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Double Blind Study of the therapeutic effectiveness of permanently magnetized foils on secondary myotendofasciopathies at different selected locations

Dr. med. Thomas Laser

Head physician of the Orthopaedic Department:

Orthopaedic - Chirotherapy and Social Medicine Practitioner

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.

2. Characteristic of the tested materials

Two formats of foils were used during the examination:

1. 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.

3. 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) humeroscapularis.

       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.

4. 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.

       

5. 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 B - restrictions in movement

       criterion C - use of pain killers

       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 1 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.

 

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