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Protocol summary
This study is a randomized clinical trial and patients are divided into intervention and control groups based on permutation blocks. The sample size in each group is 32 and the research site will be the diabetes clinic of Alavi hospital in Mashhad. For the intervention group, magnetic therapy will be used 24 hours a day for 12 weeks. In the control group, magnet which is completely similar to the intervention group without magnetic properties, will be used at the same time. Patients, the main researcher and the physician in charge of patient care and the person analyzing the data will not to know the nature of the real or neutral magnet, as well as the group position of the patients.
This study is a randomized clinical trial and patients are divided into intervention and control groups based on permutation blocks. The sample size in each group is 32 and the research site will be the diabetes clinic of Alavi hospital in Mashhad. For the intervention group, magnetic therapy will be used 24 hours a day for 12 weeks. In the control group, the magnet which is completely similar to the intervention group without magnetic properties, will be used at the same time. Patients, the main researcher and the physician in charge of patient care and the person analyzing the data will not to know the nature of the real or neutral magnet, as well as the group position of the patients.
This study is a randomized clinical trial and patients are divided into intervention and control groups based on permutation blocks. The sample size in each group is 32 and the research site will be the diabetes clinic of Alavi hospital in Mashhad. For the intervention group, magnetic therapy will be used 24 hours a day for 12 weeks. In the control group, the magnet which is completely similar to the intervention group without magnetic properties, will be used at the same time. Patients, the main researcher and the physician in charge of patient care and the person analyzing the data will not to know the nature of the real or neutral magnet, as well as the group position of the patients.
Inclusion criteria:
Patient with type 2 diabetes with neuropathy
Having informed consent to participate in the study
Having neuropathic pain and sensory disturbance according to the NSS
Age under 65 years
non Inclusion criteria:
Disease or condition affecting neuropathy (multiple sclerosis, gout, Parkinson, spinal cord injury, Guillain-Barre, rheumatic disease) with the approval of a neurologist
Proven or suspected deep vein thrombosis
Inclusion criteria:
Diabetic peripheral neuropathy at least 6 scores on score Neuropathy disability score (NDS) without Neuropathy symptoms score (NSS) or 3-5 scores on NDS with at least 5 scores on NSS
Drug-refractory neuropathic pain intensity at least 1 score on Visual analogue scale
Aged 18–70 years (either sex)
Exclusion criteria:
Pregnancy, planning a pregnancy, lactation
Inclusion criteria: PatientDiabetic peripheral neuropathy at least 6 scores on score Neuropathy disability score (NDS) without Neuropathy symptoms score (NSS) or 3-5 scores on NDS with type 2 diabetes with neuropathy Having informed consent to participate in the study Havingat least 5 scores on NSS Drug-refractory neuropathic pain and sensory disturbance according to the NSS Age under 65intensity at least 1 score on Visual analogue scale Aged 18–70 years non Inclusion(either sex) Exclusion criteria: Disease or condition affecting neuropathy (multiple sclerosisPregnancy, gout, Parkinson, spinal cord injury, Guillain-Barre, rheumatic disease) with the approval ofplanning a neurologist Proven or suspected deep vein thrombosispregnancy, lactation
شرایط ورود:
بیمار مبتلا به دیابت نوع 2 همراه با عارضه نوروپاتی
داشتن رضایت آگاهانه برای شرکت در مطالعه
داشتن درد نوروپاتی و اختلال حسی با توجه به مقیاس NSS
سن زیر 65 سال
شرایط عدم ورود:
بیماري یا شرایطی که بر نوروپـاتی تـأثیر دارد (سـکتۀ مغـزي مولتیپـل اسـکلروز، نقـرس، پارکینسون، آسیب نخاعی، گـیلن بـاره، بیمـاري روماتیسمی) با تأییـد پزشـک متخصـص مغـز و اعصاب
ترومبـوز وریـد عمقـی اثبـات شـده یا مشکوک
معیارهای ورود:
بیمار مبتلا به دیابت نوع 2 همراه با عارضه نوروپاتی محیطی یا کسب حداقل شش امتیاز از معیار ناتوانی نوروپاتی، بدون درنظرگرفتن امتیاز معیار نشانه های نوروپاتی و یا 5-3 امتیاز از معیار ناتوانی نوروپاتی همراه با حداقل پنج امتیاز از معیار نشانه های نوروپاتی
داشتن درد نوروپاتی مقاوم به درمان (حداقل امتیاز یک) باتوجه به مقیاس آنالوگ بصری
سن بین 18 تا 70 سال (هر دو جنس)
معیارهای خروج:
بارداری، شیردهی
شرایطمعیارهای ورود: بیمار مبتلا به دیابت نوع 2 همراه با عارضه نوروپاتی داشتن رضایت آگاهانه برای شرکت در مطالعهمحیطی یا کسب حداقل شش امتیاز از معیار ناتوانی نوروپاتی، بدون درنظرگرفتن امتیاز معیار نشانه های نوروپاتی و یا 5-3 امتیاز از معیار ناتوانی نوروپاتی همراه با حداقل پنج امتیاز از معیار نشانه های نوروپاتی داشتن درد نوروپاتی و اختلال حسی با توجهمقاوم به درمان (حداقل امتیاز یک) باتوجه به مقیاس NSSآنالوگ بصری سن زیر 65بین 18 تا 70 سال شرایط عدم ورود(هر دو جنس) معیارهای خروج: بیماري یا شرایطی که بر نوروپـاتی تـأثیر دارد (سـکتۀ مغـزي مولتیپـل اسـکلروزبارداری، نقـرس، پارکینسون، آسیب نخاعی، گـیلن بـاره، بیمـاري روماتیسمی) با تأییـد پزشـک متخصـص مغـز و اعصاب ترومبـوز وریـد عمقـی اثبـات شـده یا مشکوکشیردهی
Patients in the intervention group will use a magnet with intensity of 170-200 mT for local magnetic therapy. The magnet at the end of the tibial nerve pathway in the lower leg, around the ankle, will be used 24 hours a day for 12 weeks.
