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OUTCOME-RESEARCH in Thermalism Nuevos retos en medicina The New Challenge of Medicine

OUTCOME-RESEARCH in Thermalism Nuevos retos en medicina The New Challenge of Medicine. Helmut G. Pratzel, MD, PhD President of the International Society of Medical Hydrology and Climatology (I.S.M.H.). Vacaciones de salud en spa. en spa Tra-tamiento. Hospital.

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OUTCOME-RESEARCH in Thermalism Nuevos retos en medicina The New Challenge of Medicine

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  1. OUTCOME-RESEARCH in Thermalism Nuevos retos en medicinaThe New Challenge of Medicine Helmut G. Pratzel, MD, PhD President of the International Society of Medical Hydrology and Climatology (I.S.M.H.)

  2. Vacaciones de salud en spa en spa Tra-tamiento Hospital Situación y competencia térapéutica • Sano • Agotado • Enfermedades crónicas • Enfermedades agudas • Caso de emergencia Médico de familia

  3. Criterios de excelencia de las curas hydrotermales y de los lugares del termalismo dentro de las grandes opciones terapeuticas Spas and Health Resorts Rank within Health Care Systems Criteria of Efficient Treatments

  4. Long time experience by many patients Controlled trialsby few patients ¿Equivalencia de resultados clínicos?

  5. Trial objectives and purpose Trial design Randomisation, Blinding Selection and withdrawal of subjects inclusion and exclusion criteria Treatment of subjects and control medication Assessment of efficacy Assessment of safety Control of side effects and interactions Control of Compliance Statistics Direct Access to Source Data/Documents Quality control and Quality Assurance Procedures Ethics Clinical Trial Protocol by the Guidelines for Good Clinical Practice (GCP) of the European Community

  6. Primary Efficacy Variable • Only validated parameters should be used. • Only one efficacy parameter is to defined. • Endpoints used to determine efficacy should be clearly specified. • Multiple parameters should be assembled to one score parameter. • An efficacy threshold is to defined.

  7. Los métodos siguentes están permitidos • Comparación clinica • Comparación de los gastos antes y despues del tratamiento • Comparación del tiempo sin trabajo

  8. Tiempo sin trabajoControlled trial in Bad Wörishofen 1991-1994 n=115 n=248

  9. ControlledDouble-BlindTrials • Placebo-controlled trials in spa treatment are not required and are ethically suspicious. • Comparison of different treatments or different dosage without changing the normal basic complex strategy could be realised. • Trials with mono therapies have no relevance to balneotherapeutic practise

  10. Double-blind-control equipment Electronic control with bar-code-reader Bar-code-reader Magnetic valves Tap-water line Radon-water line Bath -tub Technical room Bathroom

  11. The Barcode-Reader

  12. Tres grados de la investigación son importantes • Efecto del tratamiento médico durante la cura • Resultados médicos y socio-médicos a largo plazo • Diferencia entre los gastos y el efecto

  13. Measurementof pressure painthreshold Pressure Areas 1. M. levator scapulae 2. M. supraspinatus 3. M. teres minor 4. M. deltoideus 5. M. glutaeus maximus 6. M. glutaeus medius 7. M. bizeps femoris 8. M. semimembranosus

  14. Pressure pain thresholdby Sulphur bath series kg/cm2 1,8 1 week later 2,1 SulphurWater 2 weeks later 2,4 TapWater 2,7 3,0 3 weeks later 3,3 Period of inspection

  15. Pressure pain thresholdby Radon baths series Ende der Behandlung kg/cm2 End of Treatment 3,0 2,8 After 4 month 2,6 After 2 month After 1 week 2,4 2,2 After 2 weeks After 3 weeks 2,0 RADON WATER Period of inspection TAP WATER

  16. Subjective pain feelingRheumatoide Arthritis (Radon trial Bad Brambach 1997) mm VAS Differences to 1st value and 95%-Confidence interval CO2 1stvalue Improvement Radon+CO2 N = 28/30 N = 30 N = 30/27

