Permanently Magnetized Foils
MEDICAL STUDIESKlinic Bavaria Medical Study Double Blind Study of the Therapeutic Effectiveness of Permanently Magnetized Foils on Secondary Myotendofasciopathies at Different Selected Locations Thomas Laser, MD Head Physician of the Orthopaedic Department Orthopaedic-Chirotherapy and Social Medicine Practioner Klinic Bavaria 8351 Schaufling by: Dr. Jens Martin ------------------------------------------------------------------------ TEST REPORT The object of the trial was to examine the clinical effectiveness of a local magnetic field therapy, using permanently magnetized foils, in carrying out a double blind test to compare magnetized and non-magnetized foils during the therapy of secondary myotendofasciopathies in selected locations. The statistical comparison of results with respect to selective test criteria which are obtained from magnetized and non-magnetized foils in the treatment of nosologically comparable physical symptoms appears to affirm the effectiveness of magnetic foil therapy. Characteristics of the tested materials Two formats of foils were used during the examination: I. rectangular foils of size 53 x 83 x 0.75 mm, and 2. circular foils of 40 mm diameter and a thickness of 1.5 mm. Unknown to the tester both types were magnetized sectionally with uniform magnetic strength, i.e. radially with alternating polarity, by the manufacturer. Further, an identical number of non-magnetized control products of both types were used. The foils, made available by the company Rheinmagnet GmbH were of skin compatible, flexible plastic with permanent magnetic particles imbedded therein. They were laminated with cotton textile on the side facing the body and had a thin aluminum coating on the outside, for reasons of insulation. The external appearances of both, magnetized and non-magnetized foils, were completely identical. Description of targeted population (test persons) To examine the therapeutic effectiveness of the permanently magnetized foils 100 volunteers were included in the study. 50 of these test persons were treated with magnetized foils and 50 with non-magnetized foils. Prior to commencing the test the accepted age spectrum of the tested persons was determined at minimum 20 and maximum 65 years. The sex of the tested persons was not taken into consideration. The test population was divided into three differently sized groups, each being indication dependent. The first of these groups consisted of patients with a vertebral local lumbar pain syndrome; the second group of patients with a cervical pain syndrome and the third indication group consisted of patients suffering from periarthropathy (periarthritis) hurneroscapularis. When selecting the test persons it was ensured that the patients' complaints had existed for a minimum of one month, irrespective of the group to which they belonged. Further, only locally restricted symptoms, without pain irradiation and without neurological disturbances in the extremities, were accepted. In the selection of patients for the test population, exclusion criteria was either an operation on that region of the body to be treated or to be carried out within six months prior to the test, as well as metal (such as osteosynthesis material) still in the tissue. Following the results of a pilot study, prior to the main trial, (see below) only those patients who stayed in the clinic for follow-up treatment, but not for rehabilitation purposes, could be included in the trial. Method and examination procedure To ensure the pre-conditions for the double blind study, all magnetized and non- magnetized foils were mixed carefully prior to starting the trial. Thereafter the foils were placed, side by side, flatly, on a plain surface to make a visual differentiation impossible. The foils which were to be applied were then taken from the surface indiscriminately. Prior to applying the foil the patient was informed in detail of the effects and peculiarities of local magnetic field therapy and the examination mode was explained to them. The test person was also informed that only permanent usage of the foil during the entire period of treatment could result in a therapeutic effect. The test persons were warned not to bring the foils into contact with credit cards, sensitive electronic equipment and similar. In addition, the test persons were provided with a comprehensive information leaflet. The medical personnel, sport medicine practitioners and physiotherapists were also thoroughly informed of the therapy method. Prior to commencing the therapy a specific clinical checkup of the test persons was carried out, the results of which, were documented together with the patients' data and the paraclinical parameters, in the test questionnaire, in accordance with the selected examination criteria. The foil format was chosen according to the size of the pain area which was to be treated. Fixing the foil was carried out with skin compatible Fixomull stretch