pedographic changes post anodyne therapy in diabetic peripheral

Transcription

Kingdom of Saudi Arabia
King Saud University
College of Applied Medical Sciences
Department of Rehabilitation Sciences
PEDOGRAPHIC CHANGES POST
ANODYNE THERAPY IN DIABETIC
PERIPHERAL NEUROPATHY
FEDDAH MOKBEL AL-ENAZI
A Thesis Submitted in Partial Fulfillment of The
Requirements for The Master Degree in
Physical Therapy
Department of Health Rehabilitation Sciences
College of Applied Medical Sciences
King Saud University
Riyadh, Saudi Arabia
1430 H-2009 G
CONTENTS
Chapter
Content of Chapter
Page No
Chapter (1)
Introduction
Hypothesis
Purpose Of Study
1
5
5
Chapter (2)
Literature Review
6
Chapter (3)
Subjects, materials And Procedures
14
Subjects
14
Materials
16
Assessment Procedures
17
(1)
Pain Assessment:
19
(2)
Cutaneus Sensation
19
Assessment
(3)
Vibration Perception Threshold
21
Assessment
(4)
Balance And Gait Assessment
22
(5)
Plantar Pressure Assessment
24
Treatment Procedures
26
Statistical Analysis
28
I
Results
29
Chapter (4)
Discussion
50
Chapter (5)
Summary
Chapter (6)
Conclusion
53
Recommendations
55
Bibliography
56
Appendices
57
62
II
Table No.
Titles of Table
Page No.
Table (1)
- Mean ± S.E.M for Physical Characteristics of Patients in
Both Groups
30
Table (2)
-Mean ± S.E.M of VAS Scores Pre and Post 4 Weeks in
Both Groups.
31
Table (3)
-Mean ± S.E.M of Semmes-Weinstein monofilament
32
Values Pre and Post 4 Week in Both Groups
Table (4)
-Mean ±S.E.M of Neurothesiometer for Right Feet Pre
34
and Post 4 Weeks
Table (5)
-Mean ±S.E .M of Neurothesiometer of left Feet Pre and
Post 12 Weeks.
35
Table (6)
- Mean ± S.E.M of Tinetti Scale Values for Balance and
Gait Pre and Post 4 Week in Both Groups
37
Table (7)
- Mean ± S.E.M of Force Time Integral (FTI) for
Right Feet Pre and Post 4 Weeks in Both Groups
39
Table (8)
-Mean ± S.E.M of Pressure Time Integral (PTI) for
Right and Left Feet Pre and Post 4 Weeks in Both
Groups
Table (9)
-Mean ± S.E.M of Maximum Force (MF) for Right and
Left Feet Pre and Post 4 Weeks in Both Groups
Table (10)
-Mean ± S.E.M of Peak Pressure (PP) for Right and Left
Feet Pre and Post 4 Weeks in Both Groups
41
43
45
Table (11)
-Mean ± S.E.M of Contact Area (CA) for Right and Left
47
Table (12)
-Mean ± S.E.M of Contact Time (CT) for Right and Left
49
III
LIST OF FIGURES
Figure No.
Title of Figure
Page No.
Figure (1)
Gender In Both Groups.
14
Figure (2)
(A) Weight and Height Scale, (B), Blood Pressure
Sphygmomanometer, (C) Blood Glucose Analyzer.
18
Figure (3)
Visual Analogue Scale of Pain (VAS).
19
Figure (4)
Application of Semmes - Weinstein Monofilament
20
Figure (5)
Application of Neurothesiometer for VPT Assessment.
21
Figure (6)
Balance and Gait Assessment by Tinetti Scale.
23
Figure (7)
E-MED Platform System, Novel.
25
Figure (8)
Patient with DPN treated by Anodyne Therapy System
26
Figure (9)
Mean of VAS Scores Pre and Post 4 Weeks in Both
Groups.
31
Figure (10)
Mean of SWF Value (mg) Pre and Post 4 Weeks in Both
Groups.
33
Figure (11)
Mean of Vibration Perception Threshold Value (volt) for
Rt Feet Pre and Post 4 Weeks in Both Groups.
34
Figure (12)
Mean of Neurothesiometer Value for Lt Feet Pre and Post
4 Weeks in Both Groups.
36
Figure (13)
Mean of Tinetti Scale Values for Balance and Gait Pre
and Post 4 Weeks in Both Groups.
37
Figure (14)
Mean of force Time Integral (FTI) for Right and Left Feet
Pre and Post Weeks in Both Groups.
39
Figure (15)
Mean of Pressure Time Integral (PTI) for Right and Left
Feet Pre and Post Weeks in Both Groups.
41
Figure (16)
Mean of Maximum Force (MF) for Right and Left Feet
Pre and Post Weeks in Both Groups.
43
IV
Figure (17)
Mean of Peak Pressure (PP) for Right and Left Feet Pre
and Post Weeks in Both Groups.
45
Figure (18)
Mean of Contact Areas (CA) for Right and Left Feet Pre
47
Figure (19)
Mean of Contact Time (CT) for Right and Left Feet Pre
49
V
LIST OF APPENDICES
Appendix No.
Title of Appendix
Page No.
62
Appendix 1
-Informed Consent Form.
Appendix 2
-Patient Assessment.
Appendix 3
-Physical Examination.
Appendix 4
-Data of Pedography of Both Feet Pre and Post
4Weeks of Physical Therapy for All Patients.
68
Appendix 5
-Tinetti Assessment Tools.
72
64
67
VI
LIST OF ABBREVIATIONS
Abbreviation
The Meaning
ATS
Anodyne Therapy System
CA
Contact Area
CT
Contact Time
DM
Diabetes Mellitus
DPN
Diabetic Peripheral Neuropathy
EC
Eyes Closed
FDA
Food And Drug Administration
FTI
Force-Time Integral
LOPS
Loss Of Protective Sensation
MS
Maximum Force
MHS
Metatarsal Heads
MIRE
Monochromatic Near Infrared Photo Energy Devices
PN
Peripheral Neuropathy
PP
Peak Pressure
PTI
Pressure-Time Integral
SFN
Small Fiber Neuropathies
SWM
Semmes-Weinstein Monofilaments
VAS
Visual Analogue Scale
VPT
Vibration Perception Threshold
VII
ACKNOWLEDGMENTS
First of all, a great thankful to our god for his succeed. Then I
would like to express my sincere gratitude to my parents for their
praying and feeling. Deep thanks for my husband and my suns for
their supports and their patients along my study duration. Also I
would like to thank my brothers and sisters for their supports.
I would like to thank my supervisor, prof. Alaa Abdulsalam,
Professor, Department of Health Rehabilitation Sciences, College of
Applied Medical Sciences, for his advices, instructions, and comments.
I well not forget his hard work and his time which spent to bring this
project .I appreciate his patient, his trust, and his believe on my work.
Special and great thanks for Dr. Farag Abed EL-Moneim Aly,
Assistance Professor , Department of Health Rehabilitation Sciences,
College of Applied Medical Sciences, King Saud University ,for his
help and supports to finish my work.
I am grateful to Ministry of Health represented in King Fahad
Medical City for giving me this chance to carry out this study for a
Master degree.
I would like to extend my thanks to King Saud University
represented in postgraduate center and King Abdulaziz City for
Sciences and Technology to support this research.
A deep thanks for all the staff in Physical Therapy Department,
King Abdulaziz University Hospital for their supports, help, and
kindness.
I would like to thanks Porf, Dr. Khalid Al-Rubeaan, Director of
University Diabetic Center, King Abdulaziz University Hospital, and
Consultant Endocrinologist, and all the employees for their support.
IX
I am grateful for Dr. Nasser M. Al-Daghri, Director of research
center, King Abdulaziz University Hospital, and all the employees for
their support.
I would like to thanks Dr. Saleh AL-Tayyar, Director of Foot
Print Center, for his help and support.
I am grateful for the Research Ethical Committee of the Medical
College for approving this project.
I want to thanks all patients who participated in this study, and I
grate appreciate their cooperation.
Last but not least, I would like to thanks all my colleagues in
Master Program of Geriatric Rehabilitation and everybody know me
for their support and help.
X
ABSTRACT
BACKGROUND AND PURPOSE:
Peripheral neuropathy is a frequent complication of type 1 and
type 2 diabetes, affecting between 40 and 60% of individuals.
Physiologically and pathologically, diabetic neuropathy manifests as a
lesion in the nerve fibers that is sometimes functional, and usually
anatomical. These lesions develop progressively. Hyperglycemia
definitely plays a major role in the physiological and pathological
mechanisms that lead to the lesion, even though it is not the sole factor
.Painful diabetic peripheral neuropathy (DPN) is a common
complication of diabetes. The loss of sensation associated with diabetic
peripheral neuropathy (DPN) is thought to contribute to impaired
balance, altered gait patterns, and increased risk of falling. Application
of monochromatic near infrared photo energy (MIRE) may cause at
least temporary increases in foot sensitivity and reductions in
neuropathic pain.
METHODS:
Forty two patients with diabetic peripheral neuropathy
completed this study. In control group there were (20) patients with
ages ranged from 50 to 65 years and mean 58.05±4.69 years while in
the treatment group there were (22) patients with ages ranged from 50
to 79 years and mean 60.36 ± 9.042 years. All patients in the control
group did physical assessment procedures which consists
of: pain
assessment by visual analogue scale(VAS) of pain, cutaneus sensation
assessment by Semmes-Weinstein monofilaments (SWM), vibration
perception threshold assessment by neurothesiometer, balance and gait
assessment by Tinetti Scale, plantar pressure assessment, while all
XI
patients in the treatment group did the same physical assessment
procedures mentioned above beside the application of monochromatic
near infrared photo energy (MIRE) which consists of
30-min
treatments three times a week for 4 weeks for a total of 12 treatments
for both feet. All assessment procedures were repeated after four
weeks.
RESULTS: The difference in pain score, baseline Semmes Weinstein monofilament values, and vibration perception threshold
(VPT) values of Rt & Lt feet, in the treatment group reached statistical
significance (p= 0.000) after 4 weeks of Anodyne therapy. There was
no difference in control group. While there is no significant
improvement in pedography of both feet of both groups after 4 weeks.
CONCLUSION:
There was highly statistical significant improvement in the
means of VAS of pain, baseline Semmes - Weinstein monofilament
values, and vibration perception threshold (VPT) values of Rt & Lt
feet in the treatment group after 4 weeks of Anodyne therapy, and
there was no difference in control group. While there is no significant
improvement in foot pedography in both groups after 4 weeks.
XII
INTRODUCTION
INTRODUCTION
Diabetes mellitus ( DM ) is a group of metabolic diseases
characterized by hyperglycemia resulting from defects in insulin
secretion, insulin action, or both.
The chronic hyperglycemia of
diabetes is associated with long - term damage, dysfunction, and
failure of various organs, especially the eyes, kidneys, nerves, heart,
and blood vessels.1
The prevalence of diabetes in Saudi Arabia is about 24%, one
of the highest in the world. Moreover, the world health
organization estimates that the Middle East region will have the
highest increase in the prevalence of diabetes mounting at 163% by
the year 2030.The prevalence of (DM) in the Saudi population is
high and 90% of diabetes suffers from type II DM. The highest
prevalence was in urban females aged 51 - 60 years (49%). In rural
females of similar age, the prevalence was 29%.2,3
Painful diabetic peripheral neuropathy ( DPN ) is a common
complication of diabetes. It is estimated that in patients with a 25 year history of diabetes, approximately 50% will develop
neuropathic pain. Neuropathic pain is defined by the International
Association for the Study of Pain as pain initiated or caused by a
primary lesion or dysfunction in the nervous system.
In patients
with diabetes, these lesions arise from several pathophysiological
mechanisms, including a persistent hyperglycemic state. The
overall duration and degree of hyperglycemia correlates with the
extent of nerve damage.4
The neuropathic foot has pathological changes in sensory
fibers. Due to sensory neuropathy, patients are unable to sense
pressure, pain or microtrauma on the foot. An injury or
infection in the neuropathic foot results in a serious medical
condition often leading to amputation..5
The loss of sensation associated with diabetic peripheral
neuropathy ( DPN ) is thought to contribute to impaired balance,
altered gait patterns, and increased risk of falling.
People with
DPN exhibit greater postural sway when standing and numerous
gait studies have revealed characteristic changes in walking
patterns
associated
with
DPN,
including
decreased
power
generation at the ankle, decreased knee joint flexion, and decreased
ground reaction forces. 6
Measurement of pain is difficult as pain is subjective: only the
person experiencing the pain can judge its severity. In addition, the
perception of pain may be altered by physiological, emotional, and
environmental factors. Visual analogue scales are simple and
efficient and have been widely used in clinical activity and
in
research. The most usual visual analogue scale is a 10 - cm
horizontal line with the two endpoints labeled no pain and worst
pain ever.
The patient marks a point along the line to rate their
current pain intensity.7
2
The use of Semmes-Weinstein nylon monofilament ( SWM )
in periodic mapping of the feet has been promoted as a simple,
quantitative measure of sensory neuropathy and development of
foot ulceration in patients with diabetes.8
Vibration perception threshold ( VPT ) testing is the
quantitative modality most commonly used for assessment of
diabetic sensory polyneuropathy. Results are believed to represent
large fiber sensory nerve function because of evidence for strong
associations with sural nerve action potential amplitude and with
clinical measures of large fiber function. 9
Measurements of plantar pressure provide an indication of
foot and ankle function during gait and other functional activities,
because the foot and ankle provide both the necessary support and
flexibility for weight bearing and weight shifting while performing
these activities. Although plantar pressure data have been
recognized as an important element in the assessment of clients
with diabetes and peripheral neuropathy, information derived from
plantar pressure data also can assist in determining and managing
the
impairments
associated
with
various
musculoskeletal,
integumentary, and neurological disorders. 10
Pedography is, by definition, a measurement of the force
distribution under the sole of the foot and can be done in a static
and dynamic way.
The objective documentation of foot function
before and after therapeutic intervention is greatly enhanced by the
use of devices capable of measuring dynamic foot force distribution.
3
Efforts to develop this technology date back to the late 19th century,
but only with recent advances in computers has it been possible to
produce quantitatively accurate high resolutions of foot force
distribution with high sampling rates and easily interpreted graphic
displays.
Over the years, a variety of methods have been used to
study foot pressure. 11
Gait disorders are common in elderly populations and their
prevalence increases with age. At the age of 60 years, 85% of people
have a normal gait, but at the age of 85 years or older this
proportion has dropped to 18%. Gait disorders have devastating
consequences. Perhaps the most notorious corollary is falling,
which is often caused by an underlying gait problem. Injuries
caused by accidental falls range from relatively innocent bruises to
major fractures or head trauma. Another important consequence is
reduced mobility, which leads to loss of independence. 12
Biomechanical gait analyses have shown that neuropathic
patients walk with slower speeds, shortened stride lengths, greater
double support times, decreased ankle moments and powers, and
decreased vertical and anterior–posterior ground reaction forces
when compared to matched controls.13
Anodyne therapy system is non-invasive , drug-free device that
delivers Monochromatic Near infrared Photo Energy ( MIRE )
through infrared light-emitting diodes, with a wavelength of 890
nm, that are mounted in flexible therapy pads. When the therapy
pads are placed in direct contact with the skin , the invisible
4
infrared light, is absorbed by cells in the body and blood vessels
begin to dilate, resulting in increased circulation in that area .
Increased blood circulation stimulates healing and relives pain. 14
Monochromatic Near infrared Photo Energy devices ( MIRE )
were approved by the Food and Drug Administration in 1994 to
increase circulation and reduce pain. There are reports in the
literature of the use of MIRE for treating patients with wounds and
soft-tissue trauma, but several recent studies describe the use of
MIRE
in
treating
patients
with
lower-extremity
sensory
neuropathy. 15
Purpose of Study:
The aim of this study is to investigate the effects of Anodyne
therapy on foot pattern, vibration sensation and pain in patients with
diabetic peripheral neuropathy.
HYPOTHESIS:
Anodyne therapy
will not have effects on foot pattern,
vibration sensation and pain in patients with diabetic peripheral
neuropathy.
5
LITERATURE REVIEW
LITERATURE REVIEW
Diabetes mellitus can be defined as a “syndrome of abnormal
carbohydrate metabolism with acute metabolic complications and
chronic vascular, neurological, and orthopedic complications
affecting most organ systems”. It is a leading cause of blindness,
renal disease, heart, peripheral vascular disease, and lower limb
amputation. Diabetes can have serious complications such as
hyperglycemia, ketoacidosis, diabetic neuropathy, nephropathy,
retinopathy, peripheral vascular disease and lower limb ulceration.16
Diabetic peripheral neuropathy ( DPN ) affects 30–50% of
patients with diabetes. This complex disorder affects different sets of
lower-limb nerve fibers and leads to a variety of clinical
manifestations including pain and paresthesiae, numbness in the feet,
and unsteadiness. Moreover, the gradual increase in neurological
deficits, which is central to the natural history of diabetic peripheral
neuropathy, is often accompanied paradoxically by improvement or
even
disappearance
of
painful
symptoms.
Lacking
warning
symptoms or cues to danger, this large population of relatively
asymptomatic patients is at high risk of neuropathic foot ulceration.
It is estimated that as many as 15% of individuals with diabetic
neuropathy will experience a foot ulcer during their lifetime.
