EFFECT OF HIGH TONE POWER THERAPY ON NEUROLOGICAL SYMPTOMS AND FUNCTION OUTCOME IN PATIENTS WITH DIABETIC NEUROPATHY

EFFECT OF HIGH TONE POWER THERAPY ON
NEUROLOGICAL SYMPTOMS AND FUNCTION
OUTCOME IN PATIENTS WITH DIABETIC
NEUROPATHY.
Walid K. M. Abo El-Regal* ; Hany E. Obaya*; Emad M. Taha*
And Khaled L.A. Hawaas**
*Faculty of Physical Therapy, Cairo University, Department of Physical Therapy For
Cardiovascular/Respiratory Disorder and Geriatrics.
**Farskoor Public Hospital, Ministry of Health.
Key Words: High tone power therapy, Neurological symptoms,
Function outcomes, Diabetic neuropathy, Katz Index of
Independence, Glyclated Haemoglobin Level (HbA1c),
ABSTRACT
Background: High tone power therapy has an effect on neurological
symptoms and function outcome in patients with diabetic neuropathy.
The aim: This study aimed to identify the effect of high tone power
therapy on neurological symptoms and function outcome in patients with
diabetic neuropathy.Methods: Sixty patients diagnosed with diabetic
neuropathy, Their age ranged from fifty to sixty years old from Farskoor
Public Hospital in Damietta were involved in this study. They were
assigned into 2 groups equal in numbers . thirty patients received
treatment with high tone power therapy in addition to their traditional
physical therapy program. The other thirty patients received only their
traditional physical therapy program ( active free exercises for hip
flexion,extention, adduction, abduction , knee flexion, extention and gait
training). Before inclusion in this study full description of study,
procedures for each patient and written consent had been signed. All
patients were evaluated with Katz Index of Independence and measuring
Glyclated Haemoglobin Level (HbA1c) .These evaluations are repeated
again 3 monthes later at the end of the study. The results: Control group
included 19 male with percentage of 63.33% and 11 female with
percentage of 36.66%, Study group included 18 male with percentage of
60% and 12 female with percentage of 40%. The results showed that
there were significant differences in the mean values at post-treatment of
HbA1c percentage (P=0.036; P<0.05) between study group and control
group, Study group improved KATZ scale (72.08%) than control group
(16.56%). Conclusion: High tone power therapy is effective in the
treatment of neurological symptoms and increasing function outcome in
patients with diabetic neuropathy.
Egypt. J. of Appl. Sci., 36 (1) 2021 10- 21
INTRODUCTION
Diabetes mellitus (DM) is a chronic, metabolic disease
characterized by elevated levels of blood glucose (or blood sugar), which
leads over time to serious damage to the heart, blood vessels, eyes,
kidneys, and nerves. The most common is type 2 diabetes, usually in
adults, which occurs when the body becomes resistant to insulin or does
not make enough insulin (WHO, 2018).
Diabetic neuropathies (DNs) are nerve-damaging disorders
associated with DM. These conditions are thought to result from diabetic
microvascular injury involving small blood vessels that supply nerves
(vasa nervorum) in addition to macrovascular conditions that can
culminate in diabetic neuropathy (Behl., 2015).
Electrical stimulation (ES) produces skeletal muscle contractions as
results of the percutaneous stimulation of peripheral nerves. (Hamada ,
Hayashi and Kimura , et al 2004). Transcutaneous electrical nerve
stimulation (TENS), percutaneous electrical nerve stimulation, spinal
cord stimulation , other physical therapies and acupuncture have also
successfully been used as non-pharmacological therapies for neuropathic
deficits in diabetic polyneuropathy (Leonard , et al 2004)., while
electrical stimulation therapy through stocking electrodes was not
effective (Oyibo , et al 2004).
High tone power therapy (HiTop) is a new quantum leap in the
field of electro therapy. It is electrotherapy with sinusoidal alternating
currents. The high tone power therapy provides a therapy with medium
frequency sine waves. The therapy is free of direct current (D.C.)
components. The amplitude and the frequency are modulated
simultaneously. The higher the frequency, the more energy can be
introduced corresponding to the individual threshold curve of the
patient's electrosensitivity (Reichstein et al, 2005).