In the control group, a magnet of the same size and shape but neutralized and without magnetic properties will be used at the same place and time
Patients in the intervention group will use a magnet with an intensity of 155 mT for local magnetic therapy. The magnet at the end of the tibial nerve pathway in the lower leg, around the ankle, will be used 24 hours a day for 12 weeks.
In the control group, a magnet of the same size and shape but neutralized and without magnetic properties will be used at the same place and time
Patients in the intervention group will use a magnet with an intensity of 170-200155 mT for local magnetic therapy. The magnet at the end of the tibial nerve pathway in the lower leg, around the ankle, will be used 24 hours a day for 12 weeks. In the control group, a magnet of the same size and shape but neutralized and without magnetic properties will be used at the same place and time
بیماران در گروه مداخله جهت مغناطیس درمانی موضعی از آهنربای مغناطیسی با شدت 170 تا 200 میلی تسلا استفاده خواهند کرد. آهنربا در انتهای مسیر عصب تیبیال در یک سوم تحتانی ساق پا، دور مچ پا، 24 ساعت در شبانه روز به مدت 12 هفته استفاده خواهد شد.
در گروه کنترل نیز همزمان از آهنربا با همان اندازه و شکل، با این تفاوت که آهنربای مورد استفاده در این گروه خنثی شده و خاصیت مغناطیسی ندارد، در همان محل و مدت استفاده خواهد شد.
بیماران در گروه مداخله جهت مغناطیس درمانی موضعی از آهنربای مغناطیسی با شدت 155 میلی تسلا استفاده خواهند کرد. آهنربا در انتهای مسیر عصب تیبیال در یک سوم تحتانی ساق پا، دور مچ پا، 24 ساعت در شبانه روز به مدت 12 هفته استفاده خواهد شد.
در گروه کنترل نیز همزمان از آهنربا با همان اندازه و شکل، با این تفاوت که آهنربای مورد استفاده در این گروه خنثی شده و خاصیت مغناطیسی ندارد، در همان محل و مدت استفاده خواهد شد.
بیماران در گروه مداخله جهت مغناطیس درمانی موضعی از آهنربای مغناطیسی با شدت 170 تا 200155 میلی تسلا استفاده خواهند کرد. آهنربا در انتهای مسیر عصب تیبیال در یک سوم تحتانی ساق پا، دور مچ پا، 24 ساعت در شبانه روز به مدت 12 هفته استفاده خواهد شد. در گروه کنترل نیز همزمان از آهنربا با همان اندازه و شکل، با این تفاوت که آهنربای مورد استفاده در این گروه خنثی شده و خاصیت مغناطیسی ندارد، در همان محل و مدت استفاده خواهد شد.
General information
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2021-04-20, 1400/01/31
2021-04-20 00:00:00
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2021-08-06, 1400/05/15
2021-08-06 00:00:00
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2021-11-06, 1400/08/15
2021-11-06 00:00:00
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To add study results and final changes
To add study results and final changes
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جهت اضافه کردن نتایج مطالعه و تغییرات نهایی
جهت اضافه کردن نتایج مطالعه و تغییرات نهایی
Patient with type 2 diabetes with peripheral neuropathy
The patient's willingness and conscious consent to participate in the study
Having neuropathic pain and symptoms such as paresthesia and burning and numbness according to the NSS scale
Consciousness and ability to speak and communicate to report the severity of clinical symptoms during the examination
Age under 60 years
Diabetes type 2; diagnosed by a diabetologist according to American Diabetes Association (ADA) standards
Diabetic peripheral neuropathy at least 6 scores on the Neuropathy disability score (NDS) without Neuropathy Symptoms score (NNS) or 3-5 scores on NDS with at least 5 scores on NSS
Drug-refractory neuropathic pain intensity at least 1 score on Visual analogue scale
Able to complete questionnaires and willing to sign written informed consent
Aged 18–70 years (either sex)
Patient withDiabetes type 2 diabetes with; diagnosed by a diabetologist according to American Diabetes Association (ADA) standards Diabetic peripheral neuropathy The patient's willingness and conscious consent to participate inat least 6 scores on the study HavingNeuropathy disability score (NDS) without Neuropathy Symptoms score (NNS) or 3-5 scores on NDS with at least 5 scores on NSS Drug-refractory neuropathic pain and symptoms such as paresthesiaintensity at least 1 score on Visual analogue scale Able to complete questionnaires and burning and numbness accordingwilling to the NSS scale Consciousness and ability to speak and communicate to report the severity of clinical symptoms during the examination Age under 60sign written informed consent Aged 18–70 years (either sex)
بیمار مبتلا به دیابت نوع 2 همراه با عارضه نوروپاتی محیطی
تمایل بیمار و داشتن رضایت آگاهانه برای شرکت در مطالعه
داشتن درد نوروپاتی و نشانه هایی همچون پارستزی و سوزش و بی حسی با توجه به مقیاس NSS
هوشیاری و توانایی تکلم و برقراری ارتباط جهت گزارش شدت نشانه های بالینی طی بررسی و معاینه
سن زیر 60 سال
بیمار مبتلا به دیابت نوع 2 که توسط پزشک متخصص براساس استانداردهای انجمن دیابت آمریکا تایید گردیده باشد.
