Comparative Efficacy of Platelet-Rich Plasma (PRP) Injection Versus PRP Combined with Vitamin C Injection for Partial-Thickness Rotator Cuff Tears: A Randomized Controlled Trial
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Protocol summary
1) Determining and comparing the average pain intensity in the two groups of platelet-rich plasma (PRP) and normal saline injection with PRP and vitamin C injection before, 1 month after and 3 months after the intervention.
2) Determining and comparing the average range of motion angle in the two groups of PRP and normal saline injection with PRP and vitamin C injection before, 1 month after, and 3 months after the intervention.
3) Determining and comparing the average pain intensity and range of motion angle in two groups of PRP and normal saline injection with PRP and vitamin C injection adjusted according to demographic characteristics before, 1 month after and 3 months after intervention
Comparison of the effect of platelet rich plasma injection with the combination of platelet rich plasma and vitamin C on partial thickness rotator cuff tears
1) Determining and comparingComparison of the average pain intensity in the two groupseffect of platelet-rich plasma (PRP) and normal saline injection with PRPthe combination of platelet rich plasma and vitamin C injection before, 1 month after and 3 months after the intervention. 2) Determining and comparing the average range of motion angle in the two groups of PRP and normal saline injection with PRP and vitamin C injection before, 1 month after, and 3 months after the intervention. 3) Determining and comparing the average pain intensity and range of motion angle in two groups of PRP and normal saline injection with PRP and vitamin C injection adjusted according to demographic characteristics before, 1 month after and 3 months after interventionon partial thickness rotator cuff tears
1) تعیین و مقایسه میانگین شدت درد در دو گروه تزریق پلاسمای غنی از پلاکت (PRP) و نرمال سالین با تزریق ترکیب PRP و ویتامین سی قبل، 1 ماه بعد و 3 ماه بعد از مداخله.
2) تعیین و مقایسه میانگین زاویه دامنه حرکت در دو گروه تزریق PRP و نرمال سالین با تزریق ترکیب PRP و ویتامین سی قبل، 1 ماه بعد و 3 ماه بعد از مداخله.
3) تعیین و مقایسه میانگین شدت درد و زاویه دامنه حرکت در دو گروه تزریق PRP و نرمال سالین با تزریق ترکیب PRP و ویتامین سی تعدیل شده بر حسب ویژگی های دموگرافیک قبل، 1 ماه بعد و 3 ماه بعد از مداخله.
مقایسه تاثیر تزریق پلاسمای غنی از پلاکت با ترکیب پلاسمای غنی از پلاکت و ویتامینC بر پارگی ناکامل روتاتور کاف
1) تعیین و مقایسه میانگین شدت درد در دو گروهتاثیر تزریق پلاسمای غنی از پلاکت (PRP)با ترکیب پلاسمای غنی از پلاکت و نرمال سالین با تزریق ترکیب PRP و ویتامین سی قبل، 1 ماه بعد و 3 ماه بعد از مداخله. 2) تعیین و مقایسه میانگین زاویه دامنه حرکت در دو گروه تزریق PRP و نرمال سالین با تزریق ترکیب PRP و ویتامین سی قبل، 1 ماه بعد و 3 ماه بعد از مداخله. 3) تعیین و مقایسه میانگین شدت درد و زاویه دامنه حرکت در دو گروه تزریق PRP و نرمال سالین با تزریق ترکیب PRP و ویتامین سی تعدیل شدهویتامینC بر حسب ویژگی های دموگرافیک قبل، 1 ماه بعد و 3 ماه بعد از مداخله.پارگی ناکامل روتاتور کاف
The ultrasound-guided injection will be performed in the subacromial space during two periods with an interval of 3 weeks. The first group will be treated with 1.5 ml of normal saline + 1.5 ml of PRP and the second group will be treated with 2.5 ml of PRP and 0.5 ml of vitamin C. The process of blinding for the patients and the doctor and the person evaluating the treatment result will be done during the study.
To prepare PRP, a 20 ml venous blood sample was collected from each patient and injected into a tube containing an anticoagulant (sterile sodium citrate tubes). The blood was then centrifuged at 1500 rpm for 10 minutes. Following centrifugation, the plasma located above the red blood cells was carefully transferred to a new sterile tube. The second round of centrifugation lasted for 10 minutes at a speed of 2500 rpm, and the supernatant (approximately 5–6 ml) was removed so that about 3 ml of plasma along with the cell sediments remained at the bottom of the tube. In the next step, through vortexing, we made the platelet suspension in the remaining plasma in the form of a suspension with an approximate concentration of 5 times the platelet baseline and used it with or without vitamin C for injection into the patients.
