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    scientifi c report

    page 5

    page 9

    page 21

    page 33

    page 47

    page 57

    HILT High Intensity Laser Therapy

    Cytoproliferative activity of the HILT

    Hig Intensity Laser T erapy n art rosis

    Hig Intensity Laser T erapy in t e treatment o gonart rosis

    High Intensity Laser Therapy (HILT)

    HILT vs TENS and NSAIDs

    Index

    T T ERAP

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    HILT High Intensity Laser Therapy

    HE UNIQUE PHYSICAL THERAPY FOR THE TREATMENT OF DJD

    ND OSTEO RTHRITIS.

    Conventional Lasertherapy has been present in Europe since more than25 years. More than 2000 scientific publications testify its effectivenessand the validity of this approach. It has been demonstrate moreover thatt is not toxic an it as no si e e ects. For a t ese reasons it is current yse as a monot erapy or as a comp ementary t erapy.

    Up to now, conventional Lasertherapy is applied through devices featur-ng ow or me ium power, wit interesting resu ts.et it oes not a ow to treat eep seate pat o ogies, since it oes not

    permit to deliver the necessary high doses of energy to deep layers with-out inducing thermal damage to tissues.For this reason traditional Lasertherapy can be applied with success onlyon super cia pat o ogies. Moreover, treatment times are mo erate yong.

    Today, thanks to the revolutionary patented HILT Therapy, it is possibleo treat also deeper disorders, since HILT features the power and theenergy w ic are necessary to treat a t e eep seate in ammatorycon itions, an not on y t e super cia isor ers. Moreover HILT is not

    oxic and can be performed without damaging the tissues surroundinghe pathology.

    HILT t ere ore is t e so e t erapeutic met o w ic a ows to treat sa e y

    HILT High Intensity Laser Therapy

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    a t e in ammatory states, a so i ocate in ept , in ucing - since t eery rst app ication a strong re uction or o pain, toget er wit t eecovery of the mobility. This beneficial effect can last from 4 up to 72ours after the first application. After some sessions the complete disap-

    pearance of pain and the complete mobility recovery can be achieved.

    HILT is revo utionizing t e t erapeutic approac o ort ope ic MD,physiotherapists, chiropractors, sport medicine experts etc, since its

    ain indications are:

    DJD (Degenerative Joint Disor ers) an Osteoart ritisC on ropat iesDeep Musculoskeletal Disorders

    rincip e of Action

    HILT bases its effectiveness on a particular and characteristic high peakpower Laser pulse, featuring peculiar frequencies and pulse width. ThisLaser emission was care u y an c inica y teste an oun e ective or

    a t e a ove mentione pat o ogies. T an s to its eatures it is a e todeliver in depth the correct effective dose of energy, without being toxicon the area of incidence and for the deep tissues it is able to reach.

    T an s to t e ig pea power o t e pu ses it exp oits, HILT is a e topro uce a so a very strong p otomec anica e ect: rea pressure waves

    hich propagate inside the tissues and act directly on the lymph drain-ng pump, performing their action on the inflammatory process, even ifc ronic, eaturing t e capa i ity o stimu ating co agen an ia ine car-i age regeneration. T an s to t e p otomec anica e ect HILT is a eo produce a fast resorption of the liquids leaked because of trauma ornflammation.

    HILT High Intensity Laser Therapy

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    The verticalization of energy

    This way of energy delivery is a true verticalization of energy: an highamount of energy is delivered in a very short time to a great volume ofsuffering tissue. The traditional way of energy delivery which requiresong time o emission in or er to trans er t e same amount o tota en-ergy, can be regarded instead as horizontal.The vertical way of delivering energy is completely safe when comparedo the old horizontal one, which heats up the tissues and runs the risk of

    amaging it. Moreover it is more e ective, treating greater vo umes oissues an at same time.

    he Scientific Research

    HILT is t e resu t o a ong pat o Scienti c Researc , co-or inate yhe efforts of a prestigious teamwork of scientists. The main biomedicaland clinical results which allowed to validate HILT as a new therapeuticechnique will be presented in the following pages of this report.

    HILT High Intensity Laser Therapy

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    Cytoproliferative activity of the HILT:

    in vitro investigation

    Giacomo RossiDepartment of Veterinary Science,University of Camerino

    Damiano FortunaCardio-Thoracic Department,University of Pisa

    Chiara TarantinoDepartment of Animal Pathology,rophylaxes and Alimentary Hygiene,

    University of Pisa

    Guido FlaminiDepartment of Bioorganic Chemistryand Biopharmaceutics,University of Pisa

    Leonardo MasottiDepartment of Electronics andTelecommunications,University of Florence

    ytoproliferative activity of the HILT

    Introduction

    For some time now t e use o pu se N :YAG Laser as een sprea -ng in the therapy of pain with excellent results 3,4,5. Studies exist whichdescribe the anti-inflammatory 12 anti-oedemigenic 1 and antalgic 5,9 ef-ects of Nd:YAG Laser, thus justifying its use in the therapy of pain.

    it t e exception o t e stu y y Repice et a . 6, no i iograp icaeferences exist indicating the cytoproliferative effect of Nd:YAG Lasern order to justify its use in reparative therapy.

    On t e contrary, severa aut ors 2,8 report t e cytoin i iting e ect o N :

    AG Laser. More specifically, Sroka (1999) describes having obtaineda mitotic increase with Laser at 410, 635 and 805 nm while he excludeshis with the Nd:YAG Laser.In our stu y we ave assesse t e stimu ating capacity o t e cytopro i -eration o t e N :YAG Laser in vitro.

    e used two different cell lines for investigating the cellular proliferativeesponse to the variation in the dosimetry and for verifying the specificity

    o t is response o a mitotic increase wit t e same parameters ut yarying t e ce ine. Wit t e use o a mo ecu e in i iting t e tyrosine-

    inasic metabolic pathway (isoflavone genistein) the metabolic interac-ions of the Laser radiation with one of the main metabolic pathwaysassigned to the cellular proliferation were assessed.

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    Materia s an Met o s

    Cell lines, culture mediums and growth conditionse used two cell lines in this study: HCT-8 tumoural cells (human ileo-

    cecal adenocarcinoma) and VERO cells (derivates of renal cells of therican green mon ey o t e Istituto Zoopro attico Sperimenta e e a

    Lom ar ia e e Emi ia, Brescia, Ita y).s a culture medium for the HCT-8 line we used RPMI 1640 (Gibco BRL,

    Grand Island, NY) containing 10% of bovine foetal serum (SFB,Eurobio),

    1% of sodium piruvate 1mM/lt of, glutamine 2mM (Gibco BRL), and5% o a mixture o Penici in-Streptomycin-Fungizone.s a cu ture me ium or t e VERO we use Eag es MEM containing

    10% of SFB, 1% of sodium piruvate, glutamine and 5% of the antibiotic-antimicotic mixture.Bot t e ce ines were cu tivate in unventi ate 75 mm2 as s unticon uence in t ermostat at 37C. A ter trypsinisation o t e monostra-um, the cells of both lines were dispensed into the wells of a microtitreslide for ELISA. The quantity of cells per well was determined in such a

    ay as to obtain the confluence within 24 hours in incubation condi-ions at a temperature o 37C an an atmosp ere containing CO

    25 .

    In or er to avoi t e i usion o t e Laser eam into t e a jacent we she treatment of each well containing the inoculum was surrounded byeight wells containing trypan blue at 0.4%11

    ource of irradiation and irradiation conditionss a Laser source we use a pu se N :YAG Laser evice (pw: pu seave), 1064 nm, average power 6 Watts (El.En. S.p.A., Calenzano, FI,

    Italy), with a 0,19 cm2 spot. The handpiece was fitted with a spacer inor er to guarantee a ens-we istance a owing t e spot to assume aiameter capa e o ensuring t e exact coverage o t e irra iate we .

    To protect the cells from radiation scattering each well sown wassurrounded by eight wells containing a trypan blue (0,4%) solution(Grossman, 1998)11T e we s were irra iate 6 a ter eing sown, y rep acing t e cu ture

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    e ium wit steri e PBS steri e.e per orme t e assessments y maintaining t e energetic contents o

    each pulse constant: 150 mJ, while we varied the repetition frequency(5 40 Hz) of the pulses in one second and the irradiation time (4 20sec) of the well.

    ter t e treatment t e new cu ture me ium rep ace t e PBS in t ee s an t e s i es were t en urt er incu ate or anot er 10 ours, orp to a total of 16 hours of incubation after the sowing.

    The control cells were instead irradiated with an ineffective Laser called

    a s am Laser.Eac test was repeate ve times.

    Proliferation parametersPE TR P T METR

    t t e sixteent our, t e cu ture me ium was rep ace wit 200o new me ium a e to 50 o so ution containing 3mg/m o MTT(Sigma, Italy) in PBS. After an additional 4 hours of incubation underhe same conditions, the solution contained in the wells was replacedith 200l of dimethyl sulphoxide (DMSO, Sigma) to which 25l of a

    so ution o 0.1 M o g icine an 0.1 M o NaC wit a pH o 10.5 were

    a e . T e s i e was t en imme iate y rea wit a spectrop otometeroperating at a wavelength of 450nm.Each slide was then irradiated at specific values after which all the val-es of the spectrophotometric readings were expressed in O.D. (Optical

    Density) w ic in irect y in icates t e ensity o t e vita ce s o t eonostratum.

    They were then compared with the average values of the non-radiatedcontrol cells or irradiated with the sham Laser.

    T E T

    Chamberslide (Bibby, Sterilin) slides were used for the immunohisto-chemistry tests, sowing and later irradiating each well in the same man-er as described for the ELISA slides. The groups of treated and control

    ce s were prepare in t e same way as escri e or t e spectrop o-

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    ometric examination or ot t e VERO an t e HCT-8 ine. Once t ereatment was over, t e cu ture me ium was remove rom t e we sand the monostrata fixed with methanol for 10, followed by three rapidlavages in PBS. The monostrata were then incubated for one night withhe following primary monoclonal antibodies: specific antibody for anti-gen Ki67, c one MIB-1, (DAKO) i ute at 1:50 in PBS+BSA, anti-PCNAanti o y (Novocastra) i ute at 1:50, anti-Cyc in D1 anti o y (SantaCruz) 1:100, anti-ILGF-1 antibody (Santa Cruz) at 1:200. After three 10

    ashings in PBS, the monostrata were incubated for 15 with a sec-

    on ary anti o y ( orse-anti mouse iotiny ate, 1:250 in PBS+BSA), t enas e again t ree times in PBS an incu ate or anot er 45 wit t evi in-Biotin (ABC, Vector).