بیمار مبتلا به دیابت نوع 2 همراه با عارضه نوروپاتی محیطی یا کسب حداقل شش امتیاز از معیار ناتوانی نوروپاتی، بدون درنظرگرفتن امتیاز معیار نشانه های نوروپاتی و یا 5-3 امتیاز از معیار ناتوانی نوروپاتی همراه با حداقل پنج امتیاز از معیار نشانه های نوروپاتی
داشتن درد نوروپاتی مقاوم به درمان (حداقل امتیاز یک) باتوجه به مقیاس آنالوگ بصری
داشتن رضایت آگاهانه کتبی و تمایل بیمار برای شرکت در پژوهش
سن بین 18 تا 70 سال (هر دو جنس)
بیمار مبتلا به دیابت نوع 2 که توسط پزشک متخصص براساس استانداردهای انجمن دیابت آمریکا تایید گردیده باشد. بیمار مبتلا به دیابت نوع 2 همراه با عارضه نوروپاتی محیطی تمایل بیماریا کسب حداقل شش امتیاز از معیار ناتوانی نوروپاتی، بدون درنظرگرفتن امتیاز معیار نشانه های نوروپاتی و یا 5-3 امتیاز از معیار ناتوانی نوروپاتی همراه با حداقل پنج امتیاز از معیار نشانه های نوروپاتی داشتن درد نوروپاتی مقاوم به درمان (حداقل امتیاز یک) باتوجه به مقیاس آنالوگ بصری داشتن رضایت آگاهانه کتبی و تمایل بیمار برای شرکت در مطالعه داشتن درد نوروپاتی و نشانه هایی همچون پارستزی و سوزش و بی حسی با توجه به مقیاس NSS هوشیاری و توانایی تکلم و برقراری ارتباط جهت گزارش شدت نشانه های بالینی طی بررسی و معاینهپژوهش سن زیر 60بین 18 تا 70 سال (هر دو جنس)
Disease or condition affecting neuropathy (stroke, multiple sclerosis, gout, Parkinson, spinal cord injury, Guillain-Barre, rheumatic disease) with the approval of a neurologist
Proven deep vein thrombosis or suspected deep vein thrombosis
Existence of cardiac arrhythmias
Pregnancy, planning a pregnancy, lactation
Had any of the following: Vascular insufficiency, Renal failure, Metallic implantation, Skin diseases, Foot ulcers, Prosthesis, Prior magnetic therapy, Cardiac pacemaker, Mechanical insulin pump or any electronic device
Had diabetic peripheral neuropathy from other causes than diabetes (according to the medical history and diagnosis of specialist doctors)
Opiate or drug abuse
DiseasePregnancy, planning a pregnancy, lactation Had any of the following: Vascular insufficiency, Renal failure, Metallic implantation, Skin diseases, Foot ulcers, Prosthesis, Prior magnetic therapy, Cardiac pacemaker, Mechanical insulin pump or condition affectingany electronic device Had diabetic peripheral neuropathy from other causes than diabetes (stroke, multiple sclerosis, gout, Parkinson, spinal cord injury, Guillain-Barre, rheumatic disease) withaccording to the approvalmedical history and diagnosis of a neurologist Proven deep vein thrombosisspecialist doctors) Opiate or suspected deep vein thrombosis Existence of cardiac arrhythmiasdrug abuse
بیماري یا شرایطی که بر نوروپـاتی تـأثیر دارد (سـکتۀ مغـزي، مولتیپـل اسـکلروز، نقـرس، پارکینسون، آسیب نخاعی، گـیلن بـاره، بیمـاري روماتیسمی) با تأییـد پزشـک متخصـص مغـز و اعصاب
ترومبـوز وریـد عمقـی اثبـات شـده یـا مشکوك به ترومبوز ورید عمقی
وجود آریتمی های قلبی
بارداری، شیردهی
داشتن هر یک از موارد زیر: نارسایی عروقی، نارسایی کلیوی، کاشت پلاتین، بیماری های پوستی، زخم پا، پروتز، درمان مغناطیسی قبلی، ضربان ساز قلب، پمپ انسولین مکانیکی یا هر وسیله الکترونیکی
داشتن نوروپاتی دیابتی از علل دیگری غیر از دیابت (با توجه به سابقه پزشکی و تشخیص پزشکان متخصص)
اعتیاد به مواد مخدر
بیماريبارداری، شیردهی داشتن هر یک از موارد زیر: نارسایی عروقی، نارسایی کلیوی، کاشت پلاتین، بیماری های پوستی، زخم پا، پروتز، درمان مغناطیسی قبلی، ضربان ساز قلب، پمپ انسولین مکانیکی یا شرایطی که بر نوروپـاتی تـأثیر داردهر وسیله الکترونیکی داشتن نوروپاتی دیابتی از علل دیگری غیر از دیابت (سـکتۀ مغـزي، مولتیپـل اسـکلروز، نقـرس، پارکینسون، آسیب نخاعی، گـیلن بـاره، بیمـاري روماتیسمی) با تأییـد پزشـک متخصـص مغـزتوجه به سابقه پزشکی و اعصاب ترومبـوز وریـد عمقـی اثبـات شـده یـا مشکوكتشخیص پزشکان متخصص) اعتیاد به ترومبوز ورید عمقی وجود آریتمی های قلبیمواد مخدر
