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

2. INTRODUCTION THERMAL REHABILITATION IS A BRANCH OF REHABILITATION IN WHICH THERE IS STILL A LACK OF RANDOMIZED CLINICAL TRIALS THERMAL REHABILITATION IS A BRANCH OF REHABILITATION IN WHICH THERE IS STILL A LACK OF RANDOMIZED CLINICAL TRIALS

3. ALTHOUGH THE DIFFICULTIES ALTHOUGH THE DIFFICULTIES THE RESEARCH OF EVIDENCE THE RESEARCH OF EVIDENCE MUST GO ON MUST GO ON BUT THE NECESSITY TO HAVE VALID CLINICAL GUIDELINES PUSHED US INTO THE RESEARCH FOR MORE REALISTIC PROCEDURES BUT THE NECESSITY TO HAVE VALID CLINICAL GUIDELINES PUSHED US INTO THE RESEARCH FOR MORE REALISTIC PROCEDURES SOME CONSIDERATIONS

4. THEN WE OPTED TO FOLLOW NEW RESEARCH AND TO DRAFT PRACTICAL GUIDELINES FOR THERMAL REHABILITATIONS ACCORDING TO A PROCEDURE THAT DIFFERS FROM THE USUAL ONE

5. 1) THE RESEARCH OF EVIDENCE (EBM) ON SPA AND REHABILITATIVE TREATMENTS 2) EVALUATION OF SOME RECENT METHODOLOGIES ON CLINICAL GUIDELINES 3) DEFINITIONS OF SPECIFIC PRINCIPLES OF GOOD CLINICAL PRACTICE WORK’S STEPS

6. 1)RESEARCH OF CLINICAL EVIDENCE EXAMPLES  EFFICACY OF SPA THERAPY IN LOW BACK PAIN :  THERE IS EVIDENCE OF EFFICACY VERSUS CONTROL GROUPS  JUST A FEW NUMBER OF CASES WERE CONSIDERED CONCLUSION: NECESSITY OF MORE CLINICAL TRIALS CONCLUSION: NECESSITY OF MORE CLINICAL TRIALS  * PITTLER MH,RHEUMATOLOGY,2006

7. EFFICACY OF MUD AND BALNEOTHERAPY ON KNEE ARTHROSIS  A SIGNIFICANT ENHANCEMENT WAS FOUND WITH SOME SCALES OF EVALUATION: VAS - WOMAC - NHP FOR QUALITY OF LIFE  EVIDENCE OF BETTER RESULTS WITH SPA THERAPY VERSUS PATIENTS GROUPS TREATED ONLY WITH NO-THERMAL TERMOTHERAPY  *COSTANTINO M.,CLIN.TER.,2006

8. SPONDILITHYS ANKILOSANT TREATMENT WITH CRENO-KINESITHERAPY SPONDILITHYS ANKILOSANT TREATMENT WITH CRENO-KINESITHERAPY  ADDITIONAL BENEFITS VERSUS STANDARD TREATMENTS(DRUGS, EXERCISES)   BENEFITS DURATION UP TO 40 WEEKS FROM THE END OF TREATMENT   * VAN TUBERGEN,ARTHRITIS RHEUM,2002

9. 2) METHODS  A RECENT APPROACH TO CLINICAL RESEARCH PERMITS A BETTER CLINICAL GUIDELINES DEFINITION  IT IS BASED ON A MIX OF ELEMENTS

10. DELPHI METHODOLOGY  THIS METHOD GRADES THE STRENGHT OF RECOMMENDATIONS ACCORDING NOT ONLY TO THE STRENGHT OF SUPPORTING EVIDENCES BUT ALSO TO THE OPINION OF A PANEL OF EXPERTS

11. THE TECNIQUE IS USED TO OBTAIN A CONSENSUS REGARDING A CLINICAL PROBLEM THE TECNIQUE IS USED TO OBTAIN A CONSENSUS REGARDING A CLINICAL PROBLEM FROM A TEAM OF INDIPENDENT EXPERTS WITHIN 2-3 ROUNDS FROM A TEAM OF INDIPENDENT EXPERTS WITHIN 2-3 ROUNDS

12. 3) GOOD CLINICAL PRACTICE METHOD (GPC )  WE HAVE CONSIDERED A THIRD ELEMENT TO THE TWO ABOVE – MENTIONED STRATEGIES  IS BASED ON IDENTIFICATION OF PRINCIPLES OF GOOD CLINICAL PRACTICE INSPIRED BY THE GOOD CLINICAL PRACTICE (GPC) METHOD INSPIRED BY THE GOOD CLINICAL PRACTICE (GPC) METHOD

13. ETHICS AND QUALITY NECESSARY TO ETHICS AND QUALITY NECESSARY TO - PROJET - CONDUCT - REGISTER CLINICAL STUDIES CONCERNING HUMAN BEING CLINICAL STUDIES CONCERNING HUMAN BEING GOOD CLINICAL PRACTICE WAS CREATED AS A STANDARD OF

14. THERE ARE STANDARD OPERATIVE PROCEDURES THAT PRIVILEGE PRINCIPLES OF RESPECT, WELLNES, SECURITY: Examples  INFORMED CONSENSUS  SECURITY EVALUATIONS  ADVERS REACTIONS  EFFICACY EVALUATIONS  RANDOMIZATION PROCEDURES  etc