To prepare PRP, a 20 ml venous blood sample was collected from each patient and injected into a tube containing an anticoagulant (sterile sodium citrate tubes). The ultrasound-guided injection will be performedblood was then centrifuged at 1500 rpm for 10 minutes. Following centrifugation, the plasma located above the red blood cells was carefully transferred to a new sterile tube. The second round of centrifugation lasted for 10 minutes at a speed of 2500 rpm, and the supernatant (approximately 5–6 ml) was removed so that about 3 ml of plasma along with the cell sediments remained at the bottom of the tube. In the next step, through vortexing, we made the platelet suspension in the subacromial space during two periodsremaining plasma in the form of a suspension with an intervalapproximate concentration of 3 weeks. The first group will be treated5 times the platelet baseline and used it with 1.5 ml of normal saline + 1.5 ml of PRP and the second group will be treated with 2.5 ml of PRP and 0.5 ml ofor without vitamin C. The process of blinding for injection into the patients and the doctor and the person evaluating the treatment result will be done during the study.
تزریق با هدایت اولتراسوند در فضای ساب آکرومیال طی دو دوره به فاصله 3 هفته انجام خواهد شد. گروه اول با 1/5 میلی لیتر نرمال سالین + 1/5 میلی لیتر PRP و گروه دوم با 2/5 میلی لیتر PRP و 0/5 میلی لیتر ویتامین سی تحت درمان قرار خواهند گرفت. فرایند کورسازی برای بیماران و پزشک و شخص ارزیابی کننده نتیجه درمان در طول مطالعه انجام خواهد گرفت.
برای تهیه PRP از هر بیمار یک نمونه خون وریدی 20 میلی لیتری جمع آوری شد و در لوله ای حاوی ماده ضد انعقاد (لوله های سیترات سدیم استریل) تزریق شد. سپس خون با سرعت 1500 دور در دقیقه به مدت 10 دقیقه سانتریفیوژ شد. پس از سانتریفیوژ، پلاسمای واقع در بالای گلبول های قرمز خون به دقت به یک لوله استریل جدید منتقل شد. دور دوم سانتریفیوژ به مدت 10 دقیقه با سرعت 2500 دور در دقیقه به طول انجامید و مایع رویی (تقریباً 5-6 میلی لیتر) برداشته شد به طوری که حدود 3 میلی لیتر پلاسما به همراه رسوبات سلولی در انتهای لوله باقی ماند. در مرحله بعد از طریق گرداب، سوسپانسیون پلاکتی را در پلاسمای باقیمانده به صورت سوسپانسیون با غلظت تقریبی 5 برابر سطح پایه پلاکتی ساختیم و با یا بدون ویتامین C برای تزریق به بیماران استفاده کردیم.
تزریق با هدایت اولتراسوندبرای تهیه PRP از هر بیمار یک نمونه خون وریدی 20 میلی لیتری جمع آوری شد و در فضای ساب آکرومیال طی دو دوره به فاصله 3 هفته انجام خواهدلوله ای حاوی ماده ضد انعقاد (لوله های سیترات سدیم استریل) تزریق شد. گروه اولسپس خون با 1/سرعت 1500 دور در دقیقه به مدت 10 دقیقه سانتریفیوژ شد. پس از سانتریفیوژ، پلاسمای واقع در بالای گلبول های قرمز خون به دقت به یک لوله استریل جدید منتقل شد. دور دوم سانتریفیوژ به مدت 10 دقیقه با سرعت 2500 دور در دقیقه به طول انجامید و مایع رویی (تقریباً 5-6 میلی لیتر) برداشته شد به طوری که حدود 3 میلی لیتر نرمال سالین + 1/پلاسما به همراه رسوبات سلولی در انتهای لوله باقی ماند. در مرحله بعد از طریق گرداب، سوسپانسیون پلاکتی را در پلاسمای باقیمانده به صورت سوسپانسیون با غلظت تقریبی 5 میلی لیتر PRPبرابر سطح پایه پلاکتی ساختیم و گروه دوم با 2/5 میلی لیتر PRP و 0/5 میلی لیتریا بدون ویتامین سی تحت درمان قرار خواهند گرفت. فرایند کورسازیC برای تزریق به بیماران و پزشک و شخص ارزیابی کننده نتیجه درمان در طول مطالعه انجام خواهد گرفتاستفاده کردیم.
pain intensity score; Range of motion angle score
Visual Analog Scale (VAS); Constant score; American Shoulder and Elbow Surgeons (ASES) score
pain intensityVisual Analog Scale (VAS); Constant score; Range of motion angleAmerican Shoulder and Elbow Surgeons (ASES) score
نمره شدت درد؛ نمره زاویه دامنه حرکت
مقیاس آنالوگ بصری (VAS)؛ نمره پرسشنامه Constant؛ نمره پرسشنامه جراحان شانه و آرنج آمریکا (ASES).
نمره شدت دردمقیاس آنالوگ بصری (VAS)؛ نمره زاویه دامنه حرکتپرسشنامه Constant؛ نمره پرسشنامه جراحان شانه و آرنج آمریکا (ASES).
