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Effect of Magnetic Therapy on Balance Deficits in patients with Diabetic Polyneuropathy:

Randomized Controlled Trial.

Waheed Ali Hasan Abu-Mansour Filimban1, Amir Abdel-Raouf El-Fiky2, Omar Farouk Farahat
Helal3*, Ashraf Abdelaal Mohamed Abdelaal4
1
Ph.D., Assistant Professor, Department of Pathology, the College of Medicine, Umm Al-Qura
University, Makkah, Saudi Arabia.
2,3,4
Ph.D., Assistant Professor at College of Applied Medical Sciences, Physical Therapy
Department, Umm-Al-Qura University, Makkah, Saudi Arabia.

Abstract

Background: Diabetes mellitus (DM) is one of the most common chronic diseases all over the
world. Incidence of and complications of DM has been increased over the last decade. Diabetic
polyneuropathy (DPN) plays a significant role in falling among elderly patients because of
significantly impaired sensation in the feet and reduced ability to properly control balance
during daily activities. The aim of this study was to evaluate the effect of low frequency pulsed
magnetic therapy (LFPMT) on balance in patients with DPN. Methods: Thirty male patient with
DPN were randomly assigned into two groups G1 (Study group) and G2 (Control group). Balance
was evaluated pre and post-study using the Biodex Stability System and Short Form of Berg
Balance Scale (SFBBS). G1 was treated with LFPMT for 30 min in session, 3 sessions in a week,
for six weeks, while G2 received identical sham sessions. The results: Pre-study (between
groups) comparison revealed that the mean values of the overall stability indices (OSI) were
(1.75 ± 0.75, 2.12 ± 0.45) for G1 and G2 respectively (P=0.11), the mean values of the SFBBS
were (18.8± 3.61, 19.8± 1.93) for G1 and G2 respectively (P=0.35). At the end of the study
(within groups) comparison revealed that the mean values of the OSI were (1.41 ± 0.78, 2.16 ±
0.7) for G1 (P=0.02) and G2 (P= 0.77) respectively, the mean values of the SFBBS were (23.07
± 3.61,19.6 ±1.18) for G1 (P=0.00002) and G2 (P= 0.68) respectively. Post-study (between
groups) comparison revealed that there were significant differences in SFBBS (P= 0.002) and
OSI (P = 0.01), but in favor of G1. Conclusions: LFPMT is an effective therapeutic modality in
improving balance in patients with DPN.

Key words: Diabetes - Polyneuropathy - Balance Deficits - Magnetic therapy.

* Corresponding Author: Email: dr.mon5@hotmail.com. College of Applied Medical

Sciences, Physical Therapy Department, Umm-Al-Qura University, Makkah, Saudi Arabia.

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Introduction:
Diabetes mellitus is a complex and complicated disease, two people are diagnosed with
diabetes every ten seconds; somewhere in this world. The impact of diabetes is obvious in both
developed and developing countries. The burgeoning evidence on new technologies and
therapeutic treatments is rapidly expanding knowledge and the ability to manage diabetes and its
complications is challenging physicians and other healthcare professionals who care for people
with diabetes. Diabetes with potentially devastating complications that affects all age groups, is
considered worldwide as is a serious condition. 11
Approximately 50% of all people with DM will develop mild to severe forms of nervous
system disease in the form of sensory, motor, or autonomic, peripheral neuropathy (PN) or a
combination of these types of neuropathy that appears 25 years or later after diagnosis. 19
Type 2 diabetes mellitus (T2DM) is a metabolic disease characterized by insulin
resistance and resultant hyperglycemia that can contribute to the development of both
microvascular and macrovascular disease. Although, there is a clear genetic influence on the
development of DM, environmental factors such as obesity and physical inactivity can expedite
this process in humans. 41
Type 2 diabetes is an epidemic disease has a long-term consequence translate that render
wide human suffering and economic costs; however, much of the morbidity associated with long
term microvascular and neuropathic complications can be substantially reduced by interventions
that achieve glucose levels close to the non-diabetic range. While, new classes of medications
and numerous combinations have been proved to lower glycemia, current-day management has
failed to attain and maintain the glycemic levels to provide optimal health care status for people
with diabetes. 29
Type 2 diabetes mellitus, conducts a variety of complications that include neuropathy,
nephropathy, retinopathy, and cerebrovascular and cardiovascular disease. 24
Type 2 diabetes shows a variety of signs and symptoms, and associates with complex
biochemical, functional and structural abnormalities of the peripheral nervous system. Diabetic
peripheral neuropathy (DPN) is a frequent and troublesome complication of diabetes mellitus. It
is the major reason for morbidity and mortality among diabetic patients. It is also frequently
associated with debilitating pain. 15
Because T2DM develops gradually and may not produce its apparent symptoms early; it
often goes undiagnosed for many years, and by the time of diagnosis; microvascular,
macrovascular and neuropathic complications that seriously erode quality of life are clearly
established. 18,30,16
Type 2 diabetes is a rising epidemic of giant proportions in the Arabic-speaking
countries, weaken the benefits of modernization and economic revival. 7
The devastating problem in T2DM is that it frequently remains undiagnosed for many
years, because the hyperglycemia develops gradually. Traditional symptoms of diabetes,
including polyphagia, polydipsia, and frequent urination are not obvious enough at an earlier
stage, so it is hardly discovered early by the patients. 6
As a rule, the diagnosis of diabetes can be confirmed based on either glycated
hemoglobin (HbA1c) assessment where HbA1c > 6.5% on two occasions or on plasma glucose
assessment where fasting plasma glucose > 126 mg/dl (7.0 mmol/L) or oral glucose tolerance
test – two-hour plasma glucose of 200 mg/dl (11.1 mmol/L) on two occasions or symptoms of
diabetes and a casual plasma glucose of greater than or equal to 200 mg/dl (11.1 mmol/L), 31

