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PRINCIPLES OF GOOD CLINICAL PRINCIPLES OF GOOD CLINICAL PRACTICE IN THERMAL PRACTICE IN THERMAL REHABILITATION REHABILITATION De Fabritiis M. De Fabritiis M. _ _ Masiero S. Masiero S. Mariotti S. Mariotti S. _ _ Gigante G Gigante G . . Section “of Thermal Rehabiltation” Section “of Thermal Rehabiltation” SIMFER -ITALIAN SOCIETY OF PMR SIMFER -ITALIAN SOCIETY OF PMR VENICE ,MAY, 23-27 ,2010 VENICE ,MAY, 23-27 ,2010

PRINCIPLES OF GOOD CLINICAL PRACTICE IN THERMAL REHABILITATION PRINCIPLES OF GOOD CLINICAL PRACTICE IN THERMAL REHABILITATION De Fabritiis M. _ Masiero

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PRINCIPLES OF GOOD CLINICAL PRINCIPLES OF GOOD CLINICAL PRACTICE IN THERMAL REHABILITATIONPRACTICE IN THERMAL REHABILITATION

De Fabritiis M.De Fabritiis M. _ _ Masiero S. Masiero S.

Mariotti S.Mariotti S. _ _ Gigante GGigante G .. Section “of Thermal Rehabiltation” Section “of Thermal Rehabiltation”

SIMFER -ITALIAN SOCIETY OF PMRSIMFER -ITALIAN SOCIETY OF PMR

VENICE ,MAY, 23-27 ,2010VENICE ,MAY, 23-27 ,2010

INTRODUCTION INTRODUCTION

THERMAL REHABILITATIONTHERMAL REHABILITATION IS A IS A BRANCH OF REHABILITATION IN BRANCH OF REHABILITATION IN WHICH THERE IS STILL A LACK WHICH THERE IS STILL A LACK OF RANDOMIZED CLINICAL OF RANDOMIZED CLINICAL TRIALSTRIALS

ALTHOUGH THE DIFFICULTIESALTHOUGH THE DIFFICULTIES

THE RESEARCH OF EVIDENCETHE RESEARCH OF EVIDENCE

MUST GO ONMUST GO ON

BUT THE NECESSITY TO HAVE VALID BUT THE NECESSITY TO HAVE VALID CLINICAL GUIDELINES PUSHED US INTO CLINICAL GUIDELINES PUSHED US INTO THE RESEARCH FOR MORE REALISTIC THE RESEARCH FOR MORE REALISTIC PROCEDURESPROCEDURES

SOME CONSIDERATIONSSOME CONSIDERATIONS

THENTHENWE OPTED WE OPTED

TO FOLLOW NEW RESEARCH AND TO FOLLOW NEW RESEARCH AND

TO DRAFT PRACTICAL GUIDELINES TO DRAFT PRACTICAL GUIDELINES FOR THERMAL REHABILITATIONS FOR THERMAL REHABILITATIONS ACCORDING TO A PROCEDURE ACCORDING TO A PROCEDURE THAT THAT DIFFERS FROM THE USUAL DIFFERS FROM THE USUAL ONE ONE

1) THE RESEARCH OF EVIDENCE (EBM) ON 1) THE RESEARCH OF EVIDENCE (EBM) ON SPA AND REHABILITATIVE TREATMENTSSPA AND REHABILITATIVE TREATMENTS

2) EVALUATION OF SOME RECENT 2) EVALUATION OF SOME RECENT METHODOLOGIES ON CLINICAL METHODOLOGIES ON CLINICAL GUIDELINESGUIDELINES

3) DEFINITIONS OF SPECIFIC PRINCIPLES 3) DEFINITIONS OF SPECIFIC PRINCIPLES OF GOOD CLINICAL PRACTICE OF GOOD CLINICAL PRACTICE

WORK’S STEPSWORK’S STEPS

1)RESEARCH OF CLINICAL 1)RESEARCH OF CLINICAL EVIDENCEEVIDENCE EXAMPLESEXAMPLES

EFFICACY OF SPA THERAPY IN LOW BACK PAIN :EFFICACY OF SPA THERAPY IN LOW BACK PAIN : THERE IS EVIDENCE OF EFFICACY VERSUS THERE IS EVIDENCE OF EFFICACY VERSUS