Furthermore, foot ulcers precede 85% of all nontraumatic lower
limb amputations in the U.S., resulting in high morbidity and
mortality. 17
6
Peripheral neuropathy can be categorized based on the
function of the involved nerve fibers or on their diameter and
conduction velocity. Regarding the functions of different nerve fibers,
three types of peripheral nerve fibers can be distinguished: somatic
motor fibers, somatic sensory fibers and autonomic fibers. Sensory
functions include sensation for touch, vibration, temperature and
pain. Autonomic functions include sweating, bowel movements,
lacrimation, sexual functions, blood pressure and heart rate
variability. Based on size, large diameter myelinated ( A-alpha and
A-beta ), medium size myelinated ( A-gamma ), small diameter
myelinated ( A-delta ) and unmyelinated ( C ) nerve fibers can be
distinguished. A-alpha and A-beta nerve fibers carry motor
functions, vibration sense and touch. A-gamma fibers carry motor
function to muscle spindles. A-delta fibers and C-fibers carry
temperature and pain sensation and autonomic functions. Small fiber
neuropathies ( SFN ) preferentially affect small-calibre myelinated
and unmyelinated fibers, leaving the larger myelinated fibers
relatively unaffected. 18
Carnegie et al. (2001) conducted a double-blind, placebocontrolled study of eight patients (16 limbs) with loss of protective
sensation (LOPS). Each lower limb on each patient received a single,
45-minute ATS treatment with four therapy pads. In addition, one
limb was treated with functional diode arrays, while the opposite
limb was treated with inactivated (placebo) arrays. All actively
treated limbs achieved protective sensation, as demonstrated by an
increased number of sensation sites, compared to the placebo group.
The study did not include measuring the duration of the improved
7
sensation. The study was limited by the small sample size and by a
lack of both randomization sampling and double blinding. 19
Goldman (2001) conducted a retrospective study of nine
patients who received 12 ATS treatments with two therapy pads. Reexamination occurred at 12–24 weeks after the final ATS treatment
was completed. All 18 limbs obtained improved sensation as
measured by Semmes-Weinstein monofilaments (SWMs); at followup, however, eight patients experienced a decline in sensation, and
one patient maintained the sensory improvement obtained from the
therapy. Goldman indicated that to achieve long-term restoration of
sensation, treatment would have to remain ongoing. These studies
showed that improved sensation diminished as early as 12 weeks
after the therapy ceased. No placebo was used for the study; the
sample size was small; participants were not randomly selected; and
the study was not double-blinded. 20
Kochman et al. (2002) conducted a small case study of 49
consecutive subjects to test the effectiveness of ATS in patients with
diabetic peripheral neuropathy (DPN), using sensation as an
indicator measure. All participants had established DPN and were
treated with ATS. A decrease in LOPS as a consequence of diabetic
neuropathy was the endpoint. SWMs were used to measure hot and
cold sensation. Values of 4.56 and higher were noted in all
participants prior to treatment. Patients were stratified according to
LOPS levels; seven patients (14%) had levels between 4.56 and 6.45,
and the remaining 42 patients (76%) had levels of 5.07 and higher.
Fifty-four percent of patients had no sensation, while 46% had
8
impaired sensation. After six treatments, the SWM test was repeated,
and 48 subjects (98%) exhibited some improved sensation. After 12
treatments, all had noted improved sensation. A further analysis
revealed that patients with both type I and type II diabetes benefited
from the treatment; however, after 12 weeks of treatment, none of
the participants had values higher than 4.93. Although these results
suggest that monochromatic phototherapy may provide improved
pressure and heat sensitivity in patients with DPN, the absence of a
control group prevents deriving a definitive conclusion from this
study. Additional studies are needed to determine the long-term
effect of this therapy. 21
Kochman (2004) studied 38 participants (mean age 78) with
confirmed neuropathy who received comprehensive treatment
programs of ATS and physical therapy. The study aimed to
determine if the combined therapies could improve sensation and
balance and also decrease gait deficiencies and fall risk. All
participants had experienced at least one fall in the three months
prior to treatment. Participants received daily 30- to 40-minute
treatments with ATS, followed by physical therapy. Physical therapy
interventions consisted of static and dynamic balance retraining,
neuromuscular re-education, strength training, and stretching of the
ankle plantar flexors and hip flexors. After completion of the
combined treatments, all patients had improvement in foot sensation
and reduced their fall risk, as measured on the Tinetti scale. The
author concluded that a combined therapy program could improve
foot sensation, balance and gait and thus reduce the incidence of falls.
The study was limited by its small size, as well as by a lack of control
9
group, randomization, blinding and long-term follow-up. The
methodology did not allow analysis of gains either attributable to
physical therapy alone or related to an increase in foot sensation
resulting from ATS alone. 22
Leonard et al. (2004) conducted a double-blind, randomized,
placebo-controlled study of 27 participants with diabetes and
peripheral neuropathy. The participants were stratified into two
groups, based on their ability to sense SWM 6.65 at all tested sites
(group 1: n=18) or inability to sense the SWM 6.65 (group 2: n=9).
All subjects initially received treatment with both active and sham
ATS therapy for 40 minutes, three times per week for two weeks.
This was followed by six active treatments of the same duration
administered to both limbs during the following two weeks. Group 1
subjects receiving active treatment reduced the number of insensitive
sites to the SWM. No decrease was noted with the sham device. In
group 2, there was no significant difference with active treatment
following the six or 12 treatments. Pain was reported decreased in
group 1 subjects but was not significantly reduced in group 2
subjects. Balance was reported as improved following both the sixth
and twelfth treatments in group 1 subjects. Group 2 subjects
reported improvement after six treatments in four of the nine
patients; thereafter, no further change was noted. The authors
concluded that, for diabetics with LOPS who have not progressed to
profound sensory loss, there can be a temporary improvement in
sensation with the use of ATS. The study size was small with no
randomization. The design did not measure pain reduction or
balance improvement in active compared to sham treatment of
individual limbs. There was a lack of objective measurement for
10
balance impairment, and follow-up was limited to evaluation after 12
treatments, with no analysis of long-term durability. 23
Powell et al. (2004) conducted a study of 68 participants with
diabetic neuropathy and LOPS who had no current lower extremity
ulcers. The participants received ATS treatment in a selfadministered home program. Participants treated themselves with
the device 30–40 minutes per day for two months. If improved
sensation was noted, then additional treatment was provided for an
additional 2–7 days per week. An 11-question post-treatment health
status questionnaire was sent to the participants, who were asked
about foot wounds, amputations, fall history, fear of falling, activities
of daily living, and increased foot sensitivity. One patient reported
development of a foot wound after the treatment program, and one
patient reported a burn sustained from using the ATS device after
falling asleep. The authors report that improved foot sensitivity
appears to be associated with a lower incidence (1.5%) of new
diabetic foot ulcers as compared to the expected incidence (7.3%) in
the Medicare population. The study was limited by its small size and
lack of a control group. The outcomes were based on self-reported
patient responses. 24
Clift et al. (2005) conducted a randomized, double-blinded,
placebo-controlled study of 39 subjects with diabetic peripheral
neuropathy (defined as the inability to detect the 5.07 monofilament
at any of the four test sites on the plantar surface of the foot). The
purpose of the study was to determine if the number of sites that
could sense the 5.07 monofilament on the plantar region of the foot
11
would increase after treatments with monochromatic near-infrared
photo energy (MIRE). Subjects were assigned randomly to an active
MIRE group or a placebo group. Subjects received 30 minutes of
active MIRE or placebo three times a week for four weeks. The
subjects’ plantar sensation was tested before treatment, after four
weeks of treatment/placebo and again after four weeks of
nontreatment. The average number of sites with increased sensation
increased in both groups during the treatment phase, but neither
group demonstrated any improvement during the nontreatment
phase. There were no significant differences reported between the
active and placebo groups at any measurement. The authors
concluded that the active MIRE treatment was no more effective
than the placebo MIRE. 15
DeLessis et al. (2005) reviewed the medical records of 1047
patients with peripheral neuropathy to determine whether treatment
with ATS was associated with increased foot sensitivity. The authors
reported that the number of insensitive sites based on the SWM was
7.9/10.0 before treatment and 2.3/10.0 after treatment, with 452
(43%) patients exhibiting insensitivity at all 10 sites prior to
treatment. Among these patients, there was a mean decrease of 69%
in sensory impairment after treatment. The number of treatments
was not noted. The authors concluded that 56.1% of the patients
obtained at least a temporary return of protective sensation. The
study did not incorporate a control group, randomization or blinding
of the participants, and there was no long-term follow-up to
determine the efficacy of the treatment. 25
12
Harkless et al. (2006) reviewed the medical records of 2239
patients with the diagnosis of peripheral neuropathy (PN) to
determine if the MIRE treatment, delivered by the Anodyne Therapy
System, was effective in increasing foot sensitivity and reducing
neuropathic pain. Of the 2239 patients included in the study, 1395
(62%) had PN due to diabetes. Foot sensitivity was determined by the
SWM 5.07 test, and pain was measured on the 11-point visual
analogue scale (VAS). The mean number of sites insensitive to the
SWM 5.07 (bilaterally: maximum 10 sites for both feet) was 7.1 ± 2.9
before treatment and 2.4 ± 2.6 after treatment, an improvement of
66%. Of the 2078 patients who exhibited loss of protective sensation
(defined by Medicare as a loss of sensation at two or more sites on
either foot), 1106 (53%) no longer exhibited loss of protective
sensation after treatment. Prior to treatment, 1563 patients also
exhibited neuropathic pain with a VAS of 7.2 ± 2.2 points. After
treatment, the pain was reduced by 4.8 ± 2.4 points. The authors
conclude that MIRE appears to be associated with clinical
improvement in foot sensation and reduction in neuropathic pain.
Limitations of this study include lack of randomization, a control
group and blinding, as well as the utilization of records of patients
who, after being treated with MIRE, had all exhibited improvement
in their symptoms. 26
Goldberg et al. (2005) reported that at least temporary
increases in foot sensitivity and reductions in neuropathic pain may
be achieved through the application of monochromatic near
infrared photo energy .This device is noninvasive, and published
trials report it was well tolerated by patients. 27
13
SUBJECTS ,
MATERIALS AND
PROCEDURES
SUBJECTS, MATERIALS AND PROCEDURES
SUBJECTS:
Forty two eligible patients with a type 2 diabetes
mellitus for at least five years with a diagnosis of painful
peripheral neuropathy based on patient history and physical
examination, divided on two groups: control and treatment
groups , their mean age was 59 ± 6.8 years ( range: 50 to 75 ),
were recruited from the medical outpatient clinic of the
University Diabetes Center, King Abdulaziz University
Hospital, Riyadh, Saudi Arabia.
Twenty patients were males and twenty two were
females. Before starting the study, patients were informed
about all study procedures and the possible risks. After
explaining the procedures and obtaining a written informed
consent from each patient, they were randomly assigned into
two groups: treatment group and control group. The
treatment group was 22 patients, 12 males and 10 females,
while the control group was 20 patients, 8 males and 12
females ( Figure 1 ).
All patients had Semmes - Weinstein
monofilament values not more than 5.07 (protective
sensation). The study was approved by the Research Ethical
Committee, Medicine College, Riyadh, Saudi Arabi
No of
patients
Gender in both groups
30
20
10
0
Female
Male
10
12
8
12
Control Treatment
Group Group
Figure (1): Gender In Both Groups.
14
Inclusion criteria : subjects with a confirmed
diagnosis of peripheral neuropathy of type II diabetes under
stable metabolic control (at least 5 years after date of
diagnosis. The age is between 50 and 75 years, able to
perform daily-life activities without supporting devices.
Subjects with the following health problems will be
excluded from participating this study: age less than 50
years or more than 75 years, current diagnosis of cancer,
uncontrolled type II diabetes mellitus (fasting blood glucose
greater than 300 mg/dl) for the week prior to enrollment,
uncontrolled hypertension, foot ulcer, open wounds, major
or
minor
amputation,
neurological
disorders,
deformities, and trauma or surgery to the back or knee.
15
foot
MATERIALS
ASSESSMENT TOLLS:
(1)
Pain Assessment:
By visual analogue scale (VAS) of pain.
(2)
Cutaneus Sensation Assessment:
By 5.07 Semmes - Weinstein monofilament (SWM).
(3)
Vibration Perception Threshold Assessment:
By the Neurothesiometer.
(4)
Balance and Gait Assessment:
By using Tinetti Assessment Tool.
(5)
Plantar Pressure Assessment:
By using an EMED- NT pressure platform.
(6) Treatment Procedure:
By using Anodyne Therapy System.
16
ASSESSMENT PROCEDURES
Initial
clinical
evaluation
included
history
for
confirmation of inclusion and exclusion criteria followed by
general physical and neurological examination. Medical
history assessment of both groups included age, sex; height
and weight were measured in light clothing without shoes by
( Seca 703 High Capacity Digital
( Figure 2 A ).
Physician Scale, USA)
BMI was calculated as weight (kg)/height
(m2). Blood pressure was measured by (Welch Allyn 5200-E1
Monitor, USA ) ( Figure 2 B ), Information on alcohol
consumption, smoking, medication, history of diabetes and
presence
of
other
microvascular
and
macrovascular
complications was obtained by interview. Blood glucose was
measured using ( Ascensia Elite,Co. Dublin. Ireland )
analyzer ( Figure 2 C ).
No changes were made in the
standard of medical care associated
with diabetes for these
patients, including insulin or oral hypoglycemic agents, diet,
blood pressure medications, or exercise.
All patients were screened for peripheral neuropathy
through determination of the vibration perception thresholds
(VPT) at the apex of the hallux with a neurothesiometer
(Horwell, Wilford, UK). Patients presenting with history
suggestive of positive sensory symptoms such as burning,
pricking, tingling paraesthesia with or without an element of
pain for a minimal duration of one month, with normal
findings on examination, with normal or minimally abnormal
routine nerve conduction studies, insufficient for diagnosis of
peripheral neuropathy, formed the study group.
17
All patients in treatment group were treated at the
Physical Therapy Department, King Abdulaziz University
Hospital, Riyadh. They received therapy with the ATS device
between June 2007, and August 2007).
A
B
Figure (2):
(A)
Weight and Height Scale,
(B)
Blood Pressure Sphygmomanometer,
(C)
Blood Glucose Analyzer.
C
No novel treatment or pharmaceutical that would have
uniquely modified circulation in the lower extremities were
employed for 30 days prior to the beginning of this study. 21
18
The following variables were assessed before starting
and after the end of the study for both groups.
(1)
Pain Assessment:
A visual analogue scale (VAS) of pain was used to
record patients' subjective reports of pain. The VAS
consisted of a 10 cm horizontal line, anchored with (no pain)
at the left end (i.e. threshold intensity), and (pain as bad as
could be) at the right (i.e. maximally tolerable intensity)
(Figure 3).
•
No Pain
Figure (3):
Pain as bad
as it could
possibly be
Visual Analogue Scale of Pain (VAS) 28
Each patient was instructed to grade his/her pain on VAS
form.
The patient's mark on the line was measured (in
centimeters) with a ruler.28
(2)
Cutaneus Sensation Assessment:
At the initial session, the 5.07 monofilament was
applied to the dorsum of each patient's hand to demonstrate
the testing procedure.
The test was then administered to
three test sites on the plantar surface of the foot with the
patient's eyes closed. The test sites were located at the great
toe, first metatarsal head, third metatarsal head, and fifth
19
metatarsal head. If callus or scar was present at any of the
test sites, the monofilament was applied to the perimeter of
the test area. The sites were tested in a random order with a
2- to 3-s pause between test sites.
The 5.07 monofilament
was held perpendicular to the skin and applied for 1–2 s in a
three-step sequence: touch the monofilament with enough
force to cause the monofilament to buckle to the skin, bend
the monofilament, and then lift the monofilament from the
skin. (Figure 4).
The response to the filament testing was based on the
subjective response of the subject, who was asked to say “
now ” when the filament could be felt.
In addition, the
subject was queried as to the location on the foot where the
monofilament was sensed to assure objectivity of the
measurements taken. All patients were tested by the same
researcher.15
Figure (4):
Application of Semmes - Weinstein Monofilament..
20
(3)
Vibration Perception Threshold Assessment:
Vibration perception threshold measured in volts was
measured by means of a calibrated neurothesiometer
( Horwell, Wilford, UK ) over the right and left hallux. The
procedure was performed either in the morning ( 8–12 a.m.)
or late afternoon ( 1–4 p.m. ) at room temperature.
First,
the patients were informed how to know the vibration
sensation is felt by gradually turning the amplitude from
zero to maximum, then the test began again from zero and
they were asked to say the moment that they first felt it.
Measurements were made on the planter aspect of the big
toe bilaterally, three times consecutively for each big toe.
The mean of three readings is accepted as the VPT value of
that measurement. VPT was measured by the same person
on every occasion, who has considerable experience in this
procedure. Patients having VPT values over 25 v were
accepted to have neuropathy .29(Figure 5).
Figure (5): Application of Neurothesiometer for VPT Assessment.
21
(4) Balance and Gait Assessment:
Balance and gait abnormalities were assessed using
the Tinetti Assessment Tool. This is a widely recognized
objective instrument for determining balance and gait
deficiencies and assessing the risk of future falls. Higher
Tinetti scores ( maximum 28 ) correlate inversely with risk
of falls.
Individuals with Tinetti scores under 19 are
considered to be at the highest risk for falls, those with
scores between 19 and 24 are considered to have a moderate
risk of falling, and those with scores 24 and above are
considered to be at low risk for falls. All patients presented
with a Tinetti score of 20 or less and thus were
characterized as having a known fall risk. 22
In Tinetti Scale method, the following activity items
were measured according to the instructions:
•
On balance: balance at sitting, standing up and effort
to stand up, balance at immediate standing ( the first 5
seconds ), balance at standing and pushing, standing
with the eyes closed, turning 360 degrees, and sitting
down.