A short-term intervention over 5 days with HiTop has the potential
to immediately reduce pain with a significantly stronger analgesic effect
than TENS. Particularly, the first period of intervention showed that
HTEMS reduces pain to a greater extent than TENS. From a clinical
point of view, HTEMS showed a promising result, especially when
comparing with TENS or considering the short period of intervention
time. (Hawker, 2011).
SUBJECT AND METHODS
(I) Subject’s selection:
Sixty patients diagnosed with diabetic neuropathy ranged from 50
to 60 years old from Farskoor Public Hospital in Damietta were involved
in this study.
11 Egypt. J. of Appl. Sci., 36 (1) 2021
Patients were assigned into two equal groups in number:
Group A : consisted of 30 type 2 diabetic patients with diabetic
neuropathy and was received High tone power therapy for 30 minutes , in
addition to selected physical therapy program (AROM exercises for LL,
gentle manual stretching exercises for LL and graduated gait training)..
Group B : consisted of 30 type 2 diabetic patients with diabetic
neuropathy and was received only their selected physical therapy
program (AROM exercises for LL, gentle manual stretching exercises for
LL and graduated gait training).
Ethics Committee
The study was approved by the Ethics Committee of the Faculty of
Physical Therapy, Cairo University. A written informed consent was
obtained from all the participants.
Inclusion criteria:
1. Sixty patients diagnosed with diabetic neuropathy from both genders
their ages were ranged from 50-60 years old.
2. All patients in the study were ambulant independently.
3. All patients were under full medical control
4. HbA1c was ranged from 6.5 : 7 %.
5. Patients had diabetes more than 10 years.
Exclusion criteria:
All patients were excluded from this study if they have:
6. Psychiatric disorders or seizures.
7. Visual and auditory impairment or tremors influencing balance.
8. Other neuromuscular disorders.
9. Foot deformities and ulcers.
10. Lower limb operations.
(III) Methods: (A- Instrumentations, B- Procedures):
(A) Instrumentations: (a- For evaluation, b- For treatment):
a- For evaluation:
1. Measuring Glyclated Haemoglobin Level (HbA1c) before and after
the intervention to detect effect of the intervention on blood glucose
level.
2. Katz Index of Independence: was used to measure function outcome
and ADL.
Validity and reliability of Katz Index of Independence:
Reliability was established with twelve subjects interviewed by one
interviewer with the second-rater present but not participating in the
interview process. Inter-rater reliability was established at .85. The
Egypt. J. of Appl. Sci., 36 (1) 2021 12
validity of the Katz Index of Independence was tested by determining the
correlation of the Katz Index of Independence with four scales that
measured domains of functional status. The Physical Classification (6-
point rating of physical health), Mental Status Questionnaire (10-point
test of orientation and memory), Behavior and Adjustment rating scales
(4-6-point measure of intellectual, person, behavioral and social
adjustment), and the PSMS (6-item ADLs). A total of 180 research
subjects participated in the study, however, few received all five
evaluations. All correlations were significant at the .01 or .05 level
(Wallace and Shelkey., 2007).
b- For treatment:
1. High Tone Power Therapy (HiTop 191; gbo Medizintechnik,
Rimbach, Germany).
(B) Procedures: (a- For evaluation, b- For treatment)
a- For evaluation (pre and post treatment program):
1. Measuring Glyclated Haemoglobin Level (HbA1c).
2. Katz Index of Independence: was used to measure function outcome
and ADL.
Katz Index of Independence: the index ranks adequacy of performance
in the six functions of bathing, dressing, toileting, transferring,
continence, and feeding. Clients are scored yes/no for independence in
each of the six functions. A score of 6 indicates full function, 4
indicates moderate impairment, and 2 or less indicates severe
functional impairment.
b- For treatment:
All 60 referred patients were classified into two equal groups, each
group will consist of 30 patients:
Group I (Study): Consisted of 30 patients with diabetic neuropathy and
was received High tone power therapy and a traditional physical therapy
program (AROM exercises for LL, gentle manual stretching exercises for
LL and graduated gait training).
