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OUTCOME-RESEARCH in Thermalism Nuevos retos en medicina The New Challenge of Medicine Helmut G. Pratzel, MD, PhD President of the International Society.

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Presentation on theme: "OUTCOME-RESEARCH in Thermalism Nuevos retos en medicina The New Challenge of Medicine Helmut G. Pratzel, MD, PhD President of the International Society."— Presentation transcript:

1 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.)

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

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 trials by few patients ¿Equivalencia de resultados clínicos?

5 Clinical Trial Protocol by the Guidelines for Good Clinical Practice (GCP) of the European Community  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

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 trabajo Controlled trial in Bad Wörishofen 1991-1994 n=115 n=248

9 Controlled Double - Blind Trials  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 Technical roomBathroom Tap-water line Radon-water line Bath -tub Magnetic valves Bar-code- reader

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 Measurement of pressure pain threshold 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 threshold by Sulphur bath series Period of inspection kg/cm 2 kg/cm 2 2 weeks later later 3 weeks later 3,33,3 3,03,0 2,72,7 2,42,4 2,12,1 1,81,8 Sulphur Water Tap Water 1 week later

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

16 Subjective pain feeling Rheumatoide Arthritis (Radon trial Bad Brambach 1997) 1st value CO 2 Radon+ CO 2 mm VAS N = 30N = 30/27 N = 28/30 Differences to 1st value and 95%-Confidence interval Improvement

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 Moving Test by Keitel Rheumatoide Arthritis (Radon trial Bad Brambach 1997) CO 2 Radon+CO 2 N = 30N = 28/30N = 30/29 Skt Differenzen zum Ausgangswert und 95%-Konfidenzintervall Improvement 1st value

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

20 Measurement of Patient Outcome (MOPO) Rheumatoide Arthritis (Radon trial Bad Brambach 1997) Radon+CO 2 CO 2 Differenzen zum Ausgangswert und 95%-Konfidenzintervall Skt N = 29/30 Improvement 1st value

21 Structural Assessments Musculoskeletal upper extremityDASH lower extremityWOMAC BackNASS more RegionsHAQ Sangha O Rheumatol 56:322-333, 1997

22 Disease Assessments Rheumatoide A.HAQ BechterewBASFI Narrow spinal channelLSS-Inst. OsteoarthrosisWOMAC German translation by Sangha O 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 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 Rheumatol 56:322-333, 1997

25 BASFI für Morbus Bechterew (Bath Ankylosing Spondylitis Functional Index) EasyUnimportant 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 H 2 S > 10 mg/l Radon > 1 kBq/l CO 2 > 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 CO 2 water in bath tubs and CO 2 -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 Indications Sulphured-Water in bath tubs in Rheumatology Degenerative joint disease Extra-articular rheumatism Chronic articular rheumatism Posttraumatic lesions Postoperative therapies

29 Indications Radon-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 Indications CO 2 -Water in bath tubs and CO 2 -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 Indications Brine-Water in bath tubs Psoriasis vulgaris + UV-B-irradiation Neurodermitis + UV-A-irradiation

32 Indications Brine-Water in pools for kinesitherapy Degenerative joint disease Spondylarthrosis Osteoporosis Posttraumatic and postoperative state

33 Bath effects Indications 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 effects Indications 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 effects Indications 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 risk Precaution by disorders of heart rhythm and Angina pectoris By get out: Collapse risk Precaution by venous diseases and orthostatic irregularity During bathing: Loading of respiratory and lung function Precaution by respiratory insufficiency

39 Controles de calidad (DIN ISO 9001ff) de la ejecución de los métodos terapéuticos de los remedios naturales usados de la prescripción 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 Israel 21-24 November, 2001 Contact:

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

45 News of the I.S.M.H.

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