Comparative study of corticosteroid injections and platelet rich plasma in the treatment of patients with shoulder tendinopathy compare sonographic findings
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Protocol summary
In Rheumatology clinic, patients with shoulder pain would be assessed clinically and paraclinically in order to confirm the rotator cuff or biceps tendinopathy. The patients would be referred to the sports medicine clinic and would be divided in two groups randomly; Platelet rich Plasma and corticosteroid injection groups.
The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide).
The injection for corticosteroid group, however, is applied once or twice within a month based on the Rheumatologist decision.
At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention.
Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared.
Considering the significant level 20 SD = 05/0 and test in 8/0, a sample of 32 patients per group is needed. Due to the possible data missing, 35 patients in each group are considered for this study.
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In Rheumatology clinic, patients with shoulder pain would be assessed clinically and paraclinically in order to confirm the rotator cuff or biceps tendinopathy. The patients would be referred to the sports medicine clinic and would be divided in two groups randomly; Platelet rich Plasma and corticosteroid injection groups. The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide). The injection for corticosteroid group, however, is applied once or twice within a month based on the Rheumatologist decision. At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention. Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared. Considering the significant level 20 SD = 05/0 and test in 8/0, a sample of 32 patients per group is needed. Due to the possible data missing, 35 patients in each group are considered for this study.
بیمارا ني که با شکايت درد شانه به درمانگاه روماتولوژي مراجعه کرده اند بعد از بررسي هاي لازم کلينيکي و پاراکلينيکي و تاييد تشخيص تاندينوپاتي هاي روتاتورکاف يا عضلة باي سپس توسط همکار روماتولوژيست، به بخش پزشکي ورزشي ارجاع داده مي شود. پس از مراجعه بيمار به بخش پزشکي ورزشي ارزيابي ميزان درد بر اساس شاخص VAS و و عملکرد شانه انجام مي شودو پس از آن سونوگرافي موسکولواسکلتال ناحية شانه توسط يک متخصص پزشکي ورزشي انجام شده و يافته ها ثبت مي شود. بيماران به صورت تصادفي به دو گروه تقسيم مي شوند. براي يک گروه تزريق PRP انجام شده که در اين روش بيمار دو بار به فاصلة يک ماه تزريق PRP شده و تغييرات ايجاد شده در طول اين مدت و يک ماه پس از پايان تزريق اندازه گيري مي شود.گروه دوم تزريق کورتيکواستروئيد را بنا به تشخيص فوق تخصص روماتولوژي يک يا دو بار به فاصلة يک ماه دريافت مي کنند.
هر دو هفته يک بار بيمار معاينه شده و تغييرات ايجاد شده در زمينة درد و علايم باليني ثبت مي شود. پس از 8 هفته کلية بررسي ها شامل ميزان درد، عملکرد و تغييرات سونوگرافي تکرار شده و مقايسه بين علايم کلينيک و پاراکلينيک بيمار قبل و بعد از مداخله انجام مي شود.
با در نظر گرفتن 20SD= و سطح معنيداري 05/0 و توان آزمون 8/0، حجم نمونهاي برابر 32 نفر در هر گروه مورد نياز است. با توجه به امکان ريزش نمونهها، 35 نفر در هر گروه جهت انجام تحقيق در نظر گرفته ميشود.
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بیمارا ني که با شکايت درد شانه به درمانگاه روماتولوژي مراجعه کرده اند بعد از بررسي هاي لازم کلينيکي و پاراکلينيکي و تاييد تشخيص تاندينوپاتي هاي روتاتورکاف يا عضلة باي سپس توسط همکار روماتولوژيست، به بخش پزشکي ورزشي ارجاع داده مي شود. پس از مراجعه بيمار به بخش پزشکي ورزشي ارزيابي ميزان درد بر اساس شاخص VAS و و عملکرد شانه انجام مي شودو پس از آن سونوگرافي موسکولواسکلتال ناحية شانه توسط يک متخصص پزشکي ورزشي انجام شده و يافته ها ثبت مي شود. بيماران به صورت تصادفي به دو گروه تقسيم مي شوند. براي يک گروه تزريق PRP انجام شده که در اين روش بيمار دو بار به فاصلة يک ماه تزريق PRP شده و تغييرات ايجاد شده در طول اين مدت و يک ماه پس از پايان تزريق اندازه گيري مي شود.گروه دوم تزريق کورتيکواستروئيد را بنا به تشخيص فوق تخصص روماتولوژي يک يا دو بار به فاصلة يک ماه دريافت مي کنند. هر دو هفته يک بار بيمار معاينه شده و تغييرات ايجاد شده در زمينة درد و علايم باليني ثبت مي شود. پس از 8 هفته کلية بررسي ها شامل ميزان درد، عملکرد و تغييرات سونوگرافي تکرار شده و مقايسه بين علايم کلينيک و پاراکلينيک بيمار قبل و بعد از مداخله انجام مي شود. با در نظر گرفتن 20SD= و سطح معنيداري 05/0 و توان آزمون 8/0، حجم نمونهاي برابر 32 نفر در هر گروه مورد نياز است. با توجه به امکان ريزش نمونهها، 35 نفر در هر گروه جهت انجام تحقيق در نظر گرفته ميشود.
