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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
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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.
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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