    Finally the immunohistochemical reaction was visualised via incubationith the chromogen substrata, represented by diaminobenzidine (brownye) or t e PCNA an t e ILGF-1, y Nova Re (re ye) or t e Cyc in

    D1 an Vector Re (crimson ye) or t e Ki67. In or er to assess t eexpression level of the single antigens we proceeded with the readingof the preparations with a 440x magnifying optical microscope, directlycounting the number of positive cells per field, in ten fields selectedan om y. We t en ca cu ate t e average o t e va ues o taine an

    compare t e averages o t e irra iate monostrata wit t ose o t econtrol monostrata.

    Treatment of the monostrata with genisteinIn or er to carry out an assessment o t e tyrosine- inasic meta o icpat way we use monostrata cu tivate on microtitre s i es. T ese werereated with a isoflavone genistein solution (Sigma, Italy) capable of in-ibiting this metabolic pathway.

    T e monostrata were t en treate wit ecreasing oses o genistein,ith the addition to the culture medium of a 400 mMol solution from

    a concentration of 100ml which was cytotoxic, up to concentration of50ml, which was instead cytostatic.T e ose wit t e cytostatic e ect was i enti e y means o t e use o

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    e spectrop otometric tec nique escri e a ove, an via t e irectassessment o t e mitotic in ex o t e monostrata treate wit t e genis-ein and the controls. More specifically, these cells were treated first withColcimit in order to evidence the chromatids, lysed in hyperosmolarbuffer, fixed in methanol, dyed with Giemsa, after which the count wasper orme o t e num er o metap asic nuc ei out o one t ousan nu-c ei counte .Once the dose inhibiting the cell cycle was identified, the monostrata

    ere irradiated once again with the Nd:YAG Laser with the values iden-

    ified during the first part of the study, that had demonstrated their abilityo increase t e mitotic in ex.

    tatistical analysisThe average of the samples and the standard deviation were calculatedor eac experimenta con itions, repeate ve times. T e resu ts oe repeate experiments carrie out or eac ce ine were a e y

    percentage and compared with their controls. The onetail Student t-testas used for evaluating the differences between the controls and the

    reated group.

    esults

    The irradiation of the monostrata with the Nd:YAG Laser at specific fre-quency va ues, intensity an exposure time in uces ce pro i eration.For eac test per orme or ot t e HCT8 an t e VERO we t en com-pared the O.D. values deriving from the spectrophotometric reading ofhe irradiated wells with the O.D. values of the control wells.

    e compare t e average o t e i erences (eac ca cu ate on t e veests per orme ) etween t e two groups un er investigation at t e vary-ng of the exposure time (sec.), frequency (Hz) and therefore, automati-cally the average power (Watts).Out of the 120 tests conducted, 60 per cell line (divided into 12 groupso parameters wit ve tests per group), it emerge , as in gure 1, t at

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    e comparison etween t e i erences etween t e contro an treategroups was statistica y signi cant (in icate in t e grap wit t e posi-ive ordinate value) with medium-low frequencies and exposure times.In this respect it is to be noted that in this study we maintain the energet-c content of each pulse constant (150 mJ) and varied only the frequencyan irra iation uration. More speci ca y, or t e HCT8, t e win owo optima va ues turne out to e t e one correspon ing to a quantityof energy equal to 2.7 Joule, and average power of 2.25 Watts, a flu-ence of 14.2 J/cm2, and intensity of 11.8 W/cm2 a repetition frequency

    of the pulses in one second of 15 Hz for an exposure time equal to 12secon s, w i e or t e VERO t e greatest pro i eration was o taine wit2.4 Jou es, 6 Watts o average power, 12.6 J/cm2, 31.5 W cm2, an 40Hz for 4 seconds (Figure 2). From this data it emerges that the value

    indow identified for the HCT8 cells was ineffective for the VERO cells,even creating a cytostatic e ect.T e win ows wit a cytostimu ating action are c aracterise y iglevels of nuclear expression of the antigens PCNA and Ki67, as well asby an elevated mitotic index. From the direct count of the nuclei ex-pressing the antigens Ki67 and PCNA, statistically significant differencesave come to ig t etween t e treate an contro monostrata.

    In fact, in the monostrata subjected to irradiation with cytostimulatingparameters (cyto-proliferative windows) mean expression values of thea ove-mentione antigens were o serve w ic were on an averageou e t ose s own in t e contro monostrata. T e resu ts appear to en constant corre ation wit t e mitotic in ex ca cu ate on t e two cepopulations and assessed on average as double in the treated monostratacompared to the controls.

    Cytostatic e ect o t e genistein an restoring t e ce cyc e a terrradiation of the monostratum.

    cytotoxic effect was observed with a dose of 100 l of genistein addedo the medium culture, while 50 l gave rise to an inhibiting effect ofe ce cyc e. 25 an 12.5 oses pro uce interme iate e ects, not

    ytoproliferative activity of the HILT

    ig. 1 - Cytoproliferative parameters.Shape of each pulse is constant, onlyfrequency and time are varied.

    Frequency

    (Hz)Time

    (s)O.D. Difference

    (Treated Non treated)

    5105

    151616

    40405

    1717

    121616161612

    8

    201620

    11.951.72

    13.081.139.600.67

    4.0022.453.451.261.00

    ig. 2 -Assessment of cytoproliferationafter HILT treatment (VERO cells).

    1 2 3 5 6 8 9 10 11 12

    50

    0

    30

    20

    0

    0

    -10

    -20

    -30

    Sec

    Difference

    inear

    Linear Sec

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    ig. 3 - The mitotic index of the cellstreated with genistein is clearly lower thanthat of the cells treated with HILT.

    ota y in i iting o t e ce mu tip ication.it 50 oses in act, it was possi e to o serve t e zeroing o t eitotic index as well as the absence of expression by the cells treatedith antigens like the Ki67 and PCNA, Cyclin D1 and the growth factor

    ILGF-1. These results have only been obtained on the HCT8 cell line,seeing t at or t e VERO ce ine it was not possi e to i enti y a con-centration o genistein w ic , w en a e to t e cu ture me ium, wascapable of inducing a cytostatic effect free of partial or total damage tohe monostratum (cytotoxic). The Laser irradiation of the culture with

    he cytoproliferative parameters after the cytoinhibiting effect by meanso t e iso avone genistein, resu te in eing capa e o reactivating t ece u ar cyc e espite t e oc operate y t e iso avone on t eyrosinkinasis.This metabolic pick-up is quantifiable by means of the cell count in

    etap ase (new y assessa e mitotic in ex), an a so via ce u ar neo-expression o t e Cyc in D1 an t e ILGF1.

    Figure 3 contains the graph describing the distribution of the mean val-es, evidenced by the linear for each group. From the graph it can be

    seen ow t e eve o t e mitotic in ex o t e ce s treate wit genistein

    s c ear y ower t an t at o t e ce s treate wit t e N :YAG.

    iscussion

    T e resu ts o taine wit t e spectrop otometer (in irect assessment)and with the immunohistochemistry (direct assessment) indicate the ca-pacity of the Nd:YAG Laser to induce the proliferation of the HCT-8 and

    e VERO at speci c requency va ues, exposure times, pu se s ape.

    The different reaction of the monostrata even with very slight changes inhe irradiation parameters indicate how there is an elevated specificitybetween dosimeter and effect; in fact we have observed how the ad-

    inistration o simi ar energy quantities (Jou e), o taine y varying t e

    ytoproliferative activity of the HILT

    0

    20

    00

    80

    60

    0

    20

    0

    Nd:YAG

    Linear (Nd:YAG)

    Control

    Linear (control)

    Genistein

    Linear (Genistein)

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    requency (Hz) an t e exposure time (sec) are a e to supp y io ogicae ects w ic at times are iametrica y opposite.This indicates that more important than the quantity of energy transferedo the system (Joules), is the way in which this energy is supplied:requency and exposure time.T e act t at t ere is a variation in t e parameters t at are cytostimu at-ng wit t e varying o t e ce ine use , in icates a consi era e speci-ficity of the Laser action, depending strictly not only on the quantity ofenergy supplied but also on the type of biological substratum on which

    t is use .In act y app ying t e cytostimu ating osimetric parameters to i erentce u ar ines as in icate y ot er Aut ors t ere is no increase in t e

    itotic index. Repice et al. 6 have described the biostimulating effect ofhe Nd:YAG Laser on human neuroblastoma cells using parameters thatare very i erent rom t ose use in t is stu y. Ot er Aut ors 2, aveeven escri e a constant in i iting e ect o t e N :YAG Laser on t ecellular proliferation. More specifically, Stroka 8 reports of no cytopro-liferative effect at all in the interval between 0 10 J/cm

    2which results

    n being very similar to our study (7.69 J/cm2 . For this purpose, andeiterating w at as een reporte wit regar to t e speci city o t e

    parameters an t e extreme sensitivity o t e ce s to t e N :YAG Lasere can state that in the light of our results, it is not sufficient to indicate

    he fluence for establishing the parameters of effectiveness of lack of ef-ectiveness since it is necessary to identify an effectiveness window ofenergy supp y va ues or every ce u ar su stratum, an t ese parameters

    ust re er to t e speci city o t e ce u ar ine use .In any case, on having confirmed the biostimulating effect of the Nd:AG, we believe that this is capable of justifying its use in repair therapy

    as we as in pain t erapy 3, ,5,9. Despite eing on y pre iminary, t e re-su ts o taine wit t e ou e genistein-Laser ra iation treatment o t eHCT8 cell line indicate the possibility of unblocking the cellular cyclenterrupted with the genistein by irradiating the cells.In fact, even though the blocking of the cellular cycle by the genisteinuring t e G0 p ase (in icate y t e in i ition o t e expression o