General information
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Decision to implement changes in the intervention
Decision to implement changes in the intervention
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تصمیم گیری برای اعمال تغییرات در مداخله
تصمیم گیری برای اعمال تغییرات در مداخله
Comparison of the effect of platelet rich plasma injection with the combination of platelet rich plasma and vitamin C on partial thickness rotator cuff tears
Comparative Efficacy of Platelet-Rich Plasma (PRP) Injection Versus PRP Combined with Vitamin C Injection for Partial-Thickness Rotator Cuff Tears: A Randomized Controlled Trial
ComparisonComparative Efficacy of the effect of platelet rich plasma injectionPlatelet-Rich Plasma (PRP) Injection Versus PRP Combined with the combination of platelet rich plasma and vitaminVitamin C on partial thickness rotator cuff tearsInjection for Partial-Thickness Rotator Cuff Tears: A Randomized Controlled Trial
مقایسه تاثیر تزریق پلاسمای غنی از پلاکت با ترکیب پلاسمای غنی از پلاکت و ویتامینC بر پارگی ناکامل روتاتور کاف
اثر مقایسه ای تزریق پلاسمای غنی از پلاکت (PRP) در مقابل PRP همراه با تزریق ویتامین C برای پارگی های روتاتور کاف نیمه ضخامت: یک کارآزمایی تصادفی کنترل شده
اثر مقایسه تاثیرای تزریق پلاسمای غنی از پلاکت (PRP) در مقابل PRP همراه با ترکیب پلاسمای غنی از پلاکت و ویتامینC برتزریق ویتامین C برای پارگی ناکاملهای روتاتور کاف نیمه ضخامت: یک کارآزمایی تصادفی کنترل شده
Men and women between 18 and 70 years of age
Within 6 months of initial diagnosis
Patients who, according to the clinical examination of an orthopedic specialist doctor and MRI results, according to Elman's classification system, have partial rotator cuff tears of the 1st and 2nd stage located in supraspinatus (with a size of less than 6 mm and a tendon tear less than 50 percent).
Men and women between 18 and 70 years old
Patients who had been diagnosed for 6 months
Patients with PTRCTs located in the supraspinatus tendon diagnosed via MRI.
Men and women between 18 and 70 years of age Withinold Patients who had been diagnosed for 6 months of initial diagnosis Patients who, according to the clinical examination of an orthopedic specialist doctor and MRI results, according to Elman's classification system, have partial rotator cuff tears of the 1st and 2nd stagewith PTRCTs located in the supraspinatus (with a size of less than 6 mm and a tendon tear less than 50 percent)diagnosed via MRI.
مردان و زنان بین 18 تا 70 سال
بیمارانی که 6 ماه از تشخیص اولیه آن ها می گذرد
بیمارانی که با توجه به معاینه ی بالینی پزشک متخصص ارتوپدی و نتیجه MRI، مطابق با سیستم طبقه بندی المن مبتلا به پارگی های ناکامل (پارشیال) روتاتور کاف درجه 1 و 2 واقع در ناحیه سوپرااسپیناتوس (با اندازه کمتر از 6 میلی متر و پارگی تاندون کمتر از 50 درصد) باشند.
مردان و زنان بین 18 تا 70 سال
بیمارانی که 6 ماه از تشخیص اولیه آن ها می گذرد
بیماران مبتلا به پارگی های ناکامل (پارشیال) روتاتور کاف واقع در ناحیه سوپرااسپیناتوس
مردان و زنان بین 18 تا 70 سال بیمارانی که 6 ماه از تشخیص اولیه آن ها می گذرد بیمارانی که با توجه به معاینه ی بالینی پزشک متخصص ارتوپدی و نتیجه MRI، مطابق با سیستم طبقه بندی المنبیماران مبتلا به پارگی های ناکامل (پارشیال) روتاتور کاف درجه 1 و 2 واقع در ناحیه سوپرااسپیناتوس (با اندازه کمتر از 6 میلی متر و پارگی تاندون کمتر از 50 درصد) باشند.
Elderly patients over 70 years old
Rotator cuff tears secondary to fracture
Prior surgical repair or revision arthroscopy
Prior platelet-rich plasma or other drug intervention
Pregnant patients
History of mental disorders, cardio-cerebrovascular disease
shoulder pain induced by non- rotator cuff tear
Patients treated with drugs that interfere with vitamin C
Active infection
Hemoglobin <7.0 g٫dl or platelets < 150,000٫µL
Elderly patients over 70 years of age
Rotator cuff tears following fracture and trauma
History of revision arthroscopy or previous reconstructive surgery
History of PRP injection or other drug interventions, including intra-articular corticosteroid injection
Pregnant patients
History of mental disorders, cardio-cerebrovascular disease
Shoulder pain induced by non- rotator cuff tear
Patients treated with drugs that interfere with vitamin C
Presence of active infection
Hemoglobin <7.0 g٫dl or platelets < 150,000٫µL