•
On gait: starting to walk, length, height, symmetry
and succession of the steps, route, oscillation of the
trunk, and width of gait. (Figure 6).
Each activity item was scored 0-1 or 0-2, where a
score of 0 meant inability to perform the item and a score of
1 or 2 meant complete ability to perform it. The score was
16 for the balance items and 12 for the gait items, and the
total score was 28. 30 (Appendix 5).
22
A
D
B
E
C
F
Figure (6): Balance and Gait Assessment by Tinetti Scale
(A) Sit Up, (B) Nudging, (C) Standing with eyes closed,
(D) Gait Assessment, (E) Standing with eyes open,
(F) Sit Down.
23
(5)
Plantar Pressure Assessment:
Dynamic barefoot plantar pressures were measured using an
EMED- NT pressure platform ( Novel GmbH, Munchen, Germany )
which consists of capacitance based sensors in a spatial resolution of
two sensors per cm2 that were sampled at 70 Hz. Five trials at the
patients' own pace using a ‘two-step’ gait approach to the platform
were collected. Patients were instructed to walk across the platform
in a normal manner. This method requires the patient to stand
(barefoot) two steps away from the pressure platform and, at a selfselected pace, step onto the platform and continue walking for at
least three steps. The measurements started after instruction of the
patient and familiarization with the procedure. Data from both feet
were collected. Trials in which the patient did not hit the platform
with the entire foot, targeted for the platform, or substantially
altered gait or speed, as judged by the investigator, were not saved
for analysis. The pressure data was analyzed with Novel Ortho and
Novel Win software. Automated masking divided the foot into 14
anatomically referenced regions: Total object, Hind foot, Midfoot,
Forefoot, First Metatarsal Head (MH1) , Second Metatarsal Head
(MH2) , Third Metatarsal Head (MH3) , Fourth Metatarsal Head
(MH4) , Fifth Metatarsal Head ( MH5) , Toes, Big toe, Second toe,
Toes 345, and Toes 2345.For each region, force–time integral,
pressure–time integral, , peak pressure, maximum force, contact area
,and contact time were calculated and the average from the five
walking trials. The pressure platform was calibrated by the
manufacturer according to standard procedures .31 (Figure 7).
24
A
B
C
Figure (7):
D
E-MED Platform System, Novel:
(A) Wooden Platform,
(B) Computer System,
(C) Pedographic Assessment (Rt Foot),
(D) Pedographic Assessment (Lt Foot)
25
Treatment Procedures:
The MIRE device used in the presnt study (Anodyne
Therapy
System;
Anodyne
Therapy
LLC,
Tampa,
FL,Model 480,Canada) consists of a power unit connected to
several
therapy pads, each containing 60 luminous diodes
that emit monochromatic near infrared ( 890 nanometers )
gallium aluminum arsenide diodes(diode array) photo
energy.
The anodyne therapy system unit was present to
deliver 1-3 joules of photo energy.
Each patient in the treatment group sat in relax long
sitting with socks and shoes removed.
pads
were
placed
over
the
The four therapy
following
sites
as
recommendations of the manufacturer: 1) distal posterior
leg, 2) distal anterior leg, 3) plantar foot over metatarsal
heads, and 4) plantar arch of foot. The placement of pads 3
and 4 formed a “T” on the plantar surface of the foot.
(See figure 8).
Figure (8): Patient with DPN Treated by Anodyne Therapy System.
26
Commercial plastic wrap was placed between the skin
and the MIRE pads for hygienic purposes, and the pads
were held in position with neoprene straps supplied by the
manufacturer.
Before activating the MIRE units, all
patients were told that they may or may not feel anything
from the treatment and were instructed to notify the
therapist if they felt any discomfort during the treatment
session.
peripheral
Patients received the treatment protocol for
neuropathy
as
recommended
by
the
manufacturer: 30-min treatments three times a week for 4
weeks for a total of 12 treatments for both feet.15
27
STATISTICAL ANALYSIS
Statistical software package, SPSS (version 12)
statistical software for Windows was used in the analysis of
data. This program is characterized by easy data entry,
different choices of an appropriate statistical test, good data
exploring, data transformation, and producing different
graphical images. All values are represented as mean ±
standard error of mean.
Student’s "t-test" for paired sample was used to
determine the differences between pre-physical therapy
measurements and post- physical therapy ( after 4 weeks of
physical therapy ) measurements for pain, the cutaneus
sensation, vibration perception threshold , balance and gait,
and pedography in both groups.
Student’s "t-test" for independent samples was used
to compare between the treatment group and the control
group before and after 4 weeks concerning pain, cutaneus
sensation, vibration perception threshold, balance and gait,
and pedography.
For all statistical tests, the 0.05 level of probability is
accepted as a criterion of statistical significance.
28
RESULTS
RESULTS
Forty two eligible patients with significant peripheral
neuropathy ( PN ) participated in this study after referring to the
Physical Therapy Department, King Abdulaziz University Hospital.
A signed informed consent was obtained from each one of them after
explanation of the procedures in details for them.
The patient's
assessment sheets were filled with personal data, past medical
history, and the present medical history. The heart rate, blood
pressure, weight and height were measured. Pain, cutaneus sensation,
vibration perception threshold, balance and gait, and pedography
were assessed for all patients.
Patients were divided randomly into
two groups; twenty patients as a control group followed their routine
program of treatment. While twenty two patients as treatment group
received treatment program day other day at the same time of the
day and for duration of 4 weeks.
Again the same measurements
were taken after 4 weeks of treatment.
Patients Characteristics:
Forty two patients completed this study. In the control group
the patients' ages ranged from 50 to 65 years ( 58.05 ± 4.685 ) years,
while in the treatment group the patients' ages ranged from 50 to 79
years ( 60.36 ± 9.042 ) years.
The physical characteristics of the
study population are summarized in Table (1).
29
Table (1):
Mean ± S.E.M for Physical Characteristics of Patients in
Both Groups.
Variable
Control Group
Treatment Group
(N=20)
(N=22)
Mean ±
S.E.M
Range
Mean ±
S.E.M
Range
Age ( year )
58.05(±4.69)
50-65
60.36 (± 9.04)
50-79
Weight (kg)
69.80 (±8.03)
60-85
71.80 (±8.06)
58-90
Height (meter)
1.71 (±5.69)
1.62-1.80
1.62 (±11.16)
1.42-1.83
Body mass
index
26.7 (±1.6)
23.1829.66
27.32 (±2.45)
22.5329.77
(kg/m2)
Duration of
DM(year)
17.55 (±5.5)
5-25
16.27 (±7.02)
3-30
P< 0.05
Outcomes Measurement
Pain:
The mean of the visual analogue scale of pain scores in the
control group was ( 8.2 ± 0.36 ) at the beginning of the study.
became ( 8.2 ± 0.31 ) after 4 weeks of the study.
It
The difference
between the pre and post study for pain level didn't reach a statistical
significance (p = 1.00). (Table 2, Figure 9).
30
While, in the treatment group, the mean of the visual analogue
scale of pain scores decreased from ( 7.41 ± 0.23 ) pre treatment to
( 3.09 ± 0.32 ) post treatment.
The difference between the pre and
post treatment for pain level reached a statistical significance
(p ≤ 0.05). (Table 2, Figure 9).
Table (2): Mean ± S.E.M of VAS Scores Pre and Post 4 Weeks in
Both Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
PRE
POST
PRE
POST
Mean
8.2
8.2
7.41
3.09
S.E.M
0.36
0.31
0.23
0.32
P. Value
1.00
≤ 0.05
Mean of VAS Scores
P< 0.05
9
8
7
6
5
4
3
2
1
0
Figure (9):
PRE
8.2
8.2
7.41
POST
3.09
C O N TR O L
TR E ATM E N T
Mean of VAS Scores Pre and Post 4 Weeks in Both Groups.
31
Sensation Assessment:
The mean of baseline Semmes - Weinstein monofilament
values in the control group was 0.35 ± 0.11. g at the beginning of the
study. It became 0.35 ± 0.11g after 4 weeks of the study.
The
difference between the pre and post study for sensation level didn't
reach a statistical significance (p = 1.00).
While, the mean of Semmes - Weinstein monofilament values
in the treatment group decreased significantly from 0.91 ± 0.06 g to
0.32 ± 0.10 g. (p ≤ 0.05). (Table 3, Figure 10).
Table (3): Mean ± S.E.M of Semmes-Weinstein Monofilament
Values (g) Pre and Post 4 Weeks in Both Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
PRE
POST
PRE
POST
Mean(g)
0.35
0.35
0.91
0.32
S.E.M
±0.11
±0.11
±0.06
± 0.10
P. Value
1
≤ 0.05
P< 0.05
32
PRE
POST
Mean of SWM Value
1
0.91
0.8
0.6
0.35 0.35
0.32
0.4
0.2
0
CONTROL
TREATMENT
Figure (10): Mean of SWM Values (g) Pre and Post 4 Weeks in Both Groups.
Vibration Perception Threshold Assessment (VPT):
Vibration Perception Threshold Assessment (VPT) Values of Right
Feet:
The mean of vibration perception threshold (VPT) values of Rt
feet in the control group was 18.9 ± 1.37 volts at the beginning of the
study. It became 17.85 ± 1.45 volts after 4 weeks of the study. The
difference between the pre and post study values did not reach a
statistical significance (p = 0.06).
While, the mean of vibratio
perception threshold ( VPT ) values of Rt feet in the treatment group
decreased significantly from 24.55 ± 1.93 volts to13.14 ± 1.01 volts
after 4 weeks of Anodyne therapy.(Table 4, Figure 11).
33
Table (4): Mean ± S.E.M of Vibration Perception Threshold (volt)
for Right Feet Pre and Post 4 Weeks in Both Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
PRE
POST
PRE
POST
Mean (volt)
17.85
18.9
24.55
13.14
S.E.M
±1.01
±1.93
±1.37
±1.45
P. Value
0.06
≤ 0.05
P < 0.05
24.55
PRE
25
18.9
Mean of VPT Value
20
17.85
POST
13.14
15
10
5
0
CONTROL
Figure (11):
TREATMENT
Mean of Vibration Perception Threshold Value (volt) for Rt Feet
Pre and Post 4 Weeks in Both Groups.
34
Vibration Perception Threshold Assessment (VPT) Values of Left
Feet:
The mean of vibration perception threshold ( VPT ) values of
Lt feet in the control group was 17.65 ± 1.33 volts at the beginning
of the study. It became 20.15 ± 1.44 volts after 4 weeks of the study.
The difference between the pre and post study values did not reach a
statistical significance ( p = 0.06 ).
While, the mean of vibration
perception threshold ( VPT ) values of Lt feet in the treatment group
decreased significantly from 23.77 ± 1.87 volt to 13.68 ± 0.93 volt
after 4 weeks of Anodyne therapy. (p ≤0.05). (Table 5, Figure 12).
Table (5): Mean ± S.E.M of Vibration Perception Threshold Value
(volt) of Left Feet Pre and Post 4 Weeks in Both Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
PRE
POST
PRE
POST
Mean (volt)
13.68
23.77
20.15
17.65
S.E.M
±0.93
±1.87
±1.44
±1.33
P. Value
0.003
≤ 0.05
P < 0.05
35
Mean of VPT Value
25
23.77
20.15
17.65
20
PRE
POST
13.68
15
10
5
0
Control
Figure (12):
Treatment
Mean of Vibration Perception Threshold Value (volt) for Lt Feet
Tinetti Scale Values for Balance and Gait of Both Groups:
The mean of the Tinetti Scale Value for balance and gait in
the control group was 18.8 ± 0.78 at the beginning of the study.
It
became 18.85 ± 0.94 after 4 weeks of the study. The difference
between the pre and post study didn't reach a statistical significance
( p = 0.93 ).While the mean of the Tinetti Scale Values for balance
and gait in the treatment group increased significantly from
17.95 ± 0.76 to 24.73 ± 0.034 after 4 weeks of the study. (p ≤ 0.05 ).
(Table 6, Figure 13).
36
Table (6): Mean ± S.E.M of Tinetti Scale Values for Balance and
Gait Pre and Post 4 Week in Both Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
PRE
POST
PRE
POST
Mean
18.8
18.85
17.95
24.73
S.E.M
0.78
0.94
0.76
0.34
P. Value
0.093
≤ 0.05
P < 0.05
PRE
Mean of Tinetti Scale Value
25
20
18.85
18.8
24.73
17.95
POST
15
10
5
0
CONTROL
Figure (13):
TREATMENT
Mean of Tinetti Scale Values for Balance and Gait Pre and
Post 4 Weeks in Both Groups.
37
PEDOGRAPHIC ASSESSMENT
The mean value of force time integral ( FTI ) of Rt foot in
the control group was 684.27 ±71.89 N.s at the beginning of the
study.
At the end of the study it became ± 634.74 33.52 N.s.
The difference between the pre and post study values did not
reach a statistical significance (p = 0.39). While the mean value
of force time integral ( FTI ) of Rt foot in the treatment group
was 601.93 ±31.18 N.s at the beginning of the study. At the end
of the study it became 610.21 ± 30.04 N.s. The difference
between the pre and post study values did not reach a statistical
significance (p= 0.65). (Table 7, Figure 14).
The mean value of force time integral ( FTI ) of Lt foot in
the control group was 669.3±66.32 N.s at the beginning of the
study. At the end of the study it became 655.4± 28.62 N.s .The
difference between the pre and post study values did not reach
a statistical significance ( p= 0.84 ).
While the mean value of
force time integral (FTI) of Lt foot in the treatment group was
583.31 ± 28.75 Ns at the beginning of the study. At the end of
the study it became 571.69 ± 25.81N.s. The difference between
the pre and post study values did not reach a statistical
significance (p= 0.35). (Table 7, Figure 14).
38
Table (7):
Mean ± S.E.M of Force Time Integral (FTI) Values (N.S)
for Right Foot Pre and Post 4 Weeks in Both Groups
Variable
Control Group
Treatment Group
(N=20)
(N=22)
Rt. Feet
Lt. Feet
Rt. Feet
Lt. Feet
PRE
POST
PRE
POST
PRE
POST
PRE
POST
(N.S)
684.27
63.74
669.3
655.4
601.93
610.21
583.31
571.69
S.E.M
71.89
33.52
66.32
28.62
31.18
30.04
28.75
25.81
Mean
P. Value
0.39
0.84
0.65
0.35
P< 0.05.
Rt
Lt
Mean of FTI(N.S)
700
669.3
655.4
650
600
583.31
571.69
684.27
634.74
601.93
550
610.21
Rt
500
PRE-C
POST-C
PRE-T
POST-T
Figure (14): Mean of Force Time Integral (FTI) for Right and Left Feet
39
The mean value of pressure time integral ( PTI ) of Rt
feet in the control group was 238.01 ±19.39
beginning of the study.
238.66 ± 16.72 kPa.s.
kPa.s at the
At the end of the study it became
The difference between the pre and
post study values did not reach a statistical significance
( p = 0.97). While the mean value of pressure time integral
( PTI ) of Rt feet in the treatment group was 231.88 ± 14.69
kPa.s at the beginning of the study. At the end of the study it
became 249.8± 23.65 kPa.s. The difference between the pre
and post study values did not reach a statistical significance
( p= 0.17 ). (Table 8, Figure 15).
The mean value of pressure time integral ( PTI ) of Lt feet
in the control group was 242.73 ±24.26 kPa.s at the beginning of
the study. At the end of the study it became 252.82 ± 14.93 kPa.s.
reach a statistical significance (p = 0.72 ). While the mean value
of pressure time integral ( PTI ) of Lt feet in the treatment group
was 228.02 ± 12.13 kPa.s at the beginning of the study.
end of the study it becam 220.3± 12.98 kPa.s.
At the
The difference
significance ( p= 0.23 ). (Table 8, Figure 15).
40
Table (8):
Mean ± S.E.M of Pressure Time Integral (PTI) Values (kPa.s) for
Right and Left Feet Pre and Post 4 Weeks in Both Groups.
Variable
Control Group
Treatment Group
(N=20)
(N=22)
Rt. Feet
Lt. Feet
PRE
POST
PRE
POST
(kpa.s)
238.01
238.66
242.73
252.82
S.E.M
19.39
16.72
24.26
14.93
Rt. Feet
PRE
Lt. Feet
POST
PRE
POST
231.88 249.8
228.02
220.3
14.69
12.13
12.98
Mean
P. Value
0.97
0.72
23.65
0.17
0.23
P< 0.05.
Mean of
PTI(kPa.S)
Rt
260
250
240
230
220
210
200
252.82
242.73
238.01
238.66
228.02
220.3
249.8
231.88
Rt
PRE-C
POST-C
PRE-T
POST-T
Figure (15): Mean of Pressure Time Integral (PTI) Values (Kpa.s ) for Right
and Left Feet Pre and Post 4 Weeks in Both Groups.
41
Lt
The mean value of maximum force (MF) of Rt feet in the
control group was 853.15 ±26.35 (N) at the beginning of the study.
At the end of the study it became 849.78± 24.34 N.
The difference
significance ( p = 0.51 ).
While the mean value of maximum force
( MF ) of Rt feet in the treatment group was 842.12 ( ± 25.65 ).at the
At the end of the study it became 838.4 ±
24.00 (N). The difference between the pre and post study values did
not reach a statistical significance ( p = 0.43 ). (Table 9, Figure 16 ).