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    e cyc e mar ers Cyc in D1 -expresse y t e ce s t at progress rome G1 p ase to t e S p ase- Ki67 an PCNA - ot expresse in t e S,

    G2 and M phases- and by the zeroing of the mitotic index via selectivenhibition of the tirosine-kinasic metabolic pathway) the exposition toopportune doses of Nd:YAG Laser radiation has allowed for restoring thece u ar cyc e. T is e ement is particu ar y interesting i assesse wit ina t erapeutic context. In act, it is nown t at t e omeostasis o t ecartilagineous turnover is guaranteed by the balance of the catabolic fac-ors (IL 1 beta, TNF alpha, IL 6, IL 8) and anabolic factors (ILGF-1, GH,

    TGF beta) that act through the same family of receptors (GHCitokine)n t e meta o ic pat way o t e tyrosine inase. A competitive mec a-ism is t ere ore ypot esise in t e su stratum, or w ic in cases o

    prolonged stress, the metabolic factors are not able to use the metabolicpathway of the tyrosine kinase and the tissue proceeds towards the de-generative p enomenon. T is stu y t ere ore s e s ig t on t e capacityo N :YAG Laser to promote t e restoring o t e ce u ar cyc e in spite ohe selective block operated on the tyrosine kinase.

    onc usions

    This study also demonstrates that like other lasers, the Nd:YAG Laserpossesses the biostimulating capacities even though there is an extreme-ly high sensitivity of the in vitro cells to the variations in dosimetric pa-ameters mJ, sec, Hz .

    T e most stri ing e ement arising rom t is stu y is t at in or er to in ucehe cytoproliferative effect, the manner in which this energy is supplied(frequency and exposure time) seems more important than the dose.Moreover, t is ra iation seems capa e o reactivating t e meta o icpat way o t e tyrosine inase on w ic a p armaco ogica oc isactivated; this element could explain why the degenerated tissues in

    hich this metabolic pathway is blocked are able to recover the ana-bolic phase and re-equilibrate their homeostatic balance.

    e e ieve urt er investigations are necessary or con rming our o ser-

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    ations, a ove a in t e aim o i enti ying t e cytopro i erative param-eters o ot er ce ines, especia y t e primary type.The acquisition of this data could in fact open up the field of Nd:YAGLaser use in both reparative and pain therapy.

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    High Intensity Laser Therapy in arthrosis:

    experimental investigations on animal models

    Damiano FortunaCardio-Thoracic Department,University of Pisa

    Giacomo RossiDepartment of Veterinary Science,University of Camerino

    Alessandro ZatiRizzoli institute for Orthopaedics,Bologna

    Daniela GiannessiInstitute of Clinical PhysiologyItalian National Research Council, Pisa

    ilvia del RyInstitute of Clinical PhysiologyItalian National Research Council, Pisa

    Cesare PaoliniDEKA MELA S.r.l., Calenzano (FI)

    auro PianaCentro Ortopedico Vinovo, Torino

    Paolo MondardiniCONI-FMSIInstitute of Sports Medicine of Bologna

    Leonardo Masotti

    Department of Electronics andTelecommunications,University of Florence

    Introduction

    rt rosis is a isease wit a ig socia impact as it a ects 30-35% o t epopulation. An arthrosic patient costs the public health services approxi-

    ately 4,000 euro on average a year, touching peaks of almost doublehis amount in the most severe cases 1.Conventiona t erapy oresees t e a ministration o anti-in ammatories,anta gics, an econtraction agents. T e current tren is to use c on ro-protective drugs with often encouraging results 2.The international bibliography provides results that are often contrasting

    ith regard to the clinical effectiveness of the Low Level Laser Therapy(LLLT) in t e treatment o art rosic an r eumatic comp aints, an some

    even express negative opinions 7, 8, 9, 10, 11, 12, 13, 14, 15, while others are posi-ive 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26. Over the last few years the High IntensityLaser Therapy (HILT) has been making its mark with excellent results insports traumato ogy an pain t erapy 27, 28, 29, 30, or t is reason we eci eo assess t e possi i ity o a so trans erring t is met o to t e cure oarthrosic ailments and therefore prepared an animal model with an ar-hrosic pathology in line with the indications of the various Authors 3, , 5.The majority of studies conducted over the last thirty years in Laser ther-apy ave een carrie out wit me ium an ow intensity Laser evices(Low Leve Laser T erapy: LLLT), wit wave engt s in t e in rare an

    ear infrared (600 - 900 nm). Within this spectrum the Laser beam ispartially absorbed by the natural chromophores, like melanin, whichithhold part of the energy irradiated.

    Our stu y on t e ot er an is ase on t e use o a N :YAG Hig In-

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    Wawe-length(nm)

    Averageintensitysed

    (watts)

    Spotarea(cm2)

    Powerdensity(W/cm2)

    LaserNd:YAG

    1,064 1.9 0.19 10

    LaserNd:YAG1,064 5.7 0.19 30

    LaserNd:YAG

    1,064 9.5 0.19 50

    LaserNd:YAG

    1,064 10 0.125 80

    LaserCO2

    10,600 5 1.5 3.3

    LaserDIODE

    830 1 0.03 33

    Table 1. Types of lasers and dosimetricarameters used.

    ensity T erapy (HILT) Laser, c aracterise y a wave engt (1064 nm)at a ows it to penetrate an sprea more easi y t roug t e tissue ue

    o not having an endogenous chromophore. Moreover, with the pulsedave Nd:YAG it is possible to deliver power peaks of up to 1000 Watt

    or times of 200 seconds: extremely elevated peak intensity (W/cm2) inery rie times. Suc a ig intensity in suc a s ort time prevents t eeat accumu ation y t e tissues as appens wit t e use o N :YAGith constant emission (Parra 29, 30). This all extrinsicates in a greater

    spreading capacity of the Laser beam through the tissues with a very low

    isto esive ris .In ot er wor s, quantities o energy (Jou es) an uence (J/cm2 aree ivere in t e HILT t at are not issimi ar to t e ones e ivere withe LLLT but there is an intensity (power density: W/cm2 of even up to1000 times higher.T e o jective o t is stu y was to assess t e sa ety o intensity Laser atarious power intensities (10, 30, 50 an 80 W/cm2) use on t e

    superficial and deep structures.The secondary objective was that of verifying the biological effects inivo of the three different types of Laser: CO , Diode, Nd:YAG; and more

    speci ca y, we assesse t e anta gic 32, antin ammatory 33 an

    cytopro i erative 3 e ects o t e Laser.

    Materia s an met o s

    Lasers usedThree types of Laser were used: CO (10.600 nm), Nd:YAG pulsed wave(1.064 nm), Diode (830 nm) produced by El.En. S.p.A. (Calenzano -F orence). Ta e 1 s ows t e powers use y t e t ree asers assesse .

    Investigation populationccording to Bentley 3 the ideal animal model for the study of arthrosis

    should have the following characteristics:- t e presence o precocious esions an action mec anisms simi ar to

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    Healthy 12

    Control 20

    Nd:YAG 10 W/cm2 12

    Nd:YAG 30 W/cm2 12

    Nd:YAG 50 W/cm2 12

    Nd:YAG 80 W/cm2 12

    DIODE 12

    CO2

    12

    Table 2. Breakdown of the subjects in the

    investigation groups

    ose escri e or t e uman pat o ogy;- evi ence o an initia oss o t e carti agineous matrix an su sequentappearance of fissures, fibrillations and erosions;- the cartilagineous lesions must therefore be followed by sclerosis of thesubchondrial bone;- t e a terations escri e must e rea i y repro uci e an i enti a en t e iving anima ;- the induction method of the lesions must be valid for different animalspecies and articular sites and free from systemic effects.

    In t is stu y we c ose c ic ens o t e eavy ree , re wit t e openange system to a ow amp e possi i ity or eam u ation.

    This species was preferred over others as it has a bipedal gait similar toan, ample articulations capable of supported heavy loads and an el-

    evate asa meta o ism t at a owe us to o tain c ronic egenerativeesions in re ative y rie times, a goo -nature isposition ma ing iteasy to treat with Laser. Moreover, it expresses a range of cytokins andchemokins that can be compared to those of humans.Table 2 illustrates the breakdown into groups of the population investi-gate .

    Investigation protocolThe investigation was performed in compliance with the Helsinki Decla-ation an t e Internationa Stan ar s governing researc on anima s.

    T e c ronic egenerative art rosic p enomenon was in uce via ou-e inocu ation in t e ower rig t im o eac su ject wit Freun s

    Complete Adjuvant (FCA) + formaldehyde at 10%.The inoculations were administered at one-month intervals. Eight monthsa ter t e secon in tration t e Laser t erapy was commence .Fo owing is a ist o t e activities in c rono ogica or er wit t especific examinations performed;

    ) acquisition of subjects;B) one months growth;C 1st inocu ation wit FCA;

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    D) one mont s growt ;E 2rd inocu ation wit FCA;F) growth after 8 months;G) beginning of Laser therapy:- T/0 => on all subjects: Rx, clinical evaluation of the lameness, weight,

    oo tests; ioptic ana ysis on 8 contro s (a ter eut anasia wit generaanaest etic).- T/1 => beginning of Laser therapy.- T/2 (3 weeks after T/1) => end of Laser treatment: in all 15 Laser ses-

    sions were performed spread over three weeks.- T/3 (2 wee s a ter T/2) => on a t e remaining su jects: Rx, c inicaeva uation o t e ameness weig t, oo tests; ioptic ana ysis (a tereuthanasia with general anaesthetic).

    ssessments carrie out:- X-rays in ot at- atera an antero-posterior o ot im s o eacsubject.- Serological analyses (ELISA) for: PCR, IL 1 beta, ILGF 1, TGF beta.- Macroscopic examination via photographic acquisition.- Microscopic examination: isto ogica an immuno istoc emica

    examination (IHC): istogica staining wit ematoxi in-eosin, Herovicipolychrome solution and Alcian PAS blue.- In IHC we performed assessments for: Type II Collagen, ILGF 1, MMP1,TIMP2.T e stainings wit Herovici were per orme in or er to ig ig t t epresence o protoco agen (pa e ue) as a emonstration o t e age ohe cartilage: the protocollagen precedes the formation of collagen.The synthesis activity of the mucopolysaccharidic matrix was insteadassesse via t e A cian PAS ue.T e ata co ecte were entere onto an e ectronic sprea s eet ananalysed statistically with the t-Test.

