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Scientific Study: Presentation Physiological Effects of Low Temperature Infrared Treatment. Findings of the Study. Abstract The study confirmed the working hypothesis that the use of direct low temperature infrared treatment of Study Title


  1. Scientific Study: Presentation Physiological Effects of Low Temperature Infrared Treatment.

  2. Findings of the Study. Abstract The study confirmed the working hypothesis that the use of direct low temperature infrared treatment of Study Title the back of humans (an application of Physiotherm) “Exploratory Investigations into Physiotherm Low when compared with simple heat treatment can in Temperature Infrared Treatment Technology with ILCS fact produce significant physiological and immunolo- (instant leukocyte culture system) by means of gical effects in the whole physical system. Physiological and Immune-modulating Effects” Particular Circumstances of the Study Healthy subjects - It was important in this pilot The study was designed to investigate the physio- study to have healthy subjects since an initial concern logical effects – especially on the immune system – was to demonstrate the harmlessness of the applica- of direct infrared treatment of the back of humans as tion and to create a set of data. Only now, with a an addition to and in comparison with simple heat data set obtained through trials, is it possible serious- treatment. Physiotherm infrared cabins equipped ly to plan and assess studies which investigate the with low temperature radiators were used in the immunological effects when different indications are investigations. The low temperature infrared treat- treated. ment technology means that the distance between Over 150 applicants needed to be screened before the radiation source and the body can be kept very the 18 healthy subjects, all meeting the stringent short, which ensures a relatively high infrared radiati- exclusion and inclusion criteria of the study, could be on absorption rate whilst at the same time maintai- identified and recruited. 4 subjects breached the ning relatively low room temperatures. study protocol so that only the data of 14 subjects were included in the final assessment procedure. Study Design Successful blinding - In the placebo cabins, the low Monocentric, controlled, randomised, prospective, temperature radiators were covered with aluminium single-blind pilot study. foil. This prevented direct infrared irradiation of the monocentric - carried out in a single test centre back. However, the temperature inside these cabins controlled - a control group is used to monitor the was the same as in the cabins of the verum group. effects of a placebo (placebo group) This meant that even after several treatment cycles randomised - the subjects are assigned at random the subjects could not tell whether they were in the to the different groups verum group or the placebo group, and the subjects prospective - the study follows a course of treat- confirmed this in the responses they were regularly ment throughout, assessing it continuously, not asked to give with the help of the questionnaire. just after completion (this would be retrospective) single-blind - the subjects do not know whether Optimisation of blood tests - The blood samples they are receiving real treatment (verum group) were analysed in a special laboratory (E.D.I.) in or the placebo treatment with an inactive sub- Tübingen, Germany. A particular feature of this stance (placebo group) system for immunological analyses, which has been pilot study - tests the tenability and utility of an both developed and patented there, is its high hypothesis. degree of accuracy and validity. 2

  3. Findings of the Study. Findings and Interpretation This study was the first to provide evidence under controlled conditions of the systemic effects of both a single application and a series of six applications of low temperature infrared treatments to healthy sub- jects and its superiority over simple heat treatments. Immediately after the blood samples are taken, The data obtained (circa 120 safety parameters and a they are established in culture in special vials contai- further 10 target parameters) provide a considerable ning an activator fluid which are placed in a heating body of evidence on the short-term and long-term block at body temperature. This is to increase the effects of low temperature infrared treatments. This reliability of the immunological data. After 24 hours, evidence can be used to develop treatment concepts the serum and cell components of the blood samples for particular ailments using Physiotherm low tempe- are separated and frozen at -20° C and sent to the rature infrared cabins. laboratory for analysis. Some initial application recommendations, and also ideas for further trials can be derived from the Exclusion of ambient factors - The result of prior following, careful interpretation of the data. tests was that CO2 concentrations increased sharply Apart from that, the study data obtained confirm during a cabin session whereas O2 concentrations certain important aspects of the experiences and fell. This is an effect which generally occurs when observations of users of low temperature infrared heat is applied in closed cabins (saunas, heat cabins technology. etc.) and up to now has obviously been scarcely noti- ced. In the home and on commercial premises (health cubs, hotels etc.) this needs not to be seen • as regards their physiological effects, as posing a problem, but this phenomenon does Physiotherm sessions are comparable with need to be taken into count when developing a moderate endurance training. medical product or running a study. For the • certain immune system indicators are Physiotherm study, therefore, the manufacturer deve- affected significantly. loped cabins with special control instruments, which • Physiotherm sessions cause a measurable drop kept the interior at all times within a narrow tempe- in diastolic blood pressure. rature range. • there is a measurable increase in body core temperature during verum applications. Modification of the study settings - The quality and • Physiotherm sessions increase the secretion of the cost of the trial met the standards of GCP (Good pain-reducing neurotransmitters and therefore Clinical Practice). However, to make it possible to have a pain alleviating effect. conduct the trial in a private doctor's surgery, Dr. Otto • no negative effects on the measured parame- Pecher made some modifications in the field of quali- ters were noted. ty assurance. This entailed the recruitment of additio- • Physiotherm sessions are comparable with a nal qualified staff from the Institute for Heat and moderate degree of physical training stimulus Immune Therapy (IWIT). They received training on the and the present findings show they can be particular requirements of the study and their duties recommended to persons with restricted motor were confined solely to it. ability (for example, age-related conditions). 3

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