A Double-Blind Study Using BIOflex® Magnetic Pads
to Demonstrate
Therapeutic Benefit in Heel Pain Symptomatology
By: Larry Seaman, D.P.M.
In conjunction with Barry
University,
Miami, Florida
12/6/93
OBJECTIVE:
To determine the
effectiveness of permanently magnetized pads for the treatment of heel pain
syndrome. A double-blind study was performed on patients who have had
symptoms in the above areas for at least two weeks. Permanently magnetized
and demagnetized pads will be applied to the symptomatic feet without the
patient or the clinician able to differentiate due to identical appearing
pads. Only an impartial referee is aware of the true identity of each pad.
Characteristics Of The
Material To Be Tested
1. The Bioflex® pads to be
used are rectangular and are 53 mm x 83 mm and produce about 300 gauss of
magnetic current. The magnetic coils inside each pad are arranged in
concentric circles and are not visible or palpable.
2. An identical number of
factory demagnetized pad of identical dimensions were also used for the
study.
3. All pads were provided
by Bioflex® Corporation and in Germany by Rheinmagnet, GmbH.
4. All pads have a cotton
covering on the inside which faces the skin during application and an
aluminum cover on the outside for insulation. Again, all pads appear
identical.
Patients To Be Tested
1. Twenty patients were
initially studied using the Bioflex® pads on their symptomatic feet. All
patients were seen at the foot clinics of the Barry University School of
Podiatric Medicine.
The age of patients varied
from age 21 to age 78. The sex of the patients was noted, but not thought to
be a significant factor in the study.
2. The patients tested had
either heel spur or acute plantar fascitis symptoms such as, aching, burning
or sharp pain on the heel area.
3. All patients has local
symptoms without neurological damage to their back or lower extremities.
4. Patients who underwent
foot surgery within the past year were not included.
5. Patients who had
metallic implants, such as screws or wires in their feet were excluded.
6. All patients underwent
two weeks of therapy and two weeks of minimum follow-up after the treatment.
Method Of Double-Blind
Procedure:
1. All magnetized and
demagnetized pads were randomly mixed before starting the clinical trial.
2. All pads were placed on
a flat surface next to each other so that there would be no means of
differentiating magnetized from demagnetized pads.
3. Each pad was taken
randomly for placement on the perspective patient in the study.
4. Patients were told that
they must use their pads as instructed for the entire two week trial period
to optimize therapeutic benefit.
5. Each patient was made
aware of possible side effects and possible reactions to local magnetic
therapy.
6. Patients were advised
to keep pads away from all credit cards, computer discs and sensitive
electronic equipment.
7. A medical history and
podiatric physical examination were performed on each patient with a
questionnaire and consent to medical treatment prior to starting therapy.
8. All pads were attached
to the skin of the painful area using non-allergic tape or non-adhesive
elastic wrap. Additional tape was provided for each patient reapplication
during the two week
period.
9. Each patient was
reappointed for an evaluation in 7 days.
10. The second stage of
the evaluation began after the first 7 days when the patient was reappointed
in one more week.The patient was questioned after each seven day period
concerning compliance, improvement or worsening of symptoms and side effects
during the treatment periods.
11. The clinical trial was
concluded on the fifteenth day following the start of treatment.
12. Examination of the
treated foot was performed. Results were documented according to the study
guidelines.
13. The pads were removed
and decoded by the referee using a magnetic detecting film. These results
were then recorded along with each patient's medical information taken
during the study. The decoding of the pads was done in the absence of the
patient. All pads were then filed and secured by the referee.
14. Each patient's
compliance was monitored by the clinical staff during the study.
Criteria For Test
Documentation
1. Criterion A: Subjective
pain sensation.
2. Criterion B: Ability to
ambulate without pain.
3. Criterion C: Need for
pain or anti-inflammatory medication.
4. Criterion D:
Accompanying therapy.
The Effective
Comparison Index
The effectiveness
comparison index is used to compare the therapeutic effectiveness of
magnetized and demagnetized pads between the groups in the trial population.
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 demagnetized pads of
all criteria.
p= Percentage of
efficiency with reference to the number of patients of a trial criterion
treated with magnetized pads.
n= Percentage of
efficiency with reference to the number of patients of a trial criterion
treated with demagnetized pads.
A,B,C & 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 pads. A factor of less
than 1.0 represents higher participation of the magnetized pads in the
obtained result. The higher the obtained count factor beyond 1.0, the
stronger the assumption that the therapeutic effect is due to the magnetized
pad for particular symptoms. The WVI in all categories showed a high count
factor beyond 1 in all four criteria in the clinical trial. The WVI was
greater the 0.5 in all differentiation categories.
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