The effects of deep neck muscles specific training compared to general training on pain, disability, functional indices and neck muscles thicknesses in patients with chronic non-specific neck pain
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Protocol summary
The aims of the present study are to investigate and compare the effects of deep neck muscles specific exercises versus general exercises on pain, disability, functional indices and neck muscles thicknesses in patients with chronic non-specific neck pain. The inclusion criteria for this study include presence of neck pain for at least 3 months in the past year with the pain intensity of 30 mm or more on visual analogue scale. Patients with acute neck pain or any history of spinal congenital deformity, trauma, surgery and inflammatory diseases will be excluded. A total number of 64 patients with chronic non-specific neck will participate in this single blinded randomized control trial. Volunteers will be assigned to one of the two exercises groups (deep neck muscles specific exercises (32 patients) versus general exercises (32 patients)) randomly. The exercises duration would be 8 weeks which will be performed three times a week. Deep neck muscles specific exercises include nodding with and without eye movement as well as isometric head extension. General exercises include active range of motion of the neck and the shoulder joint, seated push-up and shoulder shrugs. The primary outcomes include pain, disability and neck muscles thicknesses. The secondary outcomes include sleep quality, fear avoidance, and quality of life. The day before starting the 8-week exercises program and the day after finalizing it the primary and secondary outcomes will be measured.
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The aims of the present study are to investigate and compare the effects of deep neck muscles specific exercises versus general exercises on pain, disability, functional indices and neck muscles thicknesses in patients with chronic non-specific neck pain. The inclusion criteria for this study include presence of neck pain for at least 3 months in the past year with the pain intensity of 30 mm or more on visual analogue scale. Patients with acute neck pain or any history of spinal congenital deformity, trauma, surgery and inflammatory diseases will be excluded. A total number of 64 patients with chronic non-specific neck will participate in this single blinded randomized control trial. Volunteers will be assigned to one of the two exercises groups (deep neck muscles specific exercises (32 patients) versus general exercises (32 patients)) randomly. The exercises duration would be 8 weeks which will be performed three times a week. Deep neck muscles specific exercises include nodding with and without eye movement as well as isometric head extension. General exercises include active range of motion of the neck and the shoulder joint, seated push-up and shoulder shrugs. The primary outcomes include pain, disability and neck muscles thicknesses. The secondary outcomes include sleep quality, fear avoidance, and quality of life. The day before starting the 8-week exercises program and the day after finalizing it the primary and secondary outcomes will be measured.
هدف ازاین مطالعه بررسی و مقایسه تأثیرات تمرینات اختصاصی عضلات عمقی گردن و تمرینات عمومی بر درد، ناتوانی، شاخص های عملکردی و ضخامت عضلات گردن در بیماران مبتلا به گردن درد مزمن غیر اختصاصی می باشد. معیارهای ورود به این مطالعه شامل وجود درد گردن حداقل به مدت 3 ماه در یکسال گذشته با شدت 30 میلیمتر یا بیشتر از مقیاس دیداری درد می باشد. بیماران با درد حاد گردن و یا سابقه اختلالات مادرزادی، ضربه، جراحی و بیماریهای التهابی ستون فقرات گردنی از این مطالعه خارج خواهند شد. تعداد 64 بیمار با گردن درد مزمن غیر اختصاصی در این مطالعه کارآزمایی بالینی یکسویه کور با گروه بندی تصادفی شرکت خواهند کرد. داوطلبین به صورت تصادفی در یکی از دو گروه تمرینات اختصاصی عضلات عمقی گردن (32 نفر) و تمرینات عمومی (32 نفر) قرار خواهند گرفت. مدت زمان تمرین درمانی 8 هفته خواهد بود که سه بار در هفته انجام خواهد شد. تمرینات اختصاصی عضلات عمقی گردن شامل تمرینات خم کردن سر روی گردن با و بدون حرکات چشم و انقباض ایزومتریک عضلات صاف کننده سر می باشد. تمرینات عمومی شامل حرکات فعال گردن، شانه ، بلند کردن تنه بر روی دستها و بالا بردن شانه خواهد بود. پیامدهای اولیه شامل درد، ناتوانی و ضخامت عضلات گردن می باشد. پیامدهای ثانویه شامل کیفیت خواب، ترس از حرکت و کیفیت زندگی می باشد. کلیه پیامدهای اولیه و ثانویه روز قبل از شروع برنامه تمرینی 8 هفته ای و در روز بعد از اتمام برنامه تمرینی مورد ارزیابی قرار خواهد گرفت.