15. RESULTS  IN DRAFTING OUR PROTOCOLS FOR THERMAL REHABILITATION TREATMENTS WE IDENTIFIED A SERIES OF GENERAL PRINCIPLES TO APPLY

16. PRINCIPLES OF GOOD CLINICAL PRACTICE IN THERMAL REHABILITATION for PARADIGMATIC INDICATIONS : examples for SPA therapies  EFFICACY  COSTS/BENEFITS  HARMLESSNES  USER’S COMPLIANCE  LIMITS  CONTRAINDICATIO NS  SUITABILITY  ACCESSING TO TREATMENTS’ PROCEDURES  WATER AND MUD TEMPERATURE  DURATION OF THERAPEUTIC TREATMENTS  …….OTHERS

17. PARADIGMATIC INDICATIONS MUSCULAR-SKELETRIC PATHOLOGIES examples PARADIGMATIC INDICATIONS MUSCULAR-SKELETRIC PATHOLOGIES examples ARTHROSIS (LUMBAR,KNEE, HIP) ARTHROSIS (LUMBAR,KNEE, HIP)  CRONIC LOW BACK PAIN  POST ORTHOPEDIC SURGERY  CONSEQUENCES OF TRAUMATIC LESIONS   MUSCULAR - TENDINEUS OVERUSE PATHOLOGIES  ARTHRITIS IN PHASE OF QUIESCENCE  …OTHERS

18. PARADIGMATIC INDICATIONS  RESPIRATORY PATHOLOGIES  RHINO-BRONCHIAL SYNDROMS  CHRONIC BRONCHITHIS  COPD  VASCULAR PATHOLOGIES  LOWER EXTREMITIES OBLITERATING ARTHERIOPATY  VENOUS PATHOLOGIES  CHRONIC LYMPHOEDEMA 

19. EFFICACY SPA TREATMENTS LIST (or probably) EXAMPLES  MUD PACKS  BATHS  CAVE THERAPY PSAMMOTHERAPY PSAMMOTHERAPY  INSUFFLATIONS  INHALATIONS  HUMAGE AEROSOL AEROSOL  VASCULAR CIRCUIT  CARBONIC BATH  BALNEOTHERAPY  CRENO- KINESITHERAPY  …..OTHERS

20. Costs/ benefits  THE THERAPEUTIC ASSOCIATION BETWEEN THERMAL AND REHABILITATIVE TREATMENTS FAVORS A QUICKER RECOVERY WITH REDUCTION OF RESIDUAL FUNCTIONAL DEFICITS AND REDUCTION OF COSTS

21. COSTS/BENEFIT  OVERUSE TENDINEOUS PATHOLOGIES  POST ORTHOPAEDIC SURGERY  POST TRAUMATIC LESIONS  RHEUMATOLOGICAL PATHOLGIES

22. DURATION of THERAPEUTIC SPA TREATMENTS  THE IDEAL DURATION OF A CYCLE OF SPA TREATMENTS IS IN MANY CASES APPROXIMATELY OF 12-15 DAYS IN WHICH TIME POSITIVE REACTIONIS IS ACHIEVED WITHOUT ARRIVING TO FATIGUE

23. CONCLUSION 1  IT IS OUR OPINION THAT THE IDENTIFIED PROCEDURES WILL MAKE EASER AND MORE REALISTIC TO DEFINE GOOD CLINICAL PRACTICE GUIDELINES FOR THERMAL REHABILITATION

24. CONCLUSION 2 CONCLUSION 2  THE PROCESS WILL BE BASED ON THE APPLICATION OF STANDARD OF GOOD CLINICAL PRACTICE TO REHABILITATIVE TREATMENT PROTOCOLS

25. CONCLUSION 3  IT IS NECESSARY TO CONSIDER NOT ONLY EXPERTS’ OPINION AND CURRENTLY AVAILABLE SCIENTIFIC EVIDENCE BUT BUT  ALSO THE OPINION OF PATIENTS AND THEIR ASSOCIATIONS

26. ENDING POINT ENDING POINT  DURING THE DEFINITION OF REHABILITATIVE PROTOCOLS IN SPAS THE USE OF THERMAL AND REHABILITATIVE TREATMENTS MUST BE BASED ON THEIR RESPONDANCE TO SPECIFIC PRINCIPLES OF GOOD CLINICAL PRACTICE DISCUSSED BY EXPERTS WITH DEFINED CRITERIA THE USE OF THERMAL AND REHABILITATIVE TREATMENTS MUST BE BASED ON THEIR RESPONDANCE TO SPECIFIC PRINCIPLES OF GOOD CLINICAL PRACTICE DISCUSSED BY EXPERTS WITH DEFINED CRITERIA

27. CONCLUDING  THIS METHODOLOGY OFFERS THE ADVANTAGE TO DEFINE SOME CLINICAL RECOMMENDATIONS ALSO FOR ALSO FOR THERAPEUTIC PROCEDURES WHICH ARE NOT SUPPORTED FROM CONTROLLED CLINICAL TRIALS FOR ETHICS OR PRACTICAL REASONS THERAPEUTIC PROCEDURES WHICH ARE NOT SUPPORTED FROM CONTROLLED CLINICAL TRIALS FOR ETHICS OR PRACTICAL REASONS