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Comparison of clinical findings in patients Shoulder tendinopathy with Platelet Rich Plasma and corticosteroid injecting
Comparison of the effect of PRP and corticosteroid on pain relief in patients with shoulder tendonopathy
Comparison of the effect of PRP and corticosteroid on the range of motion of patients with shoulder tendonopathies
Comparison of PRP effect on and corticosteroid supraspinatus tendon thickness in patients with shoulder tendonopathies
Comparison of WORC and DASH questionnaire score changes after PRP and corticosteroid injection in patients with shoulder tendonopathy
Comparison of clinical findings in patients Shoulder tendinopathy with Platelet Rich Plasma and corticosteroid injecting Comparison of the effect of PRP and corticosteroid on pain relief in patients with shoulder tendonopathy Comparison of the effect of PRP and corticosteroid on the range of motion of patients with shoulder tendonopathies Comparison of PRP effect on and corticosteroid supraspinatus tendon thickness in patients with shoulder tendonopathies Comparison of WORC and DASH questionnaire score changes after PRP and corticosteroid injection in patients with shoulder tendonopathy
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مقايسه يافته هاي باليني در بيماران مبتلا به تاندينوپاتي شانه تحت درمان با PRP و گروه دريافت کنندة تزريقات کورتيکواستروئيد
مقایسه اثر PRP , کورتون در کاهش درد بیماران مبتلا به تاندينوپاتي هاي شانه
مقایسه اثر PRP, کورتون در دامنه حرکت شانه ی بيماران مبتلا به تاندينوپاتي هاي شانه
مقایسه اثر PRP, کورتون در ضخامت تاندون سوپرااسپیناتوس در بیماران مبتلا به تاندینوپاتی های شانه
مقایسه تغییرات نمرات پرسش نامه WORC و DASH پس از تزریق PRP , کورتون در بیماران مبتلا به تاندینوپاتی های شانه
مقايسه يافته هاي باليني در بيماران مبتلا به تاندينوپاتي شانه تحت درمان با PRP و گروه دريافت کنندة تزريقات کورتيکواستروئيد مقایسه اثر PRP , کورتون در کاهش درد بیماران مبتلا به تاندينوپاتي هاي شانه مقایسه اثر PRP, کورتون در دامنه حرکت شانه ی بيماران مبتلا به تاندينوپاتي هاي شانه مقایسه اثر PRP, کورتون در ضخامت تاندون سوپرااسپیناتوس در بیماران مبتلا به تاندینوپاتی های شانه مقایسه تغییرات نمرات پرسش نامه WORC و DASH پس از تزریق PRP , کورتون در بیماران مبتلا به تاندینوپاتی های شانه
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Randomized clinical trial, single blind, parallel group, 56 patients
Randomized clinical trial, single blind, parallel group, 56 patients
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کار آزمایی بالینی دارای گروه کنترل، یک سویه کور تصادفی شده بر روی 56 بیمار
کار آزمایی بالینی دارای گروه کنترل، یک سویه کور تصادفی شده بر روی 56 بیمار
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The study (injection and exercise therapy) was performed in the sports medicine department of Rasoul Hospital.
The study (injection and exercise therapy) was performed in the sports medicine department of Rasoul Hospital.
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مطالعه ( تزریق و ورزش درمانی) در بخش پزشکی ورزشی بیمارستان رسول انجام شد.
مطالعه ( تزریق و ورزش درمانی) در بخش پزشکی ورزشی بیمارستان رسول انجام شد.