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    ig. 1 - Effect of HILT treatment on

    inflammatory (IL1-beta) and anabolicIGF1) cytokines

    ig. 2 ig. 3

    ig. 2 - Control. Articular cartilage almostcompletely dextruded and destructured.The image is characterised by the almosttotal presence of bone tissue:the haversian systems are evident.

    ig. 3 - Nd:YAG 50 W/cm2. Neoformedand physiologically structured hyalinecartilage. Confirmation that this is hyalinecartilage was obtained in IHC for the TypeII collagen while the presence ofprotocollagen (Herovicis polychrome)testifies to the young age of the same.

    esu ts

    Anti-inflammatory effectThe graph in fig. 1 illustrates the mean of each subject treated with Laser

    ith a comparison between the Controls and the Healthy subjects.

    Neochondrogenic effectThe neochondrogenic effect was documented histologically andmmunohistochemically (IHC). Figures 2 and 3 show the histological

    mages referring respectively to a Control (fig. 2) and a subject treatedit N :YAG at 50 W/cm2 ( g. 3)Fig. 2 s ows t e a most comp ete y extru e carti age wit partia cov-ering of the subchondral bone tissue where in fact the haversian systemscan be observed. In fig. 3 instead, there is neoformed cartilage structuredaccor ing to t e p ysio ogica arc itecture on t e su c on ra one tis-sue; asa g o i orm isogen groups can e recognise w ic on movingowards the surface tend to arrange themselves parallel to the articularsurfaces.

    iscussion

    From an analysis of the graph in fig. 1 it is apparent that all the types ofLaser used have carried out an anti-inflammatory effect (see the curve of

    e IL 1 eta).s ar as t e istoregenerative e ect on t e articu ar carti age is con-

    cerned however, we observed a different effect between the differentypes of Laser. The CO

    2Laser offered less biostimulation.

    T e io e Laser o ere greater stimu ation compare to t e CO2

    utai e to in uce t e synt esis o very active isogen groups w ic wereowever very dishomogeneous in shape and distribution. Moreover, themmunohistochemical examination of the Type II collagen indicated thatt was fibrocartilage.It is a comp ete y i erent situation wit t e N :YAG Laser w ic prove

    High Intensity Laser Therapy in arthrosis

    30

    0

    5

    0

    5

    0Contros HILT Hea t y

    before H T treatment

    fter T reatment

    Contro s HILT Heat y

    IL 1 IGF 1

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    Morphology

    TypeII

    Collagen

    ILGF1

    MMP1

    TIMP1

    ealthy

    -

    Controls

    - - - ++

    Nd: G 10 W/ m2

    + + +

    Nd: G 30 W/ m2

    + ++ ++ +

    Nd: G 50 W/ m2

    ++ +++ +++ ++

    Nd: G 80 W m2

    + + +

    CO2

    - - -

    DIODE

    Table 3. Histological evaluations and IHCper group; classification with 4 degrees ofmerit: starting from the lowest we have:, +, ++, +++

    o e ar t e most e ective in t e neoc on rogenesis activity.Having trie various power intensities we were a e to o serve a inearrend between the therapeutic response and the dose supplied. In fact at10 W/cm2 we observed the presence of the activation threshold with theproliferation of the basal isogen groups, at 30 W/cm2 homogeneity waso serve in ot s ape an spatia istri ution o t e isogen groups, at50 W cm2 we i enti e t e most e ective ose or stimu ating t e p ysi-ologically structured hyaline cartilage, while at 80 W/cm2 we observedissular regression above all on the surface, and the lack of chondrocyte

    action of the Type II collagen (table 3).T e curve o t e ILGF-1, MMP1 an TIMP2 were particu ar y interestingn immuno istoc emistry. As ar as t e IGF-1 is concerne , an expres-sion was observed in the CO

    2which was comparable to that of the CTR

    group. The degree of expression of the growth factor with the DiodeLaser was not issimi ar to t at o t e CO

    2. Wit regar to t e egree o

    expression in t e su jects treate wit t e N :YAG Laser, t is ait u yeflects the expression of the Type II collagen with a better expressionhan subjects treated with 50 W/cm2.The trend of the MMP1 and TIMP2 in immunohistochemistry was alsoery interesting. In t is case a s arp i erence was o serve etween

    e MMP1 an TIMP2 in t e CTR, w ic was ess mar e wit t e CO2 diode, and Nd:YAG at 30 W/cm2 whereas it was highly significant withhe Nd:YAG at 50 W/cm2. Obviously this different expression of theMMP1 an t e TIMP2 as oppose tren etween t e CTR an t e N :AG group at 50 W cm . In act, in t e CTR we o taine a ig va ue

    o MMP1 an a ow va ue o TIMP2, w i e in t e N :YAG at 50 W/cm2

    hese were exactly the opposite.

    onc usion

    From this study it has emerged, in primis, that the High Intensity LaserTherapy, when administered at suitable doses, is safe in the treatmento articu ar pat o ogies an oes not in uce esions to t e sur ace an

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    eep structures.T is stu y in icates t at t e Laser is capa e o antagonising t e ex-perimentally induced athrosic phenomenon to stimulate the neochon-drogenic activity with the formation of hyaline cartilage and to inducesinovial hyperplasia.T ese e ects are c ose y in e to t e ose supp ie . More speci ca y,

    e varie t e intensity (power ensity: W/cm ) an maintaine constantenergy (Joules) and fluence (energy density: J/cm2 .It was therefore observed that the low intensity only has an anti-inflam-

    atory effect while the high intensities have a neochondrogenic andsinovia yperp astic e ect as we as t e anti-in ammatory e ect.s t is was a pi ot stu y we e ieve t at urt er investigation an con-

    firmation are indispensable. We are also of the opinion that it would bemportant to perform verifications on spontaneous arthrosic pathologiesn anima s.

    i iograp y

    . Lorenzo Mantovani.Impatto socio-sanitario dellartrosi.Atti del 6 Congresso regionale S.I.M.G. Regione Lombardia,Milano 26 27 May 2001.

    2. Reginster JY, Deroisy R, Rovati LC, et al.Long term effects of glucosamine sulphate on osteoarthritis progression:a randomised, placebo-controlled clinical trial.The Lancet, Vol. 357, 2001, p. 251-256.

    . Bentley G.Experimental OsteoArthritis.In Ali S.Y., Elves M.W. Leaback D.H. (Eds), Normal and osteoarthritic articularcartilage Institute of Orthopaedics, London, 1974 :259-280.

    . Altman RD and Dean DD.Osteoarthritis reseach animal models.

    Seminars in Arthritis and Reumatism 1990, 19(4 suppl.1):21-25.

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    . Minor RR and Farnum CE.Animal models with chondroplasia/osteochondrodysplasia.

    Pathology and Immunopathology Research 1988, 7(1-2):62-67.

    6. De Bie RA, De Vet HC, Lenssen TF, Van Den Wildenberg FA, Kootstra G,Knipschild PG.Low-level Laser therapy in ankle sprains: a randomized clinical trial.Arch Phys Med Rehabil 1998; 79(11):1415-20.

    7. Basford JR, Malanga GA, Krause DA, Harmsen WS.A randomized controlled evaluation of low-intensity Laser therapy:plantar fasciitis.Arch Phys Med Rehabil 1998; 79(3):249-54.

    8. Basford JR.Low intensity Laser therapy: still not an established clinical tool.Lasers Surg Med 1995; 16(4):331-42.

    9. Bulow PM, Jensen H, Danneskiold-Samsoe B.Low power Ga-Al-As Laser treatment of painful osteoarthritis of the knee.A double-blind placebo-controlled study.Scand J Rehabil Med 1994; 26(3):155-9.

    0. Krasheninnikoff M, Ellitsgaard N, Rogvi-Hansen B, Zeuthen A,Harder K, Larsen R, Gaardbo H.No effect of low power Laser in lateral epicondylitis.Scand J Rheumatol 1994; 23(5):260-3.

    11. Ernst E, Fialka V.Low-dose Laser therapy: critical analysis of clinical effect.Schweiz Med Wochenschr 1993; 123(18):949-54.

    2. Beckerman H, De Bie RA, Bouter LM, De Cuyper HJ, Oostendorp RA.The ef cacy of Laser therapy for musculoskeletal and skindisorders: a criteria-based meta-analysis of randomized clinical trials.Phys Ther 1992; 72(7):483-91.

    3. Vasseljen O Jr, Hoeg N, Kjeldstad B, Johnsson A, Larsen S.Low level Laser versus placebo in the treatment of tennis elbow.Scand J Rehabil Med 1992; 24(1):37-42.

    4. Haker EH, Lundeberg TC.Lateral epicondylalgia: report of noneffective midlaser treatment.

    Arch Phys Med Rehabil 1991; 72(12):984-8,.

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    5. Haker E, Lundeberg T.Laser treatment applied to acupuncture points in lateral humeral epicondylalgia.A double-blind study. Pain 1990; 43(2):243-7.

    6. am G.Low Power Laser Therapy and Analgesic Action.J Clin Laser Med Surg 1999; 1(17):29-33.

    7. Basford JR, Sheffield CG, Harmsen WS.Laser therapy: a randomized, controlled trial of the effects oflow-intensity Nd:YAG Laser irradiation on muscoloskeletal back pain.

    Arch Phys Med Rehabil 1999; 80(6):647-52.