CONTROL GROUPS CONTROL GROUPS JUST A FEW NUMBER OF CASES WERE JUST A FEW NUMBER OF CASES WERE

CONSIDERED CONSIDERED CONCLUSIONCONCLUSION: : NECESSITY OF MORE NECESSITY OF MORE

CLINICAL TRIALSCLINICAL TRIALS

**PITTLER MH,RHEUMATOLOGY,2006PITTLER MH,RHEUMATOLOGY,2006

EFFICACY OF MUD AND EFFICACY OF MUD AND BALNEOTHERAPY ON KNEE BALNEOTHERAPY ON KNEE ARTHROSISARTHROSIS

A SIGNIFICANT ENHANCEMENT WAS A SIGNIFICANT ENHANCEMENT WAS FOUND WITH SOME SCALES OF FOUND WITH SOME SCALES OF EVALUATION: VAS - WOMAC - NHP EVALUATION: VAS - WOMAC - NHP FOR QUALITY OF LIFE FOR QUALITY OF LIFE

EVIDENCE OF BETTER RESULTS WITH SPA EVIDENCE OF BETTER RESULTS WITH SPA THERAPY VERSUS PATIENTS GROUPS THERAPY VERSUS PATIENTS GROUPS TREATED ONLY WITH NO-THERMAL TREATED ONLY WITH NO-THERMAL TERMOTHERAPYTERMOTHERAPY

**COSTANTINO M.,CLIN.TER.,2006COSTANTINO M.,CLIN.TER.,2006

SPONDILITHYS ANKILOSANT SPONDILITHYS ANKILOSANT TREATMENT WITHTREATMENT WITHCRENO-KINESITHERAPY CRENO-KINESITHERAPY

ADDITIONAL BENEFITS VERSUS ADDITIONAL BENEFITS VERSUS STANDARD TREATMENTSSTANDARD TREATMENTS(DRUGS , (DRUGS , EXERCISES) EXERCISES)

BENEFITS DURATION UP TO 40 WEEKS FROM THE END OF TREATMENT

* VAN TUBERGEN,ARTHRITIS RHEUM,2002

2) METHODS2) METHODS

A RECENT APPROACH TO A RECENT APPROACH TO CLINICAL RESEARCH PERMITS A CLINICAL RESEARCH PERMITS A BETTER CLINICAL GUIDELINES BETTER CLINICAL GUIDELINES DEFINITION DEFINITION

IT IS BASED ON A MIX OF IT IS BASED ON A MIX OF ELEMENTSELEMENTS

DELPHI METHODOLOGYDELPHI METHODOLOGY

THIS METHOD GRADES THE THIS METHOD GRADES THE STRENGHT OF RECOMMENDATIONS STRENGHT OF RECOMMENDATIONS ACCORDING NOT ONLY TO THE ACCORDING NOT ONLY TO THE STRENGHT OF SUPPORTING STRENGHT OF SUPPORTING EVIDENCES EVIDENCES BUT ALSO TO THE BUT ALSO TO THE OPINION OF A PANEL OF EXPERTSOPINION OF A PANEL OF EXPERTS

THE TECNIQUE IS USED TO THE TECNIQUE IS USED TO

OBTAIN A CONSENSUS OBTAIN A CONSENSUS REGARDING A CLINICAL REGARDING A CLINICAL PROBLEM PROBLEM

FROM A TEAM OF INDIPENDENT FROM A TEAM OF INDIPENDENT EXPERTS EXPERTS WITHIN WITHIN 2-3 ROUNDS 2-3 ROUNDS

3) GOOD CLINICAL PRACTICE 3) GOOD CLINICAL PRACTICE METHOD METHOD (GPC )(GPC )

WE HAVE CONSIDERED A WE HAVE CONSIDERED A THIRD THIRD ELEMENTELEMENT TO THE TWO ABOVE – TO THE TWO ABOVE – MENTIONED STRATEGIES MENTIONED STRATEGIES

IS BASED ON IDENTIFICATION OF IS BASED ON IDENTIFICATION OF PRINCIPLESPRINCIPLES OF GOOD CLINICAL OF GOOD CLINICAL PRACTICE PRACTICE

INSPIRED BY THE GOOD CLINICAL INSPIRED BY THE GOOD CLINICAL PRACTICE PRACTICE (GPC)(GPC) METHOD METHOD

ETHICS AND QUALITYETHICS AND QUALITY NECESSARY NECESSARY TOTO

- PROJET - PROJET - CONDUCT- CONDUCT- REGISTER - REGISTER CLINICAL STUDIES CONCERNING CLINICAL STUDIES CONCERNING

HUMAN BEING HUMAN BEING

GOOD CLINICAL PRACTICE WAS GOOD CLINICAL PRACTICE WAS

CREATED AS A CREATED AS A STANDARD OFSTANDARD OF

THERE ARE STANDARD OPERATIVE THERE ARE STANDARD OPERATIVE PROCEDURES THAT PRIVILEGE PRINCIPLES OF PROCEDURES THAT PRIVILEGE PRINCIPLES OF