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Shoulder pain that lasts more than three months (162)
Age over 40 years
Shoulder pain that lasts more than three months (162) Age over 40 years
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درد شانه ای که بیشتر از سه ماه طول کشیده باش
سن بیشتر از 40 سال
درد شانه ای که بیشتر از سه ماه طول کشیده باش سن بیشتر از 40 سال
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PRP injection group,
The other group, corticosteroid injections a
PRP injection group, The other group, corticosteroid injections a
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يک گروه تزريق PRP
گروه دیگر تزریق کورتن
يک گروه تزريق PRP گروه دیگر تزریق کورتن
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Pain, Range of Motion, Thickness of tendon
Pain, Range of Motion, Thickness of tendon
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درد : دامنه حرکت : ضخامت تاندون
درد : دامنه حرکت : ضخامت تاندون
General information
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40
40
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Year
year
Yes
No
1
Not blinded
Single blinded
notblsingl
1
1
1
1
1
1
64
56
6456
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Increase the follow-up time of patients after shoulder injection
Increase the follow-up time of patients after shoulder injection
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افزایش زمان پیگیری بیماران پس از تزریق داخل شانه
افزایش زمان پیگیری بیماران پس از تزریق داخل شانه
Shoulder pain that lasts for more than 3 months
limited shoulder range of motion
Absence of radicular pain
Inflammatory disorders such as rheumatoid arthritis
Fibromyalgia
lack of complete rotator cuff tear
The ligament laxity
Non-corticosteroid injections in the past three months
Shoulder pain that lasts for more than 3 months limited shoulder range of motion Absence of radicular pain Inflammatory disorders such as rheumatoid arthritis Fibromyalgia lack of complete rotator cuff tear The ligament laxity Non-corticosteroid injections in the past three months
درد شانه ای که بیش از 3 ماه طول کشیده باشد
دامنه حرکتی مفصل شانه آنها محدود شده باشد
عدم وجود درد رادیکولار
عدم وجود اختلالات التهابی مانند روماتویید ارتریت
فیبرومیالژیا
نبود پارگی کامل روتاتور کاف
عدم وحود لاکسیتی لیگامانی
عدم تزریق کورتون در سه ماه گذشته
درد شانه ای که بیش از 3 ماه طول کشیده باشد دامنه حرکتی مفصل شانه آنها محدود شده باشد عدم وجود درد رادیکولار عدم وجود اختلالات التهابی مانند روماتویید ارتریت فیبرومیالژیا نبود پارگی کامل روتاتور کاف عدم وحود لاکسیتی لیگامانی عدم تزریق کورتون در سه ماه گذشته
Unwillingness of the patient to continue treatment
shoulder joint surgery
The presence of other disorders that limit joint motion such as frozen shoulder
Unwillingness of the patient to continue treatment shoulder joint surgery The presence of other disorders that limit joint motion such as frozen shoulder
عدم تمایل بیمار برای ادامة درمان
انجام جراحی مفصل شانه
بروز سایر اختلالات مفصلی که باعث محدودیت حرکتی شود مانند شانه منجمد
عدم تمایل بیمار برای ادامة درمان انجام جراحی مفصل شانه بروز سایر اختلالات مفصلی که باعث محدودیت حرکتی شود مانند شانه منجمد
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Patients are randomly divided into two groups based on random number table after confirming the diagnosis with MRI and referring to the sports medicine department.
Patients are randomly divided into two groups based on random number table after confirming the diagnosis with MRI and referring to the sports medicine department.
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بيماران پس از معاینه وانجام MRI جهت تایید تاندینوپاتی روتاتورکاف به بخش پزشکی ورزشی ارجاع داده می شوند . پس از مراجعه بيمار به بخش پزشکي ورزشي ميزان درد بر اساس شاخص VAS و عملکرد شانه بر اساس معاینه و تکمیل پرسش نامه ارزيابي مي شود. پس از آن سونوگرافي موسکولواسکلتال ناحيه شانه توسط يک متخصص پزشکي ورزشي انجام شده و يافته ها ثبت مي شود. سپس بیماران بر اساس جدول اعداد تصادفی به صورت به دو گروه تقسيم مي شوند.
بيماران پس از معاینه وانجام MRI جهت تایید تاندینوپاتی روتاتورکاف به بخش پزشکی ورزشی ارجاع داده می شوند . پس از مراجعه بيمار به بخش پزشکي ورزشي ميزان درد بر اساس شاخص VAS و عملکرد شانه بر اساس معاینه و تکمیل پرسش نامه ارزيابي مي شود. پس از آن سونوگرافي موسکولواسکلتال ناحيه شانه توسط يک متخصص پزشکي ورزشي انجام شده و يافته ها ثبت مي شود. سپس بیماران بر اساس جدول اعداد تصادفی به صورت به دو گروه تقسيم مي شوند.