    8. Mondardini P, Verardi L, Tanzi R, Kanellopulu S, Pagano C, Roveran G, Drago E.T rapia sica strumentale in traumatologia dello sport: impiego del Laser a910 nm pulsato nella patologia a carattere flogistico e nelle sindromi dolorosedello sportivo.Medicina dello Sport 1998; 3(51):273-83.

    9. Simunovic Z, Trobonjaca T, Trobonjaca Z.Treatment of medial and lateral epicondylitis - tennis and golfers elbow - with lowlevel Laser therapy: a multicenter double blind, placebo-controlled clinical studyon 324 patients.

    J Clin Laser Med Surg 1998; 16(3):145-51.

    20. Giavelli S, Fava G, Castronuovo G, Spinoglio L, Galanti A.Low-level Laser therapy in geriatric osteoarticular disorders.Radiol Med (Torino) 1998; 95(4):303-9.

    21. Longo L, Simunovic Z, Postiglione Marco, Postiglione Mariano.Laser Therapy for Fibromyositic Rheumatisms.J Clin Laser Med Surg 1997; 15(5):217-20.

    22. Bertolucci LE, Grey T.Clinical comparative study of microcurrent electrical stimulation to mid-Laser andplacebo treatment in degenerative joint disease of the temporo-mandibular joint.Cranio 1995; 13(2):116-20.

    23. Bertolucci LE, Grey T.Clinical analysis of mid-Laser versus placebo treatment of arthralgic TMJdegenerative joints.Cranio 1995; 13(1):26-9.

    24. artin J, Santana JR.Valoracion eficacia terapeutica del Laser de baja potencia frente al Laser placeboen el tratamiento de la epicondilitis aguda.Boletin S.E.L.M.Q. 1994; 4:9-11.

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    25. Bilotta TW, Osti R, Marchi MD, Agnelli MA, Caravita C, Beverelli MP, Maggi G,Vicenzi G, Vaccari V, Ponziani L, Impallomeni C.Il Laser CO2 nel trattamento incruento di alcune patologie ortopediche.Laser ews 1990; 3(2):11-14,.

    26. Bazzocchi G.Therapeutic Applications and Results of CO2 Laser.Atti della Fondazione Giorgio Ronchi. Anno XXXIV 1979; (45):421-27.

    27. Pesare I, Zulli F.Lutilizzo della mesoterapia e del Laser di potenza (Nd:YAG) nellatleta affetto dalesione del tendine dachille.Atti del congresso nazionale A.N.S.M.S 2000; 295-299.

    28. Lubich T, Mondardini P, Verardi L, Kanellopulu S, Zoratti M.Impiego del Laser di potenza nel trattamento precoce e nel recupero funzionaledellatleta infortunato.Medicina dello Sport 1997; 50:71-83.

    29. Parra PF, Ghinassi S, Ciuti F.Il Neodimio-YAG defocalizzato nella sua evoluzione per un trattamentosempre pi ef cace dellatleta infortunato.Laser & Technology 1992; 2(1):13-16.

    0. Parra PF.Nuova metodologia Laser per il recupero rapido dellatleta infortunato:Il Neodimio-YAG defocalizzato ad alta potenza.Laser ews 1990; 2(3):27-30.

    1. Pacini F, Arispici , Di Iorio C, Parra PF.Laser ad alta energia tipo Neodimio YAG defocalizzato:valutazione sperimentale del potere di penetrazione tissutale.Atti del XLVII Congresso Nazionale del S.I.S.Vet. Riccione, Italia 1993.

    2. Orchardson R, Peacock J M, Whitters J C.Effect of Pulsed Nd:YAG Laser Radiation on Action Potential Condution in IsolatedMammalian Spinal Nerves.Lasers Surg Med 1997; 21:142-48.

    3. Barberis G, Gamron S, Acevedo G, Cadile I, Juri H, Campana V, Castel A,Onetti CM, Palma JA.In vitro synthesis of prostaglandin E2 by synovial tissue after helium-neon Laserradiation in rheumatoid arthritis.

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    High Intensity Laser Therapy in the treatmentof gonarthrosis:the first clinical cases and the protocol for a multicentric,

    randomised, double-blind study

    Alessandro ZatiRizzoli Institute for Orthopaedics,Bologna

    Damiano FortunaCardio-Thoracic Department,University of Pisa

    manuela BenedettiRizzoli Institute for Orthopaedics,Bologna

    Irene ZaghiniRizzoli Institute for Orthopaedics,Bologna

    Teresa Wanda BilottaRizzoli Institute for Orthopaedics,Bologna

    rthrosis: state of the art

    Carti age possesses scarce reparative capacities an unti severa yearsago spontaneous or therapeutic repair of an articular lesion was not con-sidered possible. At the present time the most common cartilaginouspathology, Arthrosis (osteoarthritis) is the focus of great interest on a

    or wi e eve an as ecome t e new rontier not on y or ort o-pae ics ut a so or r eumato ogy an re a i itation, to w ic a greatdeal of energy and resources are dedicated.

    rthrosis is certainly the disease with the greatest increase in the numberof cases in the western world in consideration of the general aging of thepopu ation.

    The social and economic role of arthrosis is therefore potentially veryigh. Numerous drugs have been proposed for the therapy of arthrosisncluding:- t e new FANS (se ective in i itors o t e COX 2),- asic rugs: DMOADs (Disease Mo i ying Osteoart ritis Drugs)better known as chondroprotectors, theoretically capable of interven-ng in both the destructive and reparative process of the disease, whichnclude galactosamineglucuronoglican sulphate, diacereine, jaluronicaci .T e rea e ectiveness o t e DMOADs sti as to e emonstrate an

    he clinical impression is that these molecules represent the forerunnersof a new generation of drugs.Orthopaedics have developed a series of reparative surgical interventionso great interest aime principa y at nee-carti age reconstruction.

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    T e tec niques are ivi e into two groups: one marrow stimu ationec niques an tissue transp ant tec niques. Wort noting among t earrow stimulation techniques are chondroabrasions, perforations andicrofractures. These methods tend to stimulate the subchondrial bone

    and fill the cartilaginous lesions with fibrin coagula, rich in totipotentstem ce s. T ese tec niques give rise to t e ormation o rocarti agi-ous tissue (Type I co agen) wit scarce mec anica capacities.

    These interventions are currently reserved for lesions of less than 2 cm2 and are generally performed in arthroscopy, in one single diagnostic-

    surgica session.Far more interesting are t e tissu ar transp ant tec niques ( omo ogousransp ants, mu tip e or mosaicop astic auto ogous transp ants, auto o-gous transplants of periostal flaps, autologous chondrocyte transplants),

    hich aim at reconstructing the physiological hyaline cartilage (Type IIco agen), wit goo mec anica capacities.

    mongst t ese tec niques t e imp anting o auto ogous c on rocytes(ACI) has been particularly successful. This method consists essentiallyof arthroscopic extraction of the chondrocytary cells from areas notsubjected to stress and transplanting of the same in the athrosic lesions.T is is carrie out in 4 stages:

    1) art roscopic extraction o t e ce s;2) creating of cell cultures in highly specialised laboratories3) mounting of biomaterials deriving from the collagen) transplanting of the neo-tissue in the lesion.

    T ese met o s ave opene uturistic scenarios w ic are a rea ypartia y in progress. Mesenc yma ce s eriving rom t e one marrowand futuristic three-dimensional biomaterial deriving from hyaluronicacid (non-material materials) are already being tested in laboratories andanima mo e s. T ese new surgica rontiers must not istract us ow-ever rom t e g o a ity o t e art rosis pro em.

    Contra-indications to transplantsThe presence of significant axial deviations (greater than normal varus ora gus nee greater t an t e norm o 5) is consi ere as a mec anica

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    AUTHORAV.AGE/PATIE T

    UMBEROF

    PATIE TS

    BerrutoGobbiCherubinoDe SantisGualtieriFacciniLo BiancoRadosavjei

    284034.533363334.537

    13501840

    163610

    Table 1. Average age of clinical casessubjected to chondrocyte implant.From 1s G.I.R.C. conventIon Ischia 20-22Sept.2001

    ig. 1 - Distribution of arthrosis throughoutthe Italian population.

    m a ance capa e o compromising t e positive resu ts o t e trans-p ant; a eviations s ou e correcte in a pre iminary manner. At t esame time the absence of the meniscus due to previous meniscetomiess considered as a potentially unfavourable situation for transplants. Thesimultaneous presence of multiple cartilaginous lesions calls for a care-u assessment o t e suita i ity o resorting to c on rocytary imp antingor simi ar tec niques.More general conditions like overweight and an advanced age are otheractors considered as very important in subjecting the patient to repara-

    ive surgery of the cartilage.e on y consi ere t e patients age since, as Pe aci states, i a t esese ective criteria were to e comp ie wit , in practice, on y very ewpatients would be proposed for this type of surgical treatment.In international literature it is advised against performing transplants inpatients over 55.In actua act, t e age o t e patients su jecte to surgery is a ways ow:at the recent convention of the Gruppo Italiano di Studio dei ProcessiRiparativi del Tessuto Osteo-Cartilagineo (G.I.R.C. Italian Study Groupof Reparative Processes of Osteo-Cartilaginous Tissue at Ischia 20-22Septem er 2001) t e mean age o transp ants resu te in eing 34 years,

    it a minimum o 15 an a maximum o 40 (see ta e 1).

    If we consider the wide range of the population over 55 we are able toealise how a univocal answer to arthrosis cannot be found in surgery

    a one (see g. 1).

    igh Intensity Laser Therapy (HILT)Over t e ast ten years numerous stu ies ave een carrie outn icating t e iostimu ating action o MID asers. In particu ar, asersave been accredited with the power to accelerate the healing of skinlcers and bedsores. The Laser devices used until now have been lowntensity with a wavelength of 600-900 nm, corresponding to the nearn rare . Wit in t is spectrum t e Laser eam can e a sor e y t e

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    SURGERY

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    10 patients ave een se ecte (mean age 50 years, min. 41 years, max.65 years, 5 ema es, 2 ma es) a ecte wit primitive art rosis.