The mean value of maximum force (MF) of Lt feet in the control
group was 860.69 ( ± 25.83 ). (N) at the beginning of the study. At
the end of the study it became 857.35 ± 26.26 N.
The difference
significance
( p = 0.67 ).
While the mean
value of maximum force ( MF ) of Lt foot in the treatment group was
841.52 ( ± 24.45 ) (N) at the beginning of the study. At the end of the
study it became 830.42±25.36 N. The difference between the pre and
post study values did not reach a statistical significance ( p = 0.05 ).
42
Table (9): Mean ± S.E.M. of Maximum Force (MF) Values ( N ) for Right and
Left Feet Pre and Post 4 Weeks in Both Groups.
Variable
Control Group
Treatment Group
(N=20)
(N=22)
Rt. Feet
Lt. Feet
Rt. Feet
Lt. Feet
PRE
POST
PRE
POST
PRE
POST
PRE
POST
Mean(N)
852.15
849.78
860.69
857.35
842.19
838.4
841.52
830.42
S.E.M
26.35
24.34
25.83
26.26
25.65
24.00
24.45
25.36
P. Value
0.051
0.67
0.43
0.05
P < 0.05
Rt
Mean of
MF(N)
Lt
870
860
850
840
830
820
810
860.69
841.52
830.42
853.15
849.78
842.19
838.4
Rt
PRE-C
Figure (16):
857.35
POST-C
PRE-T
POST-T
Mean of Maximum Force (MF) for Right and Left Feet Pre and
43
The mean value of peak pressure ( PP ) of Rt feet in the control
group was 378.86 ± 14.50 kPa at the beginning of the study. At the
end of the study it became 387.72 ± 24.34 kPa.
The difference
significance (p = (0.61.
While the mean value of peak pressure
( PP ) of Rt feet in the treatment group was 406.97 ±29.80 at the
28.37 kPa .
At the end of the study it became 432.51 ±
The difference between the pre and post study values
did not reach a statistical significance (p = 0.25). (Table 10, Figure
17).
The mean value of peak pressure ( PP ) of Lt feet in the
control group was 425.75 ( ± 26.01 ).
study.
kPa at the beginning of the
At the end of the study it became 444.73 ± 27.71 kPa. The
statistical significance ( p = .0 11 ). (Table 6, Figure 23). While the
mean value of peak pressure ( PP ) of Lt feet in the treatment group
was 425.86 ± 17.22 kPa at the beginning of the study.
At the end of
the study it became 400.55 ±19.73 kPa. The difference between the
pre and post study values did not reach a statistical significance (p=
0.16). (Table 10, Figure 17).
44
Mean ± S.E.M of Peak Pressure ( PP ) Values (kPa) for Right
Table (10):
and Left Feet Pre and Left Foot Pre and Post 4 Weeks in Both
Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
Rt. Feet
PRE
Lt. Feet
POST
Rt. Feet
Lt. Feet
PRE
POST
PRE
POST
PRE
POST
Mean
(kpa)
378.86 387.72
425.75
444.73
406.97
432.51
425.86
400.55
S.E.M
14.50
26.01
27.71
29.80
28.37
17.21
19.73
P. Value
21.58
0.61
0.11
0.25
0.16
Rt
Mean of PP(kPa)
Lt
460
440
420
400
380
360
340
444.73
425.75
425.86
400.55
432.51
378.86
387.72
PRE-C
POST-C
406.97
Lt
Rt
PRE-T
POST-T
Figure (17): Mean of Peak Pressure (PP) for Right and Left Feet Pre and
45
The mean value of Contact Area ( CA ) of Rt feet in the
control group was 125.13 ± 3.05 cm
study.
2
at the beginning of the
At the end of the study it became 124.40 ± 3.67 ( CA ).
reach a statistical significance ( p = 0.61). While the mean value
of Contact Area ( CA ) of Rt feet in the treatment group was
127.42 ± 6.24 cm 2 at the beginning of the study.
cm.2
of the study it became 133.64 ±2.78
At the end
The difference
significance ( p = 0.25 ). (Table 11, Figure 18).
The mean value of contact area ( CA ) of Lt feet in the
control group was 127.86 ± 3.30 cm
2
at the beginning of the
study. At the end of the study it became 127.41 ± 3.18 cm 2.The
contact area (CA) of Lt feet in the treatment group was 133.42 ±
3.30 cm 2 at the beginning of the study. At the end of the study
it became 134.90 ± 3.23 cm.
2
The difference between the pre
( p = 0.21 ). (Table 11, Figure 18).
46
Table (11): Mean ± S.E.M of Contact Area (CA) values ( cm 2 ) for
Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
Rt. Feet
Lt. Feet
Rt. Feet
Lt. Feet
PRE
POST
PRE
POST
PRE
POST
PRE
POST
( cm 2 )
125.13
124.40
127.86
127.41
127.42
133.64
133.42
134.90
S.E.M
3.05
3.67
3.30
3.18
6.24
2.78
3.30
3.23
Mean
P. Value
0.61
0.66
0.25
0.21
Mean of CA
P < 0.05
136
134
132
130
128
126
124
122
120
118
134.9
133.41
127.86
125.13
PRE-C
127.41
133.64
127.42
124.4
POST-C
PRE-T
POST-T
Figure (18): Mean of Contact Area ( CA ) for Right and Left Feet Pre and Post 4
Weeks in Both Groups.
47
Rt
Lt
The mean value of Contact Time ( CT ) of Rt feet in the
control group was 1103.40 ± 78.28(s) at the beginning of the
study.
At the end of the study it became 1077.71 ± 78.28 s .
reach a statistical significance ( p = 0.82 ).
While the mean
value of Contact Time ( CT ) of Rt feet in the treatment group
was 1020.47.7 ± 48.51 (s) at the beginning of the study. At the
end of the study it became 1026.65 ± 48.51 s.
The difference
significance ( p = 0.8 ). ( Table 12, Figure 19 ).
The mean value of contact time ( CT ) of Lt feet in the
control group was 1079.7 ( ± 96.99 )( s) at the beginning of the
study.
At the end of the study it became 1029.05 ± 39.20 s. The
contact time ( CT ) of Lt feet in the treatment group was 981.78
± 37.45( s) at the beginning of the study. At the end of the study
it became 955.65 ± 36.03 (s) .
The difference between the pre
( p = 24 .0 ). (Table 12, Figure 19).
48
Table (12):
Mean ± S.E.M of Contact Time (CT) values (s) for
Groups.
Control Group
Treatment Group
(N=20)
(N=22)
Variable
Rt. Feet
Lt. Feet
Rt. Feet
Lt. Feet
PRE
POST
PRE
POST
PRE
POST
PRE
POST
Mean (s)
1103.40
1077.71
1079.7
1029.05
1020.47
1026.65
981.78
955.65
S.E.M
78.28
78.28
97.99
39.20
48.51
48.51
37.45
3603
P. Value
0-.82
0.64
0.85
0.24
P < 0.05
Rt
1150
Mean of CT
1100
1103.4
1079.7
1050
Lt
1077.71
1029.05
1000
1020.47
981.78
1026.65
955.65
950
900
850
PRE-C
POST-C
PRE-T
POST-T
Figure (19): Mean of Contact Time (CT) for Right and Left Feet Pre
and Post 4 Weeks in Both Groups .
49
D IS C U S S I ON
DISCUSSION
This study has been done to investigate the effect of four
weeks of Anodyne therapy on foot pattern, vibration sensation,
cutaneus sensation and pain in subjects with diabetic peripheral
neuropathy Forty two eligible patients with type 2 diabetes
mellitus had participated in this study. The results of this study
revealed that Anodyne Therapy lead to a significant improvement
in Semmes - Weinstein monofilament values, visual analogue scale
(VAS) of pain scores, vibration perception threshold (VPT) values,
and Balance and gait scores.
The results of this study has shown significant improvements
in pain and cutaneous sensation after 4 weeks of treatment by
ATS . This result could be attributed to the analgesic effects
related to the local release of neurotransmitters such as serotonin,
increased mitochondrial ATP production, increased release of
endorphins, or anti-inflammatory effects. This in addition to the
possibility of increasing the skin microcirculation .32 This
analgesic effect could also be attributed to
the activation of
neuron metabolism, increased endorphin release and increase in
pain threshold. The reflexogenic effect is associated
with the
irritation of nerve endings, excitation of nerve centers and
stimulation of physiological function. 33
The improvement in neural function may be due, in part, to
improved circulation related to the localized release of nitric oxide.
As it has been discovered that 890 nm near-infrared photo energy,
virtually identical to MIRE, increases blood flow partly through an
50
effect mediated by endothelial nitric oxide syntheses or nitric oxide;
the vasodilatation was sustained for several hours even after the
photo energy was removed. 34
Red blood cells are able to store large amounts of nitric oxide,
partly in the form of nitrosothiols, and the absorption of this
wavelength
of photo energy by hemoglobin is well documented.
Thus, vasodilatation mediated by photo energy may be due, in part,
to the localized release of nitric oxide from the red blood cells
continuously passing through vessels exposed to the MIRE.
35
Glycosylated hemoglobin, characteristic of diabetes, avidly binds
nitric oxide. This suggests that even the smaller-than-normal
amounts of nitric oxide produced by patients with diabetes may not
be easily released from red blood cell hemoglobin at microcirculatory
sites. Perhaps MIRE enables the nitric oxide to be released from
glycosylated hemoglobin more easily. 21
The result of this study has shown significant improvement
of balance and gait in diabetic patients with peripheral neuropathy
after 4 weeks of ATS that could be attributed to the reduction of pain
and improvement of foot sensation, produced by the use of ATS.
This result was in accordance with previous study that stated that
the reduction in pain and the improvement of foot sensation would be
associated with significant improvement of balance and gait, with
significant reduction of the objective measures of fall risk 22
51
The result of this study had also shown that four weeks of
ATS had improved foot pedography but failed to reach significant
improvement from the statistical point of view. This was in
accordance with one of the previous study, that could attributed this
to the short period of treatment. 36
52
SUMMARY
CONCLUSION
RECOMMENDATIONS
SUMMARY
Forty two eligible patients with type 2 diabetes mellitus for
at least five years with a diagnosis of painful peripheral
neuropathy based on patient history and physical examination,
participated in this study after referring to the Physical Therapy
Department from the Medical Outpatient Clinic of the University
Diabetic Center, King Abdulaziz University Hospital.
The
purpose of this study was to investigate the effect of Anodyne
therapy treatment on foot pattern, vibration sensation, cutaneus
sensation and pain in patients with diabetic peripheral
neuropathy. A signed informed consent was obtained from each
one of them after explanation of the procedures in details. Then
the measurements for pain by visual analogue scale ( VAS ),
cutaneus sensation by Semmes - Weinstein monofilament
( SWM ), and Vibration Perception Threshold ( VPT ) of Rt & Lt
feet by neurothesiometer, gait and balance by Tinetti scale and
pedographic assessment of both feet by E-MED Platform System,
Novel were done. Patients were divided randomly into two groups;
twenty patients as a control group followed their routine program
of treatment. While twenty two patients as a treatment group
received treatment program in Physical Therapy Department,
King Abdulaziz University Hospital by Anodyne Therapy day
other day at the same time of the day for 30 minutes and for
duration of 4 weeks. The measurements were taken
for both
groups before and after 4 weeks. All data were collected and
analyzed by using SPSS program.
53
Each patient in the treatment group sat in relax long
sitting with socks and shoes removed.
The four therapy pads
were placed over the following sites as recommendations of the
manufacturer: 1) distal posterior leg, 2) distal anterior leg, 3)
plantar foot over metatarsal heads, and
4) plantar arch of foot.
The placement of pads 3 and 4 formed a “T” on the plantar
surface of the foot. Commercial plastic wrap was placed between
the skin and the MIRE pads for hygienic purposes, and the pads
were held in position with neoprene straps supplied by the
manufacturer. Before activating the MIRE units, all patients were
told that they may or may not feel anything from the treatment
and were instructed to notify the therapist if they felt any
discomfort during the treatment session.
The results of this study revealed that Anodyne Therapy
lead to a significant improvement in Semmes - Weinstein
monofilament values, visual analogue scale ( VAS ) of pain scores,
vibration perception threshold ( VPT ) values, and Balance and
gait scores. But it showed that there is no significant improvement
in foot pedography in treatment group.
While in the control group, the results of this study showed
that there was no difference in Semmes - Weinstein monofilament
values, visual analogue scale ( VAS ) of pain scores, vibration
perception threshold ( VPT ) values, balance and gait scores, and
pedography of both feet.
54
CONCLUSION
There was highly statistical significant improvement in
the means of VAS of pain, Semmes - Weinstein monofilament values,
and vibration perception threshold (VPT) values of Rt & Lt feet in
the treatment group after 4 weeks of Anodyne therapy, and there was
no difference in control group. While there is no significant
improvement in foot pedography in both groups after 4 weeks.
These results have been attributed to dilatation of the vessels
and improved circulation related to the localized release of Nitric
Oxide, which is known to relax smooth muscle found in arteries,
veins, and lymph vessels. Nitric oxide is also a neurotransmitter and
it leads to improving the nutrition for the nerves.
55
RECOMMENDATIONS
Recommendations for future studies for researcher as follow:
1-
Increase sample of the study.
2-
Increase number of the sessions.
3-
Conduct using other tools of measurements.
4-
Conduct using other modalities of physiotherapy treatment.
5-
Conduct using different pad placements.
6-
We recommend that future studies should be only double blind
and placebo-controlled with adequate sample sizes to determine
whether active MIRE is any more effective than placebo MIRE.
7-
The design of home laser equipment might be advantageous to
facilitate patient compliance.
For physical therapist in clinical practices I recommend the
following:
1-
Building the knowledge about the Anodyne Therapy System and
its effect in treatment programs for different musculoskeletal
and neurological disorders.
2-
Increase the practice on using of low level laser or cold laser to
find the optimal use of these technologies for treatment.
56
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61
APPENDICES
Appendix 1
INFORMED CONSENT FORM ‫ﻧﻤﻮذج إﻗﺮار‬
‫اﻟﺘﻐﻴﺮات ﻓﻲ ﺗﺨﻄﻴﻂ اﻟﻘﺪم ﻋﻘﺐ اﻟﻌﻼج ﺑﺎﻻ ﻧﻮداﻳﻦ ﻟﻤﺮﺿﻰ اﻟﺘﻬﺎب اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ اﻟﺴﻜﺮي‬
Pedographic Changes Post Anodyne Therapy in Diabetic Peripheral
Neuropathy
(Control Group)
You are being asked to participate
voluntarily in a Research Study. If you
decide to take part in this study, please
sign this consent form and return it.
STUDY
PURPOSE:
Treatment
by
Anodyne therapy will increase blood flow in
the foot of patient with diabetic peripheral
neuropathy which
helping to restore
sensation and delay ulcer which often leads
to amputee.
STUDY PLAN :to find effects of Anodyne
Therapy on the pedography,pain and
numbness of the feet.
STUDY METHODOLOGY:- Assessment
procedure of the feet &repeat it after four
weeks.
BENEFITS: The results of this study may
not benefit you directly, but in the future
with God's will the Saudi
Diabetic
Peripheral Neuropathy patients will benefit
from the knowledge acquired.
SIDE EFFECTS: There are no side effects.
Your participation in this study doesn't
have any further risks or discomfort to you.
REFUSAL: If you refused to participate,
there will be no penalty or loss of benefits.