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The platelet rich plasma group is injected one time. In this group, 35 ml of venous blood was taken and by the Selex centrifuge under the RCF protocol, the blood sample is separated from rich plasma platelet by 1700 and 3200 rpm. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. The injection is performed by a sports medicine specialist in the form of intraarticular with an angle of 30-45 degrees from the posterolateral.
And if there is a partial rupture in tendon, 3 cc PRP injection is performed under ultrasound guidance at the tendon rupture site.
One week after the injection, the patient is visited, examined, given the necessary advice and also exercise prescription. Exercise is divided to scapula rehabilitation and shoulder muscles training.
After one and three months, repeated examinations, including pain, function, Completion of WORC, DASH questionnaire and ultrasound changes was achieved , and a comparison between the patient's clinical and Para clinical symptoms within these periods was performed.
The injection for corticosteroid group, however, is applied Methylprednisolone 40 mg once. For patients, one cc of Depomedrol and one cc of 2% lidocaine solution are injected into the intra articular joint in the same PRP manner. In this group, due to the blindness of the study, blood sampling of the patient is performed before corticosteroid injection.
The platelet rich plasma group is injected one time. In this group, 35 ml of venous blood was taken and by the Selex centrifuge under the RCF protocol, the blood sample is separated from rich plasma platelet by 1700 and 3200 rpm. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. The injection is performed by a sports medicine specialist in the form of intraarticular with an angle of 30-45 degrees from the posterolateral. And if there is a partial rupture in tendon, 3 cc PRP injection is performed under ultrasound guidance at the tendon rupture site. One week after the injection, the patient is visited, examined, given the necessary advice and also exercise prescription. Exercise is divided to scapula rehabilitation and shoulder muscles training. After one and three months, repeated examinations, including pain, function, Completion of WORC, DASH questionnaire and ultrasound changes was achieved , and a comparison between the patient's clinical and Para clinical symptoms within these periods was performed. The injection for corticosteroid group, however, is applied Methylprednisolone 40 mg once. For patients, one cc of Depomedrol and one cc of 2% lidocaine solution are injected into the intra articular joint in the same PRP manner. In this group, due to the blindness of the study, blood sampling of the patient is performed before corticosteroid injection.
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براي يک گروه تزريق PRP انجام شده که در اين روش بيمار یک بار تزريق PRP داشته درافراد این گروه 35 سی سی خون وریدی گرفته شده همراه 5 سی سی ACDL داخل 4 لوله به تساوی تقسیم شده و توسط دستگاه سانتریفوژ رویاژن , دور اول به مدت 10 دقیقه با سرعت 1600 دور بر ثانیه انجام شده و سپس پلاسمای به دست آمده وارد دو لوله شده و دور دوم با سرعت 3500 دور بر ثانیه به مدت 6 دقیقه انجام خواهد شد. در این حالت 6 سی سی مایع حاوی پلاکت با تغلیظ 5 تا 6 برابر به دست خواهد آمد. نمونه ها قبل و بعد از سانتریفوژ به آزمایشگاه فرستاده خواهد شد تا تغلیظ پلاکتی اثبات شود. سپس 6 سی سی مایع به دست آمده در دو سرنگ به میزان هر کدام 3 سی سی تقسیم می شود. 3 سی سی آن تزریق توسط یک متخصص پزشکی ورزشی به صورت اینتراآرتیکولاربا زاویه 30-45 درجه از پوسترولترال انجام می گردد . و در صورت وجود پارگی پارشیل یا تاندینوپاتی در تاندون ، با یک سرنگ دیگر 3 سی سی باقیمانده تحت گاید سونوگرافی در محل پارگی تاندون تزریق میشود.
در گروه دیگر تزریق کورتن به صورت اینتراآرتیکولار انجام می شود. به منظور blind بودن بیماران، از این گروه هم قبل از تزریق نمونه خون گرفته شده و جهت حفظ اخلاق پزشکی نمونه خون جهت شمارش گلبول های خون به آزمایشگاه ارسال می شود.
همچنین در هنگام تزریق دور سرنگ نوار چسبی استفاده می شود که بیمار متوجه ماده تزریق شده نشود..