immediately over the pain center. When applying the foil great care was taken to make sure that the cotton side of the foil was in direct contact with the skin. Additional strips of Fixomull stretch were handed out to the patients to enable them to reapply the foils immediately in case the original stretch became useless. The second stage of the trial was carried out on the 7th or 8th day after commencement of the foil application. interim questioning was carried out into the treatment induced changes of symptoms, and compliance behavior. In such cases where none of the discontinuing criteria applied, the therapy was extended for an application of further 7 days. The trial was concluded after 14, respectively 15 days of treatment, with a final clinical examination, final questioning of the test persons, and the documentation of treatment results in accordance with the trial criteria laid down in the examination questionnaire. As a concluding action the applied materials were decoded by checking the foils for magnetization. This was done by a metallic device which itself had no effective magnetic field. The result of the decoding was then entered into the examination questionnaire. The decoding was done in the patient's absence, the used foil was then filed and secured. In cases where the patient asked for an extension of the therapy the request was accepted. Such patients were not included further into the trial. Criteria for premature discontinuation of the treatment were distinct local skin irritations, massive subjective ill feeling, disruptions of therapy motivation with effects on the compliance behavior and rearrangement of the entire therapy plan influencing the symptoms treated by the foils. The foils used for such patients were given back into the total pool of treatment foils without decoding, but after thorough disinfecting. The compliance behavior of the patients could only be judged by the statements of the medical treatment personnel, the sport medicine practitioners, physiotherapists, as well as from the personal statements of the test persons. Additional information of the wearing process of the applied foils was indirectly provided by the condition of the material used to fix the foils. Due to the specific trial situation (patients were under clinical care within the frame work of follow-up healing treatment), a monotherapy with magnetized or non- magnetized foils was impractical. For this reason several accompanying therapies were applied during the duration of the trial. Allowance was made for this situation by specific trial criteria and special selecting conditions for the test persons. Therefore, patients included in the test population were allowed to undergo parallel treatment with physiotherapy, hydrotherapy, as well as oral medication with NSAID (non-steroidal anti- inflammatory drug) preparations. Local application of external and electro-therapeutic measures to those regions which were to be treated by the foils, were an exclusion criterion for such patients from the study. Test parameters In the selected indication groups: 1. local lumbar pain syndrome, 2. cervical pain syndrome, and 3. periarthropathy humeroscapular, the following trial criteria were quantitatively tested and documented (by differentiation categories) as follows: criterion A - subjective pain sensation criterion criterion B - restrictions in movement criterion criterion C - use of pain killers criterion criterion D - accompanying therapy Criterion A represented the summary judgment of the patient, consisting of intensity, frequency and character of pain. The patient could choose from the assessment possibilities "better", "no difference" and "worse". The restriction in movement was determined by a clinical check-up of the test person, and documented according to the Neutral-Zero-Transition Method. A difference of less than 10 degrees to the pre-test diagnosis was in the range of measuring error and was therefore listed in the "identical" category. An increase or decrease of passive mobility of more than 10 degrees was classified respectively with "increased" or "reduced". In -judging the finger-floor gap, a difference of 5 cm was necessary and for the chin-jugular a gap of more than I cm for a change in the assessment classification. In the questionnaire classification the reduction or addition of 25 mg of Diclofenec Sodium was classified respectively "reduced" or "increased". Slight changes in dosage were classified as "no change". With reference to criterion D, a minimum of 50% reduction in the application of accompanying therapy was a precondition for the classification of "reduced" Thereby the only type of additional treatment considered was that explicitly for the identical symptoms for which the foil application was prescribed. With a smaller reduction in the frequency of the application the classification was "maintained". "Withdrawn" indicated the final ending of an applied primary additional treatment. The following target counts should be evaluated and compared in the statistical data processing result: 1. Percent distribution of the sectional groups with respect to the treated indication groups being part of the total trial population, as well as within the sub-groups treated with magnetized and non-magnetized foils. 