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there is a growing tendency to use HbA1c; a marker of chronic glaucoma and a standard
biomarker for the adequacy of glycemic management. 6
Saudi Arabia is ranked with the 6th highest prevalence of DM worldwide, and is
expected to maintain this position for the coming 20 years, with a prevalence rate of 20 % among
20 - 79-year-old adults. Other countries ranked in the top ten include Kuwait (21.1%), Lebanon
(20.2%), Bahrain (19.9%) and the United Arab Emirates (19.2%). 21
Among Saudi patients, there is a 31% prevalence of retinopathy in patients who had
T2DM for at least 10 years, 2 the prevalence of neuropathy in patients with diabetes living in the
Western part of Saudi Arabia is about 82%; which represents among the highest prevalence in
the world; with another 57% being asymptomatic. 3
The most common problem affecting people with diabetes is polyneuropathy, which
appears in 50 % of patients with diabetes above the age of 60 leading to pain and impaired
movement sensation in all limbs. 13,12
People with peripheral neuropathy caused by diabetes, commonly experience a balance
disorder and consider ne of the main causes of falling among elderly patients. 25,39
Significantly impaired sensation in the feet, movement-strategy deterioration, biomechanics,
structural disorders, and proprioception impairment are different causes among diabetic patients
reducing their ability to control balance properly during daily activities. 10,4,14
The inability of the central nervous system (CNS) to fittingly integrate available postural
control information, a boost from the use of vestibular information and the dependence on visual
information are additional factors that vary the style of postural control in patients with
DN.33,8,22,20
Reported studies of patients with diabetic neuropathy postural sway propose a relative
deficit in their ability to maintain posture and elucidate a higher instability than that observed in
patients without diabetes. 38
Management of T2DM is complex and controversial, in part because of presence of wide
arrays anti-diabetic drugs. [32] The main target in all settled treatment protocols is to control
glycemia, that, the risk of vascular complications will be reduced. 36
Because T2DM is a treatable disorder; a primary interest should be to establish effective
therapeutic procedures that will able to treat the disease and alleviate its accompanied
complications for those increasing population worldwide.1
Low frequency pulsed magnetic therapy (LFPMT) is a safe, serviceable and
accompaniment tool that can be used in the management of diabetic neuropathy. Pulsed
Electromagnetic field therapy was proved to have the ability to temper some parameters of
peripheral nerve function and the possibility to commute neuropathic pain and nerve impulse in
patients with diabetic polyneuropathy. 17,9
Focusing our efforts to provide satisfactory clues for this epidemic is a priority that
cannot be postponed. More attention and effective therapeutic procedures are continuously
desired; more studies and a better focus are warranted to fight this disorder and its
complications.5

Subjects, Materials and Methods:

Subjects
Thirty diabetic polyneuropathic patients were selected and divided into two groups,
which were: 1st group (G1; Study group; n=15) and 2nd group (G2; Control group; n=15). All
patients' ages were over 50 years, they were all suffering from balance disturbance, were

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diagnosed according to their neurological diagnosis and laboratory findings, with duration of
illness (DM) over 10 years and a duration of Polyneuropathy over 12 months.