براي يک گروه تزريق PRP انجام شده که در اين روش بيمار یک بار تزريق PRP داشته درافراد این گروه 35 سی سی خون وریدی گرفته شده همراه 5 سی سی ACDL داخل 4 لوله به تساوی تقسیم شده و توسط دستگاه سانتریفوژ رویاژن , دور اول به مدت 10 دقیقه با سرعت 1600 دور بر ثانیه انجام شده و سپس پلاسمای به دست آمده وارد دو لوله شده و دور دوم با سرعت 3500 دور بر ثانیه به مدت 6 دقیقه انجام خواهد شد. در این حالت 6 سی سی مایع حاوی پلاکت با تغلیظ 5 تا 6 برابر به دست خواهد آمد. نمونه ها قبل و بعد از سانتریفوژ به آزمایشگاه فرستاده خواهد شد تا تغلیظ پلاکتی اثبات شود. سپس 6 سی سی مایع به دست آمده در دو سرنگ به میزان هر کدام 3 سی سی تقسیم می شود. 3 سی سی آن تزریق توسط یک متخصص پزشکی ورزشی به صورت اینتراآرتیکولاربا زاویه 30-45 درجه از پوسترولترال انجام می گردد . و در صورت وجود پارگی پارشیل یا تاندینوپاتی در تاندون ، با یک سرنگ دیگر 3 سی سی باقیمانده تحت گاید سونوگرافی در محل پارگی تاندون تزریق میشود. در گروه دیگر تزریق کورتن به صورت اینتراآرتیکولار انجام می شود. به منظور blind بودن بیماران، از این گروه هم قبل از تزریق نمونه خون گرفته شده و جهت حفظ اخلاق پزشکی نمونه خون جهت شمارش گلبول های خون به آزمایشگاه ارسال می شود. همچنین در هنگام تزریق دور سرنگ نوار چسبی استفاده می شود که بیمار متوجه ماده تزریق شده نشود..
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Primary outcomes
#1
every 2 weeks up to 8 weeks
every 2 weeks up to 3 months
every 2 weeks up to 8 weeks3 months
هر دو هفته تا هشت هفته
هر دو هفته تا سه ماه
هر دو هفته تا هشت هفتهسه ماه
#2
at base line and 8 weeks later
at base line and 3 months later
at base line and 8 weeks3 months later
در ابتدای مطالعه و پس از 8 هفته
در ابتدای مطالعه و پس از 3 ماه
در ابتدای مطالعه و پس از 8 هفته3 ماه
Recruitment centers
#1
Name of recruitment center - English: Rasoul Akram Hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Haleh Dadgostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Street address - English: Shahr ara street Sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
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: Rasoul Akram Hospital
Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم
Full name of responsible person - English: Haleh Dadgostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Street address - English: Shahr ara street Sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 2446
Fax:
Email: dadgostar.h@iums.ac.ir
Web page address:
Name of recruitment center - English: Rasoul Akram Hospital Name of recruitment center - Persian: بیمارستان حضرت رسول اکرم Full name of responsible person - English: Haleh Dadgostar MD Full name of responsible person - Persian: دکتر هاله دادگستر Street address - English: Shahr ara street Sattar khan street Street address - Persian: خیابان ستارخان خیابان شهر آرا City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 2446 Fax: Email: dadgostar.h@iums.ac.ir Web page address:
#2
Name of recruitment center - English: Emam Khomeini hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Shafieh Movaseghi MD
Full name of responsible person - Persian: دکتر شفیعه موثقی
Street address - English: End of Keshavars Blv
Street address - Persian: انتهای بلوار کشاورز
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: Emam Khomeini hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Shafieh Movaseghi MD
Full name of responsible person - Persian: دکتر شفیعه موثقی
Street address - English: End of Keshavars Blv
Street address - Persian: انتهای بلوار کشاورز
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 6436 2446
Fax:
Email: movaseghi@gmail.com
Web page address:
Name of recruitment center - English: Emam Khomeini hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: Shafieh Movaseghi MD Full name of responsible person - Persian: دکتر شفیعه موثقی Street address - English: End of Keshavars Blv Street address - Persian: انتهای بلوار کشاورز City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 6436 2446 Fax: Email: movaseghi@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Tehran University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Akbar Fotouhi MD
Full name of responsible person - Persian: دکتر اکبر فتوحی
Street address - English: Tehran University of Medical Sciences, Keshavarz Boulvard, Ghods st
Street address - Persian: دانشگاه علوم پزشکی تهران خیابان قدس بلوار کشاورز
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: Iran University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی ایران (معاونت تحقیقات)
Full name of responsible person - English: Abbas Motavalian, MD
Full name of responsible person - Persian: دكتر سيد عباس متوليان
Street address - English: Hemmat highway, Iran University of Medical Sciences
Street address - Persian: بزرگراه همت .بین بزرگراهای شهید شیخ فضل الله و شهید چمران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 3020
Fax:
Email: hldadgostar@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, TehranIran University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهرانایران (معاونت تحقیقات) Full name of responsible person - English: Akbar FotouhiAbbas Motavalian, MD Full name of responsible person - Persian: دکتر اکبر فتوحیدكتر سيد عباس متوليان Street address - English: TehranHemmat highway, Iran University of Medical Sciences, Keshavarz Boulvard, Ghods st Street address - Persian: دانشگاه علوم پزشکی تهران خیابان قدس بلوار کشاورزبزرگراه همت .بین بزرگراهای شهید شیخ فضل الله و شهید چمران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 8670 3020 Fax: Email: hldadgostar@gmail.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice chancellor for research, Tehran University of Medical Sciences
