (PF). It has been shown to initiate a tissue repair cascade and promote collagen generation in musculoskeletal tissue. Conduct a double blinded, randomized, sham controlled clinical study for ITU treatment of chronic Plantar Fasciitis by IRB approved clinical protocol to access clinical efficacy of the procedure.

Background Acute and Chronic Plantar Fasciitis /Fasciosis (CPF) Heel pain: A degenerative process affecting 10% of Population. Current Treatment Options: 85%-90% respond well to conservative treatments (RICE: Rest, Ice, Compress (Insole) and Elevate) 10%-15% of patients fail conservative management and continue to have symptoms. More than twenty different treatments have been used for Plantar Fasciitis including: Cortisone Injections Plasma Rich Platelets Injections ESWT Partial Fasciotomy Surgery consisting of partial PF release is often considered with 50% of patients having residual symptoms, in addition to surgical risk exposure.

Technical Approach Custom 3.2 MHz high intensity (10 kw/cm²) ultrasound therapy was designed and fabricated (GTS, Mesa, USA). Field simulations, testing and Schlieren images verified intensity, high focal pressure (17.3 MPa) and focal distance of 13-15 mm. Diagnostic ultrasound imaging performed by Spark system, 12 MHz linear array.

Hand held 3.2 MHz, 13.0 mm probe and control system

Schlieren image: 3.2 MHz, 13.0 mm focal distance

Clinical Approach Clinical protocol included (38) patients diagnosed with chronic heel pain due to Plantar Fasciitis (more than 3 months) and failed conventional treatments. Patients were randomized to standard therapy (anti-inflammatory pills, stretching and gel heel cups) plus ITU treatment (“Treatment” group, n=27) of standard therapy plus sham ITU (“Control” group, n=11).

Protocol/Methods Two treatments, 2 weeks apart consisted of 250-320 80 msec pulses creating matrices of small ablative thermal lesions of 4-5 joules at pre-programmed pitch of 1.6 mm. Each treatment time did not exceed 12 minutes. ITU placebo group consisted of the same treatment with energy set to 0. Treatment effects were assessed with Diagnostic ultrasound imaging at 12MHz Ultrasound Images were analyzed to determine changes in Plantar Fascia Thickness Peri-fascial Lesion Size Patient reported outcomes at 2, 4, 6, and 12 weeks after initiating treatment. PROMIS physical function computer adaptive test (PF-CAT), PROMIS global health, Foot Function Index pain subscale. Non-validated heel pain specific questionnaire. Principal investigator, sonographer and the study coordinator administering the patient reported outcome instruments were blinded to group assignment. P Values calculated via 2-tailed paired T-test for both treatment and sham groups for lesion volume and Foot Function Index Pain Subscale comparison.

Results

* * * * Treatment Group SROM1 Control Group SROM1 * Significant difference between Control and Treatment Group (p < .05; Χ2 test)

Foot Function Index Pain Score

FFIPS Average Pain Score Subtracted from Baseline

Diagnostic Ultrasound Imaging

Baseline & Treatment 1 2 Weeks after Treatment 2 10 Weeks after Treatment 2 Diagnostic Ultrasound Images of Treated Subject Perifascial Lesion Volume Reductions noted from Baseline to 12 Weeks

Baseline & Treatment 1 4 Weeks after Treatment 2 10 Weeks after Treatment 2 Diagnostic Ultrasound Images of Treated Subject Perifascial Lesion Volume Reductions noted from Baseline to 12 Weeks

Peri-Fascial Lesion Size by Diagnostic Ultrasound By Visit * * ** ** ** * 1 Subject reinjured their Plantar Fascia. Lesion grew 248% Diagnostic Ultrasound Imaging * P<0.05 ** P<0.001

Discussion Patient-Reported Outcome Measures compared to Baseline: The Treatment Group showed: Significantly improved pain scores (FFIPS average -8.3) Significant reduction in Peri-fascial Lesions (average -81%) The Control Group showed: Slightly improved pain scores (FFIPS average -2.0) Increasing size of Peri-fascial Lesions (average +26%)

Conclusions Results of the double blinded, randomized, sham controlled study for the treatment of Plantar Fasciitis with ITU appeared to have statistically significant positive results within 12 weeks post-treatment in 81% of subjects treated. Both quantitative measurements from diagnostic ultrasound imaging and applied standardized assessment protocols consisting of PROMIS PF-CAT, FFIPS along with Patient Reported Outcome Measures showed statistically significant coincidental improvements in treated subjects vs. control group. Intense Therapeutic Ultrasound has shown potential for effective treatment of Chronic Plantar Fasciitis. More well designed studies with increased number of subjects will be considered to support ITU as an effective tool for the proposed clinical treatment.