The research units will be selected from the people referring to the hospital clinic in a purposive sampling method by considering the inclusion criteria and then will be assigned to the two intervention and control groups using the four-shift block method. In this way, the letter A will be considered for the intervention group and the letter B will be considered for the control group. The possible states in the quadruple block are six states, each state will be written on a card and the cards will be assigned the number one to six. Then, using the dice, one of the six possible states will be selected and the selected patients will be divided into two groups. This process will continue until the sample size is completed.
The research units will be selected from the people referring to the hospital clinic in a purposive sampling method by considering the inclusion criteria. Then they will be assigned to the two intervention and control groups using the four-shift block method. In this way, the letter "A" will be considered for the intervention group, and the letter "B" will be considered for the control group. The possible states in the quadruple block are six states, each state will be written on a card and the cards will be assigned the numbers one to six. Then, using the dice, one of the six possible states will be selected and the selected patients will be divided into two groups. This process will continue until the sample size is completed.
The research units will be selected from the people referring to the hospital clinic in a purposive sampling method by considering the inclusion criteria and then. Then they will be assigned to the two intervention and control groups using the four-shift block method. In this way, the letter "A" will be considered for the intervention group, and the letter "B" will be considered for the control group. The possible states in the quadruple block are six states, each state will be written on a card and the cards will be assigned the numbernumbers one to six. Then, using the dice, one of the six possible states will be selected and the selected patients will be divided into two groups. This process will continue until the sample size is completed.
واحد های پژوهش با لحاظ کردن معیار های ورود به مطالعه از بین افراد مراجعه کننده به کلینیک بیمارستان به روش مبتنی بر هدف انتخاب و سپس با استفاده از روش بلوک های جایگشتی چهارتایی به دو گروه مداخله و کنترل تخصیص داده خواهند شد. به این شکل که برای گروه مداخله حرف A و برای گروه کنترل حرف B در نظر گرفته خواهد شد. حالت های ممکن در بلوک چهارتایی شش حالت است که هر حالت روی یک کارت نوشته خواهد شد و به کارت ها شماره یک تا شش تخصیص داده خواهد شد سپس با استفاده از تاس از شش حالت ممکن یکی انتخاب و براساس آن بیماران انتخابی به دو گروه تقسیم خواهند شد. این پروسه تا تکمیل حجم نمونه ادامه خواهد یافت.
واحد های پژوهش با لحاظ کردن معیار های ورود به مطالعه از بین افراد مراجعه کننده به کلینیک بیمارستان به روش مبتنی بر هدف انتخاب و سپس با استفاده از روش بلوک های جایگشتی چهارتایی به دو گروه مداخله و کنترل تخصیص داده خواهند شد. به این شکل که برای گروه مداخله حرف "آ" و برای گروه کنترل حرف "ب" در نظر گرفته خواهد شد. حالت های ممکن در بلوک چهارتایی شش حالت است که هر حالت روی یک کارت نوشته خواهد شد و به کارت ها شماره یک تا شش تخصیص داده خواهد شد سپس با استفاده از تاس از شش حالت ممکن یکی انتخاب و براساس آن بیماران انتخابی به دو گروه تقسیم خواهند شد. این پروسه تا تکمیل حجم نمونه ادامه خواهد یافت.