Elderly patients over 70 years oldof age Rotator cuff tears secondary tofollowing fracture Prior surgical repair orand trauma History of revision arthroscopy Prior platelet-rich plasmaor previous reconstructive surgery History of PRP injection or other drug interventioninterventions, including intra-articular corticosteroid injection Pregnant patients History of mental disorders, cardio-cerebrovascular disease shoulderShoulder pain induced by non- rotator cuff tear Patients treated with drugs that interfere with vitamin C ActivePresence of active infection Hemoglobin <7.0 g٫dl or platelets < 150,000٫µL
بیماران مسن بالای 70 سال
پارگی روتاتور کاف ثانویه به دلیل شکستگی
سابقه جراحی ترمیمی قبلی یا آرتروسکوپی ریویژن
بیماران باردار
سابقه تزریق پلاسمای غنی از پلاکت یا سایر مداخلات دارویی
سابقه اختلالات روانی، افراد مبتلا به بیماری قلبی عروقی
وجود درد شانه ناشی از علتی بجز پارگی روتاتورکاف
بیماران تحت درمان با داروهای دارای تداخل با ویتامین C
وجود عفونت فعال
میزان هموگلوبین کمتر از g٫dl 7.0 یا پلاکت کمتر از 150,000٫µL
بیماران مسن بالای 70 سال
پارگی روتاتور کاف ثانویه به دلیل شکستگی
سابقه جراحی ترمیمی قبلی یا آرتروسکوپی ریویژن
سابقه تزریق پلاسمای غنی از پلاکت یا سایر مداخلات دارویی از جمله تزریق کورتیکواستروئید
بیماران باردار
سابقه اختلالات روانی، افراد مبتلا به بیماری قلبی عروقی
وجود درد شانه ناشی از علتی بجز پارگی روتاتورکاف
بیماران تحت درمان با داروهای دارای تداخل با ویتامین C
وجود عفونت فعال
میزان هموگلوبین کمتر از g٫dl 7.0 یا پلاکت کمتر از 150,000٫µL
بیماران مسن بالای 70 سال پارگی روتاتور کاف ثانویه به دلیل شکستگی سابقه جراحی ترمیمی قبلی یا آرتروسکوپی ریویژن بیماران باردار سابقه تزریق پلاسمای غنی از پلاکت یا سایر مداخلات دارویی از جمله تزریق کورتیکواستروئید بیماران باردار سابقه اختلالات روانی، افراد مبتلا به بیماری قلبی عروقی وجود درد شانه ناشی از علتی بجز پارگی روتاتورکاف بیماران تحت درمان با داروهای دارای تداخل با ویتامین C وجود عفونت فعال میزان هموگلوبین کمتر از g٫dl 7.0 یا پلاکت کمتر از 150,000٫µL
People will be randomly assigned to two groups of normal saline + platelet-rich plasma and vitamin C + platelet-rich plasma by simple random method and based on simple random tables created by computer.
All patients who met the inclusion criteria were included in the study after providing informed consent. To evaluate the anterior-posterior tear size, scores 1 and 2 were considered in the MRI findings (score 1, less than 5 mm, and score 2, 5–10 mm) .
The participants were randomly divided into two groups, A, normal saline + PRP, and B, vitamin C + PRP, by a simple random method and simple random tables created by a computer. The injection of the therapeutic compound was performed under ultrasound guidance in the subacromial space for two consecutive periods at intervals of 3 weeks. Notably, both injections were performed by the same orthopedic specialist and via the same injection method. Group A was treated with 1.5 ml of normal saline and 1.5 ml of PRP, and group B received 1.5 ml of vitamin C and 1.5 ml of PRP.
People will beAll patients who met the inclusion criteria were included in the study after providing informed consent. To evaluate the anterior-posterior tear size, scores 1 and 2 were considered in the MRI findings (score 1, less than 5 mm, and score 2, 5–10 mm) . The participants were randomly assigned todivided into two groups of, A, normal saline + platelet-rich plasmaPRP, and B, vitamin C + platelet-rich plasmaPRP, by a simple random method and based on simple random tables created by a computer. The injection of the therapeutic compound was performed under ultrasound guidance in the subacromial space for two consecutive periods at intervals of 3 weeks. Notably, both injections were performed by the same orthopedic specialist and via the same injection method. Group A was treated with 1.5 ml of normal saline and 1.5 ml of PRP, and group B received 1.5 ml of vitamin C and 1.5 ml of PRP.
افراد به روش تصادفی ساده و بر اساس جداول تصادفی ساده ایجاد شده توسط کامپیوتر، به طور تصادفی به دو گروه نرمال سالین+ پلاسمای غنی از پلاکت و ویتامین C + پلاسمای غنی از پلاکت اختصاص داده خواهند شد.
تمامی بیمارانی که معیارهای ورود به مطالعه را داشتند پس از ارائه رضایت آگاهانه وارد مطالعه شدند. برای ارزیابی اندازه پارگی قدامی-خلفی، نمره 1 و 2 در یافته های MRI در نظر گرفته شد (نمره 1، کمتر از 5 میلی متر، و نمره 2، 5-10 میلی متر).
شرکت کنندگان به طور تصادفی به دو گروه A، نرمال سالین + PRP و B، ویتامین C + PRP، به روش تصادفی ساده و جداول تصادفی ساده که توسط رایانه ایجاد شد، تقسیم شدند. تزریق ترکیب درمانی تحت هدایت اولتراسوند در فضای ساب آکرومیال به مدت دو دوره متوالی در فواصل 3 هفته انجام شد. شایان ذکر است، هر دو تزریق توسط متخصص ارتوپدی یکسان و از طریق یک روش تزریق انجام شده است. گروه A با 1.5 میلی لیتر نرمال سالین و 1.5 میلی لیتر PRP تحت درمان قرار گرفت و گروه B 1.5 میلی لیتر ویتامین C و 1.5 میلی لیتر PRP دریافت کردند.