RESPECT, WELLNES, SECURITY:RESPECT, WELLNES, SECURITY: ExamplesExamples

INFORMED CONSENSUS INFORMED CONSENSUS SECURITY EVALUATIONS SECURITY EVALUATIONS ADVERS REACTIONS ADVERS REACTIONS EFFICACY EVALUATIONS EFFICACY EVALUATIONS RANDOMIZATION PROCEDURES RANDOMIZATION PROCEDURES etcetc

RESULTSRESULTS

IN DRAFTING OUR PROTOCOLS IN DRAFTING OUR PROTOCOLS FOR THERMAL REHABILITATION FOR THERMAL REHABILITATION TREATMENTS WE IDENTIFIED A TREATMENTS WE IDENTIFIED A SERIES OF GENERAL PRINCIPLESSERIES OF GENERAL PRINCIPLES TO APPLY TO APPLY

PRINCIPLES OF GOOD CLINICAL PRACTICE IN PRINCIPLES OF GOOD CLINICAL PRACTICE IN THERMAL REHABILITATION THERMAL REHABILITATION for for PARADIGMATIC INDICATIONSPARADIGMATIC INDICATIONS : : examples for SPA therapiesexamples for SPA therapies

EFFICACY EFFICACY COSTS/BENEFITSCOSTS/BENEFITS HARMLESSNESHARMLESSNES USER’S COMPLIANCEUSER’S COMPLIANCE LIMITSLIMITS CONTRAINDICATIONSCONTRAINDICATIONS

SUITABILITYSUITABILITY ACCESSING TO ACCESSING TO

TREATMENTS’ TREATMENTS’ PROCEDURESPROCEDURES

WATER AND MUD WATER AND MUD TEMPERATURETEMPERATURE

DURATION OF DURATION OF THERAPEUTIC THERAPEUTIC TREATMENTSTREATMENTS

…………..OTHERSOTHERS

PARADIGMATIC INDICATIONSPARADIGMATIC INDICATIONS MUSCULAR-SKELETRIC PATHOLOGIESMUSCULAR-SKELETRIC PATHOLOGIESexamplesexamples

ARTHROSIS ARTHROSIS (LUMBAR,KNEE, HIP)(LUMBAR,KNEE, HIP)

CRONIC LOW BACK CRONIC LOW BACK PAIN PAIN

POST ORTHOPEDIC POST ORTHOPEDIC SURGERY SURGERY

CONSEQUENCES OF CONSEQUENCES OF TRAUMATIC LESIONS TRAUMATIC LESIONS

MUSCULAR -MUSCULAR -TENDINEUS OVERUSE TENDINEUS OVERUSE PATHOLOGIES PATHOLOGIES

ARTHRITIS IN PHASE ARTHRITIS IN PHASE OF QUIESCENCE OF QUIESCENCE

……OTHERSOTHERS

PARADIGMATIC INDICATIONSPARADIGMATIC INDICATIONS

RESPIRATORY RESPIRATORY PATHOLOGIESPATHOLOGIES

RHINO-BRONCHIAL RHINO-BRONCHIAL SYNDROMS SYNDROMS

CHRONIC CHRONIC BRONCHITHIS BRONCHITHIS

COPDCOPD

VASCULAR VASCULAR PATHOLOGIESPATHOLOGIES

LOWER EXTREMITIES LOWER EXTREMITIES OBLITERATING OBLITERATING ARTHERIOPATYARTHERIOPATY

VENOUS VENOUS PATHOLOGIESPATHOLOGIES

CHRONIC CHRONIC LYMPHOEDEMALYMPHOEDEMA

EFFICACY SPA TREATMENTS LIST EFFICACY SPA TREATMENTS LIST (or probably)(or probably)EXAMPLESEXAMPLES

MUD PACKS MUD PACKS BATHSBATHS CAVE THERAPYCAVE THERAPY

PSAMMOTHERAPYPSAMMOTHERAPY

INSUFFLATIONSINSUFFLATIONS INHALATIONSINHALATIONS HUMAGEHUMAGE

AEROSOLAEROSOL VASCULAR CIRCUITVASCULAR CIRCUIT CARBONIC BATHCARBONIC BATH BALNEOTHERAPYBALNEOTHERAPY CRENO-CRENO-

KINESITHERAPYKINESITHERAPY ……..OTHERS..OTHERS

Costs/ benefitsCosts/ benefits

THE THERAPEUTIC ASSOCIATION THE THERAPEUTIC ASSOCIATION BETWEEN THERMAL AND BETWEEN THERMAL AND REHABILITATIVE TREATMENTS REHABILITATIVE TREATMENTS FAVORS A QUICKER RECOVERYFAVORS A QUICKER RECOVERY WITH REDUCTION OF RESIDUAL WITH REDUCTION OF RESIDUAL FUNCTIONAL DEFICITS AND FUNCTIONAL DEFICITS AND REDUCTION OF COSTSREDUCTION OF COSTS