واحد های پژوهش با لحاظ کردن معیار های ورود به مطالعه از بین افراد مراجعه کننده به کلینیک بیمارستان به روش مبتنی بر هدف انتخاب و سپس با استفاده از روش بلوک های جایگشتی چهارتایی به دو گروه مداخله و کنترل تخصیص داده خواهند شد. به این شکل که برای گروه مداخله حرف A"آ" و برای گروه کنترل حرف B"ب" در نظر گرفته خواهد شد. حالت های ممکن در بلوک چهارتایی شش حالت است که هر حالت روی یک کارت نوشته خواهد شد و به کارت ها شماره یک تا شش تخصیص داده خواهد شد سپس با استفاده از تاس از شش حالت ممکن یکی انتخاب و براساس آن بیماران انتخابی به دو گروه تقسیم خواهند شد. این پروسه تا تکمیل حجم نمونه ادامه خواهد یافت.
Secondary outcomes
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Severity of neuropathic pain
Severity of neuropathic pain
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شدت درد نوروپاتی
شدت درد نوروپاتی
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The beginning of the study and weeks 4, 8 and 12
The beginning of the study and weeks 4, 8 and 12
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ابتدای مطالعه و هفته های 4 و 8 و 12
ابتدای مطالعه و هفته های 4 و 8 و 12
empty
Visual analogue scale questionnaire
Visual analogue scale questionnaire
empty
پرسشنامه مقیاس آنالوگ بصری
پرسشنامه مقیاس آنالوگ بصری
#2
empty
Severity of neuropathy disability
Severity of neuropathy disability
empty
شدت ناتوانی نوروپاتی
شدت ناتوانی نوروپاتی
empty
The beginning of the study and the 12th week after the start of the intervention
The beginning of the study and the 12th week after the start of the intervention
empty
ابتدای مطالعه و هفته 12 بعد از شروع مداخله
ابتدای مطالعه و هفته 12 بعد از شروع مداخله
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neuropathy disability score questionnaire
neuropathy disability score questionnaire
empty
پرسشنامه امتیاز ناتوانی نوروپاتی
پرسشنامه امتیاز ناتوانی نوروپاتی
#3
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Quality of life
Quality of life
empty
کیفیت زندگی
کیفیت زندگی
empty
The beginning of the study and the 12th week after the start of the intervention
The beginning of the study and the 12th week after the start of the intervention
empty
ابتدای مطالعه و هفته 12 بعد از شروع مداخله
ابتدای مطالعه و هفته 12 بعد از شروع مداخله
empty
NeuroQol questionnaire
NeuroQol questionnaire
empty
پرسشنامه کیفیت زندگی
پرسشنامه کیفیت زندگی
Intervention groups
#1
Other
Treatment - Devices
othertreatment-devices
Intervention group: For patients in this group for local magnetic therapy, a leather wristband with a neodymium bipolar magnet with an average magnetic intensity of 170 to 200 mTesla in the size of 15 x 3 mm will be used. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks.
Intervention group: For patients in this group for local magnetic therapy, a leather wristband with a neodymium bipolar magnet with an average magnetic intensity of 155 mTesla in the size of 15 x 3 mm will be used. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks.
Intervention group: For patients in this group for local magnetic therapy, a leather wristband with a neodymium bipolar magnet with an average magnetic intensity of 170 to 200155 mTesla in the size of 15 x 3 mm will be used. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks.
گروه مداخله: برای بیماران در این گروه جهت مغناطیس درمانی موضعی از مچ بندی از جنس چرم که یک عدد آهنربای مغناطیسی دو قطبی از جنس نئودیمیم با شدت متوسط مغناطیسی 170 تا 200 میلی تسلا در اندازه 3×15 میلی متر در آن تعبیه شده است، استفاده خواهد شد. مچ بند در انتهای مسیر عصب تیبیال در یک سوم تحتانی ساق پا، دور مچ پا، به طور مداوم و 24 ساعت در شبانه روز به مدت 12 هفته مورد استفاده قرار خواهد گرفت.
گروه مداخله: برای بیماران در این گروه جهت مغناطیس درمانی موضعی از مچ بندی از جنس چرم که یک عدد آهنربای مغناطیسی دو قطبی از جنس نئودیمیم با شدت متوسط مغناطیسی 155 میلی تسلا در اندازه 3×15 میلی متر در آن تعبیه شده است، استفاده خواهد شد. مچ بند در انتهای مسیر عصب تیبیال در یک سوم تحتانی ساق پا، دور مچ پا، به طور مداوم و 24 ساعت در شبانه روز به مدت 12 هفته مورد استفاده قرار خواهد گرفت.
گروه مداخله: برای بیماران در این گروه جهت مغناطیس درمانی موضعی از مچ بندی از جنس چرم که یک عدد آهنربای مغناطیسی دو قطبی از جنس نئودیمیم با شدت متوسط مغناطیسی 170 تا 200155 میلی تسلا در اندازه 3×15 میلی متر در آن تعبیه شده است، استفاده خواهد شد. مچ بند در انتهای مسیر عصب تیبیال در یک سوم تحتانی ساق پا، دور مچ پا، به طور مداوم و 24 ساعت در شبانه روز به مدت 12 هفته مورد استفاده قرار خواهد گرفت.
