Paper Title (use style: paper title) - Actisound



Musculoskeletal Treatments Using Intense Therapy Ultrasound: Clinical Studies for Chronic Plantar Fasciitis and Lateral Epicondylitis Michael H. Slayton, Ph.D. ?, IEEE Member, Richard C. Amodei ?, Keegan B. Compton ?, Daniel Latt, MD ? and John Kearney, Jr., MD ?, 1-Guided Therapy Systems, Mesa, AZ, 2-University of Arizona, School of Medicine, Tucson, Arizona, 3-The CORE Institute & The MORE Foundation, Phoenix, Arizona Abstract— Background/ Objective: Intense Therapy Ultrasound (ITU) effectively creates thermal injury zones inside soft tissue, initiating a tissue repair cascade in the skin, promoting collagen generation. It may be feasible to promote a robust healing response in musculoskeletal tissue accelerating healing from injury [1]. The objectives of the studies were to establish the feasibility of treatment by High Frequency ITU for Plantar Fasciitis and Lateral Epicondylitis.Protocols/Methods: Chronic Plantar Fasciitis: Two treatments, 2 weeks apart, 38 patients, (27-treated, 11-sham group) consisted of 250-320 80 msec pulses creating matrices of small ablative thermal lesions of 4-5 joules at a pre-programmed pitch of 1.6 mm. Each treatment did not exceed 12 minutes. Treatment effects were assessed with diagnostic ultrasound imaging at 12 MHz. Ultrasound images were analyzed to determine changes in peri-fascial lesion size. Patients reported outcomes at 2, 4 6 and 12 weeks after initiating treatment [2].right177165 Figure 1. Ultrasound image (left) and sliced gross appearance of ITU lesions in porcine muscle tissue. 00 Figure 1. Ultrasound image (left) and sliced gross appearance of ITU lesions in porcine muscle tissue. Chronic Lateral Epicondylitis: Two treatments, 4 weeks apart, 24 patients, 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 was less than 10 minutes. Treatment effects were assessed with diagnostic ultrasound at 17MHz. Patient reported outcomes at 2, 4, 8 and 12 weeks after initial treatment. For both studies patients randomized, the principal investigator, sonographer and study coordinator administering the study were blinded to clinical assessments and diagnostic ultrasound results.Results/Conclusions: Plantar Fasciitis: Results of the double blinded, randomized, sham controlled study for the treatment of Plantar Fasciitis with ITU appeared to have significant positive results within 12 weeks’ post-treatment in 81% of patients treated. Both quantitative measurements from diagnostic ultrasound imaging and applied standardized assessment protocols showed statistically significant coincidental improvements in treated patients vs. control group. Chronic Lateral Epicondylitis: Statistically significant improvements were seen in 75% of patients and diagnostic ultrasound images show significant reduction in free fluid at 8 weeks compared to baseline images in patients with no to mild peri-tendon calcifications. These patients correlated well with significantly improved PRTEE survey scores. Few patients with little or no improvement in PRTEE scores consistently presented with moderate to severe peri-tendon calcifications. TECHNOLOGYIntense Therapy Ultrasound (ITU) Ultrasound is well established as a versatile, safe imaging modality that causes no discernable long-term effects on tissue. However, by using a highly directive source geometry with the source energy settings increased significantly, ultrasound energy can be focused spatially in a tightly confined region (< 1mm?) to cause selective tissue thermal coagulation [1,2]. The size and location of the lesions can be precisely varied. ITU is similar to high intensity focused ultrasound (HIFU), however, here we specifically use ITU to refer to the treatment modality which creates multiple, small coagulative lesions, with the specific purpose of stimulating a reparative tissue response. The ITU device used in the studies was developed by Guided Therapy Systems (GTS) AZ, USA. A series of selective thermal coagulation zones can be produced along a straight line at a given depth within the tissue (up to 25mm line of discrete lesions spaced 0.5 – 5.0 mm apart). BACKGROUNDAcute and Chronic Plantar