Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
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Protocol summary
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain patients with high pain-related anxiety
Inclusion criteria: aged 20-45 years; Right-handed patients; Anxiety score due to pain More than 30.
Exclusion criteria: Neurological diseases, Parkinson, Alzheimer; History of mental illness.
Inclusion criteria:20-45years old,right-handed,anxiety score due to pain more than30,suffering chronic low back pain; pain score less than3out of10on a visual analog scale.
Exclusion criteria:neurological and cerebellar diseases, psychological illnesses;structural deformities in the spine and lower extremities,abnormalities in the vestibular system .
Inclusion criteria: aged 20-45 years; Right45years old,right-handed patients; Anxietyhanded,anxiety score due to pain More than 30more than30,suffering chronic low back pain; pain score less than3out of10on a visual analog scale. Exclusion criteria: Neurologicalneurological and cerebellar diseases, Parkinson, Alzheimerpsychological illnesses; History of mental illnessstructural deformities in the spine and lower extremities,abnormalities in the vestibular system .
معیارهای ورود: 20-45 سال؛ بیماران راست دست؛ نمره اضطراب ناشي از درد بيش از 30؛ رنج از کمردردی مزمن ؛ نمره درد کمتر از 3 از 10 در مقیاس آنالوگ بینایی.
معیارهای خروج: بیماریهای عصبی و مخچه ای، سابقه بیماریهای روانی، ناهنجاری های ساختاری در ستون فقرات یا اندام تحتانی،ناهنجاری های سیستم وستیبولار.
معیارهای ورود: 20-45 سال؛ بیماران راست دست؛ نمره اضطراب ناشي از درد بيش از 30؛ رنج از کمردردی مزمن ؛ نمره درد کمتر از 3 از 10 در مقیاس آنالوگ بینایی. معیارهای خروج: بیماریهای عصبی و مخچه ای، پارکینسون، آلزایمر؛ سابقه بیماریهای روانی، ناهنجاری های ساختاری در ستون فقرات یا اندام تحتانی،ناهنجاری های سیستم وستیبولار.
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Intervention group2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy is applied for patients.
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex is performed for patients.
Intervention group2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex is performed for patients.
Control group: Based on the treatment protocol, placebo stimulation is applied for patients.
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients. Intervention group2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients. Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy is applied for patients.
گروه مداخله1: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی آنودال (a-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود.
گروه مداخله2: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی کاتودال (c-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود.
گروه کنترل: طبق پروتکل درمانی، تحریک پلاسبو و فیزیوتراپی روتین برای بیماران انجام می شود.
گروه مداخله1: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی آنودال (a-tDCS) بر روی کورتکس حرکتی سمت درگیر برای بیماران انجام می شود.
گروه مداخله2: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی کاتودال (c-tDCS) بر روی کورتکس حرکتی سمت درگیر برای بیماران انجام می شود.
گروه کنترل: طبق پروتکل درمانی، تحریک پلاسبو برای بیماران انجام می شود.
گروه مداخله1: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی آنودال (a-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود. گروه مداخله2: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی کاتودال (c-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود. گروه کنترل: طبق پروتکل درمانی، تحریک پلاسبو و فیزیوتراپی روتین برای بیماران انجام می شود.
Static and dynamic balance evaluation.
-Postural stability in one static and two dynamic conditions in level 7 and 4. (with both feet under open and closed eyes conditions during a 30 seconds trial, before,immediately, 48 hours and one-week after tDCS intervention).
-Error rate(number of errors/number of auditory signals (during 30 seconds test-7 trial)) and reaction time during the auditory stroop task in dual take test.
Static-Postural stability in one static and two dynamic balance evaluationconditions in level 7 and 4. (with both feet under open and closed eyes conditions during a 30 seconds trial, before,immediately, 48 hours and one-week after tDCS intervention). -Error rate(number of errors/number of auditory signals (during 30 seconds test-7 trial)) and reaction time during the auditory stroop task in dual take test.
ارزیابی تعادل ایستا و پویا.
_ شاخص های ثبات پاسچر در هر دو حالت ایستا و پویا در یک سطح ایستا و دو سطح ۷ و ۴ پویا.
( با هر دو پا در شرایط چشم باز و بسته در طی یک آزمایش 30 ثانیه ای ، قبل ، بلافاصله ، 48 ساعت و یک هفته پس از مداخله tDCS)
_ میزان خطا (تعداد خطاها / تعداد سیگنال های شنوایی(طی ۳۰ ثانیه تست_۷بار)) و زمان واکنش در طول وظیفه شنوایی استروپ طی تست شناختی تکلیفی.