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هدف ازاین مطالعه بررسی و مقایسه تأثیرات تمرینات اختصاصی عضلات عمقی گردن و تمرینات عمومی بر درد، ناتوانی، شاخص های عملکردی و ضخامت عضلات گردن در بیماران مبتلا به گردن درد مزمن غیر اختصاصی می باشد. معیارهای ورود به این مطالعه شامل وجود درد گردن حداقل به مدت 3 ماه در یکسال گذشته با شدت 30 میلیمتر یا بیشتر از مقیاس دیداری درد می باشد. بیماران با درد حاد گردن و یا سابقه اختلالات مادرزادی، ضربه، جراحی و بیماریهای التهابی ستون فقرات گردنی از این مطالعه خارج خواهند شد. تعداد 64 بیمار با گردن درد مزمن غیر اختصاصی در این مطالعه کارآزمایی بالینی یکسویه کور با گروه بندی تصادفی شرکت خواهند کرد. داوطلبین به صورت تصادفی در یکی از دو گروه تمرینات اختصاصی عضلات عمقی گردن (32 نفر) و تمرینات عمومی (32 نفر) قرار خواهند گرفت. مدت زمان تمرین درمانی 8 هفته خواهد بود که سه بار در هفته انجام خواهد شد. تمرینات اختصاصی عضلات عمقی گردن شامل تمرینات خم کردن سر روی گردن با و بدون حرکات چشم و انقباض ایزومتریک عضلات صاف کننده سر می باشد. تمرینات عمومی شامل حرکات فعال گردن، شانه ، بلند کردن تنه بر روی دستها و بالا بردن شانه خواهد بود. پیامدهای اولیه شامل درد، ناتوانی و ضخامت عضلات گردن می باشد. پیامدهای ثانویه شامل کیفیت خواب، ترس از حرکت و کیفیت زندگی می باشد. کلیه پیامدهای اولیه و ثانویه روز قبل از شروع برنامه تمرینی 8 هفته ای و در روز بعد از اتمام برنامه تمرینی مورد ارزیابی قرار خواهد گرفت.
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The aims of the present study are to investigate and compare the effects of deep neck muscles specific exercises versus general exercises on pain, disability, functional indices, and neck muscles' thicknesses in patients with chronic non-specific neck pain.
The aims of the present study are to investigate and compare the effects of deep neck muscles specific exercises versus general exercises on pain, disability, functional indices, and neck muscles' thicknesses in patients with chronic non-specific neck pain.
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هدف ازاین مطالعه بررسی و مقایسه تأثیرات تمرینات اختصاصی عضلات عمقی گردن و تمرینات عمومی بر درد، ناتوانی، شاخص های عملکردی و ضخامت عضلات گردن در بیماران مبتلا به گردن درد مزمن غیر اختصاصی می باشد
هدف ازاین مطالعه بررسی و مقایسه تأثیرات تمرینات اختصاصی عضلات عمقی گردن و تمرینات عمومی بر درد، ناتوانی، شاخص های عملکردی و ضخامت عضلات گردن در بیماران مبتلا به گردن درد مزمن غیر اختصاصی می باشد
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Single-blinded randomized control trial.
Single-blinded randomized control trial.
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کارآزمایی بالینی یکسویه کور با گروه بندی تصادفی
کارآزمایی بالینی یکسویه کور با گروه بندی تصادفی
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Participants will be assigned to one of the two exercise groups, specific neck exercises versus general exercises. specific neck exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck and the shoulder joint.The primary outcomes: pain, disability, and neck muscles' thicknesses. The secondary outcomes: sleep quality, fear-avoidance, and quality of life. The day before starting the 8-week exercise program and the day after finalizing it the primary and secondary outcomes will be measured. participants will be blinded. None of the participants will be aware of the other training group
Participants will be assigned to one of the two exercise groups, specific neck exercises versus general exercises. specific neck exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck and the shoulder joint.The primary outcomes: pain, disability, and neck muscles' thicknesses. The secondary outcomes: sleep quality, fear-avoidance, and quality of life. The day before starting the 8-week exercise program and the day after finalizing it the primary and secondary outcomes will be measured. participants will be blinded. None of the participants will be aware of the other training group
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تمرینات اختصاصی عضلات عمقی گردن شامل تمرینات خم کردن سر روی گردن با و بدون حرکات چشم و انقباض ایزومتریک عضلات صاف کننده سر می باشد. تمرینات عمومی شامل حرکات فعال گردن، شانه ، بلند کردن تنه بر روی دستها و بالا بردن شانه خواهد بود. پیامدهای اولیه شامل درد، ناتوانی و ضخامت عضلات گردن می باشد. پیامدهای ثانویه شامل کیفیت خواب، ترس از حرکت و کیفیت زندگی می باشد. کلیه پیامدهای اولیه و ثانویه روز قبل از شروع برنامه تمرینی 8 هفته ای و در روز بعد از اتمام برنامه تمرینی مورد ارزیابی قرار خواهد گرفت. شرکت کنندگان در این مطالعه کور خواهند شد به طوریکه از تمرینات گروه دیگر آگاهی نخواهند داشت.