Materials
For Assessment:
1. Short Form of Berg Balance Scale (SFBBS): which measure functional balance.
2. Biodex Stability System (Biodex Corporation, Shirley, NY): to measure dynamic balance.
3. HbA1c analysis kits: which measure level of glycated hemoglobin in last three months.
For Treatment: Low frequency pulsed magnetic field device (ASA srl Via A. Volta, 9- 36057
ARCUGNANO (VI) ITALIA).

Methods
Assessment Procedures
All patients were assessed by physicians through a neurological assessment sheet.
a. All patients were assessed by the Short Form of Berg Balance Scale (SFBBS) and Biodex
Stability System.
b. All patients were evaluated for HbA1c %.

Treatment Protocol:
All patients were evaluated at the beginning and at the end of the treatment program.
Patients in the study group received the "low frequency pulsed magnetic field treatment" for 30
min per session, applied tricer weekly for six weeks, while patients in the control group received
sham exposure for 30 min per session, applied tricer weekly for six weeks.

Statistical analysis:
Statistical analyses were performed using SPSS software (version 16.0). Descriptive
statistical analysis was performed for all pre and post treatment variables and data was expressed
as mean ± SD. Mean changes in mean values of overall stability indexes and Short Form of Berg
Balance Scale within and between groups were analyzed to test hypothesis within (Paired t-test)
and between (Unpaired t-test) groups. For SFBBS comparison, the Mann-Whitney test of
unpaired t- test was used to compare the baseline mean scores between both groups and the
Wilcoxon matched-pairs signed rank test for comparison before and after treatment mean sores
within each group. The level of significance was set at p < 0.05.

Results:
At the evaluation-1, there were non-significant differences in age, Height, Weight, body
mass index (BMI), T2DM duration, and Glycated hemoglobin % (HbA1C%) between the two
groups (p > 0.05) (Table I).

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Table (1). The general characteristics of participants in both groups

(Mean ± SD), (P< 0.05).
Study Group Control Group
Variables P-value
(Group 1; N=15) (Group 2; N=15)
Age (year) 53.8± 8.87 (33-70) 54.53±0.6 (40-72) 0.84‫٭٭‬
Height (m) 171.27±4.17 (165- 180) 172.73±3.9 (169-180) 0.33‫٭٭‬
Weight (kg) 75.07±10.52 (60-97) 76.4±8.08(65-85) 0.7‫٭٭‬
BMI 25.53 ± 2.88 25.67 ± 3.21 0.89‫٭٭‬
HbA1c (%) 8.67±2.6 9.1±2.8 0.66 ‫٭٭‬

Average DM duration (year) 12.33±7.62 (3-30) 10.33±7.05 (1-30) 0.46‫٭٭‬

Significant: P < 0.05 * Significant ** Non significant FBG= Fasting blood glucose

Pre-study results revealed that there were non-significant differences between the 2
groups in SFBBS and postural stability. Data collected from the two groups pre and post-study
were compared within and between groups (Tables II and Figures 1,2).

Table (2). Within and between groups' comparison of SFBBS and

Postural Stability (Mean ± SD)

Variables Groups Pre -study Post-study T,P values

Study group
18.8 ± 3.61 23.07 ± 3.6 (-6.35, 0.00002‫)٭‬
(N=15)
SFBBS Control group
19.8 ± 1.93 19.6±1.18 (0.42, 0.68‫)٭٭‬
(N=15)
T,P values (-0.95-, 0.35‫)٭٭‬ (3.53, 0.002‫)٭‬
Study group
1.75 ± 0.75 1.41 ± 0.78 (2.62, 0.02‫)٭‬
(N=15)
Postural Control group
2.12 ± 0.45 2.16 ± 0.7 (-0.3-, 0.77‫)٭٭‬
Stability (N=15)
T,P values (-1.65- , 0.11‫)٭٭‬ (-2.75, 0.01‫)٭‬

Significant: P< 0.05 * Significant ** Non significant

Short Form of Berg Balance Scale (SFBBS):

Within-groups' comparison revealed that there were significant increases in SFBBS mean
value between the pre and post-study evaluation points in the study group (P= 0.00002), while
there was non-significant decrease in SFBBS of the control group between the same evaluation
points (P=0. 68) (Table II). Between-group comparison revealed that there were statistically
significant difference in mean values of SFBBS between groups at post-study evaluation point;
but in favor of the study group (p= 0.002) (Table II and Figure 1).