Recruitment centers
#1
Name of recruitment center - English: Alavi hospital diabetes clinic
Name of recruitment center - Persian: کلینیک دیابت بیمارستان علوی
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Street address - English: Alavi hospital, Emam Reza 61 Alley, Emam Reza Ave, Mashhad
Street address - Persian: مشهد، خیابان امام رضا، امام رضا ۶١، بیمارستان علوی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: ٩١٧٧٨٩٩١٩١
Phone: +98 51 3851 3258
Fax:
Email: al.manager@mums.ac.ir
Web page address: https://alavi.mums.ac.ir/
Name of recruitment center - English: Alavi hospital diabetes clinic
Name of recruitment center - Persian: کلینیک دیابت بیمارستان علوی
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Street address - English: Alavi hospital, Emam Reza 61 Alley, Emam Reza Ave, Mashhad
Street address - Persian: مشهد، خیابان امام رضا، امام رضا 61، بیمارستان علوی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177899191
Phone: +98 51 3851 3258
Fax:
Email: al.manager@mums.ac.ir
Web page address: https://alavi.mums.ac.ir/
Name of recruitment center - English: Alavi hospital diabetes clinic Name of recruitment center - Persian: کلینیک دیابت بیمارستان علوی Full name of responsible person - English: Armin Nazeri Full name of responsible person - Persian: آرمین ناظری Street address - English: Alavi hospital, Emam Reza 61 Alley, Emam Reza Ave, Mashhad Street address - Persian: مشهد، خیابان امام رضا، امام رضا ۶١61، بیمارستان علوی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: ٩١٧٧٨٩٩١٩١9177899191 Phone: +98 51 3851 3258 Fax: Email: al.manager@mums.ac.ir Web page address: https://alavi.mums.ac.ir/
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali Sajjadi
Full name of responsible person - Persian: علی سجادی
Street address - English: Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Asia Road, Gonabad, Khorasan Razavi
Street address - Persian: خراسان رضوی، گناباد، حاشیه جاده آسیایي، معاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9691793718
Phone: +98 51 5723 6828
Fax:
Email: sa_1344@hotmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Ali Mohammadpour
Full name of responsible person - Persian: علی محمدپور
Street address - English: Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Asia Road, Gonabad, Khorasan Razavi
Street address - Persian: خراسان رضوی، گناباد، حاشیه جاده آسیایي، معاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9691793718
Phone: +98 51 5722 5027
Fax:
Email: amohammadpur@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Ali SajjadiMohammadpour Full name of responsible person - Persian: علی سجادیمحمدپور Street address - English: Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Asia Road, Gonabad, Khorasan Razavi Street address - Persian: خراسان رضوی، گناباد، حاشیه جاده آسیایي، معاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد City - English: Gonabad City - Persian: گناباد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9691793718 Phone: +98 51 5723 68285722 5027 Fax: Email: sa_1344amohammadpur@hotmail.comyahoo.com Web page address:
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630
630
empty
Yes
1
Private
Public
privatepublic
Persons
Academic
personsacademic
empty
This research was supported by a grant from Gonabad University of Medical Sciences.
This research was supported by a grant from Gonabad University of Medical Sciences.
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این پژوهش با کمک مالی دانشگاه علوم پزشکی گناباد حمایت شد.
این پژوهش با کمک مالی دانشگاه علوم پزشکی گناباد حمایت شد.
Armin Nazeri
Gonabad University of Medical Sciences
Armin NazeriGonabad University of Medical Sciences
آرمین ناظری
دانشگاه علوم پزشکی گناباد
آرمین ناظریدانشگاه علوم پزشکی گناباد
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1th floor, No. 25/1, Daneshjoo 21 Alley, Daneshjoo street, Vakil abad Blvd.
Street address - Persian: بلوار وکیل آباد، خیابان دانشجو، دانشجو 21، پلاک 25/1، طبقه اول
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9188375971
Phone: +98 51 3892 8559
Mobile: +98 936 093 9662
Fax:
Email: Nazeri.a.stu@gmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
Street address - Persian: خراسان رضوی، گناباد، حاشیه جاده آسیایي، معاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9691793718
Phone: +98 51 5722 5027
Mobile: +98 936 093 9662
Fax:
Email: Nazeri.a.stu@gmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Armin Nazeri Full name of responsible person - Persian: آرمین ناظری Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 1th floorVice Chancellor for Research and Technology, No. 25/1Gonabad University of Medical Sciences, Daneshjoo 21 AlleyKhorasan Razavi, Daneshjoo streetGonabad, Vakil abad Blvd.Asia Road Street address - Persian: بلوار وکیل آبادخراسان رضوی، خیابان دانشجوگناباد، دانشجو 21حاشیه جاده آسیایي، پلاک 25/1، طبقه اولمعاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد City - English: MashhadGonabad City - Persian: مشهدگناباد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91883759719691793718 Phone: +98 51 3892 85595722 5027 Mobile: +98 936 093 9662 Fax: Email: Nazeri.a.stu@gmu.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1th floor, No. 25/1, Daneshjoo 21 Alley, Daneshjoo street, Vakil abad Blvd.
