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2 INDEX HILTERAPIA Introduction Tecnology Application modality Protocols 3D videos Nd-YAG wavelengths and emissions Hilterapia : technical characteristics Hilterapia : laser-tissue interaction Hilterapia : indications, contraindications and warnings Clinical Evidences The material of support for Hilterapia® The material of support for Hilterapia®

It’s a therapy that is revolutionizing the therapeutic approach of Orthopaedics, chiropractors, physiotherapists, sport medicine doctors opening new horizons In 2003 the HILT ® patent has been achieved in USA, both as a technological innovation and a therapeutic approach. In 2005 HILT ® devices have been approved by the FDA HILTERAPIA® High Intensity Laser Therapy 3 INTRODUCTION

Our Goal Our aim was to conceive a non-invasive and non-painful therapy able to induce not only antalgic, anti-inflammatory and anti-oedema effects, but also a reparative and regenerative action on deep structures. 4

Expectations Achievement of therapeutic results in short treatment times and with long lasting benefits to the patients Analgesic effect and fast recovery just from the first session Contemporary resolution of the causes of the pathology and of the associated symptoms Deep effective action Wide treatment volume Controlled delivery of energy High safety in operation Respect of the thermal relaxation time of tissues 5

HILTERAPIA ® HILTERAPIA ® can be performed with 2 devices: SH1 (1 kW)– Pain management SH1 (1 kW)– Pain management HIRO 3.0 (3 kW)– Pain management HIRO 3.0 (3 kW)– Pain management Reparative/regenerative therapy Reparative/regenerative therapy Standard handpiece supplied with SH1 and HIRO 3.0 DJD handpiece supplied with HIRO 3.0 SH1 TECHNOLOGY 6

Delivery modes Delivery modes Fixed points (spots): Fixed points (spots): static handpiece, i.e. located on the areas to be treated (trigger points) Manual scanning: Manual scanning: - Fast scan: 10 cm/1 s - Slow scan: 10 cm/3 s APPLICATION MODALITY 7

Global approach: in order to make the most of Hilterapia® effects, we suggest a global approach. Treatment is performed not only on the tissues in the affected area, but also on all muscle groups and trigger points that are involved in the pathology, directly or indirectly. Total energy is partitioned in this way: 60% on muscolar areas 40% on pathology site and irradiation Delivery modes Delivery modes APPLICATION MODALITY 8

Scans can be longitudinal or transversal (single or, preferably, associated) to the anatomical structure to be treated, ideally following a straight lines path. It is very important to correctly position the patient during treatment, in order to utilize the most accessible optical path. Delivery modes Delivery modes APPLICATION MODALITY 9

Sessions planned for Hilterapia are normally 8-15, performed daily or every other day. Each session lasts between 10 and 20 minutes, with a total energy of 1000 to 4000 J. Delivery modes Delivery modes APPLICATION MODALITY 10

Treatment protocol Treatment protocol Standard protocol Specific protocols PROTOCOLS 11

It guarantees good results in all pathologies and clinical stages, thanks to the use of particular pre-set fluences and frequences which give an analgesic and anti-inflammatory effect. It comprises three phases: INITIAL PHASE: fast manual scanning INTERMEDIATE PHASE: trigger points treatment FINAL PHASE: slow manual scanning STANDARD HILTERAPIA ® PROTOCOL 12

TRANSMISSION IS PREVALENT ON ABSORPTION Initial phase: 3 sub-phases (steps) with increasing fluences and decreasing frequencies. The highest number of anatomic structures, both superficial and deep, are reached with an homogeneous distribution of energy. Speed scanning: - transfer of energy in depth - prevalence of photomechanical effect on photothermal effect (cold treatment) - heating is dissipated through convection STANDARD PROTOCOL 13

Intermediate phase: It is applied in presence of painful trigger points. This phase includes 4 sequential steps with increasing fluences and fixed frequencies, until each area has reached a pain reduction of about 80%. The handpiece is located directly on each painful point for a maximal time of 7 seconds. STANDARD PROTOCOL 14

