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
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