    Clinical testsThe clinical tests considered most suitable were as follows.T e W.O.M.A.C. (Western Ontario an Mc Master Universities In ex),consisting o a c inica unctiona test speci ca y or osteoart rosis (t e

    .O.M.A.C. is the only test among those used in an international con-ext to have been validated for Italy). It is easy to implement and explores

    both the functional attitude of the arthrosic knee and the patients dailyactivity.T e IKDC test is a unctiona test o t e nee consisting o a section withe patients subjective assessment of his/her own conditions in relationo his/her daily and/or sporting activities, and a clinical and objective as-sessment y t e p ysician. It is extreme y va i in t e event o t e patientaving een su jecte to art roscopy or eing a can i ate or reparativenee surgery, for which he/she has not been considered in the final as-

    sessment of the pilot study..A.S.(Visual Analogic Scale) is the traditional scale for a quantitative

    assessment o pain w ic consists o a simp e test wit easy acquisition

    an compara i ity.s laboratory analyses the following classical phlogistic tests were

    mplemented: ESR, PCR, 1glycoprotein, as well as several Interleukinan C emiKine assays i e: IL1 IGF 1, IL8 an RANTES, as an expres-sion o t e meta o ic activity o t e articu ar environment a ecte yart rosis.

    Instrumental diagnostic testss an initia si etrac ing rom t e art rosis we per orme a conventiona

    X-ray o t e nee in an antero-posterior position un er stress, a ter w ice classified the lesions using the Ahlbachs guide.

    The patients classified under grades II and III were then subjected to auclear magnetic resonance.

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    EGREE IOGR PHIC LTER TIO SSlight reduction in height of the femurotibial space (50%)

    II Moderate bone wearing away (7 mm.)

    Significant bone wearing away with articular sub-dislocation

    Magnetic resonance

    ast generation MR evice wit 1.5 T was use . W ere possi e wecompare p otograp ic images o t e art rosic esions o taine witart roscopies, wit t e images o taine rom t e various MRsequences.From the numerous tests conducted, the most suitable weights for de-ning t e art rosic a terations were t e sequences in T2 an t e SPGR

    suppresse at per orme accor ing to sagitta an corona p anes.Subsequently, it was considered opportune to use the three-dimensional

    ethods for volumetric acquisitions.

    Ultrasonography

    T e most suita e optica win ows o t e patients in t e pre iminarystudy were assessed via ultrasonography in order to allow for the diffu-sion of the Nd:YAG Laser.T ese win ows resu te in eing t e interna an externa emi-rimao t e nee ent to 90 or t e anterior c on y es an t e interna anexterna emi-rima o t e nee in t e pop iteus o ow at maximumextension for the posterior chondyles. In order to access the posteriorace of the patella the best lateral and middle windows appeared withe nee ent to 30.

    Therapeutic protocols a therapeutic protocol a total of 2500 m Joule were delivered in pulsedaves with manual scansion with a last generation Nd:YAG Laser with

    an average intensity o 6 W. T e treatment was carrie out once a ay

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    or 15 ays over a perio o t ree wee s (exc u ing o i ays). A ter t reeont s t e entire t erapeutic cyc e was repeate . At t e eginning (T0)

    and at the end (T1) of the first cycle, and likewise at the beginning (T2)and at the end (T3) of the 2nd cycle of treatment the algo-functional as-says (W.O.M.A.C. and V.A.S). and the laboratory tests: ESR, PCR, 1gly-coprotein, IL 1 IL 8, -RANTES an IGF-1 were carrie out.

    State of progress

    Seven out o t e 10 patients se ecte comp ete a t e c inicanstrumenta tests envisage .

    Clinical testsT e c inica tests VAS an WOMAC evi ence a constant improvemento ot t e a gic an unctiona symptomato ogy.

    t the end of the second Laser cycle the patients showed a reduction inpain equal to 51% (V.A.S.) and a reduction in the functional limitation(WOMAC) equal to 49%.

    Lab testsThe classical phlogosis assays showed negligible variations with valuesalways recorded within the normal range or very close to the same.Nevertheless it is worth pointing out how the trend of the ESR and PCRa ues, as we as t e a p a 1 g ycoprotein va ues appeare to e su -

    stantia y simi ar. T e va ues ten e to rise a ter eac Laser cyc e anhen return to the basic values again. The Nd:YAG Laser seems to havealtered the quiescence of the articular environment. The scarce speci-city o t ese c assica in exes o not owever a ow us to un erstanurt er t e meta o ic a terations o t e carti aginous tissue.The data obtained from the Lymphokin and ChemoKin assays appearsar more significant. As regards the IL 1, which is the expression ofhe chondrolytic and pro-inflammatory activity at the level of the car-i aginous tissue, a constant iminis ing tren rom T0 to T3 as een

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    ig. 2 - Measurement via NMR of thearea of the ulcer.

    o serve . T is atum is con rme y t e resu ts o taine y t e IGF-1,a growt an rep icative activity actor o t e c on rocytes. T e tren ohe IGF-1 in fact, has a slope which is opposed to the IL 1 with a growthn values from T0 to T3. The analysis of the h-RANTES ChemoKines andhe IL 8, having a chemioactive and activating action of the neutrophyls,as ig ig te a ecreasing tren rom T0 to T3, w ic con rms t en i iting action o t e p ogosis actors y t e N :YAG Laser.

    Magnetic resonance

    ia the MR the aim was to monitorise the morphological variations ofe art rosic nee treate wit t e N :YAG Laser. We initia y trie toquanti y any variations in t e t ic ness o t e incrustation carti age ohe femurotibial articulation.The measurement of the thickness of the cartilaginous mantles was prob-ematic wit t e i imensiona tec nique use ue to t e presence oumerous arte acts cause y t e oe ema o ten present in t e sur ace

    strata of the cartilage.It was easier to measure the cartilaginous ulcer. The images acquired inwo dimensions of an arthrosic ulcer before and after treatment with Nd:AG Laser were processe e ectronica y an compare y measuring

    e maximum iameter an t e sur aces.In the case described a marked reduction was noted in the diameter andextension of the area affected by the ulcer.

    e ave ju ge t ese images wit caution in view o t e i cu tiesnvo ve in repro ucing wit exactness t e positioning o t e im ex-amined. Nevertheless, the patient in question recorded a pronouncedmprovement in his clinical conditions with regard to both pain andunctiona ity o t e nee in question.t t e i imensiona MR o ow-up six mont s a ter t e treatment cor-

    esponding to two months after the end of the 2nd cycle, four out of theseven cases currently completed showed improvement and three werenvaried. The most evident improvements were in the reduction of thera ecu ar one oe ema an t e carti age, an in one case in t e re uc-

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    ect a goo num er o cases wit a ou e in esign.To o t at we as e or t e co a oration o t e Fon azione Don Car oGnocchi, Santa Maria agli Ulivi di Pozzolatico (FI), and of CONI- Bologna of the Servizio di Radiologia dellOspedale Nuovo di Imola(BO). We will select from these operative units 100 patients affected byi ia - emura art rosis, or pate ar- emura art rosis, age range 12-65.T e se ection met o wi e ase on ra iograp y assessment, sincehere is no reason to use a division based on arthroscopy. Radiographyill be performed along the antero-posterior axis, under loading. Only

    patients affected by II and III stage arthrosis (which correspond to car-i age esions s owing a re uction o t e joint space greater t an 50%,an a mi one wear, < 7 mm, respective y), o owing t e A acclassification, will be admitted to treatment.

    T ese patients wi t en un ergo Magnetic Resonance wit speci cweig ts or t e joint carti age in or er to con rm t e presence anbetter assess the arthrosic lesions.Images collected through this method will be then digitally elaborated inorder to describe and, possibly, measure the qualitative and quantitative

    o i cations o one an carti age components.

    Then patients will undergo to clinical tests:- W.O.M.A.C.: the Western Ontario and Mc Master Universities Index,unctional clinical test specific for osteoarthritis-2000 IKDC, test or su jective unctiona ity assessment y t e patientan o jective assessment y t e c inician.

    .A.S. quantitative scale for the assessment of pain Lab tests:o assess possi e meta o ic a terationsES, PCR, (1-g ycoprotein, IL 1, IL 8, IGF-1, TGF -RANTES)

    Patients will be randomly assigned to 2 groups.- A => will undergo a minimum power He-Ne Laser treatment (1mW)- B => wi un ergo N : YAG Laser treatment ai y or 21 .

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    Laser evices wi e provi e wit t eir own so tware w ic wi assignan om y patients to treatment A or treatment B. A ter six mont s treat-ent (A or B) will be repeated. Every patients will be administered with

    a chondroprotective drug (galattoglucoronglycan sulfate800 mg/day).Clinical tests will be repeated at the beginning and at the end of eacho t e two cyc es. At t e en , a ter twe ve mont s rom t e eginningMagnetic Resonance wi e repeate an t e images co ecte wi ecompared with the previous one.

    ll patients will be assessed again after 12 months through the lab tests

    an y Magnetic Resonance again 10 patients, ran om y c osen, wi eassesse t roug art roscopic iopsic co ections.

    herapeutic protocol

    s ar as t e t erapeutic protoco is concerne , N :YAG Laser wi emitn pulse mode, with an average power approximatively equal to 9 W.The total energy, 3000 J, will be divided in this way:500 J antero-lateral

    indows; 500 J antero-medial window; 500 J posterior-lateral window;500 J posterior-me ia win ow, 500 J me ia pate a; 500 J atera pa-

    e a, accor ing to t e in ivi uate optica win ows.

    Performing this multicentric study we want to achieve important infor-ation about the clinical outcome after Nd:YAG Laser treatment, aboute meta o ic mo i cations o t e treate osteoart ritis, an a out t eo i cation o t e anatomic an pat o ogic con itions o t e osteoar-

    hritis treated lesions.If the results achieved in vitro and on animal model were confirmed alsoon patients, interesting sceneries wou open in osteoart ritis treatment,

    ic wou gain a new approac to improve e ective y t e qua ity olife.

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    0. Pelletier J.P., Di Battista J.A., Roughley P., Mc Collum R., Martel Pelletier J.:Cytochines and inflammation in cartilage degradation.Rheum. Dis. Clin. North Am., 19, 545-568, 1993.

