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6. Results

In the orthopedic department of the Klinik 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 (22 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 periarthropathy 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).
       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 foils 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).
       Figures 7 to 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 Figures 7a to 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(D) %

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 I, 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 III, 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.
       
7. 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 wasonly 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.

 

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