ABSORPTION IS PREVALENT ON TRANSMISSION Final phase: 3 sub-phases (steps) with increasing fluences and decreasing frequencies. The highest number of anatomic structures, both superficial and deep, is reached, with an homogeneous distribution of energy. Slow scanning: - The heating is dissipated through conduction - Higher photothermal effect with hyperemia - Higher accumulation of energy STANDARD PROTOCOL 15

The specific protocols are an optimization of the standard protocol according to the pathology, the clinical situation and the type of patient. They may be composed by 3 phases or by a single phase. The parameters (fluence, frequency and total energy) are specifically set. Besides the protocols proposed for each joint, more protocols have been specified for gonarthrosis, muscular pathologies, oedemas. SPECIFIC HILTERAPIA ® PROTOCOLS 16

The proposed values are related to a normotype patient and phototype I,II e III. In a patient with scarce adipose tissue and/or muscular mass the total energy must be reduced by 20%. In a patient with abundant adipose tissue and/or muscular mass the total energy must be increased by 20%. In a patient of IV, V e VI photoype it could be necessary to reduce fluence, frequency and total energy by 10-20%. In any case the parameters have to be tested on patient before the treatment. PHOTOTYPEHAIRCOMPLEXION TENDENCY TO ERYTHEMA TAN IRedWhitish Constant +++ Always present No IIFairFair Constant ++ Slightly tanned IIIBrownFairFrequent Light tanned IV Dark brown OliveRareDark VBlackOliveExceptional Very dark VIBlackBlackNotBlack SPECIFIC PROTOCOLS 17

Gonarthrosis: there is a specific protocol for degenerative chondropathies and gonarthrosis, both for the way it is performed and for the frequency of the sessions. In particular, it includes two cycles of 15 daily sessions, with a pause of 3 months between them, during which the patient is advised to take hyaluronic acid supplements (by mouth or by infiltrations). During each session the maximal possible fluences and frequencies will be used with a slow scanning mode according to 6 optical windows, using DJD handpiece: Anteromedial and lateral with patient in supine position and knee flexed at 90° Posteromedial and lateral with patient in prone position and extended knee Medial and lateral patellar (extended knee and patellar balancing) SPECIFIC PROTOCOLS 18

According to the gonarthrosis protocol 500 joule for each optical window are supplied, for a total of 3000 joule for each session. For each optical window is suggested a single phase with maximal fluences and frequencies and slow scannnig (parameters can vary depending on patient sex, phototype and individual tolerance). SPECIFIC PROTOCOLS 19

The DJD handpiece A cavity with the shape of a bell and an internal side gold-plate for increasing the reflection power Reduced blood sprinkling for the light pressure of the handpiece on the skin Quartz window for permitting to exert a light pressure during the treatment 20

Contusions and Muscular lesions: Contusions and muscular lesions must be treated with variable parameters according to the clinical phase. In acute phase (lasting 3-7 days) a unique phase have to be performed with 3 steps at medium/low fluences and frequencies, because the precocious heat could cause dangerous complications like fibrosis and calcifications. In sub-acute and chronic phase a unique phase have to be performed with medium/high fluences and frequencies to stimulate the tissue to regenerate. SPECIFIC PROTOCOLS 21

Muscular contractures: Muscular contractures take benefit from heat, therefore have to be treated precociously with rather high energy. Also in this case a unique phase has to be made, with slow scanning, composed by 3 steps at increasing fluences and decreasing frequencies. Total energy J. SPECIFIC PROTOCOLS 22

Oedema and swelling (effusion): Oedema and post-traumatic effusion must be treated with compressing bendage and cryotherapy for at least hours. Hilterapia ® is suggested starting from the second day (during the first 24 hours the induced vasodilatation could worsen the effusion) with a specific protocol. A unique phase is suggested, with slow manual scanning composed by 3 steps with increasing fluences and decreasing frequencies. The treatment has to be performed first on the area with oedema and then on the lymphatic system, with centripetal scanning (for instance the saphenous veins), to help the drainage of effusion. SPECIFIC PROTOCOLS 23