Street address - Persian: بلوار وکیل آباد، خیابان دانشجو، دانشجو 21، پلاک 25/1، طبقه اول
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9188375971
Phone: +98 51 3892 8559
Mobile: +98 936 093 9662
Fax:
Email: Nazeri.a.stu@gmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
Street address - Persian: خراسان رضوی، گناباد، حاشیه جاده آسیایي، معاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9691793718
Phone: +98 51 5722 5027
Mobile: +98 936 093 9662
Fax:
Email: Nazeri.a.stu@gmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Armin Nazeri Full name of responsible person - Persian: آرمین ناظری Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 1th floorVice Chancellor for Research and Technology, No. 25/1Gonabad University of Medical Sciences, Daneshjoo 21 AlleyKhorasan Razavi, Daneshjoo streetGonabad, Vakil abad Blvd.Asia Road Street address - Persian: بلوار وکیل آبادخراسان رضوی، خیابان دانشجوگناباد، دانشجو 21حاشیه جاده آسیایي، پلاک 25/1، طبقه اولمعاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد City - English: MashhadGonabad City - Persian: مشهدگناباد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91883759719691793718 Phone: +98 51 3892 85595722 5027 Mobile: +98 936 093 9662 Fax: Email: Nazeri.a.stu@gmu.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: 1th floor, No. 25/1, Daneshjoo 21 Alley, Daneshjoo street, Vakil abad Blvd.
Street address - Persian: بلوار وکیل آباد، خیابان دانشجو، دانشجو 21، پلاک 25/1، طبقه اول
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9188375971
Phone: +98 51 3892 8559
Mobile: +98 936 093 9662
Fax:
Email: Nazeri.a.stu@gmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Armin Nazeri
Full name of responsible person - Persian: آرمین ناظری
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
Street address - Persian: خراسان رضوی، گناباد، حاشیه جاده آسیایي، معاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد
City - English: Gonabad
City - Persian: گناباد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9691793718
Phone: +98 51 5722 5027
Mobile: +98 936 093 9662
Fax:
Email: Nazeri.a.stu@gmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Armin Nazeri Full name of responsible person - Persian: آرمین ناظری Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: 1th floorVice Chancellor for Research and Technology, No. 25/1Gonabad University of Medical Sciences, Daneshjoo 21 AlleyKhorasan Razavi, Daneshjoo streetGonabad, Vakil abad Blvd.Asia Road Street address - Persian: بلوار وکیل آبادخراسان رضوی، خیابان دانشجوگناباد، دانشجو 21حاشیه جاده آسیایي، پلاک 25/1، طبقه اولمعاونت تحقيقات و فناوري دانشگاه علوم پزشکي گناباد City - English: MashhadGonabad City - Persian: مشهدگناباد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 91883759719691793718 Phone: +98 51 3892 85595722 5027 Mobile: +98 936 093 9662 Fax: Email: Nazeri.a.stu@gmu.ac.ir Web page address:
Background: Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
Methods: A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients' quality of life.
Results: Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P=0.50), NDS scores (P=0.74), VAS scores (P=0.17), and Neuro-QoL scores (P=0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P<0.001), NDS scores (P<0.001), VAS scores (P<0.001), and Neuro-QoL scores (P<0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
Conclusion: According to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
Background: Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes. Methods: A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients' quality of life. Results: Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P=0.50), NDS scores (P=0.74), VAS scores (P=0.17), and Neuro-QoL scores (P=0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P<0.001), NDS scores (P<0.001), VAS scores (P<0.001), and Neuro-QoL scores (P<0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant. Conclusion: According to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
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Protocol summary
Study aim
Determining the effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with type 2 diabetes
Design
A randomised, double-blind, sham controlled clinical trial with a parallel group design of 64 patients
Settings and conduct
This study is a randomized clinical trial and patients are divided into intervention and control groups based on permutation blocks. The sample size in each group is 32 and the research site will be the diabetes clinic of Alavi hospital in Mashhad. For the intervention group, magnetic therapy will be used 24 hours a day for 12 weeks. In the control group, the magnet which is completely similar to the intervention group without magnetic properties, will be used at the same time. Patients, the main researcher and the physician in charge of patient care and the person analyzing the data will not to know the nature of the real or neutral magnet, as well as the group position of the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diabetic peripheral neuropathy at least 6 scores on score Neuropathy disability score (NDS) without Neuropathy symptoms score (NSS) or 3-5 scores on NDS with at least 5 scores on NSS
Drug-refractory neuropathic pain intensity at least 1 score on Visual analogue scale
Aged 18–70 years (either sex)
Exclusion criteria:
Pregnancy, planning a pregnancy, lactation
Intervention groups
Patients in the intervention group will use a magnet with an intensity of 155 mT for local magnetic therapy. The magnet at the end of the tibial nerve pathway in the lower leg, around the ankle, will be used 24 hours a day for 12 weeks.