    1. Pulsatelli L., Dolzani P., Piacentini A., Silvestri T., Ruggeri R., Gualtieri G.,Meliconi R. and Facchini A.:Chemokine prodiction by human Condrocytes.The J. of Rheumatology, 26-29, 1999.

    2. Schindl A., Schindl M., Pernerstorfer-Schon H., Kerschan K:Neuropathic foot ulcers: succesfull treatment by low intensity lase therapy.Dermatology, 198, 314-316, 1999.

    3. Zati A. Degli Esposti S., Bilotta T.W.:Analgesic and Psychological effects of CO2 Laser treatment: a clinical study.Laser and Technology, v.7. 23-30, 1997.

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    High Intensity Laser Therapy (HILT):

    state of the art in sporting traumatology and pain therapy

    Paolo MondardiniDirector of the Department ofInstrumental Physical TherapyRehabilitation and Cinesiology

    CONI-FMSIInstitute of Sports Medicine of Bologna

    Faculty of Motory ScienceUniversity of Bologna

    Lecturer of the PhysicalTherapy and Rehabilitation Course

    Sports Medicine Specialisation School atthe University of Bologna

    Research activities in the therapeutic and rehabilitative sector have al-

    ays pursue t e goa o maximum e ectiveness an minimumnvasiveness in t e surgica , p armaco ogica an instrumenta e s.This has led to the developing of a wide variety of electromedical de-ices, especially in the physical therapy sector, but over the years theseave unfortunately resulted in being of no or very little use.

    T e main causes o t e scarce e ectiveness o instrumenta t erapy areo e oun in t e ina equacy o t e o concept o instruments anhe lack of serious clinical and laboratory research. There are in fact,arious sources of energy used and physico-biological interactions ex-

    ploited, often in the absence of suitable experimentation or a real thera-peutic rationa e.

    The musculo-tendinous and minor articular pathology represents an ex-remely frequent event in numerous sporting disciplines.Due to being invalidating, even after a certain amount of time, this callsor a time y, correct an equa y e ective t erapeutic intervention.On t e ot er an , t e continua expansion o t e p aying o sports inncreasingly wider circles of the population (especially over the lastdecade), apart from reaching a number of between 12 and 14 millionplayers of sport, has also created a new series of problems for healthoperators in t is sector. T ese range rom acci ent-prevention to t eapi recovery o t e person invo ve , w ose temporary inva i ity, apart

    rom personal damage, also gives rise to significant effects on the labourorce, with considerable social implications.It is not the aim of this report to make an in-depth examination of thisp enomenon.

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    In or er to provi e a correct picture etter o t is type o speci c trau-ato ogy, it is wort pointing out t at in t e past t ere as een a great

    deal of research by specialists in this sector for outlining a pathologicalcause-and-effect profile, with particular emphasis on chronic lesions,hat are now known by the term athlopathies, almost as though identi-ying t e preva ent or exc usive aetio ogy o t e at etic gesture.Late y t ere as een t e ten ency o not consi ering sports pat o o-gies as any different from those generally found in people who do notpractice sports.

    Over recent years t e increase interest s own in t e various sportingiscip ines as orce ea t operators in t is sector to use new t era-peutic met o s capa e o acce erating t e ea ing process o t e i -erent pathologies, with the resulting reduction in recovery times for theathlete. Included in this context is the work of Laser experimentationcarrie out y our team at t e CONI FMSI Institute o Sports Me icineo Bo ogna.Laser is a source of coherent electromagnetic radiation and is the acro-ym of Light Amplification by Stimulated Emission of Radiation.

    It therefore defines a physical means that produces energy under theorm o a ig t wave o owing a stimu ate emission o ra iation.

    Laser evice is un amenta y system orme y t ree e ements:a) the active means,b) the activation source,c) t e optic resonator 1.

    a) t e active means consists o so i , iqui or gaseous materia w ic ,hen suitably stimulated, emits a radiation; it is responsible for theevelength of the emission) t e activation source, in ispensa e or triggering t e reaction,

    supp ies t e active materia t at a ows or t e emission o t eadiation

    c) the optic resonator consists of a system of mirrors that allows foramplifying the electromagnetic waves of the Laser light

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    T e parameters t at ave to e ta en into consi eration or e ning t ep ysica c aracteristics o t e Laser are:1) the wavelength,2) the intensity,3) the emission mode.T e various types o asers use in t e treatment t e i erent pat o ogieso t e ocomotor system, are e ne accor ing to t e active means, t e

    avelength and the intensity of the emission (soft-Laser, midlaser andpower-Laser), of which the gallium arsenide and helio-neon are

    a so ute y t e most wi esprea an stu ie .T e semiconductorLaser is a so i Laser: t e most common is t e ga -ium arseni e Laser w ic emits in t e in rare wit average powers inhe range of the mW: it is therefore equipped with good penetration butsca ce powe .T e Helio-Neon is a gas Laser t at emits re ig t 632,8 nm in t e visi espectrum wit powers t at vary rom etween 1 an 50 mW: it t ere oreas extremely low power and scarce penetration.

    In literature there are many works on the effects of the soft and mid-la-sers and the results of these studies are very contrasting.For t is purpose t e stu y o He een Bec erman et a 2 is mentione ,

    n w ic s e as groupe toget er an meta-ana yse t e iterature onLaser in physical therapy, arriving at the conclusion that the method-ologically most correct and comprehensive studies reported positive ef-ects, without however underestimating the validity of several studiesat instea enie t e t erapeutic e ectiveness o asers. As mentione

    previous y, t e imits o Laser t erapy up unti severa years ago wereabove all due to the low tissular penetration power and scarce intensity,n other words the scarce in-depth therapeutic effect 3.Recent y more wi esprea use as een ma e in p ysica t erapy oig intensity Laser evices o surgica erivation, i e t e CO an

    Neodymium YAG (Nd:YAG) lasers.The CO Laser is a gas Laser whose active material is carbon dioxide andt produced an invisible light in the far infrared with a lambda of 10600m an a ig intensity: its ra iation is a so a sor e y water an

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    Q-switc e ( rie emissions at ig pea intensity).T e pu se emission represents an a itiona possi i ity or mo u atinghe Laser effects, as demonstrated by the studies of Coche 12. In fact, dif-erent frequencies and pulsations have different effects on the substrate,n particular, with equal lambda and powers, the lower the frequency thegreater t e interaction wit t e con uction structures an vice-versa.Irrespective o t e origin, e it irect trauma, unctiona over oa , an /oracute or chronic evolution, in the majority of these affections the symp-oms of pain and functio lesa dominate the clinical picture and the

    hree following pathogenic events are evident as the common denomi-ator:1. acute or c ronic p ogosis;2. micro and/or macro-circulatory alterations;3. lesions of the fibres and connective tissue.

    On t e asis o t e type o pat o ogy treate , t e met o an osesemployed, Laser radiation seems capable of acting by raising the thresh-old of the perception of pain via the direct action on by stimulating theeleasing of endorphins in loco and in the liquor 1 . Moreover, induced

    active Laser yperaemia 15 an macrop agic activation 16 re ucing t e

    sc emia an oca stasis o t e a gogenic su stances, wou seem toexclude other possible causes of the onset of pain and inflammation 17 The reintegration of the cellular membrane potential seems finally tocontribute towards the interruption of the contractivevasoconstrictive-pain tria an t e reso ution o t e in ammation 18. As ar as t e tissu aresion is concerne , various experimenta resu ts ave emonstrate t eegenerative biological stimulus determined by Laser radiation.

    On the basis of the above pulsed Nd:Yag Laser has been used over aperio o seven years at t e epartment o Instrumenta P ysica T erapyan Re a i itation o t e Institute, ot or t e purposes o researc anexperimentation, and also for treatment of over 1500 patients.The equipment used was an Nd:YAG Laser supplied in collaboration

    ith the company DEKA MELA of Calenzano (FI) which emits coherentig t wit a wave engt o 1064 nm wit a pea intensity o 750 W, an

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    No. 118 DEGENERATIVEPATHOLOGIESRESULTS (86 Excellent, 11 fair, 21 negative)

    o. 5 SUDECK SY DROMES3 E, 0 F, 2 )

    No. 45ARTHROSIS OF THE SPINELUMBAR-SACRAL SECTION35 E, 3 F, 7 )

    o. 32 ARTHROSIS OF THE SPI ECERVICAL-DORSAL SECTIO

    (22 E, 3 F, 7 N)

    No. 35 ARTHROSIS OF THETIBIAL-FEMORAL ARTICULATION25 E, 5 F, 5 )

    o. 1 HUMERAL ARTHROSISE, 0 F, 0 )

    Table 1.

    a justa e emission requency o etween 10 an 40 Hz, a justa epu se energy etween 30 an 150 mJ an an a justa e average powerof between 0.3 and 6 Watts. In this study we present a selected case his-ory (405 cases with an age of between 11 and 73 years (mean age 37.5)obtained by gathering together various groups from different investiga-ion wor s. T e o jective is t at o o ering a representative overview oe various most- requent y o serve c inica an anatomo-pat o ogi-

    cal situations (table 1). A protocol was applied to each subject treated,standardised according to the type, intensity and extension of the patho-

    ogica process in progress, an ro en own into ai y sessions wita maximum o 12 an a minimum o 5, wit an average o 10 sessionspe case.The densities of the power administered varied from between 8,7 and9,5 W/cm2 for 7 sec. of punctiform applications and between 13.7 and15.8 W/cm2 or 40/60 secon s o t e manua scanner app ication a apt-ng t e amount o energy a ministere on t e asis o t e somatic c ar-acteristics of the subject in relation to the irradiation area.The assessment of the subjects was performed according to the clinicalanalysis before and after the application with the Laser, using objectivean su jective assessment tests.