‫ﻧﺮﺟﻮ ﻣﻨﻚ اﻟﻤﺸﺎرآﺔ ﻓ ﻲ ه ﺬﻩ اﻟﺪراﺳ ﺔ اﻟﺒﺤﺜﻴ ﺔ‬
‫و ﻋﻨﺪ ﻣﻮاﻓﻘﺘﻚ ﺑﺬﻟﻚ ﻧﺮﺟ ﻮ ﻣﻨ ﻚ اﻟﺘﻮﻗﻴ ﻊ ﻋﻠ ﻰ ه ﺬﻩ‬
.‫اﻟﻮرﻗﺔ وإرﺟﺎﻋﻬﺎ‬
‫ اﻟﻌﻼج ﺑﺎﻻﻧﻮداﻳﻦ ﻳ ﺆدي إﻟ ﻰ‬:‫اﻟﻐﺮض ﻣﻦ اﻟﺪراﺳﺔ‬
‫زﻳ ﺎدة ﺗ ﺪﻓﻖ اﻟ ﺪم ﻓ ﻲ أﻗ ﺪام ﻣ ﺮﻳﺾ اﻷﻋ ﺼﺎب‬
‫اﻟﻄﺮﻓﻴ ﺔ اﻟ ﺴﻜﺮي ﻓﻴ ﺴﺎﻋﺪ ذﻟ ﻚ ﻋﻠ ﻰ اﺳ ﺘﻌﺎدة‬
‫اﻹﺣ ﺴﺎس و زﻳ ﺎدة اﻟ ﺪورة اﻟﺪﻣﻮﻳ ﺔ ﻣﻤ ﺎ ﻳ ﺆﺧﺮ ﻣ ﻦ‬
.‫ﻇﻬﻮر اﻟﺘﻘﺮﺣﺎت اﻟﺘﻲ ﻏﺎﻟﺒﺎ ﺗﺆدي إﻟﻰ اﻟﺒﺘﺮ‬
‫ ﺗﻬ ﺪف إﻟ ﻰ اآﺘ ﺸﺎف ﺗ ﺄﺛﻴﺮ‬:‫اﻟﻬ ﺪف ﻣ ﻦ اﻟﺪراﺳ ﺔ‬
‫اﻟﻌ ﻼج ﺑ ﺎﻻ ﻧ ﻮدﻳﻦ ﻋﻠ ﻰ ﺗﺨﻄ ﻴﻂ اﻟﻘ ﺪﻣﻴﻦ و ﻋﻠ ﻰ‬
‫اﻵﻻم و اﻟﺘﻨﻤﻴﻞ ﻓﻴﻬﻤ ﺎ ﻟﻤﺮﺿ ﻰ اﻟﺘﻬ ﺎب اﻷﻋ ﺼﺎب‬
.‫اﻟﻄﺮﻓﻴﺔ اﻟﺴﻜﺮي ﻣﻦ اﻟﻨﻮع اﻟﺜﺎﻧﻲ‬
‫ﻋﻤﻞ ﻗﻴﺎﺳﺎت ﻣﻌﻴﻨﻪ ﻟﻠﻘﺪﻣﻴﻦ وﻣ ﻦ‬-:‫ﻃﺮﻳﻘﺔ اﻟﺪراﺳﺔ‬
.‫ﺛﻢ إﻋﺎدة هﺬﻩ اﻟﻘﻴﺎﺳﺎت ﺑﻌﺪ أرﺑﻌﺔ أﺳﺎﺑﻴﻊ‬
‫ إن اﻻﺳﺘﻔﺎدة ﻣﻦ‬:‫اﻻﺳﺘﻔﺎدة اﻟﻤﺮﺟﻮة ﻣﻦ اﻟﺪراﺳﺔ‬
‫ه ﺬﻩ اﻟﺪراﺳ ﺔ ﻗ ﺪ ﻻ ﺗﻌ ﻮد ﻋﻠﻴ ﻚ ﻣﺒﺎﺷ ﺮة و ﻟﻜ ﻦ ﻗ ﺪ‬
‫ﺗﻜ ﻮن ﻟﻨﺘ ﺎﺋﺞ ه ﺬا اﻟﺒﺤ ﺚ ﺗ ﺄﺛﻴﺮات ﻋﻠ ﻰ ﻣﻌﺎﻟﺠ ﺔ‬
.‫اﻟﻤﺮﺿﻰ اﻵﺧﺮﻳﻦ‬
‫ ﻻ ﺗﻮﺟ ﺪ هﻨ ﺎك أي أﺿ ﺮار ﺟﺎﻧﺒﻴ ﺔ‬:‫اﻵﺛ ﺎر اﻟ ﺴﻠﺒﻴﺔ‬
‫ﻣ ﻦ ه ﺬﻩ اﻟﺪراﺳ ﺔ و ﻣ ﺸﺎرآﺘﻚ ﻻ ﺗ ﺴﺒﺐ أي إزﻋ ﺎج‬
.‫أو ﻣﺨﺎﻃﺮ ﻣﺴﺘﻘﺒﻼ‬
‫ إذا رﻓ ﻀﺖ اﻟﻤ ﺸﺎرآﺔ‬:‫ﻋﺪم اﻟﺮﻏﺒ ﺔ ﻓ ﻲ اﻟﻤ ﺸﺎرآﺔ‬
‫ﻓ ﻲ ه ﺬﻩ اﻟﺪراﺳ ﺔ ﻓﺎﻧ ﻚ ﻟ ﻦ ﺗﺘﻌ ﺮض ﻷي ﺟ ﺰاء أو‬
.‫ﻓﻘﺪان ﻟﻠﻤﺰاﻳﺎ‬
CONFIDENTIALITY: Your participation
in this study will be kept confidential. The
results of this research may be published,
however, your identity will never be
revealed.
‫ إن ﻣ ﺸﺎرآﺘﻚ ﻓ ﻲ ه ﺬﻩ اﻟﺪراﺳ ﺔ‬:‫ﺳﺮﻳﺔ اﻟﻤﻌﻠﻮﻣ ﺎت‬
‫ﻗ ﺪ ﻳ ﺘﻢ ﻧ ﺸﺮ ﻧﺘ ﺎﺋﺞ ه ﺬا‬.‫ﺳ ﺘﻜﻮن ﻓ ﻲ ﻏﺎﻳ ﺔ اﻟ ﺴﺮﻳﺔ‬
‫اﻟﺒﺤﺚ ﻷﻏﺮاض أآﺎدﻳﻤﻴﺔ وﻟﻜﻦ ﻟﻦ ﻳﺘﻢ اﻟﻜ ﺸﻒ ﻋ ﻦ‬
.‫هﻮﻳﺘﻚ ﻓﻲ أي ﺣﺎل ﻣﻦ اﻷﺣﻮال‬
Participant name:……………….
‫ﻟﻘﺪ أﻋﻄﻴﺖ اﻟﻔﺮﺻﺔ ﻟﻄ ﺮح أﻳ ﺔ أﺳ ﺌﻠﺔ ﻟ ﺪي وﺗﻠﻘﻴ ﺖ‬
.‫إﺟﺎﺑﺎت ﻣﺮﺿﻴﺔ ﻋﻨﻬﺎ‬
Signature:……………….……….
...............................‫اﺳﻢ اﻟﻤﺸﺘﺮك‬
Date:……………………………..
.......................................‫اﻟﺘﻮﻗﻴﻊ‬
.......................................‫اﻟﺘﺎرﻳﺦ‬
62
INFORMED CONSENT FORM ‫ﻧﻤﻮذج إﻗﺮار‬
‫اﻟﺘﻐﻴﺮات ﻓﻲ ﺗﺨﻄﻴﻂ اﻟﻘﺪم ﻋﻘﺐ اﻟﻌﻼج ﺑﺎﻻ ﻧﻮداﻳﻦ ﻟﻤﺮﺿﻰ اﻟﺘﻬﺎب اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ اﻟﺴﻜﺮي‬
Pedographic Changes Post Anodyne Therapy in Diabetic Peripheral
Neuropathy
(Treatment Group)
You are being asked to participate
voluntarily in a Research Study. If you
decide to take part in this study, please
sign this consent form and return it.
STUDY PURPOSE: Treatment by
Anodyne therapy will increase blood flow
in the foot of patient with diabetic
peripheral neuropathy which helping to
restore sensation and delay ulcer which
often leads to amputee.
STUDY PLAN :
To find effects of
Anodyne
Therapy
on
the
pedography,pain and numbness of the
feet.
STUDY METHODOLOGY:- Assessment
procedure of the feet pre & post the
program.
-Attend three times per a week for four
weeks for the treatment in PT Dept.
The results of this study
BENEFITS:
may benefit you directly, but in the future
with God's will the Saudi
Diabetic
Peripheral Neuropathy patients will
benefit from the knowledge acquired.
SIDE EFFECTS: There are no side
effects. Your participation in this study
doesn't have any further risks or
discomfort to you.
REFUSAL: If you refused to participate,
there will be no penalty or loss of benefits.
Your
CONFIDENTIALITY:
participation in this study will be kept
confidential. The results of this research
may be published, however ,your identity
will never be revealed.
Participant name:……………….
Signature:……………….……….
Date:……………………………..
63
‫ﻧﺮﺟﻮ ﻣﻨﻚ اﻟﻤﺸﺎرآﺔ ﻓﻲ هﺬﻩ اﻟﺪراﺳﺔ اﻟﺒﺤﺜﻴﺔ‬
‫و ﻋﻨﺪ ﻣﻮاﻓﻘﺘﻚ ﺑﺬﻟﻚ ﻧﺮﺟﻮ ﻣﻨﻚ اﻟﺘﻮﻗﻴﻊ ﻋﻠﻰ هﺬﻩ‬
.‫اﻟﻮرﻗﺔ و إرﺟﺎﻋﻬﺎ‬
‫ اﻟﻌﻼج ﺑﺎﻻ ﻧﻮداﻳﻦ‬:‫اﻟﻐﺮض ﻣﻦ اﻟﺪراﺳﺔ‬
‫ﻳﺆدي إﻟﻰ زﻳﺎدة ﺗﺪﻓﻖ اﻟﺪم ﻓﻲ أﻗﺪام ﻣﺮﻳﺾ‬
‫اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ اﻟﺴﻜﺮي ﻓﻴﺴﺎﻋﺪ ذﻟﻚ ﻋﻠﻰ‬
‫اﺳﺘﻌﺎدة اﻹﺣﺴﺎس و زﻳﺎدة اﻟﺪورة اﻟﺪﻣﻮﻳﺔ ﻣﻤﺎ‬
‫ﻳﺆﺧﺮ ﻣﻦ ﻇﻬﻮر اﻟﺘﻘﺮﺣﺎت اﻟﺘﻲ ﻏﺎﻟﺒﺎ ﺗﺆدي إﻟﻰ‬
. ‫اﻟﺒﺘﺮ‬
‫ ﺗﻬﺪف إﻟﻰ اآﺘﺸﺎف ﺗﺄﺛﻴﺮ‬:‫اﻟﻬﺪف ﻣﻦ اﻟﺪراﺳﺔ‬
‫اﻟﻌﻼج ﺑﺎﻻ ﻧﻮدﻳﻦ ﻋﻠﻰ ﺗﺨﻄﻴﻂ اﻟﻘﺪﻣﻴﻦ و ﻋﻠﻰ‬
‫اﻵﻻم و اﻟﺘﻨﻤﻴﻞ ﻓﻴﻬﻤﺎ ﻟﻤﺮﺿﻰ اﻟﺘﻬﺎب اﻷﻋﺼﺎب‬
.‫اﻟﻄﺮﻓﻴﺔ اﻟﺴﻜﺮي ﻣﻦ اﻟﻨﻮع اﻟﺜﺎﻧﻲ‬
:‫ﻃﺮﻳﻘﺔ اﻟﺪراﺳﺔ‬
‫* ﻋﻤﻞ ﻗﻴﺎﺳﺎت ﻟﻠﻘﺪﻣﻴﻦ ﻗﺒﻞ ﺑﺪاﻳﺔ اﻟﺒﺮﻧﺎﻣﺞ‬
.‫وﺑﻌﺪﻩ‬
‫* اﻟﺤﻀﻮر ﺛﻼث ﻣﺮات ﻓﻲ اﻷﺳﺒﻮع ﻟﻤﺪة أرﺑﻌﺔ‬
‫أﺳﺎﺑﻴﻊ ﻟﻌﻤﻞ اﻟﺒﺮﻧﺎﻣﺞ اﻟﻌﻼﺟﻲ ﻓﻲ ﻗﺴﻢ اﻟﻌﻼج‬
.‫اﻟﻄﺒﻴﻌﻲ‬
‫ إن اﻻﺳﺘﻔﺎدة‬:‫اﻻﺳﺘﻔﺎدة اﻟﻤﺮﺟﻮة ﻣﻦ اﻟﺪراﺳﺔ‬
‫ﻣﻦ هﺬﻩ اﻟﺪراﺳﺔ ﻗﺪ ﺗﻌﻮد ﻋﻠﻴﻚ ﻣﺒﺎﺷﺮة و ﻟﻜﻦ ﻗﺪ‬
‫ﺗﻜﻮن ﻟﻨﺘﺎﺋﺞ هﺬا اﻟﺒﺤﺚ ﺗﺄﺛﻴﺮات ﻋﻠﻰ ﻣﻌﺎﻟﺠﺔ‬
.‫اﻟﻤﺮﺿﻰ اﻵﺧﺮﻳﻦ‬
‫ ﻻ ﺗﻮﺟﺪ هﻨﺎك أي أﺿﺮار ﺟﺎﻧﺒﻴﺔ‬:‫اﻵﺛﺎر اﻟﺴﻠﺒﻴﺔ‬
‫ﻣﻦ هﺬﻩ اﻟﺪراﺳﺔ و ﻣﺸﺎرآﺘﻚ ﻻ ﺗﺴﺒﺐ أي إزﻋﺎج‬
.‫أو ﻣﺨﺎﻃﺮ ﻣﺴﺘﻘﺒﻼ‬
‫ إذا رﻓﻀﺖ اﻟﻤﺸﺎرآﺔ‬:‫ﻋﺪم اﻟﺮﻏﺒﺔ ﻓﻲ اﻟﻤﺸﺎرآﺔ‬
‫ﻓﻲ هﺬﻩ اﻟﺪراﺳﺔ ﻓﺎﻧﻚ ﻟﻦ ﺗﺘﻌﺮض ﻷي ﺟﺰاء أو‬
.‫ﻓﻘﺪان ﻟﻠﻤﺰاﻳﺎ‬
‫ إن ﻣﺸﺎرآﺘﻚ ﻓﻲ هﺬﻩ اﻟﺪراﺳﺔ‬:‫ﺳﺮﻳﺔ اﻟﻤﻌﻠﻮﻣﺎت‬
‫ﻗﺪ ﻳﺘﻢ ﻧﺸﺮ ﻧﺘﺎﺋﺞ هﺬا‬.‫ﺳﺘﻜﻮن ﻓﻲ ﻏﺎﻳﺔ اﻟﺴﺮﻳﺔ‬
‫اﻟﺒﺤﺚ ﻷﻏﺮاض أآﺎدﻳﻤﻴﺔ وﻟﻜﻦ ﻟﻦ ﻳﺘﻢ اﻟﻜﺸﻒ‬
.‫ﻋﻦ هﻮﻳﺘﻚ ﻓﻲ أي ﺣﺎل ﻣﻦ اﻷﺣﻮال‬
‫ﻟﻘﺪ أﻋﻄﻴﺖ اﻟﻔﺮﺻﺔ ﻟﻄﺮح أﻳﺔ أﺳﺌﻠﺔ ﻟﺪي‬
.‫وﺗﻠﻘﻴﺖ إﺟﺎﺑﺎت ﻣﺮﺿﻴﺔ ﻋﻨﻬﺎ‬
...............................‫اﺳﻢ اﻟﻤﺸﺘﺮك‬
.......................................‫اﻟﺘﻮﻗﻴﻊ‬
.......................................‫اﻟﺘﺎرﻳﺦ‬
Appendix 2
PATIENT ASSESSMENT
Pedographic changes post Anodyne Therapy in diabetic peripheral
neuropathy
Questionnaire
Personal Data
Date
‫اﻟﺘﺎرﻳﺦ‬
Name : ( Optional )
( ‫اﻷﺳﻢ ) اﺧﺘﻴﺎري‬
Date of Birth
‫ﺗﺎرﻳﺦ اﻟﻤﻴﻼد‬
Age ( In years)hg
‫اﻟﻌﻤﺮ ﺑﺎﻟﺴﻨﻴﻦ‬
Sex
‫اﻟﺠﻨﺲ‬
File No.
‫رﻗﻢ اﻟﻤﻠﻒ‬
ID No.
‫رﻗﻢ اﻟﻬﻮﻳﺔ‬
Street Address
‫اﻟﻌﻨﻮان‬
Residence
‫ﻣﻜﺎن اﻹﻗﺎﻣﺔ‬
Home Phone
‫هﺎﺗﻒ اﻟﻤﻨﺰل‬
Mobile No.