افرادتمامی بیمارانی که معیارهای ورود به روش تصادفی سادهمطالعه را داشتند پس از ارائه رضایت آگاهانه وارد مطالعه شدند. برای ارزیابی اندازه پارگی قدامی-خلفی، نمره 1 و بر اساس جداول تصادفی ساده ایجاد شده توسط کامپیوتر2 در یافته های MRI در نظر گرفته شد (نمره 1، کمتر از 5 میلی متر، و نمره 2، 5-10 میلی متر). شرکت کنندگان به طور تصادفی به دو گروه A، نرمال سالین+ پلاسمای غنی از پلاکتPRP و B، ویتامین C + پلاسمای غنیPRP، به روش تصادفی ساده و جداول تصادفی ساده که توسط رایانه ایجاد شد، تقسیم شدند. تزریق ترکیب درمانی تحت هدایت اولتراسوند در فضای ساب آکرومیال به مدت دو دوره متوالی در فواصل 3 هفته انجام شد. شایان ذکر است، هر دو تزریق توسط متخصص ارتوپدی یکسان و از پلاکت اختصاص داده خواهند شدطریق یک روش تزریق انجام شده است. گروه A با 1.5 میلی لیتر نرمال سالین و 1.5 میلی لیتر PRP تحت درمان قرار گرفت و گروه B 1.5 میلی لیتر ویتامین C و 1.5 میلی لیتر PRP دریافت کردند.
Despite obtaining informed consent from the participants in the study, these people are unaware of which treatment intervention group they will be placed in.
The preparation of platelet-rich plasma (PRP) is performed by a hematologist at the Comprehensive Center for Stem Cells and Regenerative Medicine. He combines the PRP prepared from the patients with normal saline or vitamin C and by writing the names of the patients, he is aware of what type of treatment intervention will be done for each person. In addition, the syringe containing any type of therapeutic combination (normal saline + PRP and vitamin C + PRP) will be labeled as A or B by convention, and the mentioned hematologist is aware of how to mark according to the type of therapeutic intervention.
The orthopedic specialist who is responsible for injecting the therapeutic combination is unaware of the type of therapeutic combination and is generally kept blind in the study process.
The researcher, who is actually the person who evaluates the treatment outcomes and patients' questionnaires, is also kept blind in the study process.
The statistical consultant of the research who is in charge of data analysis is also kept blind in the study process.
Despite obtaining informed consent from the participants in the study, they remain unaware of their assigned treatment intervention group. The preparation of platelet-rich plasma (PRP) is conducted by a hematologist at the Comprehensive Center for Stem Cells and Regenerative Medicine. The hematologist combines the PRP obtained from the patients with either normal saline or vitamin C. Moreover, the hematologist is aware of the treatment intervention for each participant as they record patient names alongside the respective treatment type. Furthermore, syringes containing the therapeutic combinations (normal saline + PRP and vitamin C + PRP) are conventionally labeled as A or B, with the hematologist knowledgeable about how to designate each according to the therapeutic intervention type.
Subsequently, the orthopedic specialist responsible for administering the therapeutic combination remains blinded to the specific type of intervention.
Despite obtaining informed consent from the participants in the study, these people arethey remain unaware of whichtheir assigned treatment intervention group they will be placed in. The preparation of platelet-rich plasma (PRP) is performedconducted by a hematologist at the Comprehensive Center for Stem Cells and Regenerative Medicine. HeThe hematologist combines the PRP preparedobtained from the patients with either normal saline or vitamin C and by writing. Moreover, the names of the patients, hehematologist is aware of what type ofthe treatment intervention will be done for each person. In addition,participant as they record patient names alongside the syringerespective treatment type. Furthermore, syringes containing any type ofthe therapeutic combinationcombinations (normal saline + PRP and vitamin C + PRP) will beare conventionally labeled as A or B by convention, andwith the mentioned hematologist is aware ofknowledgeable about how to markdesignate each according to the type of therapeutic intervention type. TheSubsequently, the orthopedic specialist who is responsible for injectingadministering the therapeutic combination is unaware ofremains blinded to the specific type of therapeutic combination and is generally kept blind in the study processintervention. The researcher, who is actually the person who evaluates the treatment outcomes and patients' questionnaires, is also kept blind in the study process. The statistical consultant of the research who is in charge of data analysis is also kept blind in the study process.