Iran University of Medical Sciences
Vice chancellor for research, TehranIran University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی تهران
دانشگاه علوم پزشکی ایران (معاونت تحقیقات)
معاونت پژوهشی دانشگاه علوم پزشکی تهرانایران (معاونت تحقیقات)
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Sports Medicine Research Center.Tehran University of Medical Sciences . Tehran. Iran
Name of organization / entity - Persian: مرکز تحقیقات پزشکی ورزشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Haleh Dadgostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Position - English: Assistance Professor
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: Shahr Ara street Sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
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 6435 2446
Mobile: +98 912 607 6993
Fax:
Email: hldadgostar@gmail.comhdadgostar@tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: sports medicine department Rasoul e Akram hospital
Name of organization / entity - Persian: بخش پزشکی ورزشی بیمارستان حضرت رسول
Full name of responsible person - English: Haleh Dadgostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Position - English: Associated Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 33
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahr Ara street Sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 2446
Mobile: +98 912 607 6993
Fax:
Email: hldadgostar@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Sports Medicine Research Center.Tehran University of Medical Sciences . Tehran. Iransports medicine department Rasoul e Akram hospital Name of organization / entity - Persian: مرکز تحقیقاتبخش پزشکی ورزشی دانشگاه علوم پزشکی تهرانبیمارستان حضرت رسول Full name of responsible person - English: Haleh Dadgostar MD Full name of responsible person - Persian: دکتر هاله دادگستر Position - English: AssistanceAssociated Professor Position - Persian: دکترای تخصصیدانشیار Latest degree: specialist Area of specialty/work: 033 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahr Ara street Sattar khan street Street address - Persian: خیابان ستارخان خیابان شهر آرا City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 2446 Mobile: +98 912 607 6993 Fax: Email: hldadgostar@gmail.comhdadgostar@tums.ac.irgmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Sports Medicine Research Center Tehran University of Medical Sciences Tehran Iran
Name of organization / entity - Persian: مرکز تحقیقات پزشکی ورزشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Haleh Dadgostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Position - English: Assistance Professor
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: Shahr Ara street Sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
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 6435 2446
Mobile: +98 912 607 6993
Fax:
Email: hldadgostar@gmail.comhdadgostar@tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Sports Medicine Research Center Tehran University of Medical Sciences Tehran Iran
Name of organization / entity - Persian: مرکز تحقیقات پزشکی ورزشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Haleh Dadgostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Position - English: Assistance Professor
Position - Persian: دکترای تخصصی
Latest degree: specialist
Area of specialty/work: 33
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahr Ara street Sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 2446
Mobile: +98 912 607 6993
Fax:
Email: hldadgostar@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Sports Medicine Research Center Tehran University of Medical Sciences Tehran Iran Name of organization / entity - Persian: مرکز تحقیقات پزشکی ورزشی دانشگاه علوم پزشکی تهران Full name of responsible person - English: Haleh Dadgostar MD Full name of responsible person - Persian: دکتر هاله دادگستر Position - English: Assistance Professor Position - Persian: دکترای تخصصی Latest degree: specialist Area of specialty/work: 033 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahr Ara street Sattar khan street Street address - Persian: خیابان ستارخان خیابان شهر آرا City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 2446 Mobile: +98 912 607 6993 Fax: Email: hldadgostar@gmail.comhdadgostar@tums.ac.irgmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Sports Medicine Research center Tehran University of Medical University Tehran Iran
Name of organization / entity - Persian: مرکز تحقیقات پزشکی ورزشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Haleh Ddagostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Position - English: Assistance Professor
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: Shahr Ara street sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
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 6435 2446
Mobile: +98 912 607 6993
Fax:
Email: hldadgostar@gmail.comhdadgostar@tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Sports Medicine department, Rasoul e Akram Hospital
Name of organization / entity - Persian: بخش پزشکی ورزشی بیمارستان حضرت رسول
Full name of responsible person - English: Haleh Ddagostar MD