  17. Moving test by Keitel • To bend the fingers • Motility of hand joins and arms • Stand up from lying • Active straddle of legs from lying • Stand up from a stool • Standing on toes and heel • Knee-crooking • Standing on one foot • Outside Rotation of the hit join • Mobility of legs and feet • Walking • Climbing stairs

  18. Improvement Moving Test by KeitelRheumatoide Arthritis (Radon trial Bad Brambach 1997) Skt Differenzen zum Ausgangswert und 95%-Konfidenzintervall Radon+CO2 1st value CO2 N = 30 N = 28/30 N = 30/29

  19. Measurement of Patient Outcome - MOPOPhysical handicap and psychosocial Consequences by Rheumatoid Arthritis Assessment included: • Mobility • Physical activity • Skill • Activities at home • Activities in daily life • Social activities • Pain • Depression • Anxiety

  20. Improvement Measurement of Patient Outcome (MOPO)Rheumatoide Arthritis (Radon trial Bad Brambach 1997) Skt Differenzen zum Ausgangswert und 95%-Konfidenzintervall Radon+CO2 1st value CO2 N = 29/30 N = 29/30

  21. Structural AssessmentsMusculoskeletal • upper extremity DASH • lower extremity WOMAC • Back NASS • more Regions HAQ Sangha O et.al.Rheumatol 56:322-333, 1997

  22. Disease Assessments • Rheumatoide A. HAQ • Bechterew BASFI • Narrow spinal channel LSS-Inst. • Osteoarthrosis WOMAC German translation by Sangha O et.al.Rheumatol 56:322-333, 1997

  23. BASFI für Morbus Bechterew (Ankylosing Spondylitis) • Ohne Hilfe und Hilfsmittel Socken und Strümpfe anziehen • Ohne Hilfe von der Hüfte aus nach vorn beugen um einen Kugelschreiber vom Boden aufzuheben • Ohne Hilfe etwas von einem Regal nehmen • Von einem Wohnzimmerstuhl ohne Armlehne aufstehen ohne dabei die Hände oder eine andere Hilfe zu benutzen • Ohne Hilfe vom Boden aufstehen, wenn Sie auf dem Rücken liegen German translation by Sangha O et.al.Rheumatol 56:322-333, 1997

  24. BASFI für Morbus Bechterew (Ankylosing Spondylitis) • Ohne Schmerzen 10 Minuten stehen ohne sich anzulehnen • Ohne Benutzung eines Geländers oder Gehhilfen 12-15 Treppenstufen steigen. 1 Fuß pro Stufe • Über die Schulter schauen ohne dabei den Körper abzudrehen. • Körperlich anstrengende Tätigkeiten verrichten (z.B. krankengymnastische Übungen, Gartenarbeit oder Sport) • Zu Hause oder bei der Arbeit den ganzen Tag aktiv sein. German translation by Sangha O et.al.Rheumatol 56:322-333, 1997

  25. BASFI für Morbus Bechterew(Bath Ankylosing Spondylitis Functional Index) Easy Unimportant Each question 11 positions! Ruof J et al, Z. Rheumatol 58:218-225 (1999)

  26. Mineral water for bathing • Chemical quality can be used only in bath tubs • Without any disinfections of water • With minimal concentrations of following substances • H2S > 10 mg/l • Radon > 1 kBq/l • CO2 > 1 g/l • Brine 10-150 g/l (Dermatitis low – Psoriasis high) • In pools only physical quality can be used • With disinfections (chlorine) • Temperature must be more than 30 °C

  27. Indications • Sulphured water in bath tubs in rheumatology • Radon water in bath tubs and Radon-gas-baths or Radon-mines • CO2 water in bath tubs and CO2-gas-baths • Brine water in bath tubs • Brine water in pools for kinesitherapy • Thermo-neutral baths (35 °C) • Cold baths (<32 °C) • Cold-warm changing baths • Hot baths (>39 °C)