ارزیابی تعادل_ شاخص های ثبات پاسچر در هر دو حالت ایستا و پویا در یک سطح ایستا و دو سطح ۷ و ۴ پویا. ( با هر دو پا در شرایط چشم باز و بسته در طی یک آزمایش 30 ثانیه ای ، قبل ، بلافاصله ، 48 ساعت و یک هفته پس از مداخله tDCS) _ میزان خطا (تعداد خطاها / تعداد سیگنال های شنوایی(طی ۳۰ ثانیه تست_۷بار)) و زمان واکنش در طول وظیفه شنوایی استروپ طی تست شناختی تکلیفی.
General information
2020-03-15, 1398/12/25
2020-03-19, 1398/12/29
2020-03-1519 00:00:00
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Defective information in the design variables section.
Defective information in the design variables section.
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نقص اطلاعات بخش متغیرهای طرح.
نقص اطلاعات بخش متغیرهای طرح.
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain patients with high pain-related anxiety
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in patients with chronic low back pain patients with high pain-related anxiety
20-45 years old;
Right-handed patients;
Anxiety score due to pain More than 30.
20-45 years old;
Right-handed patients;
Having pain-related anxiety score more than 30, based on Pain Anxiety Symptoms Scale (PASS)
Suffering from chronic LBP (for more than six weeks or recurrent LBP with at least three episodes lasted more than one week over the past 12 months)
A pain score less than 3 out of 10 on a visual analog scale (VAS) on the testing day
20-45 years old; Right-handed patients; AnxietyHaving pain-related anxiety score due to pain Moremore than 30., based on Pain Anxiety Symptoms Scale (PASS) Suffering from chronic LBP (for more than six weeks or recurrent LBP with at least three episodes lasted more than one week over the past 12 months) A pain score less than 3 out of 10 on a visual analog scale (VAS) on the testing day
20-45 سال
بیماران راست دست
نمره اضطراب ناشي از درد بيش از 30
20-45 سال
بیماران راست دست
نمره اضطراب ناشي از درد بيش از 30، برپایه ی پرسشنامه ترس از درد PASS
رنج از کمردردمزمن( برای بیش از شش هفته و یا درد ;مر مکرر با حداقل 3 دفعه در طول بیش از یک هفته در 12 ماه گذشته )
نمره درد کمتر از 3 از 10 در مقیاس آنالوگ بینایی
20-45 سال بیماران راست دست نمره اضطراب ناشي از درد بيش از 30، برپایه ی پرسشنامه ترس از درد PASS رنج از کمردردمزمن( برای بیش از شش هفته و یا درد ;مر مکرر با حداقل 3 دفعه در طول بیش از یک هفته در 12 ماه گذشته ) نمره درد کمتر از 3 از 10 در مقیاس آنالوگ بینایی
Neurological diseases: Parkinson, Alzheimer
History of mental illness
Any history of neurological diseases, such as Parkinson’s Disease, Alzheimer
Reporting any history of psychological illnesses
Presence of any signs of radiculopathy or root lumbar spinal cord involvement
Structural deformities in the spine or the lower extremities such as scoliosis, kyphosis, or lordosis
Any abnormalities in the vestibular system
Cerebellar disorders
NeurologicalAny history of neurological diseases:, such as Parkinson’s Disease, Alzheimer HistoryReporting any history of mental illnesspsychological illnesses Presence of any signs of radiculopathy or root lumbar spinal cord involvement Structural deformities in the spine or the lower extremities such as scoliosis, kyphosis, or lordosis Any abnormalities in the vestibular system Cerebellar disorders
سابقه ی هر نوع بیماری عصبی برای مثال اختلال پارکینسون ،آلزایمر
سابقه بیماریهای روانی
وجود هر دسته از نشانه های رادیکولوپاتی و یا درگیری ریشه های ستون فقرات کمری
ناهنجاری های ساختاری در ستون فقرات یا اندام تحتانی مثل اسکولیوز، مایفوز، یا لوردوز
هر نوع اختلال در سیستم وستیبولار
ناهنجاری های مخچه ای
بیماریهایسابقه ی هر نوع بیماری عصبی: برای مثال اختلال پارکینسون،آلزایمر سابقه بیماریهای روانی وجود هر دسته از نشانه های رادیکولوپاتی و یا درگیری ریشه های ستون فقرات کمری ناهنجاری های ساختاری در ستون فقرات یا اندام تحتانی مثل اسکولیوز، مایفوز، یا لوردوز هر نوع اختلال در سیستم وستیبولار ناهنجاری های مخچه ای
Primary outcomes
#1
Static and dynamic balance evaluation
Static and dynamic balance evaluation ( in static and 4,7 level of dynamic condition; with both feet under open and closed eyes conditions during a 30 seconds trial)
Static and dynamic balance evaluation ( in static and 4,7 level of dynamic condition; with both feet under open and closed eyes conditions during a 30 seconds trial)