تمرینات اختصاصی عضلات عمقی گردن شامل تمرینات خم کردن سر روی گردن با و بدون حرکات چشم و انقباض ایزومتریک عضلات صاف کننده سر می باشد. تمرینات عمومی شامل حرکات فعال گردن، شانه ، بلند کردن تنه بر روی دستها و بالا بردن شانه خواهد بود. پیامدهای اولیه شامل درد، ناتوانی و ضخامت عضلات گردن می باشد. پیامدهای ثانویه شامل کیفیت خواب، ترس از حرکت و کیفیت زندگی می باشد. کلیه پیامدهای اولیه و ثانویه روز قبل از شروع برنامه تمرینی 8 هفته ای و در روز بعد از اتمام برنامه تمرینی مورد ارزیابی قرار خواهد گرفت. شرکت کنندگان در این مطالعه کور خواهند شد به طوریکه از تمرینات گروه دیگر آگاهی نخواهند داشت.
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A total number of 64 patients with chronic non-specific neck will participate in this study. The inclusion criteria for this study include the presence of neck pain for at least 3 months in the past year with a pain intensity of 30 mm or more on the visual analog scale. Patients with acute neck pain or any history of spinal congenital deformity, trauma, surgery, and inflammatory diseases will be excluded.
A total number of 64 patients with chronic non-specific neck will participate in this study. The inclusion criteria for this study include the presence of neck pain for at least 3 months in the past year with a pain intensity of 30 mm or more on the visual analog scale. Patients with acute neck pain or any history of spinal congenital deformity, trauma, surgery, and inflammatory diseases will be excluded.
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تعداد 64 بیمار با گردن درد مزمن غیر اختصاصی در این مطالعه شرکت خواهند کرد. معیارهای ورود به این مطالعه شامل وجود درد گردن حداقل به مدت 3 ماه در یکسال گذشته با شدت 30 میلیمتر یا بیشتر از مقیاس دیداری درد می باشد. بیماران با درد حاد گردن و یا سابقه اختلالات مادرزادی، ضربه، جراحی و بیماریهای التهابی ستون فقرات گردنی از این مطالعه خارج خواهند شد
تعداد 64 بیمار با گردن درد مزمن غیر اختصاصی در این مطالعه شرکت خواهند کرد. معیارهای ورود به این مطالعه شامل وجود درد گردن حداقل به مدت 3 ماه در یکسال گذشته با شدت 30 میلیمتر یا بیشتر از مقیاس دیداری درد می باشد. بیماران با درد حاد گردن و یا سابقه اختلالات مادرزادی، ضربه، جراحی و بیماریهای التهابی ستون فقرات گردنی از این مطالعه خارج خواهند شد
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Two intervention groups including specific and general neck exercise groups. Deep neck muscles specific exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck, shoulder joint, seated push-up, and shoulder shrugs.
Two intervention groups including specific and general neck exercise groups. Deep neck muscles specific exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck, shoulder joint, seated push-up, and shoulder shrugs.
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دو گروه تمرینات اختصاصی عضلات عمقی گردن و تمرینات عمومی.تمرینات اختصاصی عضلات عمقی گردن شامل تمرینات خم کردن سر روی گردن با و بدون حرکات چشم و انقباض ایزومتریک عضلات صاف کننده سر می باشد. تمرینات عمومی شامل حرکات فعال گردن، شانه ، بلند کردن تنه بر روی دستها و بالا بردن شانه خواهد بود.
دو گروه تمرینات اختصاصی عضلات عمقی گردن و تمرینات عمومی.تمرینات اختصاصی عضلات عمقی گردن شامل تمرینات خم کردن سر روی گردن با و بدون حرکات چشم و انقباض ایزومتریک عضلات صاف کننده سر می باشد. تمرینات عمومی شامل حرکات فعال گردن، شانه ، بلند کردن تنه بر روی دستها و بالا بردن شانه خواهد بود.
