3.BTL-6000 Super Inductive System STUDY Repetitive Peripheral Inductive Stimulation in Musculoskeletal Pain Management EN100 Preview

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Repetitive Peripheral Inductive Stimulation in

Musculoskeletal Pain Management – A Pilot Study


Pětioký J.1,Váňa Z.1, Šubert D.1, Žarković D.2, Prouza O.2, Bittner V.3

1
Rehabilitation Center Kladruby, Kladruby, Czech Republic
2
Charles University in Prague, Faculty of Physical Education and Sports, Prague, Czech Republic
3
Technical University of Liberec, Liberec, Czech Republic
Published: Rehabilitace a fyzikální lékařství, 2016, Vol. 4(23), p. 195—200

Summary
Background: Repetitive peripheral inductive stimulation is a solution in musculoskeletal pain management in medical branches such
as neurology, orthopaedics, rehabilitation and physical medicine. Therapy is based on the principle of time-varying electromagnetic
field passing through neural and muscular tissue, in which electric currents are induced. By affecting conductive tissue, a chain
reaction including changes in action potential and leading to muscle contraction is performed.

Aim: Aim of the pilot study was to investigate immediate pain relief effect of the repetitive peripheral inductive stimulation device
BTL-6000 Super Inductive System (BTL Industries Ltd.) in musculoskeletal diseases.

Methods: 31 subjects from Rehabilitation Center Kladruby were comprised in the pilot study. Subjects underwent approx. 7 therapies
individually. A handheld applicator type „focus field“ was used. Pulse repetition rates matching with gate theory and peripheral pattern
theory were applied to achieve pain relief effect. A Visual Analog Scale (VAS) was used to evaluate pain before and after each therapy.

Results: Immediate pain relief effect of the repetitive peripheral inductive stimulation in 62 % patients with musculoskeletal diseases
was observed.

Conclusion: Despite small number of subjects, decrease of painful perception and pain relief effect were achieved. Although,
the study design does not allow comparison with placebo effect, statistically significant (α = 0.2) immediate pain relief effect in
50 – 74 % of subjects might be expected.

Keywords: pain, pain relief effect, gate control theory, peripheral pattern theory, repetitive peripheral inductive stimulation,
vertebrogenic algic syndrome, Visual Analog Scale
Introduction Repetitive peripheral
inductive stimulation
World Health Organization (WHO) defines pain
as “an unpleasant sensory or emotional experience Repetitive peripheral inductive stimulation (rPIS)
associated with actual or potential tissue damage, is a technology and method, which has been proven
or described in terms of such damage” (4). Pain of in the early 80´s. The technology uses pulsed high
musculoskeletal system seems to be one of the most intensity electromagnetic field with the intensity
frequent reasons to search for medical assistance. of magnetic induction measured in units of Tesla.
About 30 – 50 % of the adult population state that Such an intensive electromagnetic field induces
they experience pain, which negatively affects their electric current in the neuromuscular tissue, which
psychosocial condition (6, 16). results in muscle contraction (15, 19). In the early
stage, the technology was used for the purpose of
Treatment of painful conditions transcranial magnetic stimulation (TMS), which
was introduced in 1985 in England. TMS was
Physical therapy is known for using different mainly indicated for treatment of psychiatric and
types of external energy to achieve pain relief neurologic diseases (so-called central application).
(14). Its pain relief has been explained through After some time, rPIS was applied in orthopaedics,
neurophysiological pain control theories. One urology, gynecology, rehabilitation and physical
of the most known is definitely Melzack´s and medicine, where it is widely used as so-called
Wall Gate control theory. The theory is based peripheral application (1, 2, 7).
on the explanation that pain is transferred to the
brain interpretation center through nerve fibers
and ´spinal gate´. Thin diameter nerve fibers can
´open the spinal gate´ and transfer pain to the brain
interpretation center. Large diameter nerve fibers
´close the spinal gate´ and pain is not transferred
to the brain interpretation center. When stimulating
affected area with SIS and frequencies in the
range 60 – 100 Hz, large diameter nerve fibers are
stimulated and pain revealed (12, 13, 14).
Another pain control theory is the ´peripheral
pattern theory of pain´. The theory is based on the
explanation that pain is transferred from the affected
area as a code to the pain interpretation center in
the CNS, where it is further decoded and analyzed.
Due to frequency modulation, the information is
not presented as pain. To achieve pain relief, the
affected area needs to be treated with stimulation
frequencies above 100 Hz and application time for
approx. 15 minutes. These 2 neurophysiological
theories can be used for pain management with SIS,
because the device allows the user to set stimulation
frequency up to 150 Hz.