Full name of responsible person - Persian: دکتر هاله دادگستر
Position - English: Associated Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 33
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahr Ara street sattar khan street
Street address - Persian: خیابان ستارخان خیابان شهر آرا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1445613131
Phone: +98 21 6435 2446
Mobile: +98 912 607 6993
Fax:
Email: hldadgostar@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Sports Medicine Research center Tehran University of Medical University Tehran Irandepartment, Rasoul e Akram Hospital Name of organization / entity - Persian: مرکز تحقیقاتبخش پزشکی ورزشی دانشگاه علوم پزشکی تهرانبیمارستان حضرت رسول Full name of responsible person - English: Haleh Ddagostar MD Full name of responsible person - Persian: دکتر هاله دادگستر Position - English: AssistanceAssociated Professor Position - Persian: دکترای تخصصیدانشیار Latest degree: specialist Area of specialty/work: 033 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahr Ara street sattar khan street Street address - Persian: خیابان ستارخان خیابان شهر آرا City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1445613131 Phone: +98 21 6435 2446 Mobile: +98 912 607 6993 Fax: Email: hldadgostar@gmail.comhdadgostar@tums.ac.irgmail.com Web page address:
Sharing plan
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
no
no
no
no
empty
After deidentifing participants, sharing data related to pain, ROM, function and thickness of tendon will be happened
After deidentifing participants, sharing data related to pain, ROM, function and thickness of tendon will be happened
empty
دیتاها پس از عیر قابل شناسایی کردن افراد در زمینه درد و دامنه حرکت و عملکرد شانه و ضخامت تاندون به اشتراک گذاشته خواهد شد.
دیتاها پس از عیر قابل شناسایی کردن افراد در زمینه درد و دامنه حرکت و عملکرد شانه و ضخامت تاندون به اشتراک گذاشته خواهد شد.
empty
starting 6 months after publication
starting 6 months after publication
empty
6 ماه پس از چاپ نتایج
6 ماه پس از چاپ نتایج
empty
Researchers and people working in Academic institution
Researchers and people working in Academic institution
empty
برای محققین و شاغلین در مراکز دانشگاهی
برای محققین و شاغلین در مراکز دانشگاهی
empty
To applied in research or manuscript
To applied in research or manuscript
empty
برای استفاده در تحقیق یا مقاله
برای استفاده در تحقیق یا مقاله
empty
Personal email, Mobile phone , research gate
Personal email, Mobile phone , research gate
empty
با ای میل یا موبایل و درخواست در سایت research gate
با ای میل یا موبایل و درخواست در سایت research gate
empty
3 months after applying, the document will send through email
3 months after applying, the document will send through email
empty
3 ماه پس از درخواست از طریق ای میل به دسا تقاصا کننده خواهد رسید
3 ماه پس از درخواست از طریق ای میل به دسا تقاصا کننده خواهد رسید
Protocol summary
Study aim
Comparison of clinical findings in patients Shoulder tendinopathy with Platelet Rich Plasma and corticosteroid injecting
Comparison of the effect of PRP and corticosteroid on pain relief in patients with shoulder tendonopathy
Comparison of the effect of PRP and corticosteroid on the range of motion of patients with shoulder tendonopathies
Comparison of PRP effect on and corticosteroid supraspinatus tendon thickness in patients with shoulder tendonopathies
Comparison of WORC and DASH questionnaire score changes after PRP and corticosteroid injection in patients with shoulder tendonopathy
Design
Randomized clinical trial, single blind, parallel group, 56 patients
Settings and conduct
The study (injection and exercise therapy) was performed in the sports medicine department of Rasoul Hospital.
Participants/Inclusion and exclusion criteria
Shoulder pain that lasts more than three months (162)
Age over 40 years
Intervention groups
PRP injection group,
The other group, corticosteroid injections a
Main outcome variables
Pain, Range of Motion, Thickness of tendon
General information
Reason for update
Increase the follow-up time of patients after shoulder injection
Acronym
PRP
IRCT registration information
IRCT registration number:IRCT201302174251N9
Registration date:2013-05-03, 1392/02/13
Registration timing:registered_while_recruiting
Last update:2020-05-16, 1399/02/27
Update count:1
Registration date
2013-05-03, 1392/02/13
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
dadgostar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of corticosteroid injections and platelet rich plasma in the treatment of patients with shoulder tendinopathy compare sonographic findings
Public title
Comparing the effect of corticosteroid injections and platelet rich plasma on the treatment of shoulder tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Shoulder pain that lasts for more than 3 months
limited shoulder range of motion
Absence of radicular pain
Inflammatory disorders such as rheumatoid arthritis
Fibromyalgia
lack of complete rotator cuff tear
The ligament laxity
Non-corticosteroid injections in the past three months
Exclusion criteria:
Unwillingness of the patient to continue treatment
shoulder joint surgery
The presence of other disorders that limit joint motion such as frozen shoulder
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups based on random number table after confirming the diagnosis with MRI and referring to the sports medicine department.