Group II (Control): Consisted of 30 patients with diabetic neuropathy
and was received only a traditional physical therapy program (AROM
exercises for LL, gentle manual stretching exercises for LL and
graduated gait training).
2. High Tone Power Therapy (HiTop 191): (For group I).
The high tone power therapy through using a device (HiTop 191; gbo
Medizintechnik, Rimbach, Germany).
Statistical Analysis
All statistical measurements have been carried out using the
statistical package for social sciences version26 (SPSS Inc., Chicago,
Illinois, USA). In this study, mean SD± was calculated for all measured
13 Egypt. J. of Appl. Sci., 36 (1) 2021
variables. Descriptive statistics and t-test were used for comparing mean
demographic data between both groups. Paired t-test was applied for
comparing mean demographic data between both the groups. Paired t-test
was applied for comparison within the same group. Independent t-teat
was applied for comparison between both the groups before and after the
intervention. A value of P less than 0.05 was considered statistically
significant.
Prior for final analysis, data were screened, for normality assumption
test by using Shapiro-Wilk test (P<0.05) and homogeneity of variance by
Levene's test (P<0.05). The data was not normally distributed and nonparametric
analysis. The statistical analysis was conducted by using
statistical SPSS Package program version 25 for Windows (SPSS, Inc.,
Chicago, IL). All data are expressed as mean and standard deviation for
Dermoscopy assessment and SCORAD scale assessment variables.
Wilcoxon signed ranks test to compare within each group and using
Mann-Whitney test to compare between two groups. All statistical
analyses were significant at level of probability less than an equal 0.05 (P
≤ 0.05).
RESULTS
A total of 60 type II diabetic patients participated in this study; they
were randomly distributed into 2 groups (30 patients/group). In control
group, the number frequency (percentage) of gender distribution were 19
male (63.33%) and 11 female (36.66%) and in study group were 18 male
(60.00%) and 12 female (40.00%). Comparing the general characteristics
of the subjects of both groups (Table 1) revealed that no significant
differences in age (P=0.482; P>0.05), weight (P=0.561; P>0.05), and
height (P=0.834; P>0.05) between control group and study group.
Table 1. Comparison mean values of demographic data between both
groups.
Variables
Groups (Mean ±SD)
P-value
Control group (n=30) Study group (n=30)
Age (Year) 55.13 ± 2.93 55.66 ± 2.90 0.482
Weight (kg) 82.96 ± 7.89 84.30 ± 9.68 0.561
Height (cm) 169.83 ± 9.09 169.3 ± 9.34 0.834
Data are expressed as mean ± standard deviation (SD)
P-value: probability value
The statistical analysis within each group (Table 2 and Figure 1)
revealed that there were significant difference in HbA1c percentage
(P=0.002; P<0.05) when comparing the pre-treatment mean values with
post-treatment mean values. Moreover, study group improved HbA1c
percentage (7.03%) than control group (8.77%).
Egypt. J. of Appl. Sci., 36 (1) 2021 14
The statistical analysis between study group and control group
(Table 2 and Figure 1) showed no significant differences in mean values
at pre-treatment of HbA1c percentage (P=0.907; P>0.05). However, there
were significant differences in the mean values at post-treatment of
HbA1c percentage (P=0.036; P<0.05) between study group and control
group.
Table 2: Comparison of HbA1c % variables within and between two
groups.
Variables
Groups (Mean ±SD) PControl
group (n=30) Study group (n=30) value
HbA1c %
Pre-treatment 6.73 ±0.15 6.83 ±0.16 0.907
Post-treatment 6.14 ±0.38 6.35 ±0.36 0.036*
Change 0.006 0.005
Improvement % 8.77% 7.03%
P-value 0.001* 0.0001*
Data are expressed as mean ± standard deviation (SD)
P-value: probability value * Significant (P<0.05)
Figure 1: Mean values of pre- and post-treatment of HbA1c % in study
and control groups.