‫رﻗﻢ اﻟﺠﻮال‬
64
‫اﻟﻤﻌﻠﻮﻣﺎت اﻟﻄﺒﻴﺔ‬
‫‪Medical Information‬‬
‫) ‪ ( 1‬هﻞ ﻟﺪﻳﻚ ﻣﺮض اﻟﺴﻜﺮ ؟‬
‫ﻻ)‬
‫ﻧﻌﻢ ) (‬
‫(‬
‫) ‪ ( 2‬أي ﻧﻮع ﻣﻦ ﻣﺮض اﻟﺴﻜﺮ ؟‬
‫)‬
‫)‬
‫( ‪Type 2 DM‬‬
‫( ‪.Type 1 DM‬‬
‫) ‪ ( 3‬آﻢ ﺳﻨﺔ وأﻧﺖ ﻣﺮﻳﺾ ﺳﻜﺮ ؟‬
‫) ‪ ( 1‬أﻗﻞ ﻣﻦ ﺳﻨﺔ ) (‬
‫) ‪ 5 – 2 ( 2‬ﺳﻨﻮات ) (‬
‫) ‪ ( 3‬أآﺜﺮ ﻣﻦ ‪ 5‬ﺳﻨﻮات ‪.‬‬
‫) ‪ ( 4‬هﻞ ﺗﺴﺘﺨﺪم ﻋﻼﺟﺎ ﻟﻠﺴﻜﺮ ﺣﺎﻟﻴﺎ ؟‬
‫ﻧﻌﻢ ) (‬
‫(‬
‫ﻻ)‬
‫إذا آﺎﻧﺖ اﻹﺟﺎﺑﺔ ﺑﻨﻌﻢ ) أي ﻧﻮع وﻟﻤﺪة آﻢ (‬
‫ﻋﻼج اﻟﺴﻜﺮ ) ﺣﺒﻮب (‬
‫(‬
‫)‬
‫‪............................................................‬‬
‫ﻋﻼج اﻟﺴﻜﺮ ﻣﻊ اﻟﺘﻤﺎرﻳﻦ‬
‫(‬
‫)‬
‫‪.........................................................‬‬
‫اﻟﺤﻤﻴﺔ ﻣﻊ اﻟﺘﻤﺎرﻳﻦ‬
‫(‬
‫)‬
‫‪................................................................‬‬
‫اﻷﻧﺴﻮﻟﻴﻦ‬
‫(‬
‫)‬
‫‪............................................................................‬‬
‫اﻷﻧﺴﻮﻟﻴﻦ ﻣﻊ اﻟﺘﻤﺎرﻳﻦ‬
‫(‬
‫)‬
‫‪............................................................‬‬
‫ﻋﻼﺟﺎت أﺧﺮى ) ﺣﺪد (‬
‫(‬
‫)‬
‫‪...........................................................‬‬
‫‪.........................................................................................‬‬
‫) ‪ ( 5‬هﻞ ﺗﺴﺘﺨﺪم ﻋﻼﺟﺎت ﻷﻣﺮاض أﺧﺮى ) ﺣﺪد (‬
‫‪- 2 ......................................‬‬
‫‪-1‬‬
‫‪...............................................‬‬
‫‪..................................... - 3‬‬
‫‪................................................‬‬
‫‪65‬‬
‫‪-4‬‬
‫) ‪ ( 6‬هﻞ ﺗﻌﺎﻧﻲ ﻣﻦ اﻵم ﻓﻲ اﻟﻘﺪﻣﻴﻦ ؟‬
‫ﻧﻌﻢ‬
‫)‬
‫(‬
‫ﻻ)‬
‫(‬
‫إذا آﺎﻧﺖ اﻹﺟﺎﺑﺔ ﺑﻨﻌﻢ ﺣﺪد ﻧﻮع اﻵم ‪:‬‬
‫أﻟﻢ ﺣﺎد )‬
‫أﻟﻢ آﺎﻟﺤﺮوق‬
‫(‬
‫) ‪ ( 7‬هﻞ ﺗﻌﺎﻧﻲ ﻣﻦ ﺗﻨﻤﻴﻞ أو ﺧﺪران ﻓﻲ اﻟﻘﺪﻣﻴﻦ ؟‬
‫ﻧﻌﻢ ) (‬
‫(‬
‫ﻻ)‬
‫) ‪ ( 8‬هﻞ اﻟﺴﻜﺮ ﻣﻨﺘﻈﻢ ﻣﻌﻚ اﻟﻔﺘﺮة اﻷﺧﻴﺮة ؟‬
‫ﻧﻌﻢ )‬
‫(‬
‫(‬
‫ﻻ)‬
‫) ‪ ( 9‬هﻞ ﺗﻌﺎﻧﻲ ﻣﻦ ﺿﻐﻂ اﻟﺪم ؟‬
‫ﻧﻌﻢ ) (‬
‫(‬
‫ﻻ)‬
‫إذا آﺎﻧﺖ اﻹﺟﺎﺑﺔ ﺑﻨﻌﻢ هﻞ ﺿﻐﻂ اﻟﺪم ﻣﻨﺘﻈﻤ ًﺎ ﻣﻌﻚ ؟‬
‫ﻧﻌﻢ ) (‬
‫(‬
‫ﻻ)‬
‫‪66‬‬
‫)‬
‫(‬
Appendix 3
Physical Examination
WEIGHT:
• HEIGHT:
• BMI:
• PULSE RATE:
• BP:
• FASTING BLOOD SUGAR:
• GLUCOSE 2H PP:
67
Appendix 4
Data of Pedography of Both Feet
Pre and Post 4Weeks of Physical Therapy for All Subjects
Patient Name:
Date of Birth:
PRE
Total object
Data files
Force-time
integral
(N*s)
Pressuretime integral
(kPa*s)
Maximum
force (N)
Peak pressure Contact
Contact time
(kPa)
area (cm²)
(ms)
Mean
(Rt Foot)
(Lt Foot)
Mask name: Hind foot
Data files
Forcetime
integral
(N*s)
(kPa*s)
Maximum
force (N)
Mean:
Right Foot
Mean:
Left Foot
68
Peak
pressure
(kPa)
Contact area
(cm²)
Contact time
(ms)
PRE
Mask name: Midfoot
Data files
Forcetime
integral
(N*s)
(kPa*s)
Maximum
force (N)
Peak pressure Contact area
(kPa)
(cm²)
Contact time
(ms)
Mean:
Right Foot
Mean:
Left Foot
Mask name: Forefoot
Data files
Forcetime
integral
(N*s)
(kPa*s)
Maximum
force (N)
Mean:
Right Foot
Mean:
Left Foot
69
Peak
pressure
(kPa)
Contact area
(cm²)
Contact time
(ms)
POST
Total object
Force-time
Data files integral
(N*s)
Pressuretime
integral
(kPa*s)
Maximum
force (N)
Peak pressure
(kPa)
Contact
Contact time
area (cm²)
(ms)
Mean
(Rt Foot)
(Lt Foot)
Mask name: Hind foot
Data files
Forcetime
integral
(N*s)
(kPa*s)
Maximum
force (N)
Mean:
Right Foot
Mean:
Left Foot
70
Peak
pressure
(kPa)
Contact area
(cm²)
Contact time
(ms)
POST
Mask name: Midfoot
Data files
Forcetime
integral
(N*s)
(kPa*s)
Maximum
force (N)
Peak
pressure
(kPa)
Contact area
(cm²)
Contact time
(ms)
Contact area
(cm²)
Contact time
(ms)
Mean:
Right Foot
Mean:
Left FOOT
Mask name: Forefoot
Data files
Forcetime
integral
(N*s)
(kPa*s)
Maximum
force (N)
Mean:
Right Foot
Mean:
Left Foot
71
Peak
pressure
(kPa)
Appendix 5
Tinetti Assessment Tool: Balance
Patient: _____________________________________ Date:
___________
Location: ____________________________________ Rater:
__________
1. Sitting balance:
• Leans or slides in chair =0
• Steady, safe =1
2. Arises:
• Unable without help =0
• Able, uses arms to help =1
• Able without using arms =2
3. Attempts to arise:
• Unable without help =0
• Able, requires> 1 attempt =1
• Able to arise, 1 attempt =2
4. Immediate standing balance (first five seconds):
• Unsteady (swaggers, moves feet, trunk sway =0
• Steady but uses walker or other support =1
• Steady without walker or other support =2
5. tanding balance :
• Unsteady =0 Steady but wide stance ( medial heels >4
in apart )
•
uses cane or other support =1
72
• Narrow stance without support =2
6. Nudged (subject at maximum position with feet as close
together as possible, examiner pushes lightly on subject’s
sternum with palm of hand 3 times):
• Begins to fall =0
• Staggers,grabs, catches self =1
•
Steady =2
7. Eyes Closed :
• Unsteady =0
• Steady =1
8. Turning 360 degrees:
• Discontinuous Steps =0
• Continuous =1
• Unsteady (grabs, staggers) =0
•
Steady =1
9. Sitting down :
• Unsafe (misjudges distance, falls into chair) =0
• Uses arms or not a smooth motion =1
•
Safe, smooth motion =2
Balance Score: _____/16
73
Tinetti Assessment Tool: Gait
Patient:
______________________________________
Date:
____________________________________
Rater:
___________
Location:
__________
Initial instructions: Subject stands with examiner, walks down
hallway or across room, first at “usual” pace, then back at “rapid,
but safe” pace (using usual walking aids).
