pedographic changes post anodyne therapy in diabetic peripheral
Transcription
pedographic changes post anodyne therapy in diabetic peripheral
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 Feet Pre and Post 4 Weeks in Both Groups 47 Table (12) -Mean ± S.E.M of Contact Time (CT) for Right and Left Feet Pre and Post 4 Weeks in Both Groups 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 and Post Weeks in Both Groups. 47 Figure (19) Mean of Contact Time (CT) for Right and Left Feet Pre and Post Weeks in Both Groups. 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 Pre and Post 4 Weeks in Both Groups. 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 Pre and Post 4 Weeks in Both Groups. 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. The difference between the pre and post study values did not 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 between the pre and post study values did not reach a statistical 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 between the pre and post study values did not reach a statistical 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 beginning of the study. 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 between the pre and post study values did not reach a statistical significance ( p = 0.67 ). (Table 9, Figure 16). 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 ). (Table 9, Figure 16). 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 Post 4 Weeks in Both Groups. 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 between the pre and post study values did not reach a statistical 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 beginning of the study. 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 difference between the pre and post study values did not reach a 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 Post 4 Weeks in Both Groups. 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 ). The difference between the pre and post study values did not 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 between the pre and post study values did not reach a statistical 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 difference between the pre and post study values did not reach a statistical significance ( p = 0.66 ). While the mean value of 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 and post study values did not reach a statistical significance ( p = 0.21 ). (Table 11, Figure 18). 46 Table (11): Mean ± S.E.M of Contact Area (CA) values ( cm 2 ) for Right and Left Feet Pre and Post 4 Weeks in Both 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 . The difference between the pre and post study values did not 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 between the pre and post study values did not reach a statistical 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 difference between the pre and post study values did not reach a statistical significance ( p = 0.64 ). While the mean value of 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 and post study values did not reach a statistical significance ( p = 24 .0 ). (Table 12, Figure 19). 48 Table (12): Mean ± S.E.M of Contact Time (CT) values (s) for Right and Left Feet Pre and Post 4 Weeks in Both 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 BIBLIOGRAPHY REFERENCES 1. American Diabetes Association.: Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2004; 27(1):S5 –S10. 2. Eledrisi M.; Alhaj B.; Rehmani R.; Alotaibi M.; Mustafa M.; Akbar D and Matboli S.: Quality of Diabetes Care in Saudi Arabi Diabetes Res Clin Pract. 2007; 78(1): 145-146. 3. Al-Khader A.A .: Impact of Diabetes in Renal Diseases in Saudi Arabia. Nephrol Dial Transplant.2001;16:2132-2135. 4. Tolle T.; Xu X and Sadosky AB.: Painful Diabetic Neuropathy: A Cross-Sectional Survey of Health State Impairment and Treatment Patterns. J Diabetes Complications. 2006 ; 20 : 26-33. 5. Prabhu K.G .; Agrawa D .; Patil K.M .; Srinivasan S .: Parameters for Analysis of Walking Foot Pressures at Different Levels of Diabetic Neuropathy and Detection of Plantar Ulcers at Early Stages. ITBM-RBM.2001 ; 22 : 159169. 6. Menz H .B.; Lord S.R.; Reb.R.; George R.S and Fitzpatrick R.C .: Walking Stability and Sensorimotor Function in Older People with Diabetic Peripheral Neuropathy. Arch Phys Med Rehabil . 2004; 85(2): 245-252 7. Cooper S.M.; Hofman D and Burge S.M.: Leg Ulcers and Pain: A Review. Low Extrem Wounds.2003; 2(4):189–197. 57 8. Modawal A.; Fley J.; Shukla R.; Rudawsky D.; Welge J and Yang J.: Use of Monofilament in the Detection of Foot Lesions in Older Adults. JFAS. 2006; 45(2):76-81. 9. Zinman L.H.; Bril V and Perkins B.A .: Cooling Detection Thresholds in the Assessment of Diabetic Sensory Polyneuropathy. Diabetes Care. 2004; 27(7): 1674– 1679. 10. Orlin M.N and Mcpoil T.G.: Plantar Pressure Assessment .Phys Ther.2000 ; 80(4):399-409. 11. Richter M.; Frink M.; Zech.S.; Vanin N; Geerling J.; Droste P and Krettek C.: Intraoperative Pedography: A Validated Method for Static Intraoperative Biomechanical Assessment. Foot Ankle Int. 2006; 27(10):833-842. 