The statistical analysis within each group (Table 3 and Figure 2)
revealed that there were significant difference in KATZ scale (P=0.001;
P<0.05) when comparing the pre-treatment mean values with posttreatment
mean values. Moreover, study group improved KATZ scale
(72.08%) than control group (16.56%).
The statistical analysis between study group and control group
(Table 3 and Figure 2) showed no significant differences in mean values
at pre-treatment KATZ scale (P=0.665; P>0.05). Moreover, no
significant differences in the mean values at post-treatment of KATZ
scale (P=0.587; P>0.05) between study group and control group.
15 Egypt. J. of Appl. Sci., 36 (1) 2021
Table 3: Comparison of KATZ scale variables within and between
two groups.
Variables
Groups (Mean ±SD) PControl
group (n=30) Study group (n=30) value
KATZ scale
Pre-treatment 3.20 ±0.80 2.40 ±0.81 0.665
Post-treatment 3.73 ±0.86 4.13 ± 0.50 0.587
Change 0.53 1.73
Improvement % 16.56% 72.08%
P-value 0.001* 0.0001*
Data are expressed as mean ± standard deviation (SD)
P-value: probability value * Significant (P<0.05)
Figure 2: Mean values of pre- and post-treatment of KATZ scale in
study and control groups.
DISCUSSION
This study aimed to identify the effect of high tone power
therapy on neurological symptoms and function outcome in patients
with diabetic neuropathy.
Sixty patients diagnosed with diabetic neuropathy ranged from 50
to 60 years old from different hospitals and out-patient clinics of internal
medicine and neurology in Damietta were involved in this study. Before
inclusion in this study full description of study, procedures for each
patient and written consent had been signed. Subjects included in the
study had the following criteria: should be ambulant independently,
should be under full medical control, HbA1c was ranged from 6.5: 7 %,
had diabetes more than 10 years. All patients were evaluated with
diabetic neuropathy from both genders.
Egypt. J. of Appl. Sci., 36 (1) 2021 16
The findings of the study showed that: Control group included 19
male with percentage of 63.33% and 11 female with percentage of
36.66%, Study group included 18 male with percentage of 60% and 12
female with percentage of 40%. The results showed that there were
significant differences in the mean values at post-treatment of HbA1c
percentage (P=0.036; P<0.05) between study group and control group.
Study group improved KATZ scale (72.08%) than control group
(16.56%). Moreover, no significant differences in the mean values at
post-treatment of KATZ scale (P=0.587; P>0.05) between study group
and control group.
Watkins and Koeze, 1993 reported that high-frequency electrical
spinal cord stimulation with implanted electrodes has been shown to be
effective in the relief of chronic diabetic neuropathic pain, As they used
special stimulation system (HiTop 181-H) for external muscle
contraction. They applied 1-s frequencies of 4,096–32,768 Hz,
introducing up to 5,000 mW into the muscles. Mima et. al., 2004
reported that high-frequency electrical spinal cord stimulation is effective
in the treatment of several other chronic painful conditions, including
back pain, phantom-limb pain, peripheral vascular disease and severe
angina
Tesfaye et al., 1992 had proposed that electrical stimulation
activates the dorsal columns that inhibit the C fibres, thus interrupting/
gating pain input. Furthermore, Tesfaye et al., 1993 reported that shortterm
high-frequency electrical nerve stimulation decreases human motor
cortex excitability.
The study of Kerstin et al., 2018 demonstrated that a short-term
intervention over 5 days with HTEMS has the potential to immediately
reduce sciatic pain with a significantly stronger analgesic effect than
TENS in middle-aged patients with chronic sciatica.
Although the exact mechanisms are unknown, so far it was
postulated that HTEMS enhances the release of endogenous analgesics
(Robinson A., 2008). Additionally, it increases vasodilatation (enhanced
bioavailability of nitric oxide) leading to improved microcirculation and
endoneural blood flow (locally and systemically) (Di et al., 2014).
Another important assumption is that the application of neuromuscular
electrical stimulation improves muscle strength contributing to an
improved state of motor control of the spine as it was also shown after
motor control exercise (Saragiotto et al., 2016) and (Di et al., 2014).