2. Number of test persons in the differentiation categories of the trial criteria, with reference to the total trial population. 3. Percent partition of the patient to the differentiation categories of the trial criteria within the sectional groups treated with magnetized and non-magnetized foils. 4. Percent partition of the patients to the differentiation categories of the trial criteria within the sectional groups treated with magnetized and non- magnetized foils, separated into indication groups. 5. Percent partition of the patients to the differentiation categories of the trial criteria, separated according to indication groups, with respect to the actual number of individual patients treated with magnetized and non-magnetized foils. 6. Calculation of the comparative effect indicators of all indication groups of the "positive", "medium", and "negative" differentiation categories. Results In the orthopedic department of the Klinic Bavaria Schaufling, a total- of 100 test persons were examined in accordance with the requirements of the trial plan. Whereby, in accordance with the symptoms (indication groups) 50 patients were treated with magnetized foils and 50 patients with non-magnetized foils-.- 30 women participated in the study with an average age of 47.5 (31 to 58) years and 61 men with average age of 51.3 (99 to 64) years. 69 patients of the trial population were treated for a local lumbar pain syndrome. Within this indication group the relationship of magnetized and non-magnetized foils was 39:30. 13 (5:8) test persons were treated with the foil application for a cervical pain syndrome, 18 (6:12) for periarthropatliy humeroscapularis. Of the patients treated with the magnetic foils, 78% of the cases were for a local lumbar pain syndrome, 10% for a cervical pain 'syndrome and 12% for periarthropathy humeroscapularis. Within the groups treated with magnetic foil the indication groups were partitioned as follows; 60% local lumbar, 16% cervical pain syndrome and 24% periarthropathy humeroscapularis (Figure 1) and (Figure 2). Viewing the total trial population which was aimed to be treated, irrespective of sickness symptoms and irrespective of the type of foil used, after'14 days treatment the subjective pain sensation in 43 test persons was unchanged, in 9 test persons it had increased and in 48 test persons it was reduced. With reference to restrictions of movement, 33 persons showed a reduction, 63 no change and 4 an increase. The use of medications could be reduced in 28 patients. In 65 of the cases the oral medication remained largely unchanged. After conclusion of the treatment 7 test persons required higher dosage of pain killers than they did before. The accompanying therapy could be totally dispensed with in 6 test persons, and reduced in 16 cases, 78 test persons had no change in their additional treatment. For criterion A, after decoding, the comparison of results of patients treated with a)magnetized foils and those treated with b)non-magnetized foils showed, within the sectional groups, the following; relief of pain in a) 70% in b) 26% unchanged pain sensation in a) 26% in b) 60% pain increases in a) 5% in b)14% of the cases (Figure 3). For criterion B a reduction of movement restriction was found in a) 50% in b)76% and an increase of movement restrictions in none of the cases treated with magnetized foils; but in 8% of the cases treated with non-magnetized foils (Figure 4). Usage of pain killers was reduced in a) by 46%, respectively in b) by 10%, was unchanged in a) 52% and in b) 78%, and was increased after conclusion of the two week treatment period in a) 2%, respectively in b) 12% of the cases (Figure 5). For patients treated with magnetized fails the accompanying therapy specifically prescribed for the examined symptoms could be dispensed with in 8% of the patients and reduced in 18%. In the placebo group this figure was 4%, respectively 14%. The other test persons of the sectional groups a) 74% and b) 82% had no change in their supplementary treatment (Figure 6). Figure 7, Figure 8, Figure 9 and Figure 10 show the percentage quota of the treatment results Obtained by applying magnetized or non-magnetized foils, separated into indication groups for the assessment categories of the examination criteria A to D.