Health conditions studied
#1
Partial rotator cuff tear
Partial thickness rotator cuff tear
Partial thickness rotator cuff tear
Primary outcomes
#1
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
At the beginning of the study, 1 month and 3 months after the intervention
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Visual analog scale, American shoulder and elbow surgeons questionnaire
Visual analog scale
Visual analog scale, American shoulder and elbow surgeons questionnaire
مقیاس انالوگ بصری و پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
مقیاس انالوگ بصری
مقیاس انالوگ بصری و پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
#2
Range of motion angle score in the standardized evaluation questionnaire of American shoulder and elbow surgeons
American Shoulder and Elbow Surgeons (ASES) score
Range of motion angle score in the standardized evaluation questionnaire of American shoulderShoulder and elbow surgeonsElbow Surgeons (ASES) score
نمره زاویه دامنه حرکت در پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
نمره پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
نمره زاویه دامنه حرکت در پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
At the beginning of the study, 1 month and 3 months after the intervention
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
#3
Range of motion angle score in the Constant Shoulder Score questionnaire
Constant Score
Range of motion angle score in the Constant Shoulder Score questionnaire
نمره زاویه دامنه حرکت در پرسشنامه Constant Shoulder Score
نمره پرسشنامه Constant Score
نمره زاویه دامنه حرکت در پرسشنامه Constant Shoulder Score
Constant Shoulder Score
Constant Score
Constant Shoulder Score
پرسشنامه Constant Shoulder Score
پرسشنامه Constant Score
پرسشنامه Constant Shoulder Score
Secondary outcomes
#1
Pain intensity score
Visual analog scale
Pain intensity scoreVisual analog scale
نمره شدت درد
نمره مقیاس آنالوگ بصری
نمره شدت دردمقیاس آنالوگ بصری
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
At the beginning of the study , 1 month and 3 months after the intervention
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Visual analog scale, American shoulder and elbow surgeons questionnaire
Visual analog scale
Visual analog scale, American shoulder and elbow surgeons questionnaire
مقیاس انالوگ بصری و پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
مقیاس انالوگ بصری
مقیاس انالوگ بصری و پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
#2
Range of motion angle score
American Shoulder and Elbow Surgeons (ASES) score
Range of motion angleAmerican Shoulder and Elbow Surgeons (ASES) score
نمره زاویه دامنه حرکت
نمره پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
نمره زاویه دامنه حرکتپرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
At the beginning of the study, 1 month and 3 months after the intervention
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
American shoulder and elbow surgeons questionnaire, Constant Shoulder Score
American shoulder and elbow surgeons questionnaire,
American shoulder and elbow surgeons questionnaire, Constant Shoulder Score
پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا و پرسشنامه Constant
پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا
پرسشنامه ارزيابي استاندارد شده جراحان شانه و آرنج آمريكا و پرسشنامه Constant
#3
empty
Constant Score
Constant Score
empty
نمره پرسشنامه Constant Score
نمره پرسشنامه Constant Score
empty
At the beginning of the study , 1 month and 3 months after the intervention
At the beginning of the study , 1 month and 3 months after the intervention
empty
ابتدای مطالعه(قبل از شروع مداخله)، 1 ماه و 3 ماه بعد از مداخله
ابتدای مطالعه(قبل از شروع مداخله)، 1 ماه و 3 ماه بعد از مداخله
empty
Constant Score
Constant Score
empty
پرسشنامه Constant Score
پرسشنامه Constant Score
Recruitment centers
#1
Name of recruitment center - English: Orthopedic specialist office
Name of recruitment center - Persian: مطب متخصص ارتوپدی
Full name of responsible person - English: Dr. Amirreza Sadeghifar
Full name of responsible person - Persian: دکتر امیررضا صادقی فر
Street address - English: Jahad Boulevard, Baran doctors building, 4th floor, Unit 409
Street address - Persian: بلوار جهاد، ساختمان پزشکان باران، طبقه 4، واحد 409
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7613747181
Phone: +98 34 3223 5280
Fax:
Email: drsadeghifar2000@gmail.com
Web page address:
Name of recruitment center - English: Orthopedic specialist office
Name of recruitment center - Persian: مطب متخصص ارتوپدی
Full name of responsible person - English: Dr. Amirreza Sadeghifar
Full name of responsible person - Persian: دکتر امیررضا صادقی فر
Street address - English: Unit 409, 4th floor, Baran doctors complex, Jahad Boulevard, Kerman, Iran
Street address - Persian: ایران، کرمان، بلوار جهاد، ساختمان پزشکان باران، طبقه 4، واحد 409
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7619817189
Phone: +98 34 3223 5280
Fax:
Email: drsadeghifar2000@gmail.com
Web page address:
Name of recruitment center - English: Orthopedic specialist office Name of recruitment center - Persian: مطب متخصص ارتوپدی Full name of responsible person - English: Dr. Amirreza Sadeghifar Full name of responsible person - Persian: دکتر امیررضا صادقی فر Street address - English: Jahad Boulevard, Baran doctors buildingUnit 409, 4th floor, Unit 409Baran doctors complex, Jahad Boulevard, Kerman, Iran Street address - Persian: ایران، کرمان، بلوار جهاد، ساختمان پزشکان باران، طبقه 4، واحد 409 City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 76137471817619817189 Phone: +98 34 3223 5280 Fax: Email: drsadeghifar2000@gmail.com Web page address:
#2
Name of recruitment center - English: Stem Cells and Regenerative Medicine Innovation Center
Name of recruitment center - Persian: مرکز نوآوری سلول های بنیادی و پزشکی بازساختی
Full name of responsible person - English: Dr. Alireza Farsinejad
Full name of responsible person - Persian: دکتر علیرضا فارسی نژاد
Street address - English: Islamic Republic Blvd., Shafa Intersection, Stem Cells and Regenerative Medicine Innovation Center
Street address - Persian: بلوار جمهوری اسلامی، چهارراه شفا، مرکز نوآوری سلول های بنیادی و پزشکی بازساختی
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7618747653
Phone: +98 34 3121 5683
Fax: +98 34 3121 5682
Email: info.SIC@kmu.ac.ir
Web page address:
Name of recruitment center - English: Stem Cells and Regenerative Medicine Innovation Center
Name of recruitment center - Persian: مرکز نوآوری سلول های بنیادی و پزشکی بازساختی
Full name of responsible person - English: Dr. Alireza Farsinejad
Full name of responsible person - Persian: دکتر علیرضا فارسی نژاد
Street address - English: Stem Cells and Regenerative Medicine Innovation Center, Shafa Intersection, Islamic Republic Blvd., Kerman, Iran
Street address - Persian: ایران، کرمان، بلوار جمهوری اسلامی، چهارراه شفا، مرکز نوآوری سلول های بنیادی و پزشکی بازساختی
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7618747653
Phone: +98 34 3121 5683
Fax: +98 34 3121 5682
Email: info.SIC@kmu.ac.ir
Web page address:
Name of recruitment center - English: Stem Cells and Regenerative Medicine Innovation Center Name of recruitment center - Persian: مرکز نوآوری سلول های بنیادی و پزشکی بازساختی Full name of responsible person - English: Dr. Alireza Farsinejad Full name of responsible person - Persian: دکتر علیرضا فارسی نژاد Street address - English: Islamic Republic Blvd., Shafa Intersection, Stem Cells and Regenerative Medicine Innovation Center, Shafa Intersection, Islamic Republic Blvd., Kerman, Iran Street address - Persian: ایران، کرمان، بلوار جمهوری اسلامی، چهارراه شفا، مرکز نوآوری سلول های بنیادی و پزشکی بازساختی City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7618747653 Phone: +98 34 3121 5683 Fax: +98 34 3121 5682 Email: info.SIC@kmu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amin Salehi Abargoui
Full name of responsible person - Persian: امین صالحی ابرقویی
Street address - English: Imam Hossein Square, Daneshjoo Blvd., Imam Reza (a.s.) educational and research complex, vice president of research and technology, Shahid Sadougi University of Medical Sciences, Yazd
Street address - Persian: میدان امام حسین (ع)، ابتدای بلوار دانشجو، مجتمع آموزشی پژوهشی امام رضا(ع)، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی یزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۱۸۸۶۳۷
Phone: +98 35 3628 8114
Fax:
Email: dvc.research@ssu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amin Salehi Abargoui
Full name of responsible person - Persian: امین صالحی ابرقویی
Street address - English: Vice President of Research and Technology, Shahid Sadoughi University of Medical Sciences, Imam Reza (a.s.) educational and research complex, Daneshjoo Blvd., Imam Hossein Square, Yazd, Iran
Street address - Persian: ایران، یزد، میدان امام حسین (ع)، ابتدای بلوار دانشجو، مجتمع آموزشی پژوهشی امام رضا(ع)، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی یزد
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۱۸۸۶۳۷
Phone: +98 35 3628 8114
Fax:
Email: dvc.research@ssu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Amin Salehi Abargoui Full name of responsible person - Persian: امین صالحی ابرقویی Street address - English: Imam Hossein SquareVice President of Research and Technology, Daneshjoo Blvd.Shahid Sadoughi University of Medical Sciences, Imam Reza (a.s.) educational and research complex, vice president of research and technologyDaneshjoo Blvd., Shahid Sadougi University of Medical SciencesImam Hossein Square, Yazd, Iran Street address - Persian: ایران، یزد، میدان امام حسین (ع)، ابتدای بلوار دانشجو، مجتمع آموزشی پژوهشی امام رضا(ع)، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی شهید صدوقی یزد City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۱۸۸۶۳۷ Phone: +98 35 3628 8114 Fax: Email: dvc.research@ssu.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the effect of platelet rich plasma injection with the combination of platelet rich plasma and vitamin C on partial thickness rotator cuff tears
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 110 patients. Simple random tables created by computer were used for randomization.
Settings and conduct
To prepare PRP, a 20 ml venous blood sample was collected from each patient and injected into a tube containing an anticoagulant (sterile sodium citrate tubes). The blood was then centrifuged at 1500 rpm for 10 minutes. Following centrifugation, the plasma located above the red blood cells was carefully transferred to a new sterile tube. The second round of centrifugation lasted for 10 minutes at a speed of 2500 rpm, and the supernatant (approximately 5–6 ml) was removed so that about 3 ml of plasma along with the cell sediments remained at the bottom of the tube. In the next step, through vortexing, we made the platelet suspension in the remaining plasma in the form of a suspension with an approximate concentration of 5 times the platelet baseline and used it with or without vitamin C for injection into the patients.