12. Snijders A.H .; Warrenburg B.P.V.D .; Giladi N and Bloem B.R.: Neurological Gait Disorders in Elderly People: Clinical Approach and Classification. Lancet Neurol. 2007; 6(1):63-74. 13. Dingwell J.B and Cavanaghb P.R.: Increased Variability of Continuous Over ground Walking in Neuropathic Patients is Only Indirectly Related to Sensory Loss. Gait Posture. 2001 ;14: 1 – 10. 14. Kendric C.: The Photobiological Basis of Low Level Laser Radiation Therapy.Lser Therapy. 1991; 3 (1):242-245. 15. Clifft J.K.; Kasser R.J.; Newton T.S and Bush A.J.: The Effect of Monochromatic Infrared Energy on Sensation in Patients with Diabetic Peripheral Neuropathy. Diabetes Care. 2005; 28(12): 2896–2900. 58 16. Afiq Rahman M.; Aziz Z. .; Acharya R. .; Ha T.P.; Kannathal N.; Ng E.Y.K.; Law C.; Subramaniam T.; Shuen W.Y and Fang S.C.: Analysis of Plantar Pressure in Diabetic Type 2 Subjects with and without Neuropathy.ITBM-RBM.2006; 27 : 46–55. 17. Vileikyte L.; Peyrot M .; Bundy C.; Rubin R.R .; Leventhal H .; Mora P .; Shaw J.E .; Baker P .; and Boulton A.J.M .: The Development and Validation of A Neuropathy- and Foot Ulcer-Specific Quality of Life Instrument .Diabetes Care.2003;26(9):2549-2555. 18. Hoitsmaa E .; Reulena J.P.H .; Baetsb M .; Drentc M.; Spaansa F and Faberb C.G .: Small Fiber Neuropathy: A Common and Important Clinical Disorder. J Neurol Sci .2004; ( 227): 119–130. 19. Carnegie D.: The use of monochromatic infrared energy therapy in podiatry. Podiatry Management. 2002 ; (11): 12934. 20. Goldman SM.: Long term restoration of sensation in diabetic patients with peripheral neuropathy. American Physical Therapy Association Combined Sections Meeting. Tampa, FL. 2003. Feb. 21. Kochman A.B .; Carnegie D.H and Burke T.J .: Symptomatic Reversal of Peripheral Neuropathy in Patients with Diabetes. J Am Podiatr Med Assoc .2002; 92(3):125130. 22. Kochman. A.B .: Monochromatic Infrared Photo Energy and Physical Therapy for Peripheral Neuropathy: Influence on Sensation. Balance, and Falls. J Geriatr Phys Ther.2004;27:16-19. 59 23. Leonard D.R .; Farooqi M.H and Myers S .: Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects with Diabetic Peripheral Neuropathy: A DoubleBlind, Randomized, Placebo-Controlled Study with Monochromatic Near-Infrared Treatment. Diabetes Care. 2004; 27(1) :168–172. 24. Powell M.W; Carnegie D.E and Burke T.J .: Reversal of Diabetic Peripheral Neuropathy and New Wound Incidence: The Role of MIRE . Adv Skin Wound Care.2004; 17(6): 295-300. 25. DeLellis SL.; Carnegie DH.; Burke TJ.: Improved sensitivity in patients with peripheral neuropathy. J Am Podiatr Med.2005; 95 (2):143-7. 26. Harkless L.B.; DeLellis S.; Carnegie D.H and Burke T.J.: Improved Foot Sensitivity and Pain Reduction in Patients with Peripheral Neuropathy after Treatment with Monochromatic Infrared Photo Energy—MIRE. J Diabetes Complications. 2006; 20: 81– 87. 27. Goldberg N.: Monochromatic Infrared Photo Energy and DPN. Diabetic Microvascular Complications Today. 2005;4 :30-32. 28. Mc Caffery M, Pasero C, eds.: Pain: Clinical Manual, 2nd ed.St. Louis, MO:Mosby ;1999. 29. Damci T .; Osar Z.; Beyhan S .; Ilkova H .; Ozyazar M .; Gorpe U and Bagriacik N.: Does Instantaneous Blood Glucose affect Vibration Perception Threshold Measurement Using Biothesiometer? Diabetes Res Clin Pract.1999;46:19– 22. 60 30. Rubenstein L.Z and Trueblood P.R .: Gait and Balance Assessment in Older Persons. Annals of Long-Term Care: Clinical Care and Aging 2004; 12(2):39-45. 31. Bus S.A and Lange A.D .: A Comparison of the 1 Step, 2Step, and 3-Step Protocols for Obtaining Barefoot Plantar Pressure Data in the Diabetic Neuropathic Foot . Clin Biomech .2005;20:892–899. 32. Zinman L.H.; Ngo M.; Ng E.T.; New K.T.; Gogov S and Bril V.: Low-Intensity Laser Therapy for Painful Symptoms of Diabetic Sensorimotor Polyneuropathy .Diabetes Care. 2004; 27(4): 921–924. 33. Peric Z and Cvetkovic B.: Electrophysiological Evaluation of Low-Intensity Laser Therapy in Patients with Diabetic Polyneuropathy. Med Biol .2006;13(1): 11-14. 34. Maegawa Y, Itoh, Hosokawa .: Effects of near-infrared low-level laser irradiation on microcirculation. Lasers surg med .2000;(27):427. 35. Burke T.J.;Page B.T.;Vail C.:Increase in serum nitric oxide induced by near infrared phototherapy (NIP ) .Assoc Equine Sports Medicine.20th Annual Meeting.2000;(9):6. 36. Madani S.P .;Lessan N .; Akbari M .; Amirimoghaddam S .; Heshmat R and Larijani B .: Effect of Monochromatic Near Infrared Energy on Neuropathy, Plantar Pressure Distribution and Balance in Patients with Diabetic Neuropathy.Eur J Pain.2007;11(S1) :S59–S207. 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) Pressuretime integral (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) Pressuretime integral (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) Pressuretime integral (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) Pressuretime integral (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) Pressuretime integral (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) Pressuretime integral (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.