Due to the differing number of test persons treated with magnetized or non-magnetized foils within the individual indication groups and due to the differently sized sectional groups of the treated symptoms, a direct comparison of the treatment results could only be obtained after relevant statistical processing.Thus, the results indicated in Figure 7a, Figure 8a, 7nbsp; Figure 9a and Figure 10a only allow differentiated statements as to the differing effectiveness of the therapy with magnetized or non-magnetized foils in indication groups and simultaneously, allows a comparison of results between the symptoms included into the trials. For example, of all patients within indication group II who experienced subjective improvement of their pain sensation from the therapy, 66% had been treated with magnetized foils and 33% with non-magnetized foils (Figure 7). 80% of the patients within this indication group who were treated with magnetized foils, experienced a reduction of their subjective pain sensation from the therapy. From the patients treated with non-magnetized foils however, only 25% noted a reduction of subjective pain sensation (Figure 7a). The effectiveness comparison index was introduced from complex comparison of the therapeutic effectiveness of magnetized and non-magnetized foils between the indication groups. With reference to the same differentiation category within the indication group this corresponds to the quotient of the sums of the percentage values describing the clinical effectiveness of magnetized or non-magnetized foils of all trial criteria (Figures 7a to 10a). * p" Percentage of efficiency with reference to the number of patients of a trial criterion, treated with magnetized foils. * n= Percentage of efficiency, with reference to the number of patients of a trial criterion, treated with non-magnetized foils. A...D= Trial criteria WVI= p(A) + p(B) + p(C) + p(D) % ------------------------------------------------------------------------ n(A) + n(B) + n(C) +.n(ID) % A WVI of 1.0 is equal to an equivalent effect of magnetized and non-magnetized foils. A factor of less than 1.0 represents higher participation of the magnetized foils in the obtained result. The higher the obtained count factor is beyond 1.0, the more definitely one can assume a therapeutic effect of the local magnetic foil therapy for the examined symptom. The WVI of indication group 1, with reference to the "positive" differentiation category (reduction of subjective pain sensation, reduction of movement restrictions, reduction in medication use, dismissal of accompanying therapy) was 2.5; for indication group II = 4.6 and for indication group III = 4.1. For the "average" differentiation category of the trial criteria (no relevant change of pain sensation according to the trial conditions, of movement restrictions, of medication use, or reduction of the accompanying therapy) the WVI for the indication groups I, II, and Ill, reached factors of 0.7; 0.5 and 0.6. Accordingly, the WVI referring to the "negative" differentiation category, was 0.7; 0.5 and 0.6. Evaluation and discussion of the trial results Compared to the control groups a significantly higher therapeutic effectiveness was found for all trial criteria in all indication groups with magnetized foils. The best results in reducing the subjective pain sensation was achieved by magnetic foil application when treating the cervical pain syndrome. 80% of all test persons treated with the magnetized foils of this indication group reported pain relief. With reference to movement restrictions, in these patients the highest efficiency was also achieved, with an improvement rate of 60%. The drug consumption with cervical pain syndrome and periarthropathy humeroscapularis could similarly be positively influenced (60%). With local lumbar pain syndrome the result was lower, by approximately a quarter, at (44.9%). A relevant change in the accompanying therapy ("dismissed" or "reduced") was achieved, mainly within the indication groups II and III, with a total of 40%, respectively 38%. The relevant factor for the patients treated with non-magnetized foils was only 25% (Figures 7a to 10a). By assessing these results it must be considered that the test population of indication group I contained five, or four times the number of test persons of indication groups II, respectively III. Despite statistic result processing, the valence of comparing statements between the indication groups are influenced by a comparatively low number of test cases within indication groups II and III. A general differentiation assessment of the application qualification of magnetic foil therapy within the examined indication groups is dependent upon a large number of further factors and is not comprehensively possible on the basis of the test results alone. These factors consist of patients' compliance, motivation for the therapy, coping with the sickness, the duration and intensity of the symptoms which require treatment, as well as the general condition and other symptoms for which there may or may not be current therapy. In this condition it must be noted that the symptoms treated within the study are often intercurrent ailments of the examined test persons and therefore, due to the over-all therapy concept, a specific test situation existed. When selecting the patients it