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pain, disability and neck muscles thicknesses, and cervical joint repositioning error (added in the amendment)
pain, disability and neck muscles thicknesses, and cervical joint repositioning error (added in the amendment)
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درد، ناتوانی و ضخامت عضلات گردن و خطای بازسازی زاویه (اضافه شده از نیمه مطالعه)
درد، ناتوانی و ضخامت عضلات گردن و خطای بازسازی زاویه (اضافه شده از نیمه مطالعه)
General information
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2018-03-21, 1397/01/01
2019-03-18, 1397/12/27
20182019-03-2118 00:00:00
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To adapt the new version of IRCT software
To adapt the new version of IRCT software
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به روز رسانی جهت انطباق با فرمت جدید مرکز ثبت ترایال می باشد.
به روز رسانی جهت انطباق با فرمت جدید مرکز ثبت ترایال می باشد.
A positive history of neck pain for at least three months in the past year
Pain intensity of more than 30 mm on visual analogue scale
Non-specific neck pain
A positive history of neck pain for at least three months in the past year Pain intensity of more than 30 mm on visual analogue scale Non-specific neck pain
سابقه گردن درد حداقل سه ماه در یک سال گذشته
شدت درد 30 میلیمتر از مقیاس دیداری درد و بیشتر از آن
گردن درد غیر اختصاصی
سابقه گردن درد حداقل سه ماه در یک سال گذشته شدت درد 30 میلیمتر از مقیاس دیداری درد و بیشتر از آن گردن درد غیر اختصاصی
Acute neck pain
A positive history of spine surgery
Cervical Fracture or tumor
Discopathy or radicular pain distributed in to shoulder or presence of any neurogenic signs
History of cervical trauma or car accident
Congenital spinal abnormality
Systemic inflammatory diseases
Vertigo and vestibular disorders
Diabetes
Receiving any shoulder or neck muscles training , physiotherapy or manual therapy on the neck in the past 6 months
Acute neck pain A positive history of spine surgery Cervical Fracture or tumor Discopathy or radicular pain distributed in to shoulder or presence of any neurogenic signs History of cervical trauma or car accident Congenital spinal abnormality Systemic inflammatory diseases Vertigo and vestibular disorders Diabetes Receiving any shoulder or neck muscles training , physiotherapy or manual therapy on the neck in the past 6 months
گردن درد حاد
سابقه جراحی ستون فقرات
شکستگی و یا توده های سرطانی در گردن
دیسکوپاتی و درد تیر کشنده به بازو و یا وجود هرگونه علایم نوروژنیک
سابقه تروما به گردن یا تصادف رانندگی
ابنورمالیتی های مادرزادی در ستون فقرات
بیماری های التهابی سیستمیک
سرگیجه و اختلالات وستیبولار
دیابت
هرگونه تمرین تقویتی عضلات گردن یا شانه، فیزیوتراپی و در مان های دستی در 6 ماه گذشته
گردن درد حاد سابقه جراحی ستون فقرات شکستگی و یا توده های سرطانی در گردن دیسکوپاتی و درد تیر کشنده به بازو و یا وجود هرگونه علایم نوروژنیک سابقه تروما به گردن یا تصادف رانندگی ابنورمالیتی های مادرزادی در ستون فقرات بیماری های التهابی سیستمیک سرگیجه و اختلالات وستیبولار دیابت هرگونه تمرین تقویتی عضلات گردن یا شانه، فیزیوتراپی و در مان های دستی در 6 ماه گذشته
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Randomization will be performed using sealed envelopes. Each participant will choose one of the sealed envelopes to be allocated to one of the exercise groups. The envelope will then be returned to the envelope box. Randomization will be carried out by someone who is not involved in evaluation or treatment.
Randomization will be performed using sealed envelopes. Each participant will choose one of the sealed envelopes to be allocated to one of the exercise groups. The envelope will then be returned to the envelope box. Randomization will be carried out by someone who is not involved in evaluation or treatment.
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تصادفی سازی با استفاده از پاکت های مهر و موم شده اجرا خواهد شد. هر شرکت کننده یکی از این دو پاکت را انتخاب کرده و وارد گروه تمرین درمانی انتخاب شده میشود.پاکت ها پس از گروه بندی به داخل صندوق پاکت ها برگردانده خواهد شد. تصادفی سازی توسط شخصی که در مطالعه نقشی ندارد انجام خواهد گرفت.