Task Description of Gait Score
10. Initiation of gait (immediately after told to “go”).
• Any hesitancy or multiple attempts to start =0
• No hesitancy =1
11.
Step length and height:
a.
Right swing foot:
• does not pass left stance foot with step =0
• passes left stance foot =1
• right foot does not clear floor completely with step =0
• right foot completely clears floor =1
b.
Left swing foot:
• does not pass right stance foot with step =0
• passes right stance foot =1
• left foot does not clear floor completely with step =0
74
• left foot completely clears floor =1
11. Step Symmetry:
• Right and left step length not equal (estimate) =0
• Right and left step appear equal =1
12. Step Continuity:
• Stopping or discontinuity between steps =0
• Steps appear continuous =1
13. Path (estimated in relation to floor tiles, 12-inch diameter;
observe excursion of 1 foot over about 10 ft. of the course.)
• Marked deviation =0
•
Mild/moderate deviator or uses walking aid =1
•
Straight without walking aid =2
14. Trunk :
• Marked sway or uses walking aid =0
• No sway but flexion of knees or back or spreads arms
out while walking =1
• No sway, no flexion, no use of arms, and not use of
walking aid =2
15. Walking Time:
• Heels apart =0
• Heels almost touching while walking =1
Gait Score: /12 Balance + Gait Score: /28
75
‫اﻟﺘﻐﻴﺮات ﻓﻲ ﺗﺨﻄﻴﻂ اﻟﻘﺪم ﻋﻘﺐ اﻟﻌﻼج ﺑﺎﻷﻧﻮداﻳﻦ ﻟﻤﺮﺿﻰ ٳﻟﺘﻬﺎب اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ‬
‫اﻟﺴﻜﺮي‬
‫ﻣﻠﺨﺺ اﻟﺮﺳﺎﻟﺔ‬
‫ﺧﻠﻔﻴﺔ اﻟﺪراﺳﺔ‪:‬‬
‫ٳﻋﺘﻼﻻت اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ هﻲ اﺣﺪ اﻟﻤﻀﺎﻋﻔﺎت اﻟﺸﺎﺋﻌﺔ ﻟﺪاء اﻟﺴﻜﺮي ﺳﻮاء ﻣﻦ اﻟﻨﻮع‬
‫اﻷول أو ﻣﻦ اﻟﻨﻮع اﻟﺜﺎﻧﻲ‪ ،‬ﻓﻬﻲ ﺗﺼﻴﺐ ﻣﺎ ﻳﻘﺎرب ‪ ٤٠‬إﻟﻰ ‪ % ٦٠‬ﻣﻦ اﻷﺷﺨﺎص‪ .‬ﻣﻦ اﻟﻨﺎﺣﻴﺔ‬
‫اﻟﻔﺴﻴﻮﻟﻮﺟﻴﺔ وﻣﻦ اﻟﻨﺎﺣﻴﺔ اﻟﻤﺮﺿﻴﺔ ﻓﺈن ٳﻋﺘﻼﻻت اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ واﻟﻨﺎﺗﺠﺔ ﻋﻦ داء اﻟﺴﻜﺮي‬
‫ﺗﺤﺼﻞ ﻧﺘﻴﺠﺔ إﺻﺎﺑﺔ اﻷﻟﻴﺎف اﻟﻌﺼﺒﻴﺔ واﻟﺘﻲ ﻗﺪ ﺗﻜﻮن ﻓﻲ ﺑﻌﺾ اﻷوﻗﺎت إﺻﺎﺑﺔ وﻇﻴﻔﻴﺔ إﻻ أﻧﻬﺎ‬
‫ﻋﺎدة ﻣﺎ ﺗﻜﻮن إﺻﺎﺑﺔ ﻋﻀﻮﻳﺔ‪ .‬ﻋﺎدة ﻣﺎ ﻳﺤﺼﻞ هﺬا اﻟﻨﻮع ﻣﻦ اﻹﺻﺎﺑﺎت ﺑﺼﻮرة ﺗﺪرﻳﺠﻴﺔ‪.‬وﻣﻦ‬
‫اﻟﻤﺆآﺪ أن ٳرﺗﻔﺎع ﻣﻌﺪل اﻟﺴﻜﺮ ﻓﻲ اﻟﺪم ﻟﻪ دور آﺒﻴﺮ ﻓﻲ ﺗﻔﺴﻴﺮ اﻵﻟﻴﺔ اﻟﻔﺴﻴﻮﻟﻮﺟﻴﺔ واﻟﻤﺮﺿﻴﺔ‬
‫اﻟﺘﻲ ﺗﺆدي ﻟﻺﺻﺎﺑﺔ ﺑﻬﺬا اﻟﻨﻮع ﻣﻦ اﻻﻋﺘﻼﻻت‪ ،‬ﻋﻠﻰ اﻟﺮﻏﻢ ﻣﻦ أﻧﻪ ﻟﻴﺲ ﻓﻘﻂ اﻟﻌﺎﻣﻞ اﻟﻮﺣﻴﺪ‬
‫اﻟﻤﺆدي ﻟﺬﻟﻚ‪ .‬ﻓﻘﺪان اﻹﺣﺴﺎس اﻟﺬي ﻳﺮاﻓﻖ اﻻﻋﺘﻼﻻت اﻟﻌﺼﺒﻴﺔ اﻟﻄﺮﻓﻴﺔ ﻟﺪاء اﻟﺴﻜﺮي ﻳﺴﺎهﻢ ﻓﻲ‬
‫أﺿﻌﺎف اﻟﺘﻮازن وﺗﻐﻴﺮ ﻣﻈﻬﺮ اﻟﻤﺸﻴﺔ ﻣﻤﺎ ﻳﺰﻳﺪ ﻣﻦ إﺣﺘﻤﺎﻻت اﻟﺴﻘﻮط‪ .‬إن ﺗﻄﺒﻴﻖ ﺗﻘﻨﻴﺔ ﻃﺎﻗﺔ‬
‫اﻷﺷﻌﺔ اﻟﻀﻮﺋﻴﺔ ﺗﺤﺖ اﻟﺤﻤﺮاء أﺣﺎدﻳﺔ اﻟﻠﻮن ﻗﺪ ﻳﺴﺎهﻢ‪ ،‬ﻋﻠﻰ اﻷﻗﻞ ﻣﺆﻗﺘ ًﺎ‪ ،‬ﻓﻲ زﻳﺎدة اﻹﺣﺴﺎس‬
‫ﻓﻲ اﻟﻘﺪﻣﻴﻦ وإﻧﻘﺎص اﻷﻟﻢ اﻟﻨﺎﺗﺞ ﻋﻦ اﻋﺘﻼﻻت اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ‪.‬‬
‫اﻟﻬﺪف ﻣﻦ اﻟﺪراﺳﺔ‪:‬‬
‫اﻟﻬﺪف ﻣﻦ هﺬﻩ اﻟﺪراﺳﺔ هﻮ ﻓﺤﺺ ﺗﺄﺛﻴﺮ اﻟﻌﻼج ﺑﺎﻷﻧﻮداﻳﻦ ﻋﻠﻰ ﺗﺨﻄﻴﻂ اﻟﻘﺪم‪،‬‬
‫اﻹﺣﺴﺎس ﺑﺎﻟﺬﺑﺬﺑﺎت واﻷﻟﻢ ﻟﺪى اﻷﺷﺨﺎص اﻟﺬﻳﻦ ﻳﻌﺎﻧﻮن ﻣﻦ ٳﻋﺘﻼﻻت ﻋﺼﺒﻴﺔ ﻃﺮﻓﻴﺔ ﻧﺎﺷﺌﺔ ﻋﻦ‬
‫داء اﻟﺴﻜﺮي‪.‬‬
‫ﻋﻴﻨﺔ اﻟﺪراﺳﺔ‪:‬‬
‫ﺗﻢ إﺟﺮاء هﺬﻩ اﻟﺪراﺳﺔ ﻋﻠﻰ اﺛﻨﻴﻦ وأرﺑﻌﻴﻦ ﻣﺮﻳﻀ ًﺎ) ‪٢٢‬ﺳﻴﺪﻩ و‪ ٢٠‬رﺟﻼ (‪،‬ﻳﻌﺎﻧﻮن ﻣﻦ‬
‫ﻣﺮض اﻟﺴﻜﺮي اﻟﻨﻮع اﻟﺜﺎﻧﻲ‪،‬وﻟﺪﻳﻬﻢ أﻋﺮاض اﻟﺘﻬﺎب اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ‪،‬وﻗﺪ ﺗﻢ ﺗﻘﺴﻤﻬﻢ إﻟﻰ‬
‫ﻣﺠﻤﻮﻋﺘﻴﻦ ﻓﻔﻲ اﻟﻤﺠﻤﻮﻋﺔ اﻷوﻟﻰ ﻋﺸﺮﻳﻦ ﻣﺮﻳﻀﺎ‪،‬اﺛﻨﺎ ﻋﺸﺮ ﺳﻴﺪة ﺛﻤﺎﻧﻴﺔ رﺟﺎل وﻗﺪ ﺗﺮاوﺣﺖ‬
‫أﻋﻤﺎرهﻢ ﺑﻴﻦ‪ ٥٠‬إﻟﻰ ‪ ٦٥‬ﻋﺎﻣﺎ وﻣﺘﻮﺳﻂ اﻟﻌﻤﺮ ﻟﺪﻳﻬﻢ آﺎن ‪ ٤٫٦٩ ± ٥٨٫٠٥‬ﻋﺎﻣﺎ‪ ،‬آﻤﺎ أن هﻨﺎك‬
‫اﺛﻨﻴﻦ وﻋﺸﺮﻳﻦ ﻣﺮﻳﻀﺎ ﻓﻲ اﻟﻤﺠﻤﻮﻋﺔ اﻟﺜﺎﻧﻴﺔ‪ ،‬ﻋﺸﺮة ﺳﻴﺪات و اﺛﻨﺎ ﻋﺸﺮ رﺟﻼ ﺗﺮاوﺣﺖ‬
‫أﻋﻤﺎرهﻢ ﺑﻴﻦ‪ ٥٠‬إﻟﻰ ‪ ٧٩‬ﻋﺎﻣﺎ وﻣﺘﻮﺳﻂ اﻟﻌﻤﺮ ﻟﺪﻳﻬﻢ ‪ ٩٫٠٤ ± ٦٠٫٣٦‬ﻋﺎﻣﺎ‪.‬‬
‫إﺟﺮاءات اﻟﺪراﺳﺔ‪:‬‬
‫ﺗﻢ ﺗﻄﺒﻴﻖ هﺬﻩ اﻟﺪراﺳﺔ ﻋﻠﻰ ‪ ٤٢‬ﻣﺮﻳﻀﺎ ﻣﺼﺎﺑﻴﻦ ﺑﺎﻋﺘﻼﻻت ﻋﺼﺒﻴﺔ ﻃﺮﻓﻴﺔ ﻧﺎﺗﺠﺔ ﻋﻦ‬
‫داء اﻟﺴﻜﺮي‪ .‬ﻓﻲ ﻣﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ اﻟﺬﻳﻦ ﺗﻤﺖ ﻣﺮاﻗﺒﺘﻬﻢ‪ ،‬آﺎن هﻨﺎك ‪ ٢٠‬ﻣﺮﻳﻀﺎ ﺗﺘﺮاوح‬
‫أﻋﻤﺎرهﻢ ﻣﺎ ﺑﻴﻦ ‪ ٥٠‬إﻟﻰ ‪ ٦٥‬ﻋﺎﻣﺎ وﻣﺘﻮﺳﻂ اﻟﻌﻤﺮ ﻟﺪﻳﻬﻢ آﺎن ‪ ،٤٫٦٩ ± ٥٨٫٠٥‬ﻋﺎﻣﺎ ﺑﻴﻨﻤﺎ ﻓﻲ‬
‫اﻟﻤﺠﻤﻮﻋﺔ اﻟﺘﻲ اﺳﺘﻔﺎدت ﻣﻦ اﻟﻄﺮق اﻟﻌﻼﺟﻴﺔ آﺎن هﻨﺎك ‪ ٢٢‬ﻣﺮﻳﻀﺎ ﺗﺘﺮاوح أﻋﻤﺎرهﻢ ﻣﺎ ﺑﻴﻦ‬
‫‪ ٥٠‬إﻟﻰ ‪ ٧٩‬ﻋﺎﻣﺎ وﻣﺘﻮﺳﻂ اﻟﻌﻤﺮ ﻟﺪﻳﻬﻢ ‪ ٩٫٠٤ ± ٦٠٫٣٦‬ﻋﺎﻣﺎ‪ .‬ﺗﻢ ﻋﻤﻞ ﺗﻘﻴﻴﻢ ﺑﺪﻧﻲ آﺎﻣﻞ‬
‫ﻟﻤﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ اﻟﺬﻳﻦ ﺗﻤﺖ ﻣﺮاﻗﺒﺘﻬﻢ‪ ،‬واﺷﺘﻤﻞ هﺬا ﻋﻠﻰ ﺗﻘﻴﻴﻢ اﻟﺸﻌﻮر ﺑﺎﻷﻟﻢ ﺑﺎﺳﺘﻌﻤﺎل‬
‫اﻟﻤﻘﻴﺎس اﻟﺒﺼﺮي ﻟﺘﻘﻴﻴﻢ اﻟﺸﻌﻮر ﺑﺎﻷﻟﻢ‪ ،‬ﺗﻘﻴﻴﻢ اﻟﺸﻌﻮر اﻟﺠﻠﺪي ﺑﺎﺳﺘﻌﻤﺎل أﻟﻴﺎف ﺳﻴﻤﻴﺰ ﻓﺎﻳﻨﺸﺘﺎﻳﻦ‬
‫اﻟﺪﻗﻴﻘﺔ‪ ،‬ﺗﻘﻴﻴﻢ ﻋﺘﺒﺔ اﻹﺣﺴﺎس ﺑﺎﻟﺬﺑﺬﺑﺎت ﺑﺎﺳﺘﻌﻤﺎل ﺟﻬﺎز ﺗﻘﻴﻴﻢ اﻹﺣﺴﺎس اﻟﻌﺼﺒﻲ اﻟﻜﻬﺮﺑﺎﺋﻲ‬
‫)اﻟﻨﻴﻮروﺛﻴﺰﻳﻮﻣﻴﺘﺮ(‪ ،‬ﺗﻘﻴﻴﻢ اﻟﺘﻮازن واﻟﻤﺸﻴﺔ ﺑﺎﺳﺘﻌﻤﺎل ﻣﻘﻴﺎس ﺗﻴﻨﻴﺘﻲ‪ ،‬ﺑﺎﻹﺿﺎﻓﺔ ﻟﺘﻘﻴﻴﻢ اﻟﻀﻐﻂ‬
‫ﻓﻲ أﺧﻤﺺ اﻟﻘﺪم‪ .‬أﻣﺎ ﺑﺎﻟﻨﺴﺒﺔ ﻟﻤﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ اﻟﺘﻲ اﺳﺘﻔﺎدت ﻣﻦ اﻟﻌﻼج‪ ،‬ﻓﻘﺪ ﻋﻤﻠﺖ ﻟﻬﻢ‬
‫ﺟﻤﻴﻊ إﺟﺮاءات اﻟﺘﻘﻴﻴﻢ اﻟﺒﺪﻧﻲ اﻟﺴﺎﺑﻘﺔ اﻟﺬآﺮ ﺑﺎﻹﺿﺎﻓﺔ ﻟﺘﻄﺒﻴﻖ ﺗﻘﻨﻴﺔ ﻃﺎﻗﺔ اﻷﺷﻌﺔ اﻟﻀﻮﺋﻴﺔ ﺗﺤﺖ‬
‫اﻟﺤﻤﺮاء أﺣﺎدﻳﺔ اﻟﻠﻮن واﻟﺘﻲ اﻋﺘﻤﺪت ﻋﻠﻰ ﺗﻄﺒﻴﻖ هﺬا اﻟﻌﻼج ﻟﻤﺪة ‪ ٣٠‬دﻗﻴﻘﺔ ﺛﻼث ﻣﺮات ﻓﻲ‬
‫اﻷﺳﺒﻮع وﻟﻔﺘﺮة ‪ ٤‬أﺳﺎﺑﻴﻊ ﻟﺘﻜﻮن ﺑﺬﻟﻚ ﻣﺪة اﻟﻌﻼج اﻹﺟﻤﺎﻟﻴﺔ ‪ ١٢‬ﻋﻼﺟﺎ ﻟﻜﻼ اﻟﻘﺪﻣﻴﻦ‪.‬‬
‫ﻧﺘﺎﺋﺞ اﻟﺪراﺳﺔ‪:‬‬
‫ﺑﻠﻐﺖ اﺧﺘﻼﻓﺎت ﻗﻴﺎﺳﺎت ﻣﻘﺪار اﻟﺸﻌﻮر ﺑﺎﻷﻟﻢ‪ ،‬ﻗﻴﻢ اﻟﻔﺤﺺ ﺑﺎﺳﺘﻌﻤﺎل أﻟﻴﺎف ﺳﻴﻤﻴﺰ‬
‫ﻓﺎﻳﻨﺸﺘﺎﻳﻦ اﻟﺪﻗﻴﻘﺔ‪ ،‬وﻗﻴﻢ ﻋﺘﺒﺔ اﻹﺣﺴﺎس ﺑﺎﻟﺬﺑﺬﺑﺎت ﻣﺎ ﺑﻴﻦ اﻟﻘﺪﻣﻴﻦ اﻟﻴﻤﻨﻰ واﻟﻴﺴﺮى‪ ،‬وذﻟﻚ ﻓﻲ‬
‫ﻣﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ اﻟﺘﻲ ﺗﻠﻘﺖ اﻟﻌﻼج‪ ،‬ﻗﻴﻤﺎ ذات دﻻﻟﺔ إﺣﺼﺎﺋﻴﺔ ﻣﺆﺛﺮة )ﻗﻴﻤﺔ اﻟﻤﻌﺎﻣﻞ ب =‬
‫‪ (٠٫٠٠٠‬وذﻟﻚ ﺑﻌﺪ ‪ ٤‬أﺳﺎﺑﻴﻊ ﻣﻦ اﻟﻌﻼج ﺑﺎﻟﻌﻘﺎر‪ .‬وﻟﻢ ﺗﻜﻦ هﻨﺎك ﻓﺮوق ﻓﻲ ﻣﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ‬
‫اﻟﺘﻲ ﺗﻤﺖ رﻗﺎﺑﺘﻬﺎ‪ .‬وﻟﻢ ﻳﻜﻦ هﻨﺎك ﺗﺤﺴﻦ ذو دﻻﻟﺔ واﺿﺤﺔ ﻓﻲ ﺻﻮرة اﻟﺮﺳﻢ اﻟﺒﻴﺎﻧﻲ ﻷي ﻣﻦ‬
‫اﻟﻘﺪﻣﻴﻦ ﻓﻲ آﻼ ﻣﺠﻤﻮﻋﺘﻲ اﻟﻤﺮﺿﻰ وذﻟﻚ ﺑﻌﺪ ‪ ٤‬أﺳﺎﺑﻴﻊ ﻣﻦ اﻟﻌﻼج‪.‬‬