Fasciitis is heel pain caused by a degenerative process of the planta fascia and the surrounding peri-fascial tissues. It is the most common cause of heel pain affecting 10% of the population [3]. Acute and Chronic Lateral Epicondylitis is a degenerative change to the Common Extensor Tendon (CET) affecting 1-3% of the total population [4]. Both conditions are associated with lost recreation time, decreased quality of life and work related disability claims. The current conservative treatment options for both indications are: RICE (Rest, Ice, Compress and Elevate), NSAIDS for acute pain and inflammation. Aggressive treatments are: Cortisone injections, Plasma Rich Platelets, Tenotomy (cutting of the tendon), ESWT and surgery. HYPOTHESISThe long-term goal of the research was to establish Intense Therapeutic Ultrasound (ITU) as an effective strategy for promoting healing of musculoskeletal tissue. ITU can selectively and effectively create minute thermal injury zones deep inside tissues, while sparing overlaying structures [5,6]. Because these damage zones are small (0.1-1mm) they initiate a tissue repair cascade [7]. This effect has been best studied in the skin, where ITU has been shown to promote collagen generation [8-10] and is FDA approved for brow elevation and submental skin tightening. We proposed to test this hypothesis in two separate clinical studies; Chronic Plantar Fasciitis and Chronic Lateral Epicondylitis. We hypothesize that ITU will do one or more of the following: (1) cause an earlier, more robust healing response (measured by cytokine, growth factors, and collagen production gene expression) [1]; (2) lead to an earlier return to normal mechanical properties (measured by ultimate load and maximum tangential modulus [1], and (3) lead to healed tissue with collagen structure more similar to control tissue (measured by diagnostic ultrasound imaging by a certified sonographer).CLINICAL APPROACHITU creates small zones of thermal injury in the tissue at desired depth up to 20 mm.It restarts and enhances the production of endogenous growth factors in connective tissue through three phases of activity:Inflammatory Phase-disruptive cells release “growth factors”.Proliferative Phase – angiogenesis and fibroblasts migrate, deposit type II collagenMaturation and Remodeling Phase – type III collagen converts to type I and elastin fibers, along with formation of collagen fiber cross linkageThe proposed effort represents to our knowledge, the first attempt to use intense therapy ultrasound to modulate healing tissue response in Chronic Plantar Fasciitis and Chronic Lateral Epicondylitis. ITU is well established clinically for facial collagen rejuvenation [8-10], but very little is understood about the mechanisms of that treatment. V. STUDY DESIGNChronic Plantar Fasciitis: An IRB approved study with a total of 38 patients who were diagnosed with chronic heel pain due to Plantar Fasciitis (more than 3 months) and failed conventional treatments. The patients were randomized to standard therapy (anti-inflammatory pills, stretching and gel heel cups) plus ITU treatment. The treatment group consisted of 27 patients and the control group 11 patients. Two treatments 2 weeks apart consisted of 250-320 80 msec pulses creating matrices of small ablative thermal lesions of 4-5 joules at a pre-programmed pitch of 1.6 mm. Each treatment time did not exceed 12 minutes. The ITU control group consisted of the same treatment time with the energy set to 0. Treatment effects were assessed with diagnostic ultrasound imaging at 12 MHz by a certified sonographer. Ultrasound images were analyzed to determine changes in Plantar Fascia thickness and peri-fascial lesion size. Patient reported outcomes occurred at 2, 4, 6 and 12 weeks after initiating treatment. Outcomes were reported using: PROMIS physical function computer adaptive test (PF-CAT), PROMIS global health, Foot Function Index pain subscale and non-validated heel pain specific questionnaire [11]. Chronic Lateral Epicondylitis: An IRB approved study with a total of 25 patients who were diagnosed with chronic elbow pain due to Tennis Elbow or Lateral Epicondylitis (more than 3 months) and failed conventional treatment. The patients were subjected to standard therapy (stretching and strength exercises, hot and cold compresses and compression support) plus ITU. 