ارزیابی تعادل ایستا و پویا
ارزیابی تعادل ایستا و پویا (ایستا و پویا در دو سطح 4 و 7. باهردوپا، در شرایط چشم باز و بسته، با و بدون تکلیف شناختی تکلیفی - شنیداری طی 30 ثانیه )
ارزیابی تعادل ایستا و پویا (ایستا و پویا در دو سطح 4 و 7. باهردوپا، در شرایط چشم باز و بسته، با و بدون تکلیف شناختی تکلیفی - شنیداری طی 30 ثانیه )
Before and after intervention
Before and immediately ,48 hours and one week after intervention
Before and immediately ,48 hours and one week after intervention
قبل و بعد از مداخله
قبل و بلافاصله بعد از مداخله ، 24 ساعت و یک هفته بعد از مداخله
قبل و بلافاصله بعد از مداخله ، 24 ساعت و یک هفته بعد از مداخله
Biodex Balance System & Biodex Medical Systems
Biodex Balance System (BBS) (302-950 model, Biodex Medical Systems, Inc. 20, New York, USA)
Biodex Balance System &(BBS) (302-950 model, Biodex Medical Systems, Inc. 20, New York, USA)
سیستم تعادل بایودکس و سیستمهای پزشکی بایودکس
سیستم تعادلی بایودکس ( مدل 302-950، سیستمهای پزشکی بایودکس،Inc. 20, New York, USA)
سیستم تعادلتعادلی بایودکس و( مدل 302-950، سیستمهای پزشکی بایودکس،Inc. 20, New York, USA)
Secondary outcomes
#1
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Error rate (number of errors/number of auditory signals(during 30 seconds test-7 trial)) during the auditory stroop task in dual take test
Error rate (number of errors/number of auditory signals(during 30 seconds test-7 trial)) during the auditory stroop task in dual take test
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میزان خطا (تعداد خطاها / تعداد سیگنال های شنوایی(طی ۳۰ ثانیه تست_۷بار)) در طول وظیفه شنوایی استروپ طی تست شناختی تکلیفی
میزان خطا (تعداد خطاها / تعداد سیگنال های شنوایی(طی ۳۰ ثانیه تست_۷بار)) در طول وظیفه شنوایی استروپ طی تست شناختی تکلیفی
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Before and immediately ,48 hours and one week after intervention
Before and immediately ,48 hours and one week after intervention
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قبل و بلافاصله بعد از مداخله ، 24 ساعت و یک هفته بعد از مداخله
قبل و بلافاصله بعد از مداخله ، 24 ساعت و یک هفته بعد از مداخله
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Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
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تست شنیداری استروپ (AST) که توسط برنامه نویس دربستر نرم افزار متلب (R2018A, Mathworks, Navick, MA, USA) برنامه نویسی و اجرا شده است.
تست شنیداری استروپ (AST) که توسط برنامه نویس دربستر نرم افزار متلب (R2018A, Mathworks, Navick, MA, USA) برنامه نویسی و اجرا شده است.
#2
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Reaction time during the auditory stroop task in dual take test (the interval between the two consecutive stimuli will be randomized (2,000 ms to 3,000 ms). All reactions with response delays longer than 3,500 ms will be discarded)
Reaction time during the auditory stroop task in dual take test (the interval between the two consecutive stimuli will be randomized (2,000 ms to 3,000 ms). All reactions with response delays longer than 3,500 ms will be discarded)
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زمان واکنش در طول وظیفه شنوایی استروپ طی تست شناختی تکلیفی ( فاصله بین دو محرک متوالی به صورت تصادفی (2،000 ms تا 3000 ms) خواهد بود. تمام واکنش های با تاخیر در پاسخ بیش از 3500 میلی ثانیه دور انداخته می شوند)
زمان واکنش در طول وظیفه شنوایی استروپ طی تست شناختی تکلیفی ( فاصله بین دو محرک متوالی به صورت تصادفی (2،000 ms تا 3000 ms) خواهد بود. تمام واکنش های با تاخیر در پاسخ بیش از 3500 میلی ثانیه دور انداخته می شوند)
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Before and immediately ,48 hours and one week after intervention
Before and immediately ,48 hours and one week after intervention
empty
قبل و بلافاصله بعد از مداخله ، 24 ساعت و یک هفته بعد از مداخله
قبل و بلافاصله بعد از مداخله ، 24 ساعت و یک هفته بعد از مداخله
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Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
empty
تست شنیداری استروپ (AST) که توسط برنامه نویس دربستر نرم افزار متلب (R2018A, Mathworks, Navick, MA, USA) برنامه نویسی و اجرا شده است.