Picture 1: BTL-6000 Super Inductive System with


„focus field“ applicator (Source: BTL Industries Ltd.)
Table 1: Percentual distribution of particular diagnosis

Diagnosis Number of patients (N) Percentual distribution

Vertebrogenic algic syndrome N = 24 77.41 %


Degenerative joint diseases N=4 12.90 %
Central motor impairment N=3 9.67 %

Due to wide range of therapeutic effects such as ±52 years) from Rehabilitation Center (RC) Kladruby
pain relief, myostimulation, antispastic effect, were comprised in the pilot study. The biggest
rPIS can be easily applicable in modern medicine distribution of patients were patients with vertebrogenic
and comprehensive rehabilitation (10, 11, 17, 18). algic syndrome (VAS), less distribution had patients
The aim of this pilot study was to evaluate the with degenerative joint diseases of lower limbs and
immediate pain relief effect of rPIS (BTL-6000 central motor impairment (see Table 1).
Super Inductive System – SIS, BTL Industries
Ltd.) in pain conditions of musculoskeletal system Measurement protocol and data collection
by using high frequencies, which are indicated in SIS was incorporated in a comprehensive rehabilitation
pain management according to gate control and program in RC Kladruby. Subjects underwent approx.
peripheral pattern theory of pain. 7 therapies individually (min. 3, max. 10) and therapy
duration was set to 10 minutes. A hand-held ´focus
Methodology field´ type applicator with magnetic induction intensity
of up to 2.5 T was used. Pulse repetition rate in the
Methods range of 60 – 150 Hz matching with gate theory and
In this pilot study immediate pain relief of SIS in peripheral pattern theory were applied to achieve
patients with musculoskeletal diseases of various a pain relief effect. A Visual Analog Scale (VAS) was
etiology was investigated. The study was designed used to evaluate pain before and immediately after
as a 1-group unblinded experiment without each therapy (0 – no pain up to 10 – the worst pain)
a placebo group. (3, 5, 8, 9). Pain evaluation was performed according to
patient´s subjective perception before and immediately
Experimental group after each therapy. Values were noted into the patient´s
31 subjects (18 women, ±54 years; 13 men, score sheet (see Picture 2).

Picture 2: BTL-6000 Super Inductive System – therapy example VAS LSp. (Source: BTL Industries Ltd.)
Data analysis Results

For statistical purposes we have created a scientific In Diagram 1 is shown a frequency of a class interval,
question: values present condition before and immediately after
Does the rPIS provide immediate pain relief? therapy. A distribution of 196 therapies, which were
To analyze the collected data, we have used delivered to 31 patients is showed. From the histogram
descriptive statistics and frequency of a class it is obvious that in 62 % of treated patients pain
interval according to the following mathematical decreased on the VAS by at least 1 point, in 33 % of
formula. cases therapy had no effect, in the 5 % of cases therapy
led to a temporary increase of pain. The Diagram 2
shows general class intervals for particular levels of
statistical significance. Based on statistical analysis, it
can be stated that after SIS therapies, immediate pain
– Estimation of relative frequency relief can be expected in more than 50 % of treated
N – Number of subjects (N = 31) patients, which can be observed as a decrease of the
t1α-/2(N-1) – Quantile function of Student distribution pain level on the VAS by 1 or 2 points.
α – Level of statistical significance
Discussion
Data was analyzed on the levels of statistical
significance α = 0.05; α = 0.1 and α = 0.2. In all The pilot study shows the results of the SIS therapy
patients, a decrease of min. 1 point on the VAS in painful musculoskeletal conditions. Immediate pain
immediately after therapy was considered as relief can be explained through gate control theory of
statistically significant. pain by using frequencies in the range 60 – 100 Hz and

40
n = 196
35

30
Relative frequency

25

20

15

10

0
-5 and more -4 -3 -2 -1 0 1 2 and more

Decrease of pain Temporary increase of pain

Diagram 1: Histogram of relative frequency of immediate pain relief after therapy with the BTL-6000 Super Inductive System
(Negative values represent decrease of pain on the VAS, positive values represent increase of pain)
Table 2: Statistical calculations of confidence intervals

Level of statistical significance α 0.05 0.1 0.2

Improvement (%) 44 – 80 47 – 77 50 – 74
No effect (%) 15 – 51 18 – 48 22 – 44
Aggravation of condition (%) 0 – 13 0 – 12 0 – 10

an application time 5 – 10 minutes; peripheral pattern statistically significant. This value is also subjective
theory of pain by using frequencies above 100 Hz and interindividual – the significance of a 1 point
and application time of up to 15 minutes. Gate decrease on the VAS is different for every patient. In
control theory is intended in acute pain conditions this pilot study, immediate pain relief effect was proved
as well as in patients with low adaptability, latence in correlation with gate control and peripheral pattern
of analgesic effect takes few hours. By increasing theory of pain in 62 % of treated patients. According
the application time one can increase the latence, to statistical calculations of confidence intervals, it
but not the analgesic effect. The peripheral pattern can be stated that at the level of statistical significance
theory of pain has main advantage – immediate α = 0.05 improvement can be expected in 44 – 80 %
pain relief but with a short latence of up to 20 of patients; α = 0,1 improvement can be expected in
minutes. Therefore it presents an ideal preparation 47 – 77 % of patients; α = 0.2 improvement can be
phase before further kinesiotherapy or facilitation expected in 50 – 74 % of patients (see Table 2).
for further therapy (12, 13, 14, 20). For future research, we strongly recommend to
Because the pain is evaluated subjectively complete the methodology part with other measuring
and interindividually in every patient, every tool (e.g. algometer); increase the number of subjects
measurement is associated with an error. In this and create a control group, in which we can also
pilot study a decrease of a min. 1 point on the explore a placebo effect or to compare SIS with some
VAS immediately after therapy was considered as other therapy or add a follow-up.
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