Blinding (investigator's opinion)
Single blinded
Blinding description
The platelet rich plasma group is injected one time. In this group, 35 ml of venous blood was taken and by the Selex centrifuge under the RCF protocol, the blood sample is separated from rich plasma platelet by 1700 and 3200 rpm. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. The injection is performed by a sports medicine specialist in the form of intraarticular with an angle of 30-45 degrees from the posterolateral.
And if there is a partial rupture in tendon, 3 cc PRP injection is performed under ultrasound guidance at the tendon rupture site.
One week after the injection, the patient is visited, examined, given the necessary advice and also exercise prescription. Exercise is divided to scapula rehabilitation and shoulder muscles training.
After one and three months, repeated examinations, including pain, function, Completion of WORC, DASH questionnaire and ultrasound changes was achieved , and a comparison between the patient's clinical and Para clinical symptoms within these periods was performed.
The injection for corticosteroid group, however, is applied Methylprednisolone 40 mg once. For patients, one cc of Depomedrol and one cc of 2% lidocaine solution are injected into the intra articular joint in the same PRP manner. In this group, due to the blindness of the study, blood sampling of the patient is performed before corticosteroid injection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ghods street Keshavars Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2012-07-20, 1391/04/30
Ethics committee reference number
19910-91-4-30
Health conditions studied
1
Description of health condition studied
Shoulder Tendinopathy
ICD-10 code
M75.1
ICD-10 code description
rotator cuff syndrome rotator cuff or supraspinatous tear or rupture (complete ) ( incomplete ) not specified as traumatic
Primary outcomes
1
Description
Pain
Timepoint
every 2 weeks up to 8 weeks
Method of measurement
VAS scale
2
Description
range of motion
Timepoint
every 2 weeks up to 3 months
Method of measurement
Goniameter
3
Description
Sonographic finding
Timepoint
at base line and 3 months later
Method of measurement
Sonographic prob
Secondary outcomes
empty
Intervention groups
1
Description
The platelet rich plasma group is injected twice within a month. In this group, 20 ml of venous blood was taken by centrifuges Selex protocol RCF, blood samples from the men with the 1800 and 2000 cycles and women with 1600 and 2000 cycle. Plasma rich platelets are separated after adding calcium gluconate 10% cc platelet concentrate obtained. Under ultrasound Guide, in collaboration with a radiologist and a sports medicine specialist in the area of sub-45 degree lateral Acromion is injected (based on Sonographic Guide). Assessment of clinical sing such as pain (based on VAS measurement), shoulder range of motion and its function is occurred. Moreover, musculoskeletal sonography is applied by two clinician experts. These (findings are) recorded and compared
Category
Treatment - Drugs
2
Description
The injection for corticosteroid group, however, is applied MethylPrednisolone 40 mg once or twice within a month based on the Rheumatologist decision.
At the baseline, after four weeks and also eight weeks after intervention, all the studies including pain, range of motion, function, and Sonographic findings changes are evaluated and compared with the data which is recorded before intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Haleh Dadgostar MD
Street address
Shahr ara street Sattar khan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Email
dadgostar.h@iums.ac.ir
2
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Shafieh Movaseghi MD
Street address
End of Keshavars Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6436 2446
Email
movaseghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motavalian, MD
Street address
Hemmat highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 3020
Email
hldadgostar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
sports medicine department Rasoul e Akram hospital
Full name of responsible person
Haleh Dadgostar MD
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Shahr Ara street Sattar khan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sports Medicine Research Center Tehran University of Medical Sciences Tehran Iran
Full name of responsible person
Haleh Dadgostar MD
Position
Assistance Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Shahr Ara street Sattar khan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sports Medicine department, Rasoul e Akram Hospital
Full name of responsible person
Haleh Ddagostar MD
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Shahr Ara street sattar khan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2446
Fax
Email
hldadgostar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
After deidentifing participants, sharing data related to pain, ROM, function and thickness of tendon will be happened
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Researchers and people working in Academic institution
Under which criteria data/document could be used
To applied in research or manuscript
From where data/document is obtainable
Personal email, Mobile phone , research gate
What processes are involved for a request to access data/document
3 months after applying, the document will send through email