تست شنیداری استروپ (AST) که توسط برنامه نویس دربستر نرم افزار متلب (R2018A, Mathworks, Navick, MA, USA) برنامه نویسی و اجرا شده است.
Intervention groups
#1
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex is performed for patients.
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
گروه مداخله1: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی آنودال (a-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود.
گروه مداخله1: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی آنودال (a-tDCS) بر روی کورتکس حرکتی سمت درگیر برای بیماران انجام می شود.
گروه مداخله1: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی آنودال (a-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود.
#2
Intervention group2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Intervention group 2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex is performed for patients.
Intervention group2group 2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
گروه مداخله2: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی کاتودال (c-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود.
گروه مداخله2: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی کاتودال (c-tDCS) بر روی کورتکس حرکتی سمت درگیر برای بیماران انجام می شود.
گروه مداخله2: طبق پروتکل درمانی، اعمال تحریک جریان مستقیم ترانس کرانیالی کاتودال (c-tDCS) بر روی کورتکس حرکتی سمت درگیر و فیزیوتراپی روتین برای بیماران انجام می شود.
#3
Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy is applied for patients.
Control group: Based on the treatment protocol, placebo stimulation is applied for patients.
Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy is applied for patients.
گروه کنترل: طبق پروتکل درمانی، تحریک پلاسبو و فیزیوتراپی روتین برای بیماران انجام می شود.
گروه کنترل: طبق پروتکل درمانی، تحریک پلاسبو برای بیماران انجام می شود.
گروه کنترل: طبق پروتکل درمانی، تحریک پلاسبو و فیزیوتراپی روتین برای بیماران انجام می شود.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fatemeh Ehsani
Full name of responsible person - Persian: فاطمه احسانی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Street address - Persian: میدان مشاهیر، بلوار قدس، مرکز تحقیقات توانبخشی عصبی عضلانی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3365 4180
Mobile: +98 919 131 0755
Fax:
Email: fatemehehsani59@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mona Masoudi
Full name of responsible person - Persian: منا مسعودی
Position - English: student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Street address - Persian: میدان مشاهیر، بلوار قدس، مرکز تحقیقات توانبخشی عصبی عضلانی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3365 4180
Mobile: +98 911 745 8082
Fax:
Email: masoudi.m94@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Fatemeh EhsaniMona Masoudi Full name of responsible person - Persian: فاطمه احسانیمنا مسعودی Position - English: Associate professorstudent Position - Persian: استادیاردانشجو Latest degree: phdmaster Area of specialty/work: 68 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven. Street address - Persian: میدان مشاهیر، بلوار قدس، مرکز تحقیقات توانبخشی عصبی عضلانی City - English: Semnan City - Persian: سمنان Province: Semnan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3513138111 Phone: +98 23 3365 4180 Mobile: +98 919 131 0755911 745 8082 Fax: Email: fatemehehsani59masoudi.m94@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mona Masoudi
Full name of responsible person - Persian: مونا مسعودی
Position - English: Student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Street address - Persian: میدان مشاهیر، بلوار قدس، مرکز تحقیقات توانبخشی عصبی عضلانی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3365 4180
Mobile: +98 912 731 2407
Fax:
Email: are20935@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mona Masoudi
Full name of responsible person - Persian: منا مسعودی
Position - English: Student
Position - Persian: دانشجو
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
Street address - Persian: میدان مشاهیر، بلوار قدس، مرکز تحقیقات توانبخشی عصبی عضلانی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3365 4180
Mobile: +98 911 745 8082
Fax:
Email: masoudi.m94@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mona Masoudi Full name of responsible person - Persian: مونامنا مسعودی Position - English: Student Position - Persian: دانشجو Latest degree: master Area of specialty/work: 68 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven. Street address - Persian: میدان مشاهیر، بلوار قدس، مرکز تحقیقات توانبخشی عصبی عضلانی City - English: Semnan City - Persian: سمنان Province: Semnan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3513138111 Phone: +98 23 3365 4180 Mobile: +98 912 731 2407911 745 8082 Fax: Email: are20935masoudi.m94@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
Design
Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 66 people.