was therefore ensured that (as stated above) the accompanying therapies and medications included in the assessment were explicitly ordained for the symptom which was supposed to be treated with the magnetic foils. However, it can by no means be precluded that a systemic effect caused by the prescribed therapeutic measures to treat the basic sickness of the test person, has lead to a parallel influence of the treated sickness symptoms. The significance of the aforesaid therapy motivation and coping with the sickness showed up during the initial pilot study which was carried out under the precautions of the test plan, both for patients being treated in a follow-up healing process and with patients undergoing rehabilitation treatment. In the symptoms of rehabilitation patients, which were often overshadowed by psychosocial aspects, an aggravation-free assessment of the treatment effects, or an acceptable therapy compliance from the patient, could only be obtained in exceptional cases. Premature discontinuations were registered in a total of 7 cases. 4 patients had to be taken to another hospital for acute deterioration, or complications of their basic sickness (deep lower leg venous thrombosis) before conclusion of the examination. One female patient developed a skin irritation with defined pruritus under the applied foil and two patients refused continuation of the treatment, because of lack of improvement. Conclusions 1. With reference to the tested trial criteria the therapeutic effectiveness of the magnetized foils is unmistakably higher than the placebo effect of the non-magnetized foils applied to the control group. 2. The average effectiveness comparison index for the "positive" differentiation category (see above) of the test criteria was with 4.6, the highest when treating the cervical pain syndrome, followed with 4.1 of the magnetic foil therapy for periarthropathy humeroscapularis and finally, amounted to 2.5 for the treatment of the local lumbar pain syndrome. 3. A principal statement in favor of a better application capability of the magnetic foil therapy within indication groups II and III is not possible, as the sectional groups did not always contain the same number of patients. A number of further factors, not controlled in the test, influenced conclusions to this effect. Summary of results of test sheets 1 to 100 Evaluation prior to decoding (100 patients) Criterion A Category Number Of Patients Better 48 Same 43 Worse 9 Criterion B Category Number Of Patients Reduced 33 Same 63 Increased 4 Criterion C Category Number Of Patients Reduced 28 Same 65 Higher 7 Criterion D Category Number Of Patients Discontinuations 6 Reduced 16 Maintained 78 Evaluation after decoding Magnetized foils total (50 patients) Criterion A Category Number Of Patients Percentage Better 35 70% Same 13 26% Worse 2 4% Criterion B Category Number Of Patients Percentage Reduced 25 50% Same 25 50% Increased 0 0% Criterion C Category Number Of Patients Percentage Decreased 23 46% Same 26 52% Higher 1 2% Criterion D Category Number Of Patients Percentage Discontinuations 4 8% Reduced 9 18% Maintained 37 74% Magnetic foils total (Placebo control group = 50 patients) Criterion A Category Number Of Patients Percentage Better 13 26% Same 30 60% Worse 7 14% Criterion B Category Number Of Patients Percentage Reduced 8 16% Same 38 76% Increased 4 8% Criterion C Category Number Of Patients Percentage Decreased 5 10% Same 39 78% Higher 6 12% Criterion D Category Number Of Patients Percentage Discontinuations 2 4% Reduced 7 14% Maintained 41 82% Evaluation after decoding (50p./50p.) Patients' statements to magnetized BIOflex® foils (p) and non-magnetized BIOflex® foils (n) List of abbreviations Abbreviation Meaning n Number of patients treated with non magnetized foils p Number of patients treated with magnetized foils g Total number of patients 1.1. Local lumbar pain syndrome cerv. Cervical pain syndrome PHS Periarthropathy (periarthritis) humeroscapularis 1. Assessment of subjective pain sensation (crit. A) Differentiation Category Number Of Patients Better 48 Same 43 Worse 9 p 1.1 g n 27 37 10 10 25 15 2 7 5 p cerv. g n 4 6 2 1 6 5 0 1 1 p PHS g n 4 5 1 2 12 10 0 1 1 2. Movement restriction (crit. B) Differentiation Category Number Of Patients Reduced 33 Same Increased 4 p 1.1 g n 20 24 4 19 43 24 0 2 2 p Cerv. g n 3 4 1 2 8 6 0 1 1 p PHS g n 2 5 66 4 12 6 0 1 1 3. Usage of pain killers (crit. C) Category Number Of Patients Decreased 28 Reduced 65 Maintained 7 p 1.1 g n 17 20 3 21 45 24 1 4 3 p 1.1 g n 3 4 1 2 8 6 0 1 1 p PHS g n 3 4 1 3 12 9 0 2 2 4. Other necessary accompanying therapy (crit. D) Differentiation Category Number Of Patients Discontinuations 6 Reduced 16 Worse 78 p 1.1 g n 2 4 2 7 9 2 30 56 26 p cerv. g n 1 1 0 1 3 2 3 9 6 p PHS g n 1 1 0 1 4 3 4 13 9 Test period: 01.10.91 to 01.04.92 Klinic Bavaria Schaufling, April 1992 signed: Superintendent of clinical test Thomas Laser, MD Physician authorized for test J. Martin, MD