تصادفی سازی با استفاده از پاکت های مهر و موم شده اجرا خواهد شد. هر شرکت کننده یکی از این دو پاکت را انتخاب کرده و وارد گروه تمرین درمانی انتخاب شده میشود.پاکت ها پس از گروه بندی به داخل صندوق پاکت ها برگردانده خواهد شد. تصادفی سازی توسط شخصی که در مطالعه نقشی ندارد انجام خواهد گرفت.
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None of the participants will be aware of the other training group.
None of the participants will be aware of the other training group.
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هیچ یک از شرکت کنندگان از تمرینات گروه دیگر اطلاع نخواهد داشت.
هیچ یک از شرکت کنندگان از تمرینات گروه دیگر اطلاع نخواهد داشت.
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Primary outcomes
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Cervical Joint Position Error
Cervical Joint Position Error
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خطای بازسازس زاویه
خطای بازسازس زاویه
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One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
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یک روز قبل از شروع برنامه تمرین درمانی و یک روز بعد از اتمام برنامه تمرین درمانی 8 هفته ای اندازه گیری می شود
یک روز قبل از شروع برنامه تمرین درمانی و یک روز بعد از اتمام برنامه تمرین درمانی 8 هفته ای اندازه گیری می شود
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Subjects had to rotate their head from a relaxed position, turn to one direction and return to the original position. A laser pointer was used to measure the cervical joint repositioning error. The angle between the target and reference point in degrees will be defined as the joint position error. This variable has been added to the trial when IRB approval was received for the additions to the main protocol.
Subjects had to rotate their head from a relaxed position, turn to one direction and return to the original position. A laser pointer was used to measure the cervical joint repositioning error. The angle between the target and reference point in degrees will be defined as the joint position error. This variable has been added to the trial when IRB approval was received for the additions to the main protocol.
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با استفاده از پوینتر لیزری و انجام حرکت چرخش سر و نهایتا بازسازی نقطه اولیه ای که در هنگام شروع حرکت پوینتر بر روی دیوار نشان می دهد. زاویه بین نقطه شروع و نقطه بازسازی جدید به عنوان خطای بازسازی در نظر گرفته می شود. این متغیر پس از شروع مطالعه اصلی و پس از دریافت اجازه از کمیته اخلاق اضافه شده است.
با استفاده از پوینتر لیزری و انجام حرکت چرخش سر و نهایتا بازسازی نقطه اولیه ای که در هنگام شروع حرکت پوینتر بر روی دیوار نشان می دهد. زاویه بین نقطه شروع و نقطه بازسازی جدید به عنوان خطای بازسازی در نظر گرفته می شود. این متغیر پس از شروع مطالعه اصلی و پس از دریافت اجازه از کمیته اخلاق اضافه شده است.
Secondary outcomes
#1
Pain and work disability
Quality of life
Pain and work disabilityQuality of life
درد و ناتوانی از کار
کیفیت زندگی
درد و ناتوانی از کارکیفیت زندگی
One day before the starting the exercise program and one day after finishing the program.
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
One day before the starting the exercise program and one day after finishingfinalizing the 8-week exercise program.
Orebro musculoskeletal pain questionnaire, Persian version
Sf-36 questionnaire, Persian version
Orebro musculoskeletal painSf-36 questionnaire, Persian version
پرسشنامه بومی شده (فارسی) دردهای اسکلتی-عضلانی اربرو
پرسشنامه بومی شده (فارسی) اس-اف 36
پرسشنامه بومی شده (فارسی) دردهای اسکلتیاس-عضلانی اربرواف 36
#2
Quality of life
Fear avoidance
Quality of lifeFear avoidance
کیفیت زندگی
ترس از حرکت
کیفیت زندگیترس از حرکت
Sf-36 questionnaire, Persian version
Tampa Scale of Kinesiophobia, Persian version
Sf-36 questionnaireTampa Scale of Kinesiophobia, Persian version
پرسشنامه بومی شده (فارسی) اس-اف 36
پرسشنامه بومی شده (فارسی) شاخص تامپا
پرسشنامه بومی شده (فارسی) اس-اف 36شاخص تامپا
#3
Fear avoidance
empty
Fear avoidance
ترس از حرکت
empty
ترس از حرکت
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
empty
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
یک روز قبل از شروع برنامه تمرین درمانی و یک روز بعد از اتمام برنامه تمرین درمانی 8 هفته ای اندازه گیری می شود
empty
یک روز قبل از شروع برنامه تمرین درمانی و یک روز بعد از اتمام برنامه تمرین درمانی 8 هفته ای اندازه گیری می شود
Tampa Scale of Kinesiophobia, Persian version
empty
Tampa Scale of Kinesiophobia, Persian version
پرسشنامه بومی شده (فارسی) شاخص تامپا
empty
پرسشنامه بومی شده (فارسی) شاخص تامپا
Recruitment centers
#1
Name of recruitment center - English: University of Social Welfare and Rehabilitation Scienses and the related hospitals