COSTS/BENEFITCOSTS/BENEFIT

OVERUSE TENDINEOUS OVERUSE TENDINEOUS PATHOLOGIESPATHOLOGIES

POST ORTHOPAEDIC SURGERYPOST ORTHOPAEDIC SURGERY POST TRAUMATIC LESIONSPOST TRAUMATIC LESIONS RHEUMATOLOGICAL PATHOLGIESRHEUMATOLOGICAL PATHOLGIES

DURATION of THERAPEUTIC DURATION of THERAPEUTIC SPA TREATMENTSSPA TREATMENTS

THE IDEAL DURATION OF A CYCLE THE IDEAL DURATION OF A CYCLE OF SPA TREATMENTS IS IN MANY OF SPA TREATMENTS IS IN MANY CASES CASES APPROXIMATELY OF 12-15 APPROXIMATELY OF 12-15 DAYSDAYS IN WHICH TIME POSITIVE IN WHICH TIME POSITIVE REACTIONIS IS ACHIEVED REACTIONIS IS ACHIEVED WITHOUT WITHOUT ARRIVING TO FATIGUEARRIVING TO FATIGUE

CONCLUSION 1CONCLUSION 1

IT IS OUR OPINION THAT THE IT IS OUR OPINION THAT THE IDENTIFIED PROCEDURES WILL IDENTIFIED PROCEDURES WILL MAKE EASER AND MORE REALISTICMAKE EASER AND MORE REALISTIC TO DEFINE GOOD CLINICAL TO DEFINE GOOD CLINICAL PRACTICE GUIDELINES FOR PRACTICE GUIDELINES FOR THERMAL REHABILITATION THERMAL REHABILITATION

CONCLUSIONCONCLUSION 2 2

THE PROCESS WILL BE BASED ON THE PROCESS WILL BE BASED ON THE APPLICATION OF STANDARD OF THE APPLICATION OF STANDARD OF GOOD CLINICAL PRACTICE TO GOOD CLINICAL PRACTICE TO REHABILITATIVE TREATMENT REHABILITATIVE TREATMENT PROTOCOLSPROTOCOLS

CONCLUSION 3CONCLUSION 3

ITIT IS NECESSARY TO CONSIDER NOT IS NECESSARY TO CONSIDER NOT ONLY EXPERTS’ OPINION AND ONLY EXPERTS’ OPINION AND CURRENTLY AVAILABLE SCIENTIFIC CURRENTLY AVAILABLE SCIENTIFIC EVIDENCE EVIDENCE

BUT BUT ALSO THE OPINION OF PATIENTS ALSO THE OPINION OF PATIENTS

AND THEIR ASSOCIATIONS AND THEIR ASSOCIATIONS

ENDING POINTENDING POINT

DURING THE DEFINITION OF DURING THE DEFINITION OF REHABILITATIVE PROTOCOLS IN REHABILITATIVE PROTOCOLS IN SPASSPAS

THE USE OF THERMAL AND THE USE OF THERMAL AND REHABILITATIVE TREATMENTS MUST REHABILITATIVE TREATMENTS MUST BE BASED ON THEIR RESPONDANCE BE BASED ON THEIR RESPONDANCE TO TO SPECIFIC PRINCIPLES OF GOOD SPECIFIC PRINCIPLES OF GOOD CLINICAL PRACTICECLINICAL PRACTICE DISCUSSED BY DISCUSSED BY EXPERTS WITH DEFINED CRITERIAEXPERTS WITH DEFINED CRITERIA

CONCLUDINGCONCLUDING

THIS METHODOLOGY OFFERS THE THIS METHODOLOGY OFFERS THE ADVANTAGE TO DEFINE SOME ADVANTAGE TO DEFINE SOME CLINICAL RECOMMENDATIONS CLINICAL RECOMMENDATIONS

ALSO FORALSO FOR

THERAPEUTIC PROCEDURES WHICH THERAPEUTIC PROCEDURES WHICH ARE NOT SUPPORTED FROM ARE NOT SUPPORTED FROM CONTROLLED CLINICAL TRIALS CONTROLLED CLINICAL TRIALS FOR FOR ETHICS OR PRACTICAL REASONSETHICS OR PRACTICAL REASONS