In the control group, a magnet of the same size and shape but neutralized and without magnetic properties will be used at the same place and time
Main outcome variables
Clinical symptoms of neuropathy
General information
Reason for update
To add study results and final changes
Acronym
IRCT registration information
IRCT registration number:IRCT20210315050706N1
Registration date:2021-03-16, 1399/12/26
Registration timing:prospective
Last update:2024-01-04, 1402/10/14
Update count:1
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Armin Nazeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5027
Email address
nazeri.a.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-27, 1400/01/07
Expected recruitment end date
2021-04-27, 1400/02/07
Actual recruitment start date
2021-04-20, 1400/01/31
Actual recruitment end date
2021-08-06, 1400/05/15
Trial completion date
2021-11-06, 1400/08/15
Scientific title
The effect of local magnetic therapy on clinical symptoms of peripheral neuropathy in patients with diabetes type 2
Public title
The effect of local magnetic therapy on the clinical symptoms of peripheral neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes type 2; diagnosed by a diabetologist according to American Diabetes Association (ADA) standards
Diabetic peripheral neuropathy at least 6 scores on the Neuropathy disability score (NDS) without Neuropathy Symptoms score (NNS) or 3-5 scores on NDS with at least 5 scores on NSS
Drug-refractory neuropathic pain intensity at least 1 score on Visual analogue scale
Able to complete questionnaires and willing to sign written informed consent
Aged 18–70 years (either sex)
Exclusion criteria:
Pregnancy, planning a pregnancy, lactation
Had any of the following: Vascular insufficiency, Renal failure, Metallic implantation, Skin diseases, Foot ulcers, Prosthesis, Prior magnetic therapy, Cardiac pacemaker, Mechanical insulin pump or any electronic device
Had diabetic peripheral neuropathy from other causes than diabetes (according to the medical history and diagnosis of specialist doctors)
Opiate or drug abuse
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The research units will be selected from the people referring to the hospital clinic in a purposive sampling method by considering the inclusion criteria. Then they will be assigned to the two intervention and control groups using the four-shift block method. In this way, the letter "A" will be considered for the intervention group, and the letter "B" will be considered for the control group. The possible states in the quadruple block are six states, each state will be written on a card and the cards will be assigned the numbers one to six. Then, using the dice, one of the six possible states will be selected and the selected patients will be divided into two groups. This process will continue until the sample size is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, as well as the corresponding author, the outcome evaluator, the data analyst, and the physician in charge of patient care, became unaware of the group position of patients, as well as the nature of the wristband containing the real or neutral magnet.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.GMU.REC.1399.132
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
G99.0
ICD-10 code description
Autonomic neuropathy in diseases classified elsewhere
Primary outcomes
1
Description
Severity of clinical symptoms of diabetic neuropathy
Timepoint
At the beginning of the study and 4, 8 and 12 weeks after the start of the intervention
Method of measurement
Neuropathy symptom score questionnaire
Secondary outcomes
1
Description
Severity of neuropathic pain
Timepoint
The beginning of the study and weeks 4, 8 and 12
Method of measurement
Visual analogue scale questionnaire
2
Description
Severity of neuropathy disability
Timepoint
The beginning of the study and the 12th week after the start of the intervention
Method of measurement
neuropathy disability score questionnaire
3
Description
Quality of life
Timepoint
The beginning of the study and the 12th week after the start of the intervention
Method of measurement
NeuroQol questionnaire
Intervention groups
1
Description
Intervention group: For patients in this group for local magnetic therapy, a leather wristband with a neodymium bipolar magnet with an average magnetic intensity of 155 mTesla in the size of 15 x 3 mm will be used. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks.
Category
Treatment - Devices
2
Description
Control group: In this group, the same wristband and magnet with the same size and shape will be used at the same time, with the difference that the magnet used in this group is neutral and does not have magnetic properties. The wristband at the end of the tibial nerve pathway in the lower of the leg, around the ankle, will be used continuously 24 hours a day for 12 weeks.
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Asia Road, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
amohammadpur@yahoo.com
Grant name
This research was supported by a grant from Gonabad University of Medical Sciences.
Grant code / Reference number
630
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Armin Nazeri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
Email
Nazeri.a.stu@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Armin Nazeri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
Email
Nazeri.a.stu@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Armin Nazeri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vice Chancellor for Research and Technology, Gonabad University of Medical Sciences, Khorasan Razavi, Gonabad, Asia Road
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
Email
Nazeri.a.stu@gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document
There is no more information
Comments
Trial results
Please tick if results have been published
Yes
Summary result posting date
2024-01-04, 1402/10/14
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
2023-07-04, 1402/04/13
Abstract of published paper
Background: Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
Methods: A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients' quality of life.
Results: Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P=0.50), NDS scores (P=0.74), VAS scores (P=0.17), and Neuro-QoL scores (P=0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P<0.001), NDS scores (P<0.001), VAS scores (P<0.001), and Neuro-QoL scores (P<0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
Conclusion: According to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.