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 [12] physical examination, Universal Analog Visual Pain Score and Patient Reported Satisfaction Survey.In both studies patients were randomized, the 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.VI. RESULTSPlantar FasciitisTreatment Group SROM1 Control Group SROM1 FFIPS Average Pain Score Subtracted from BaselineLateral Epicondylitis Plantar FasciitisPatient-reported outcome measures were compared to the baseline:The Treatment Group showed significantly improved pain scores (FFIPS average -8.3) and significant reduction in peri-fascial lesions (average -81%). The Control Group showed slightly improved pain scores (FFIPS average -2.0) and increasing size of peri-fascial lesions (average +26%).Lateral EpicondylitisDiagnostic Ultrasound images show significant reduction in free fluid at 8 weeks, compared to baseline images in patients with none to mild peri-tendon calcifications. These patients correlated well with improving PRTEE survey scores (average, 70.4 down to 20.2, see results above).Patients with little or no improvement in PRTEE scores consistently presented with moderate to severe peri-tendon calcifications. P-vales 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).VII. diagnostic ultrasound imagingPlantar FasciitisPeri-Fascial Lesion Size by Diagnostic Ultrasound by VisitLateral EpicondylitisExamples of Ultrasound images of Peri-tendon FluidLE=Lateral Epicondyle, RH=Radial Head, CET=Common Exterior Tendon, FL=Fluid, RFL=Resolving FluidVisit 1 Week 0 Upper Image/Visit 4 Week 8 Lower ImageVisit 1 Week 0 Upper Image/Visit 4 Week 10 Lower Image Ultrasound Image of Microcalcifications (MC)Visit 1 Week 0VIII. CONCLUSIONSPlantar FasciitisResults 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 patients 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 patients vs. the control group.Intense Therapeutic Ultrasound has shown potential for effective treatment of Chronic Plantar Fasciitis. More well designed studies with an increased number of patients to support the treatments are under way.Lateral EpicondylitisSignificant reduction of pain scores per activities (PRTEE) and Self-Reported Outcome Measures (82-91% improvement) with average Universal Pain Scores reduction from 25.3 to 9.9 (PRTEE) were statistically significant (P<0.05) at 4, 8, 12 and 26 weeks’ post treatment.Feasibility of successful Intense Therapeutic Ultrasound treatments for chronic Lateral Epicondylitis have been established with the initial results (n=24) of the ongoing study. REFERENCESSlayton, M., Barton, J.., Healing tissue response with ITU (Intense herapy Ultrasound) in musculoskeletal tissue, feasibility study, Ultrasonics Symposium (IUS), 2014 IEEE International, pp. 1654-1657.Slayton, M., Amodei, R., McNelly, A., Latt, D., Intense Therapy Ultrasound (ITU) for the Treatment of Chronic Plantar Fasciitis: Preliminary Results of Clinical Study, 37th International Conference of he IEEE Engineering in Medicine and Biology; Milan, Italy, August 2015.Neufeld, S.K. and R. Cerrato, Plantar fasciitis: evaluation and treatment, J Am Acad Ortho Surg., 2008, 16(6): p.388-46.Hong QN, Durand MJ, Loisel P. Treatment of lateral epicondylitis: where is the evidence? Joint Bone Spine 2004; 71(5):369–373. T.D. Mast, I. R. Makin, W. Fadi, M. Runk, P. Barthe and M. Slayton, “Bulk Ablation of Soft Tissue with Intense Ultrasound: Modeling and Experiments” J. Acoust. Soc. Am. 118 (4). October 2005.W. M. White, I. R. Makin, P. Barthe, M. Slayton, and R. 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Tanzi, “Microfocused Ultrasound for Skin Tightening”, Semin Cutan Med Surg 32:18-25, 2013.Budiman-Mak, E., Conrad, K.J., Roach, K.E., The Foot Function Index; a measure of foot pain and disability, J. Clin Epidemiology 1991, 44(6):561-579.Rompe JD1, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire.J Hand Ther. 2007 Jan-Mar;2007 (1):3-10: quiz 11. ................
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