‫ﺧﻼﺻﺔ اﻟﺪراﺳﺔ‪:‬‬
‫آﺎﻧﺖ هﻨﺎك ﻓﻮرق إﺣﺼﺎﺋﻴﺔ ذات دﻻﻟﺔ واﺿﺤﺔ ﻓﻲ ﻣﺘﻮﺳﻂ ﻗﻴﻤﺔ اﻟﻤﻘﻴﺎس اﻟﺒﺼﺮي ﻟﺘﻘﻴﻴﻢ‬
‫اﻟﺸﻌﻮر ﺑﺎﻷﻟﻢ‪ ،‬اﻟﻘﻴﻤﺔ اﻷﺳﺎﺳﻴﺔ ﻟﻠﻔﺤﺺ ﺑﺎﺳﺘﻌﻤﺎل أﻟﻴﺎف ﺳﻴﻤﻴﺰ ﻓﺎﻳﻨﺸﺘﺎﻳﻦ اﻟﺪﻗﻴﻘﺔ‪ ،‬وﻓﻲ ﻗﻴﻤﺔ‬
‫ﻋﺘﺒﺔ اﻹﺣﺴﺎس ﺑﺎﻟﺬﺑﺬﺑﺎت ﻓﻲ آﻼ اﻟﻘﺪﻣﻴﻦ اﻟﻴﻤﻨﻰ واﻟﻴﺴﺮى ﻓﻲ ﻣﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ اﻟﺘﻲ ﺗﻢ‬
‫ﻋﻼﺟﻬﺎ وذﻟﻚ ﺑﻌﺪ ‪ ٤‬أﺳﺎﺑﻴﻊ ﻣﻦ اﻟﻌﻼج ﺑﺎﻷﻧﻮداﻳﻦ‪ ،‬وﻟﻢ ﺗﻜﻦ هﻨﺎك أي ﻓﺮوق ﻓﻲ ﻣﺠﻤﻮﻋﺔ‬
‫اﻟﻤﺮﺿﻰ اﻟﺘﻲ ﺗﻤﺖ ﻣﺮاﻗﺒﺘﻬﺎ‪ .‬ﻻ ﻳﻮﺟﺪ هﻨﺎك أي ﺗﺤﺴﻦ واﺿﺢ ﻓﻲ ﺻﻮرة اﻟﺮﺳﻢ اﻟﺒﻴﺎﻧﻲ ﻟﻠﻘﺪم ﻓﻲ‬
‫آﻼ ﻣﺠﻤﻮﻋﺘﻲ اﻟﻤﺮﺿﻰ ﺑﻌﺪ ‪ ٤‬أﺳﺎﺑﻴﻊ ﻣﻦ اﻟﻌﻼج‪.‬‬
‫ﻣﺤﺘﻮى اﻟﺮﺳﺎﻟﺔ‬
‫ﺗﺤﺘ ﻮي اﻟﺮﺳ ﺎﻟﺔ ﻋﻠ ﻰ ﺳ ﺘﺔ ﻓ ﺼﻮل‪،‬ﺗ ﺴﻌﺔ ﻣﻼﺣ ﻖ‪ ،‬وﻣﻠﺨ ﺼﻴﻦ ﺑ ﺎﻟﻠﻐﺘﻴﻦ اﻟﻌﺮﺑﻴ ﺔ و‬
‫اﻻﻧﺠﻠﻴﺰﻳﺔ‪،‬هﺬا ﺑﺎﻹﺿﺎﻓﺔ إﻟﻰ ﻗﺎﺋﻤﺔ اﻟﻤﺮاﺟﻊ‪ .‬آﻤﺎ ﺗﻢ ﺗﺰوﻳﺪ اﻟﺮﺳﺎﻟﺔ ﺑﺎﻟﻔﻬﺮس اﻟﻌ ﺎم ﻟﻠﻤﻮﺿ ﻮﻋﺎت‬
‫اﻟﻤﺪرﺟﺔ ﻓﻴﻬﺎ وآﺬﻟﻚ اﻟﻔﻬﺎرس اﻟﻔﺮﻋﻴﺔ اﻟﺨﺎﺻﺔ ﺑﺎﻟﺠﺪاول واﻟﻨﻤ ﺎذج اﻟﺘﻮﺿ ﻴﺤﻴﺔ‪.‬وﺟ ﺎءت ﻓ ﺼﻮل‬
‫اﻟﺮﺳﺎﻟﺔ آﻤﺎ ﻳﻠﻲ‪:‬‬
‫‪-‬‬
‫اﻟﻤﻘﺪﻣﺔ‪:‬‬
‫ﺗﺤﺘﻮي ﻣﻘﺪﻣﺔ اﻟﺮﺳﺎﻟﺔ ﻋﻠﻰ ﻧﺒ ﺬة ﻣﺨﺘ ﺼﺮة ﻋ ﻦ داء اﻟ ﺴﻜﺮي ﻣ ﻦ اﻟﻨ ﻮع اﻟﺜ ﺎﻧﻲ‬
‫‪،‬واﻟﺘﻬﺎب اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴﺔ اﻟ ﺴﻜﺮي‪،‬وﻣ ﺪى اﻧﺘ ﺸﺎر ه ﺬا اﻟﻤ ﺮض ﻓ ﻲ اﻟ ﺴﻌﻮدﻳﺔ أو ﻓ ﻲ‬
‫اﻟﻌﺎﻟﻢ وﻣﺪى أهﻤﻴﺔ ﺗﻘﻴﻴﻢ اﻹﻋﺮاض اﻟﺠﺎﻧﺒﻴﺔ ﻟﻬﺬا اﻟﺪاء و اﻟﻌﻼج اﻟﺒ ﺪﻳﻞ ﻟ ﻪ‪ .‬آﻤ ﺎ اﺣﺘ ﻮت‬
‫ﻋﻠﻰ اﻟﻬﺪف اﻟﺬي ﺗﻢ ﻣﻦ اﺟﻠﻪ إﻋﺪاد اﻟﺮﺳﺎﻟﺔ‪ ،‬آﻤ ﺎ أن هﻨ ﺎك ﻓﺮﺿ ﻴﺔ وﺿ ﻌﺖ ﻓ ﻲ ﻣﻘﺪﻣ ﺔ‬
‫اﻟﺮﺳﺎﻟﺔ وهﻲ آﻤﺎ ﻳﻠﻲ‪:‬‬
‫‪-‬‬
‫اﻟﻔﺮﺿﻴﺔ‪:‬‬
‫ﻻ ﻳﻮﺟ ﺪ ﺗ ﺄﺛﻴﺮ ﻟﻠﻌ ﻼج ﺑ ﺎﻻﻧﻮداﻳﻦ ﻋﻠ ﻰ ﺷ ﻜﻞ اﻟﻘ ﺪم ﻋﻠ ﻰ اﻹﺣ ﺴﺎس‬
‫ﺑﺎﻟﺬﺑﺬﺑﺎت واﻷﻟﻢ ﻟﺪى اﻟﻤﺮﺿﻰ اﻟﻤﺼﺎﺑﻴﻦ ﺑﺎﻋﺘﻼﻻت اﻷﻋﺼﺎب اﻟﻄﺮﻓﻴ ﺔ اﻟﻨﺎﺷ ﺌﺔ‬
‫ﻋﻦ ﻣﺮض اﻟﺴﻜﺮي‪.‬‬
‫‪-‬‬
‫اﻟﻤﺴﺢ اﻷدﺑﻲ ﻟﻠﺪراﺳﺎت اﻟﺴﺎﺑﻘﺔ‪:‬‬
‫اﺳﺘﻌﺮض هﺬا اﻟﻔﺼﻞ اﻏﻠ ﺐ اﻟﺪراﺳ ﺎت اﻟ ﺴﺎﺑﻘﺔ ذات اﻟﻌﻼﻗ ﺔ ﺑﻤﻮﺿ ﻮع اﻟﺮﺳ ﺎﻟﺔ‬
‫ﻣﻊ اﻟﺘﺮآﻴﺰ ﻋﻠﻰ إﻋﻄﺎء ﻧﺒﺬة ﻣﻔﺼﻠﺔ ﻣﺮض اﻟﺴﻜﺮي‪،‬أﻧﻮاﻋﻪ‪،‬ﻣﻀﺎﻋﻔﺎﺗﻪ وﺗﻌﺮﻳﻒ اﻟﺘﻬﺎب‬
‫اﻷﻋ ﺼﺎب اﻟﻄﺮﻓﻴ ﺔ اﻟ ﺴﻜﺮي وذآ ﺮ أﻋﺮاﺿ ﻪ‪ ،‬ﻣ ﻀﺎﻋﻔﺎﺗﻪ اﻟﺘ ﻲ ﻟﻬ ﺎ ﺗ ﺄﺛﻴﺮ ﻋﻠ ﻰ ﻧ ﺸﺎﻃﺎت‬
‫اﻟﻤ ﺮﻳﺾ اﻟﻴﻮﻣﻴ ﺔ ﻟﻤ ﻞ ﺗ ﺴﺒﺒﻪ ﻣ ﻦ ﻋ ﻮارض ﻣﺮﺿ ﻴﺔ ﺑﻨ ﺎء ﻋﻠ ﻰ اﻟﺪراﺳ ﺎت اﻟ ﺴﺎﺑﻘﺔ‪ .‬ﺛ ﻢ‬
‫ﺗﻨﺎول هﺬا اﻟﻘﺴﻢ ﺷﺮﺣﺎ ﻟﻠﻄﺮق اﻟﻤﺴﺘﺨﺪﻣﺔ ﻓﻲ ﺗﻘﻴ ﻴﻢ ﻣﺮﺿ ﻰ اﻟﺘﻬ ﺎب اﻷﻋ ﺼﺎب اﻟﻄﺮﻓﻴ ﺔ‬
‫اﻟﺴﻜﺮي ﻣﻦ ﺧﻼل اﻟﺪراﺳﺎت اﻟﺴﺎﺑﻘﺔ ﻓﻲ ه ﺬا اﻟﻤﻮﺿ ﻮع‪.‬آﻤ ﺎ ﺗﻄ ﺮق اﻟﺤ ﺪﻳﺚ إﻟ ﻰ اﻟﻌ ﻼج‬
‫ﺑﺎﻟﻠﻴﺰر وﺑﺨﺎﺻﺔ اﻟﻌﻼج ﺑﺎﻷﻧﻮداﻳﻦ‪.‬‬
‫أدوات و ﻃﺮق اﻟﺮﺳﺎﻟﺔ‪:‬‬
‫ﺗﻨﺎوﻟﺖ ﺑﺪاﻳﺔ هﺬا اﻟﻔﺼﻞ وﺻﻔﺎ ﺷﺎﻣﻼ ﻟﻌﻴﻨﺔ اﻟﺪراﺳﺔ‪،‬ﺣﻴﺚ ﺗﻢ إﺟﺮاء هﺬﻩ اﻟﺪراﺳﺔ ﻋﻠﻰ‬
‫اﺛﻨﻴﻦ وأرﺑﻌﻴﻦ ﻣﺮﻳﻀﺎ ‪،‬اﺛﻨﺎن وﻋﺸﺮون ﺳﻴﺪة و ﻋﺸﺮون رﺟﻼ‪،‬ﺗﻢ ﺗﻘﺴﻴﻤﻬﻢ إﻟﻰ ﻣﺠﻤﻮﻋﺘﻴﻦ ﻓﻔﻲ‬
‫اﻟﻤﺠﻤﻮﻋﺔ اﻷوﻟﻰ ﻋﺸﺮﻳﻦ ﻣﺮﻳﻀﺎ‪،‬اﺛﻨﺎ ﻋﺸﺮ ﺳﻴﺪة ﺛﻤﺎﻧﻴﺔ رﺟﺎل‪،‬وﻗﺪ ﺗﺮاوﺣﺖ أﻋﻤﺎرهﻢ ﺑﻴﻦ‬
‫ﺑﻴﻦ‪ ٥٠‬إﻟﻰ ‪ ٦٥‬ﻋﺎﻣﺎ وﻣﺘﻮﺳﻂ اﻟﻌﻤﺮ ﻟﺪﻳﻬﻢ آﺎن ‪ ٤٫٦٩ ± ٥٨٫٠٥‬ﻋﺎﻣﺎ‪،‬آﻤﺎ أن هﻨﺎك اﺛﻨﻴﻦ‬
‫وﻋﺸﺮﻳﻦ ﻣﺮﻳﻀﺎ ﻓﻲ اﻟﻤﺠﻤﻮﻋﺔ ال ﻋﻴﺜﺎﻧﻴﺔ‪،‬ﻋﺸﺮة ﺳﻴﺪات و اﺛﻨﺎ ﻋﺸﺮ رﺟﻼ‪ ،‬ﺗﺮاوﺣﺖ أﻋﻤﺎرهﻢ‬
‫ﺑﻴﻦ‪ ٥٠‬إﻟﻰ ‪ ٧٩‬ﻋﺎﻣﺎ وﻣﺘﻮﺳﻂ اﻟﻌﻤﺮ ﻟﺪﻳﻬﻢ ‪ ٩٫٠٤ ± ٦٠٫٣٦‬ﻋﺎﻣﺎ‪.‬إﺟﺮاءات اﻟﺪراﺳﺔ‪ . :‬ﺗﻢ‬
‫ﻋﻤﻞ ﺗﻘﻴﻴﻢ ﺑﺪﻧﻲ آﺎﻣﻞ ﻟﻤﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ اﻟﺬﻳﻦ ﺗﻤﺖ ﻣﺮاﻗﺒﺘﻬﻢ‪ ،‬واﺷﺘﻤﻞ هﺬا ﻋﻠﻰ ﺗﻘﻴﻴﻢ اﻟﺸﻌﻮر‬
‫ﺑﺎﻷﻟﻢ ﺑﺎﺳﺘﻌﻤﺎل اﻟﻤﻘﻴﺎس اﻟﺒﺼﺮي ﻟﺘﻘﻴﻴﻢ اﻟﺸﻌﻮر ﺑﺎﻷﻟﻢ‪ ،‬ﺗﻘﻴﻴﻢ اﻟﺸﻌﻮر اﻟﺠﻠﺪي ﺑﺎﺳﺘﻌﻤﺎل أﻟﻴﺎف‬
‫ﺳﻴﻤﻴﺰ ﻓﺎﻳﻨﺸﺘﺎﻳﻦ اﻟﺪﻗﻴﻘﺔ‪ ،‬ﺗﻘﻴﻴﻢ ﻋﺘﺒﺔ اﻹﺣﺴﺎس ﺑﺎﻟﺬﺑﺬﺑﺎت ﺑﺎﺳﺘﻌﻤﺎل ﺟﻬﺎز ﺗﻘﻴﻴﻢ اﻹﺣﺴﺎس‬
‫اﻟﻌﺼﺒﻲ اﻟﻜﻬﺮﺑﺎﺋﻲ ) اﻟﻨﻴﻮروﺛﻴﺰﻳﻮﻣﻴﺘﺮ (‪ ،‬ﺗﻘﻴﻴﻢ اﻟﺘﻮازن واﻟﻤﺸﻴﺔ ﺑﺎﺳﺘﻌﻤﺎل ﻣﻘﻴﺎس ﺗﻴﻨﻴﺘﻲ‪،‬‬
‫ﺑﺎﻹﺿﺎﻓﺔ ﻟﺘﻘﻴﻴﻢ اﻟﻀﻐﻂ ﻓﻲ أﺧﻤﺺ اﻟﻘﺪم‪ .‬أﻣﺎ ﺑﺎﻟﻨﺴﺒﺔ ﻟﻤﺠﻤﻮﻋﺔ اﻟﻤﺮﺿﻰ اﻟﺘﻲ اﺳﺘﻔﺎدت ﻣﻦ‬
‫اﻟﻌﻼج‪ ،‬ﻓﻘﺪ ﻋﻤﻠﺖ ﻟﻬﻢ ﺟﻤﻴﻊ إﺟﺮاءات اﻟﺘﻘﻴﻴﻢ اﻟﺒﺪﻧﻲ اﻟﺴﺎﺑﻘﺔ اﻟﺬآﺮ ﺑﺎﻹﺿﺎﻓﺔ ﻟﺘﻄﺒﻴﻖ ﺗﻘﻨﻴﺔ ﻃﺎﻗﺔ‬
‫اﻷﺷﻌﺔ اﻟﻀﻮﺋﻴﺔ ﺗﺤﺖ اﻟﺤﻤﺮاء أﺣﺎدﻳﺔ اﻟﻠﻮن واﻟﺘﻲ اﻋﺘﻤﺪت ﻋﻠﻰ ﺗﻄﺒﻴﻖ هﺬا اﻟﻌﻼج ﻟﻤﺪة ‪٣٠‬‬
‫دﻗﻴﻘﺔ ﺛﻼث ﻣﺮات ﻓﻲ اﻷﺳﺒﻮع وﻟﻔﺘﺮة ‪ ٤‬أﺳﺎﺑﻴﻊ ﻟﺘﻜﻮن ﺑﺬﻟﻚ ﻣﺪة اﻟﻌﻼج اﻹﺟﻤﺎﻟﻴﺔ ‪ ١٢‬ﺟﻠﺴﺔ‬
‫ﻋﻼﺟﻴﺔ ﻟﻜﻼ اﻟﻘﺪﻣﻴﻦ‪.‬‬
‫ﻧﺘﺎﺋﺞ اﻟﺪراﺳﺔ‪:‬‬
‫ﻓﻲ هﺬا اﻟﻔﺼﻞ ﺗﻤﺖ ﻣﻨﺎﻗﺸﺔ ﻧﺘﺎﺋﺞ اﻟﺪراﺳﺔ وﻣﻘﺎرﻧﺘﻬﺎ ﺑﻨﺘﺎﺋﺞ اﻟﺪراﺳﺎت‬
‫اﻟﺴﺎﺑﻘﺔ‪،‬واﻷﺳﺒﺎب اﻟﻌﻤﻠﻴﺔ وراء ﻧﺘﺎﺋﺞ هﺬﻩ اﻟﺪراﺳﺔ‪.‬‬
‫اﻟﺨﺎﺗﻤﺔ واﻟﺘﻮﺻﻴﺎت‪:‬‬
‫ﻓﻲ هﺬا اﻟﻔﺼﻞ ﺗﻢ اﻟﺘﻨﻮﻳﻪ ﻋﻦ ﺧﺎﺗﻤﺔ وﺧﻼﺻﺔ هﺬﻩ اﻟﺪراﺳﺔ ﺑﺎﻹﺿﺎﻓﺔ إﻟﻰ ﺗﻘﺪﻳﻢ ﻋﺪد ﻣﻦ‬
‫اﻟﻤﻘﺘﺮﺣﺎت اﻟﺘﻲ ﻳﻤﻜﻦ ﻣﻦ ﺧﻼﻟﻬﺎ ﻋﻤﻞ اﻟﻌﺪﻳﺪ ﻣﻦ اﻟﺪراﺳﺎت اﻟﻤﺴﺘﻘﺒﻠﻴﺔ اﻟﺘﻲ ﻳﻤﻜﻦ أن ﺗﺨﺪم هﺬﻩ‬
‫اﻟﻤﺸﻜﻠﺔ وﻣﻨﻬﺎ‪:‬‬
‫•‬
‫اﻻﻗﺘﺮاﺣﺎت‪:‬‬
‫ﻧﻘﺘﺮح ﻟﻠﺪراﺳﺎت اﻟﻤﺴﺘﻘﺒﻠﻴﺔ اﻟﺘﻲ ﻳﻨﻮي اﻟﻘﻴﺎم ﺑﻬﺎ اﻟﺒﺎﺣﺜﻮن ﻣﺎ ﻳﻠﻲ‪:‬‬
‫‪.١‬‬
‫زﻳﺎدة ﻋﺪد أﻓﺮاد ﻋﻴﻨﺔ اﻟﺪراﺳﺔ‬
‫‪.٢‬‬
‫زﻳﺎدة ﻋﺪد ﺣﺼﺺ اﻟﻌﻼج‬
‫‪.٣‬‬
‫اﻋﺘﻤﺎد أدوات ﻗﻴﺎﺳﻴﺔ أﺧﺮى‬
‫‪.٤‬‬
‫اﻋﺘﻤﺎد ﻃﺮق أﺧﺮى ﻟﻠﻌﻼج اﻟﻄﺒﻴﻌﻲ‬
‫‪.٥‬‬
‫اﻋﺘﻤﺎد ﻣﻮاﺿﻊ أﺧﺮى ﻣﺨﺘﻠﻔﺔ ﻟﻠﻀﻤﺎدات اﻟﻌﻼﺟﻴﺔ‬
‫‪.٦‬‬
‫ﻧﻮﺻﻲ ﺑﺎن ﺗﻜﻮن اﻟﺪراﺳﺎت اﻟﻤﺴﺘﻘﺒﻠﻴﺔ ﻣﻌﺘﻤﺪة ﻋﻠﻰ ﻋﺪم ﻋﻠﻢ آﻞ ﻣﻦ اﻟﻄﺒﻴﺐ‬
‫اﻟﻤﻌﺎﻟﺞ واﻟﻤﺮﻳﺾ وﻳﺘﻢ ﻓﻴﻬﺎ اﺳﺘﻌﻤﺎل ﻋﻼج آﺎذب‪ ،‬وﺗﻜﻮن ﻓﻴﻬﺎ أﺣﺠﺎم اﻟﻌﻴﻨﺔ‬
‫ﻣﻨﺎﺳﺒﺔ ﻟﺘﺤﺪﻳﺪ ﻣﺎ إذا آﺎﻧﺖ اﻟﻄﺎﻗﺔ اﻟﻀﻮﺋﻴﺔ ﻣﻦ اﻷﺷﻌﺔ ﺗﺤﺖ اﻟﺤﻤﺮاء أﺣﺎدﻳﺔ اﻟﻠﻮن‬
‫أآﺜﺮ ﻓﻌﺎﻟﻴﺔ ﻣﻦ اﻟﻌﻼج اﻟﻜﺎذب أم ﻻ‪.‬‬
‫‪.٧‬‬
‫ﻗﺪ ﻳﻜﻮن اﺳﺘﺨﺪام وﺣﺪة اﻟﻠﻴﺰر اﻟﻤﻨﺰﻟﻲ ﻣﺸﺠﻌﺎ ﻋﻠﻰ ﺗﺴﻬﻴﻞ اﻧﻀﺒﺎط اﻟﻤﺮﺿﻰ ﻋﻠﻰ‬
‫اﻟﻌﻼج‪.‬‬
‫•‬
‫اﻟﺘﻮﺻﻴﺎت‪:‬‬
‫أوﺻﻲ أﺧﺼﺎﺋﻲ اﻟﻌﻼج اﻟﻄﺒﻴﻌﻲ أﺛﻨﺎء اﻟﻤﻤﺎرﺳﺎت اﻹآﻠﻴﻨﻴﻜﻴﺔ ﺑﺎﻟﺘﺎﻟﻲ‪:‬‬
‫‪.١‬‬
‫ﺑﻨﺎء ﻣﻌﺮﻓﺔ ﻋﻦ ﻧﻈﺎم اﻟﻌﻼج ﺑﺎﻻﻧﻮداﻳﻦ وﺗﺄﺛﻴﺮهﺎ ﻓﻲ ﺑﺮاﻣﺞ اﻟﻌﻼج ﻟﻤﺨﺘﻠﻒ‬
‫اﺿﻄﺮاﺑﺎت اﻷﻋﺼﺎب واﻟﻬﻴﻜﻞ اﻟﻌﻈﻤﻲ اﻟﻌﻀﻠﻲ‪.‬‬
‫‪.٢‬‬
‫زﻳﺎدة اﻟﻤﻤﺎرﺳﺔ ﺑﺎﺳﺘﻌﻤﺎل ﻟﻴﺰر ﻣﻨﺨﻔﺾ اﻟﻤﺴﺘﻮى أو ﻣﺎ ﻳﺴﻤﻰ اﻟﻠﻴﺰر اﻟﺒﺎرد ﺣﺘﻰ‬
‫ﻧﺠﺪ اﻻﺳﺘﻌﻤﺎل اﻷﻣﺜﻞ ﻟﻬﺬﻩ اﻟﺘﻘﻨﻴﺔ ﻓﻲ اﻟﻌﻼج‪.‬‬
‫‪.٣‬‬
‫إﺿﺎﻓﺔ ﺗﻤﺎرﻳﻦ ﺣﺮآﻴﺔ إﻟﻰ ﺟﻤﻴﻊ ﺑﺮاﻣﺞ اﻟﻌﻼﺟﺎت اﻟﻄﺒﻴﻌﻴﺔ ﺣﻴﺚ ﺗﺤﺎآﻲ هﺬﻩ‬
‫اﻟﺘﻤﺎرﻳﻦ دور ﻋﻀﻼت اﻷﻃﺮاف اﻟﺴﻔﻠﻴﺔ ﻓﻲ اﻟﻨﺸﺎﻃﺎت اﻟﻴﻮﻣﻴﺔ‪.‬‬
‫أﻣﺎ اﻟﻤﻼﺣﻖ ﻓﻘﺪ ﺗﻨﺎوﻟﺖ ﻣﺎﻳﻠﻲ‪ :‬ﻧﻤﻮذج إﻗﺮار ﻣﻮاﻓﻘﺔ اﻟﻤﺮﻳﺾ اﻟﻄﻮﻋﻲ ﻋﻠﻰ‬
‫اﻟﺪﺧﻮل ﻓﻲ اﻟﺪراﺳﺔ ‪،‬ﻧﻤﻮذج ﺗﻘﻴﻴﻢ اﻟﻤﺮﻳﺾ ‪،‬ﻧﻤﻮذج اﻟﺘﻘﻴﻴﻢ اﻟﺒﺪﻧﻲ ‪ ،‬ﺗﻘﻴﻴﻢ اﻟﺘﻮازن‬
‫واﻟﻤﺸﻴﺔ ﺑﺎﺳﺘﻌﻤﺎل ﻣﻘﻴﺎس ﺗﻴﻨﻴﺘﻲ‪ ،‬ﺑﺎﻹﺿﺎﻓﺔ ﻟﺘﻘﻴﻴﻢ ﺗﺨﻄﻴﻂ اﻟﻘﺪم وآﺬﻟﻚ اﻟﺒﻴﺎﻧﺎت اﻟﺨﺎﺻﺔ‬
‫ﻟﻜﻞ اﻟﻤﺮﺿﻰ‪.‬‬

pedographic changes post anodyne therapy in diabetic peripheral

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