Name of recruitment center - Persian: دانشگاه علوم بهزیستی و توانبخشی تهران و بیمارستان های تابعه
Full name of responsible person - English: Pegah Kashfi
Full name of responsible person - Persian: پگاه کشفی
Street address - English: velenjak, koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: University of Social Welfare and Rehabilitation Scienses and the related hospitals
Name of recruitment center - Persian: دانشگاه علوم بهزیستی و توانبخشی تهران و بیمارستان های تابعه
Full name of responsible person - English: Pegah Kashfi
Full name of responsible person - Persian: پگاه کشفی
Street address - English: velenjak, koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2218 0083
Fax:
Email: pegah.kashfi@yahoo.com
Web page address:
Name of recruitment center - English: University of Social Welfare and Rehabilitation Scienses and the related hospitals Name of recruitment center - Persian: دانشگاه علوم بهزیستی و توانبخشی تهران و بیمارستان های تابعه Full name of responsible person - English: Pegah Kashfi Full name of responsible person - Persian: پگاه کشفی Street address - English: velenjak, koudakyar dead end Street address - Persian: ولنجک، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 2218 0083 Fax: Email: pegah.kashfi@yahoo.com Web page address:
#2
Name of recruitment center - English: Shahid Beheshti University of Medical Sciences and its related hospitals
Name of recruitment center - Persian: دانشگاه علوم پزشکی شهید بهشتی و بیمارستان های تابعه
Full name of responsible person - English: Pegah Kashfi
Full name of responsible person - Persian: پگاه کشفی
Street address - English: Velenjak, Koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Shahid Beheshti University of Medical Sciences and its related hospitals
Name of recruitment center - Persian: دانشگاه علوم پزشکی شهید بهشتی و بیمارستان های تابعه
Full name of responsible person - English: Pegah Kashfi
Full name of responsible person - Persian: پگاه کشفی
Street address - English: Velenjak, Koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2218 0083
Fax:
Email: pegah.kashfi@yahoo.com
Web page address:
Name of recruitment center - English: Shahid Beheshti University of Medical Sciences and its related hospitals Name of recruitment center - Persian: دانشگاه علوم پزشکی شهید بهشتی و بیمارستان های تابعه Full name of responsible person - English: Pegah Kashfi Full name of responsible person - Persian: پگاه کشفی Street address - English: Velenjak, Koudakyar dead end Street address - Persian: ولنجک، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 2218 0083 Fax: Email: pegah.kashfi@yahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Dr. Hamid-Reza Khankeh
Full name of responsible person - Persian: دکتر حمیدرضا خانکه
Street address - English: Velenjak, Koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Dr. Hamid-Reza Khankeh
Full name of responsible person - Persian: دکتر حمیدرضا خانکه
Street address - English: Velenjak, Koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2218 0083
Fax:
Email: pegah.kashfi@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Dr. Hamid-Reza Khankeh Full name of responsible person - Persian: دکتر حمیدرضا خانکه Street address - English: Velenjak, Koudakyar dead end Street address - Persian: ولنجک، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 2218 0083 Fax: Email: pegah.kashfi@yahoo.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Pegah Kashfi
Full name of responsible person - Persian: پگاه کشفی
Position - English: Physiotherapy MSc student
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: velengak, koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 22180084
Mobile: +91 6646822
Fax:
Email: pegah.kashfi@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Pegah Kashfi
Full name of responsible person - Persian: پگاه کشفی
Position - English: Physiotherapy MSc student
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree: bachelor
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: velengak, koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۹۸۵۷۱۳۸۳۴
Phone: +98 22180084
Mobile: +98 910 664 6822
Fax:
Email: pegah.kashfi@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Pegah Kashfi Full name of responsible person - Persian: پگاه کشفی Position - English: Physiotherapy MSc student Position - Persian: دانشجوی کارشناسی ارشد Latest degree: bachelor Area of specialty/work: 068 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: velengak, koudakyar dead end Street address - Persian: ولنجک، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۹۸۵۷۱۳۸۳۴ Phone: +98 22180084 Mobile: +91 664682298 910 664 6822 Fax: Email: pegah.kashfi@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Scienses