  28. IndicationsSulphured-Water in bath tubs in Rheumatology • Degenerative joint disease • Extra-articular rheumatism • Chronic articular rheumatism • Posttraumatic lesions • Postoperative therapies

  29. IndicationsRadon-Water in bath tubs and Radon-Gas-baths or Radon-mines • Ankylosing spondylitis • Degenerative joint disease • Spondylarthrosis • Myofascial soft tissue syndrome • Ovarian hypofunction • Allergic bronchial Asthma

  30. IndicationsCO2-Water in bath tubs and CO2-Gas-baths • Disorder of microcirculation of the skin • Trophic ulcera of the skin, venous ulcera • Decubitus • Peripheral arterial occlusive disease in any stage • Functional disorder of vascularity • Polyneuropathy (Malum perforans) • Cerebral disorders of microcirculation • Arterial hypertension • Algodystrophy (M. Sudeck)

  31. IndicationsBrine-Water in bath tubs • Psoriasis vulgaris + UV-B-irradiation • Neurodermitis + UV-A-irradiation

  32. IndicationsBrine-Water in pools for kinesitherapy • Degenerative joint disease • Spondylarthrosis • Osteoporosis • Posttraumatic and postoperative state

  33. Bath effectsIndications thermoneutral baths (35 °C) • Relaxation of muscles and exoneration of joints • Rheumatic Diseases • Relaxation effect by sympathicolysis, suppression of stress hormones and muscle relaxation • Psycho-vegetative syndrome • Psycho-physical overloading • Convalescence

  34. Bath effectsIndications thermoneutral baths (35 °C) • Dehydration by increase of capillary re-absorption and diuresis • Rheumatic diseases • Posttraumatic und postoperative state • Oedema • Training vegetative-hormonal functions like blood volume, blood pressure and electrolyte regulation • Convalescence • Disorder of heart-circulation-regulation • Psycho-vegetative syndrome

  35. Bath effectsIndications cold baths (<32 °C) • Thermic stimuli for training of vascular regulation • Functional disorders of vascularity • Phlebopathies • Heart-circulation disorders • Thermic stimuli for training to inure • Infect prophylaxis

  36. Bath effects Indications cold-warm changing baths • Thermic stimuli for training of vegetative-hormonal functions • Convalescence • Psycho-vegetative syndrome • Disorder of heart-circulation-regulation • Metabolic disorders

  37. Bath effects Indications hot baths (>39 °C) • Muscle relaxation • Increase of distensibility of connective tissue structures • Analgesic • Antiphlogistic by hyperthermia • Rheumatic diseases • Chronic-inflammatory diseases of the urogenital system • Posttraumatic und postoperative state

  38. Risks of bathing • By immerse:increased cardiac preload result in a decompensation riskPrecaution by disorders of heart rhythm and Angina pectoris • By get out:Collapse riskPrecaution by venous diseases andorthostatic irregularity • During bathing:Loading of respiratory and lung function Precaution by respiratory insufficiency

  39. Controles de calidad (DIN ISO 9001ff) de la prescripción de los remedios naturales usados de la ejecución de los métodos terapéuticos de los resultados terapéuticos

  40. Quality of Health Resort Medicine • Quality control of • Mineral waters • Air and climate • Treatment strategies • Quality assurance by • Technical systems • Protection of resources • Definition of performance standards

  41. Conclusión • Pacientes con enfermedades crónicas dependen de los ofrecimientos de las estaciones balnearias • En Europa no conocemos métodos mejores para esos pacientes

  42. End of Slides

  43. International Congress on Natural Spa Therapy of the I.S.M.H. Dead Sea Israel21-24 November, 2001 Contact: dorit@ofakim.co.il

  44. 34th WORLD CONGRESS of the I.S.M.H. Budapest-Heviz (Hungary)14-19 October, 2002Contact: http://www.ismh2002.huVideofilm during this Congress !

  45. News of the I.S.M.H. http://www.med.uni-muenchen.de/ismh

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