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Figure (1): The SFBBS mean values in both groups

Postural Stability test:

Within-group comparison revealed that there were significant decrease in postural
stability test mean values between the pre and post-study evaluation points in the study group
(P= 0.02), while there was non-significant increase in postural stability of the control group
between the same evaluation points (P=0. 77) (Table II). Between-groups' comparison revealed
that there were statistically significant difference in mean values of postural stability between
groups at post-study evaluation point; but in favor of the study group (p= 0.01) (Table II and
Figure 2).

Figure (2): The overall postural stability test means values in both groups.

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Discussion:
The primary aim of this study was to assess the effect of pulsed electromagnetic therapy
on balance in patients with diabetic polyneuropathy using the postural stability test as a part of
the Biodex stability system and Short Form of Berg Balance Scale (SFBBS) test as tools to
assess balance impairment.
The study was conducted on thirty male patients suffering from diabetic polyneuropathy.
They were divided equally into a study group (G1) and control group (G2) in which they were
closely matched as possible in term of age, body weight, height and duration of illness.
The results revealed a significant difference in the mean values of the overall stability indexes
between the study and control groups. The results also show a highly statistically significant
difference in the mean values of the SFBBS between the two groups.
The results discussed above clearly indicate that pulsed electromagnetic therapy has an
effect on balance in patient with diabetic polyneuropathy. The possible explanation for this could
be that frequency-modulated electromagnetic neural stimulation (FREMS) is able to commute
some parameters of peripheral nerve function; increase in sensory tactile perception and motor
nerve conduction velocity. 9
Application of Pulsed electromagnetic field (PEMF-CM) facilitate recession of the main
clinical symptoms of DPN, improve the conductive function of peripheral nerves, improve the
state of l a afferents, and improve the reflex excitability of functionally diverse motor neurons in
the spinal cord. 27
Pulsed electromagnetic field (PEMF-CM) at 10 Hz was found to have therapeutic
efficacy, especially in the initial stages of DPN and in patients with diabetes mellitus for up to 10
years. 28
Smith 35 found that PEMF stimulate the arteriolar micro vessel diameters in rat cremester
muscle, which, in turn, support that it can improve the microenvironment for the tissues leading
to regeneration.
Another probable reason for the improvement what stated by Vinik 40 that PEMF
stimulates neuropathic factors that is known to play an important role in the development,
keeping, and permanence of neural tissues. The effect of PEMF is to arouse a biologic response
such as cell proliferation that enhances nerve regeneration and accelerates recovery.17
Our findings support the hypothesis conducted by Mert et al.26 that PEMF had a
significant anti-hyperglycemia efficacy in diabetic rats, and this reduction in blood glucose level
could have a positive effect on improving nerve conduction velocity.
A previous study by Greek et al. 17 provided conclusive evidence that PEMF treatment has the
chance to modulate neuropathic pain and nerve impulse through a decrease in endoneural
hypoxia, and improve in microcirculation that leads to positive changes after 30 min for 12
consecutive days treatment with PEMF.
Our results correspond with Salsabili et al. 34 who reported that training using sensory
and reactive movement strategies with external visual feedback improves standing postural
control in patients with DN by modifying the subclinical constraints that contribute to disordered
balance.
Moreover, our hypothesis is supported by a study done by Tasset et al. 37 which had
indicated that PEMF stimulation can accelerate nerve conduction velocity and increase
compound action potential of sciatic nerve, enhance nerve growth factor levels, and reduce both
oxidative damage and neuronal loss.

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Lei et al 23 suggested that Pulsed electromagnetic field (PEMF) might have direct corrective
effects on injured nerves and would be a potentially promising non-invasive therapeutic tool for
the treatment of DPN.

Conclusion
The results of the present study showed a very highly significant difference in the mean
values of the overall scores of the postural stability (Biodex stability system) and highly
significant difference in the mean values of the Berg Balance Scale (BBS) test after pulsed
electromagnetic therapy for 30 min, 3 sessions per week, for four weeks. Our study provides a
conclusion that pulsed electromagnetic therapy has a significant effect on improving balance in
patients with diabetic polyneuropathy.

Acknowledgements
The authors would like to thank the Institute of Scientific Research and Revival of Islamic
Heritage at Umm Al-Qura University (project # 43309001) for financial support.

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