Settings and conduct
Neuromuscular Rehabilitation Research Center, Semnan.
Study participants and evaluators are unaware of the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:20-45years old,right-handed,anxiety score due to pain more than30,suffering chronic low back pain; pain score less than3out of10on a visual analog scale.
Exclusion criteria:neurological and cerebellar diseases, psychological illnesses;structural deformities in the spine and lower extremities,abnormalities in the vestibular system .
Intervention groups
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex is performed for patients.
Intervention group2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex is performed for patients.
Control group: Based on the treatment protocol, placebo stimulation is applied for patients.
Main outcome variables
-Postural stability in one static and two dynamic conditions in level 7 and 4. (with both feet under open and closed eyes conditions during a 30 seconds trial, before,immediately, 48 hours and one-week after tDCS intervention).
-Error rate(number of errors/number of auditory signals (during 30 seconds test-7 trial)) and reaction time during the auditory stroop task in dual take test.
General information
Reason for update
Defective information in the design variables section.
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N46
Registration date:2019-11-27, 1398/09/06
Registration timing:registered_while_recruiting
Last update:2021-02-12, 1399/11/24
Update count:1
Registration date
2019-11-27, 1398/09/06
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-16, 1398/03/26
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
Public title
Comparative effect of anodal and cathodal direct cerebral electrical stimulation on postural control in chronic low back pain patients with high pain-related anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
20-45 years old;
Right-handed patients;
Having pain-related anxiety score more than 30, based on Pain Anxiety Symptoms Scale (PASS)
Suffering from chronic LBP (for more than six weeks or recurrent LBP with at least three episodes lasted more than one week over the past 12 months)
A pain score less than 3 out of 10 on a visual analog scale (VAS) on the testing day
Exclusion criteria:
Any history of neurological diseases, such as Parkinson’s Disease, Alzheimer
Reporting any history of psychological illnesses
Presence of any signs of radiculopathy or root lumbar spinal cord involvement
Structural deformities in the spine or the lower extremities such as scoliosis, kyphosis, or lordosis
Any abnormalities in the vestibular system
Cerebellar disorders
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study participants and evaluators are unaware of the allocation of study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee National Institute for Medical Research Development
Street address
No. 2, Besat Street, West Fatemi Street, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.NIMAD.REC.1398.251
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Static and dynamic balance evaluation ( in static and 4,7 level of dynamic condition; with both feet under open and closed eyes conditions during a 30 seconds trial)
Timepoint
Before and immediately ,48 hours and one week after intervention
Method of measurement
Biodex Balance System (BBS) (302-950 model, Biodex Medical Systems, Inc. 20, New York, USA)
Secondary outcomes
1
Description
Error rate (number of errors/number of auditory signals(during 30 seconds test-7 trial)) during the auditory stroop task in dual take test
Timepoint
Before and immediately ,48 hours and one week after intervention
Method of measurement
Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
2
Description
Reaction time during the auditory stroop task in dual take test (the interval between the two consecutive stimuli will be randomized (2,000 ms to 3,000 ms). All reactions with response delays longer than 3,500 ms will be discarded)
Timepoint
Before and immediately ,48 hours and one week after intervention
Method of measurement
Auditory stroop task (AST) written by a programmer and implemented by Matlab (R2018A, Mathworks, Navick, MA, USA) software
Intervention groups
1
Description
Intervention group1: According to the treatment protocol, Anodal trans-cranial direct current stimulation (a-tDCS) is applied to the affected motor cortex is performed for patients.
Category
Rehabilitation
2
Description
Intervention group 2: According to the treatment protocol, Cathodal trans-cranial direct current stimulation (c-tDCS) is applied to the affected motor cortex is performed for patients.
Category
Rehabilitation
3
Description
Control group: Based on the treatment protocol, placebo stimulation is applied for patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mona Masoudi
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
masoudi.m94@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Semnan
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mona Masoudi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
masoudi.m94@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Fatemeh Ehsani. Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 9191310755
What processes are involved for a request to access data/document