    In 88% o t e cases, in or er to o tain con rmation o t e iagnosis post-clinically, the assessment was also performed via imaging with instru-

    ental diagnostic methods: echotomography, C.A.T. scans or N.M.R.,X-rays an iso inetic ergometry.

    e use t e c inica eva uation criteria escri e to group t e resu ts oe cases treate on t e asis o t e resu ts o t e t erapy wit t e o -

    lowing criteria:- EXCELLENT, with the disappearance of the painful symptomatologyan any unctiona an /or articu ation e cits an a rapi resuming o

    e activity;- FAIR, with a moderate regression of the symptomatology and a reduc-ion and/or disappearance of the deficits and resuming of the activity;- NEGATIVE, with scarce or no variation in the symptomatology after thereatment.

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    7. Karu T.Photobiology of low-power Laser effects.Health Phys. 1989;56:691-704.

    8. Spector WS.Handbook of Biological Data.Ed. WB Saunders Co, Philadelphia, 1956.

    9. Belkin M, Schwartz M.New biological phenomena associated with Laser radiation.Health Phys. 1989;56:687-690

    0.Balaban P, Esenaliev R, et al.

    He-Ne Laser irradiation of single identi ed neurons.

    1.King PR.Low-level Laser therapy. A review.Lasers in Medical Science 1989;4:141-50.

    2.Coche P.Lnergie douce face la douleur.Ed. ATEIM, Tolouse, 1985.

    3.Olson J.E, Schimmerling W, Tobias C.A.Laser Action Spectrum of reduced excitability in nerve cells.Brain Res.,1981;204:436-440.

    4.Giacobini E.

    Endor ne ed encefaline: la conoscenza di questi nuovi neuropeptidi sta invadendonuovi campi clinici.Fed. Med. 1982;XXXV(1):16-21.

    5.Benedicenti A, Capone F.Teletermogra a pre- e post-laserterapia 904 nm nelle sindromi algiche.Parodontol.e Stomatol. Nuova, 1983;I:165-176.

    6. ester E.Risultati clinici di stimolazione Laser e studi sperimentali circa il meccanismo dazione.Min. Med., 1981;72:2195-2199.

    7.Sesti A.G, Taddei G.L, Colafranceschi M, Meli A, Maggi C.A, Longo L, Turchi R,Bilotta-Lombardi G, Bencini E.Sviluppi delle tecnologie Laser in biostimolazione: risultati sperimentali e clinici.

    Atti Congr.Internaz. Soc. Geriatr., Ancona, 5-12 September 1982.

    8.Benedicenti A.Atlante di laserterapia. Ed. LTM, Turin, 1982.

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    HILT vs TENS and NSAIDs:

    A clinical study on low back pain from herniated

    inter-vertebral disk

    Alessandro ZatiRizzoli Institute for Orthopaedics,Bologna

    Damiano FortunaCardio-Thoracic Department,University of Pisa

    manuela BenedettiRizzoli Institute for Orthopaedics,Bologna

    Irene ZaghiniRizzoli Institute for Orthopaedics,Bologna

    Teresa Wanda BilottaRizzoli Institute for Orthopaedics,Bologna

    Introduction

    T e term ac pain is use to in icate a c inica situation c aracteriseby pain of the lumbar rachis that may irradiate to the buttocks or lowerlimbs.This is a very common disorder: from 50 to 80 % of adults suffer from ateast one episo e o ac pain uring t eir ives 1 In t e Unite Statest represents t e primary cause o time o wor ; in epi emio ogica re-search carried out between 1984 and 1985, 14% of employees underhe age of 45 lost one or two days off work for this reason 2. The eco-omical consequences from back pain in the United States fluctuaterom etween 16 i ion an 50 i ion o ars a year. Accor ing to t e

    National Center for Health Statistics, the direct costs of back pain pa-hologies amount to $12,922,740,000 a year and indirect costs come to2,950,020,000 3.

    One o t e causes o ac pain is erniate interverte ra is .T is consists o a protrusion o t e interverte ra is into t e one mar-ow canal or the protrusion of a fragment of discal tissue outside the

    boundaries of the disk, with the consequent compression of the nervousoots . This can be observed with greater frequency in patients of be-ween 30 an 50 years wit a ratio o 2:1 o ma es an ema es. T e astwo um ar is s are t e seat o t e ernia in 90% o cases.

    The natural history of the herniated intervertebral disk foresees a pos-sible reduction in volume over several months: more voluminous her-ias, an migrate or expe e ernias ave a greater ten ency to imin-s in vo ume w i e t is on y occurs in 40% o containe ernias. T e

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    ec anisms via w ic t is occurs are macrop agica p agocytosis ane y ration o t e erniate tissue. T is evo ution exp ains w y t e ma-

    jority of back pain cases clear up spontaneously after several months,and also why it is opportune for the first-choice treatment to be of theconservative type in the majority of cases According to the North

    merican Spine Society 6 in act, in 70% o patients t e pain is re uceor isappears wit t e conservative treatment. T is type o treatment isecommended in the acute and subacute forms, as well as in the chronicorms 7.

    Surgical treatment (mini-invasive or open section) must be reserved forcases t at are resistant against conservative t erapy or t ose w ic man-est motor e ciencies.ithin the field of conservative treatments the most common are drugs

    and physical therapy ,9,10T e gui e ines o t e Nort American Spine Society (NASS) 11 in 2000ecommen NSAIDs among t e rst in ot t e acute 12 an c ronic

    phases 13,14 while the use of TENS 15,16 is recommended among the vari-ous physical forms. Nevertheless, for some time now the use of Laserherapy has become widespread. In fact, its anti-inflammatory 17, an-a gesic 18,19 an antie emigenous 17 e ects are we - nown. Moreover,

    ria s con ucte in vitro y Repice 20 ave emonstrate its neurotrop icpowers as well. Finally, in bibliography trials have been conducted byToshew 21 and Miriutova 22 which confirm the efficacy of Laser therapyn the case of back pain.Our intention in t is stu y was t at o comparing t ree i erent t era-peutic met o s in symptomato ogica treatment o ac pain rom erni-ated intervertebral disk, testing their efficacy over time.

    e compared NSAIDs (ketoprofen), with power Laser HILT and an elec-rot erapeutica met o (TENS).

    The trial was conducted in compliance with the Geneva Conventionand the Helsinki Treaty. In particular, patients were required to give their

    ritten informed consent.

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    Materia s an met o s

    tudy population:e selected 60 patients affected by symptomatic L4-L5 and L5-S1 EDD.

    The patients, who were all in the sub-acute phase, already showedsymptoms rom 1 6 mont s.T ey were ran omise into t ree groups o 20 patients eac an everygroup was subjected to a different type of therapy:- HILT;

    - TENS;- SAIDs.

    Therapies adopted:HILT: Nd:YAG pulsed wave (pw), average power of 6 W, peak power of1,000 W.TENS: requency 100 Hz, spi e wi t 100 sec.NSAIDs: Ketoprofen.

    Inclusive and exclusive criteria:Patients w o ai e to give t eir in orme consent were exc u e rom

    e stu y.ll patients were assessed with algo/functional clinical tests: Backill Test

    and VAS.The Backill measuring scale is an instrument that measures theseverity of the symptomatology; it targets the rachis and assesses thepain an isa i ity wit in t e activity e o ai y i e. T e score variesrom 9 (severe pain u symptomato ogy an severe isa i ity) to 44 (a -sence of pain and full personal autonomy).The VAS is an analogical-visual test which assesses the painful symp-omato ogy. T e score varies etween un interva o 0 (a sence o pain)an 20 (maximum pain imagina e).

    e carried out controls (follow-ups) according to the following pattern:T/1: at the end of the treatment lasting 15 days;T/2: 45 days after T/0 (T/0: date of beginning treatment);T/3: a ter 180 ays.

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    Scanning

    treatmen

    Level

    Dose

    mJ/cm2

    Accumulated

    energy

    Therapy 1Therapy 2Therapy 3

    1098

    460560610

    500 joule500 joule500 joule

    Table 1. Values used in treatment withHILT

    Backill(9-44)

    HILT

    TENS

    NSAIDs

    ANOVA/*KrusW

    T 0 26 4,50 23,35 3,34 23, 0 2,69 p=0.02

    T/1 0,60 4,85 30,40 2,28 29,25 2,07 * n.s.

    T/2 2,70 4,6 25 4,69 22,85 2,64 0,0005

    T/3 ,60 4,09 24,70 3, 24,95 4,30 p 0,0005

    Table 2. Statistical analysis among HILT,TENS and NSAIDs groups with respect toscore obtained by the Backill scale at T/0,T/1,T/2 and T/3: One way ANOVA andKruskal Wallis (*)

    Therapeutic protocols:HILT group: we carrie out t e treatment in manua scansion o t e para-ertebral region of the lumbar rachis at the speed of 1 cm a second.

    Table 1 illustrates the values used in the therapeutic treatment.The therapeutic cycle foresaw one session a day for a total of 10 sessionsistri ute over two wee s.

    The TENS was applied with the method with 4 electrodes applied tocrossed fields in the region concerned.The therapeutic cycle foresaw 10 sessions (1/die) each lasting 30 min-

    tes, istri ute t roug out 2 wee s.T e patients in t e NSAIDs group were a ministere Ketopro en at adose of 100 mg/die, via os B.I.D., for 15 days.

    tatistical analysis:continuous ata are expresse in terms o mean an stan ar evia-

    ion o t e mean. One Way ANOVA an Repeate Measure T test wereperformed to test the means hypotheses of respectively different groupsand the follow up of single measure. When the Levene test for homo-geneity of variances was significant (p

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    Backill

    (9-44)

    HILT

    TENS

    NSAIDs

    T test T 0 vs. T -4,604,38 - 7,054, 3 - 6, 52,23

    T test T 0 vs. T 2 6,704, 6 - ,654, 6 - 0,25 ,29

    T test T 0 s. T 3 5,60 4,65 - ,35 , 9 - ,854,84

    Table 3. Statistical analysis with respectto the differences among Backill values atT/0, T/1, T/2 e T/3 in each group: T-testfor paired data

    VAS(0-20)

    HILT

    TENS

    NSAIDs

    ANOVA/*KrusW

    T/0 13,40 4,37 13 3,63 13,45 3,90 n.s.

    T/1 7,20 3,09 7,40 3,33 9,65 4,27 n.s.