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Dr. Leila Rahnama
Full name of responsible person - Persian: دکتر لیلا رهنما
Position - English: PhD
Position - Persian: دکترای تخصصی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: velenjak, koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 22180084
Mobile: +98 917 328 1197
Fax:
Email: l.rahnama@uswr.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Scienses
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Dr. Leila Rahnama
Full name of responsible person - Persian: دکتر لیلا رهنما
Position - English: PhD
Position - Persian: دکترای تخصصی
Latest degree: phd
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: velenjak, koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۹۸۵۷۱۳۸۳۴
Phone: +98 22180084
Mobile: +98 917 328 1197
Fax:
Email: l.rahnama@uswr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Scienses Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Dr. Leila Rahnama Full name of responsible person - Persian: دکتر لیلا رهنما Position - English: PhD Position - Persian: دکترای تخصصی Latest degree: phd Area of specialty/work: 068 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: velenjak, koudakyar dead end Street address - Persian: ولنجک، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۹۸۵۷۱۳۸۳۴ Phone: +98 22180084 Mobile: +98 917 328 1197 Fax: Email: l.rahnama@uswr.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: University of Social welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Dr. Leila Rahnama
Full name of responsible person - Persian: دکتر لیلا رهنما
Position - English: PhD, Assistant Professor
Position - Persian: دکتری تخصصی، استادیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: velenjak, Koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2218 0085
Mobile: +98 917 328 1197
Fax:
Email: lrahnama@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Dr. Leila Rahnama
Full name of responsible person - Persian: دکتر لیلا رهنما
Position - English: PhD, Assistant Professor
Position - Persian: دکتری تخصصی، استادیار
Latest degree: phd
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: velenjak, Koudakyar dead end
Street address - Persian: ولنجک، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: ۱۹۸۵۷۱۳۸۳۴
Phone: +98 21 2218 0085
Mobile: +98 917 328 1197
Fax:
Email: lrahnama@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Dr. Leila Rahnama Full name of responsible person - Persian: دکتر لیلا رهنما Position - English: PhD, Assistant Professor Position - Persian: دکتری تخصصی، استادیار Latest degree: phd Area of specialty/work: 068 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: velenjak, Koudakyar dead end Street address - Persian: ولنجک، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: ۱۹۸۵۷۱۳۸۳۴ Phone: +98 21 2218 0085 Mobile: +98 917 328 1197 Fax: Email: lrahnama@gmail.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
there is no further information
there is no further information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
The aims of the present study are to investigate and compare the effects of deep neck muscles specific exercises versus general exercises on pain, disability, functional indices, and neck muscles' thicknesses in patients with chronic non-specific neck pain.
Design
Single-blinded randomized control trial.
Settings and conduct
Participants will be assigned to one of the two exercise groups, specific neck exercises versus general exercises. specific neck exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck and the shoulder joint.The primary outcomes: pain, disability, and neck muscles' thicknesses. The secondary outcomes: sleep quality, fear-avoidance, and quality of life. The day before starting the 8-week exercise program and the day after finalizing it the primary and secondary outcomes will be measured. participants will be blinded. None of the participants will be aware of the other training group
Participants/Inclusion and exclusion criteria
A total number of 64 patients with chronic non-specific neck will participate in this study. The inclusion criteria for this study include the presence of neck pain for at least 3 months in the past year with a pain intensity of 30 mm or more on the visual analog scale. Patients with acute neck pain or any history of spinal congenital deformity, trauma, surgery, and inflammatory diseases will be excluded.
Intervention groups
Two intervention groups including specific and general neck exercise groups. Deep neck muscles specific exercises: nodding with and without eye movement, isometric head extension. General exercises: active range of motion of the neck, shoulder joint, seated push-up, and shoulder shrugs.