17 Egypt. J. of Appl. Sci., 36 (1) 2021
Experiments indicated that electrical stimulation was followed by a
decrease in the concentrations of the excitatory amino acids glutamate
and aspartate in the dorsal horn, and that this effect is mediated by a
GABAergic mechanism and microvascular changes, reduced blood flow,
nerve oxygen tension (Stevens et al., 1995) contribute to the
pathogenesis of diabetic neuropathy. Interestingly, electrical stimulation
has been reported to improve microvascular blood flow in severe limb
ischemia (Jacobs et al., 1988), effects on wound healing (indicating
improved tissue circulation (Baker et al., 1997) and improve insulin
resistance (Hamada et al., 2004).
L. Reichstein et al., 2005 founded that HF is a useful non-invasive,
non-pharmacological treatment for the management of peripheral
polyneuropathy in patients with diabetes.
CONCLUSION
On the basis of the study, It was concluded that high tone power
therapy has an effect on neurological symptoms and function outcome in
patients with diabetic neuropathy.
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November. 2018.
تأثير العلاج بجهاز التردد العالي عمي الأع ا رض العصبية والوظيفية في حالات
التهاب الأعصاب الطرفية لمرضي السکر.
وليد خالد محمود أبو الرجال * ، هاني عزت عباية * ؛ عماد محمد طه * ؛
خالد لطفي عبد الحميم حواس **
* کمية العلاج الطبيعي جامعة القاهرة قسم العلاج الطبيعي لأم ا رض القمب والأوعية الدموية / الجهاز التنفسي
وطب الشيخوخة.
** مستشفى فارسکور العام بو ا زرة الصحة.
هدفت هذه الد ا رسة إلى تحديد تأثير العلاج بجهاز التردد العالي عمي الأع ا رض العصبية
والوظيفية في حالات التهاب الأعصاب الطرفية لمرضي السکر.
ضمت هذه الد ا رسة ستون مريضا تم تشخيص إصابتهم باعتلال الأعصاب السکري ،
تت ا روح أعمارهم بين خمسين وستين عاما من مستشفي فارسکور العام بدمياط. قبل تضمين
الوصف الکامل ، تم التوقيع عمى إج ا رءات لکل مريض وموافقة کتابية. تم تقييم جميع المرضى
و مؤشر کاتز للاستقلالية. )HbA1c( من خلال قياس مستوى الهيموجموبين السکري
کان لدى الأشخاص الذين شممتهم الد ا رسة المعايير التالية: کان جميع المرضى
يستطيعون الحرکة بشکل مستقل بمفردهم. حالتهم الطبية مستقرة؛ت ا روح مستوى الهيموجموبين
7٪ و يعانون من مرض السکرمنذ أکثر من 01 سنوات. : السکري بين 5.6
Egypt. J. of Appl. Sci., 36 (1) 2021 20
تم استبعاد جميع المرضى الذين يعانون من: الاضط ا ربات النفسية أو النوبات؛ ضعف
البصر والسمع أو اله ا زت المؤثرة عمى التوازن؛ اضط ا ربات عصبية عضمية أخرى وتشوهات
وتقرحات القدم و عمميات الأط ا رف السفمية.
تم تقسيم الستين مريض الي مجموعتين متساويتين في العدد. تمقت المجموعة الاولي
العلاج بجهاز التردد العالي بالاضافة الي برنامج العلاج الطبيعي ) التدرب عمي المشي، تمارين
نشطة حرة لحرکات مفصمي الفخذ والرکبة(، في حين تمقت المجموعة الاخري نفس برنامج
العلاج الطبيعي فقط.
و )HbA1c( تم تقييم جميع المرضى من خلال قياس مستوى الهيموجموبين السکري
مؤشر کاتز للاستقلالية وذلک قبل بداية الد ا رسة واعادتها مرة اخري بعد ثلاثة اشهر عقب انتهاء
الد ا رسة.
في نهاية الد ا رسة وجد أن العلاج بجهاز التردد العالي يحسن من الأع ا رض العصبية
والوظيفية في حالات التهاب الأعصاب الطرفية لمرضي السکر.
21 Egypt. J. of Appl. Sci., 36 (1) 2021