Main outcome variables
pain, disability and neck muscles thicknesses, and cervical joint repositioning error (added in the amendment)
General information
Reason for update
To adapt the new version of IRCT software
Acronym
IRCT registration information
IRCT registration number:IRCT2017091620787N2
Registration date:2017-11-11, 1396/08/20
Registration timing:prospective
Last update:2021-02-07, 1399/11/19
Update count:1
Registration date
2017-11-11, 1396/08/20
Registrant information
Name
Leila Rahnama
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0039
Email address
l.rahnama@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2017-11-15, 1396/08/24
Expected recruitment end date
2019-03-18, 1397/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of deep neck muscles specific training compared to general training on pain, disability, functional indices and neck muscles thicknesses in patients with chronic non-specific neck pain
Public title
The effects of neck specific and general exercises on pain and functional indices in patients with neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A positive history of neck pain for at least three months in the past year
Pain intensity of more than 30 mm on visual analogue scale
Non-specific neck pain
Exclusion criteria:
Acute neck pain
A positive history of spine surgery
Cervical Fracture or tumor
Discopathy or radicular pain distributed in to shoulder or presence of any neurogenic signs
History of cervical trauma or car accident
Congenital spinal abnormality
Systemic inflammatory diseases
Vertigo and vestibular disorders
Diabetes
Receiving any shoulder or neck muscles training , physiotherapy or manual therapy on the neck in the past 6 months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using sealed envelopes. Each participant will choose one of the sealed envelopes to be allocated to one of the exercise groups. The envelope will then be returned to the envelope box. Randomization will be carried out by someone who is not involved in evaluation or treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the participants will be aware of the other training group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Board, University of Social Welfare and Rehabilitation Sciences
Street address
Velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
IR.USWR.REC.1396.194
Health conditions studied
1
Description of health condition studied
Chronic non-specific neck pain
ICD-10 code
R52.2
ICD-10 code description
Other Chronic Pain
Primary outcomes
1
Description
Pain
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Pain will also be measured before and immediately after each exercise session.
Method of measurement
visual analog scale
2
Description
Disability
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Neck disability index (NDI) questionnaire, Persian version
3
Description
Neck muscle thickness
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Ultrasound device with a 45-millimeter linear array probe and frequency of 12 MHz for neck flexor muscles and 6 MHz for neck extensor muscles.
4
Description
Cervical Joint Position Error
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Subjects had to rotate their head from a relaxed position, turn to one direction and return to the original position. A laser pointer was used to measure the cervical joint repositioning error. The angle between the target and reference point in degrees will be defined as the joint position error. This variable has been added to the trial when IRB approval was received for the additions to the main protocol.
Secondary outcomes
1
Description
Sleep quality
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Pittsburgh Sleep Quality Index, Persian version
2
Description
Neck range of motion
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Goniameter
3
Description
Neck Muscles Maximum Isometric Voluntary Contraction
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Tensiometer unit for extensor muscles and Pressure Biofeedback Unit for flexor muscles
4
Description
Quality of life
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Sf-36 questionnaire, Persian version
5
Description
Fear avoidance
Timepoint
One day before the starting the exercise program and one day after finalizing the 8-week exercise program.
Method of measurement
Tampa Scale of Kinesiophobia, Persian version
Intervention groups
1
Description
Deep neck muscles specific exercises:
1) IN the supine position, the participant moves his/her eyes upward without any movement on the head and neck as much as possible and holds it for 5 seconds. Then the participant moves his/her eyes downward as much as possible and holds it for 5 seconds.
2) In the supine position the participant performs a light isometric nodding along with moving his/her eyes from forward to downward. A gentle pressure will be applied to the participant’s chin with his/her own hand. This exercise will be held for 5 seconds.
3) In the supine position the participant presses his/her occiput area with submaximal pressure to the bed and holds it for 5 seconds.
4) In the supine position the participant performs the nodding exercise by closing his/her chin to the sternum and holds it for 5 seconds.
All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial.
Category
Rehabilitation
2
Description
General exercises:
1) Neck active free range of motion in flexion, extension, bilateral side flexion and bilateral rotation while the participant is seated.
2) Shoulder active free range of motion in flexion, extension, abduction, adduction and internal and external rotation while the participant is seated.
3) Seated push-ups.
4) Seated shoulder shrug exercise while the participant holds a one Kg weight in his/her hands.
All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Scienses and the related hospitals
Full name of responsible person
Pegah Kashfi
Street address
velenjak, koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
pegah.kashfi@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences and its related hospitals
Full name of responsible person
Pegah Kashfi
Street address
Velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
pegah.kashfi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Hamid-Reza Khankeh
Street address
Velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
pegah.kashfi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Pegah Kashfi
Position
Physiotherapy MSc student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
velengak, koudakyar dead end
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 22180084
Fax
Email
pegah.kashfi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Scienses
Full name of responsible person
Dr. Leila Rahnama
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
velenjak, koudakyar dead end
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 22180084
Fax
Email
l.rahnama@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Leila Rahnama
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
velenjak, Koudakyar dead end
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0085
Fax
Email
lrahnama@gmail.com
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available