Participants/Inclusion and exclusion criteria
Entry conditions:
Patients who, according to the clinical examination of an orthopedic specialist doctor and MRI results, according to Elman's classification system, have partial rotator cuff tears of the 1st and 2nd stage located in supraspinatus.
Non-entry conditions:
Rotator cuff tears secondary to fracture
Prior surgical repair or revision arthroscopy
Intervention groups
Patients will be randomly assigned to one of two groups: normal saline + PRP or vitamin C + PRP.
Main outcome variables
Visual Analog Scale (VAS); Constant score; American Shoulder and Elbow Surgeons (ASES) score
General information
Reason for update
Decision to implement changes in the intervention
Acronym
IRCT registration information
IRCT registration number:IRCT20230821059205N1
Registration date:2023-08-26, 1402/06/04
Registration timing:prospective
Last update:2024-04-08, 1403/01/20
Update count:1
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Fatemeh Mohammadi Vahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 0435
Email address
fatemehmohammadi.v98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Efficacy of Platelet-Rich Plasma (PRP) Injection Versus PRP Combined with Vitamin C Injection for Partial-Thickness Rotator Cuff Tears: A Randomized Controlled Trial
Public title
The effect of platelet rich plasma and vitamin C on rotator cuff tears
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between 18 and 70 years old
Patients who had been diagnosed for 6 months
Patients with PTRCTs located in the supraspinatus tendon diagnosed via MRI.
Exclusion criteria:
Elderly patients over 70 years of age
Rotator cuff tears following fracture and trauma
History of revision arthroscopy or previous reconstructive surgery
History of PRP injection or other drug interventions, including intra-articular corticosteroid injection
Pregnant patients
History of mental disorders, cardio-cerebrovascular disease
Shoulder pain induced by non- rotator cuff tear
Patients treated with drugs that interfere with vitamin C
Presence of active infection
Hemoglobin <7.0 g٫dl or platelets < 150,000٫µL
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
All patients who met the inclusion criteria were included in the study after providing informed consent. To evaluate the anterior-posterior tear size, scores 1 and 2 were considered in the MRI findings (score 1, less than 5 mm, and score 2, 5–10 mm) .
The participants were randomly divided into two groups, A, normal saline + PRP, and B, vitamin C + PRP, by a simple random method and simple random tables created by a computer. The injection of the therapeutic compound was performed under ultrasound guidance in the subacromial space for two consecutive periods at intervals of 3 weeks. Notably, both injections were performed by the same orthopedic specialist and via the same injection method. Group A was treated with 1.5 ml of normal saline and 1.5 ml of PRP, and group B received 1.5 ml of vitamin C and 1.5 ml of PRP.
Blinding (investigator's opinion)
Double blinded
Blinding description
Despite obtaining informed consent from the participants in the study, they remain unaware of their assigned treatment intervention group. The preparation of platelet-rich plasma (PRP) is conducted by a hematologist at the Comprehensive Center for Stem Cells and Regenerative Medicine. The hematologist combines the PRP obtained from the patients with either normal saline or vitamin C. Moreover, the hematologist is aware of the treatment intervention for each participant as they record patient names alongside the respective treatment type. Furthermore, syringes containing the therapeutic combinations (normal saline + PRP and vitamin C + PRP) are conventionally labeled as A or B, with the hematologist knowledgeable about how to designate each according to the therapeutic intervention type.
Subsequently, the orthopedic specialist responsible for administering the therapeutic combination remains blinded to the specific type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Public Health - Shahid Sadoughi University of Medical Scienc
Street address
Faculty of Health, Campus of Shahid Sadoughi University of Medical Sciences and Health Services, Shohday Gomnam Blvd., Alem Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2023-07-29, 1402/05/07
Ethics committee reference number
IR.SSU.SPH.REC.1402.045
Health conditions studied
1
Description of health condition studied
Partial thickness rotator cuff tear
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
Primary outcomes
1
Description
Pain intensity score of patients on visual analog scale
Timepoint
At the beginning of the study, 1 month and 3 months after the intervention
Method of measurement
Visual analog scale
2
Description
American Shoulder and Elbow Surgeons (ASES) score
Timepoint
At the beginning of the study, 1 month and 3 months after the intervention
Method of measurement
American shoulder and elbow surgeons questionnaire,
3
Description
Constant Score
Timepoint
At the beginning of the study (before the start of the intervention), 1 month and 3 months after the intervention
Method of measurement
Constant Score
Secondary outcomes
1
Description
Visual analog scale
Timepoint
At the beginning of the study , 1 month and 3 months after the intervention
Method of measurement
Visual analog scale
2
Description
American Shoulder and Elbow Surgeons (ASES) score
Timepoint
At the beginning of the study, 1 month and 3 months after the intervention
Method of measurement
American shoulder and elbow surgeons questionnaire,
3
Description
Constant Score
Timepoint
At the beginning of the study , 1 month and 3 months after the intervention
Method of measurement
Constant Score
Intervention groups
1
Description
Intervention group: Injection of 0.5 ml of vitamin C and 2.5 ml of platelet-rich plasma will be performed under ultrasound guidance in the subacromial space during two periods with an interval of 3 weeks.
Category
Treatment - Drugs
2
Description
Control group: Injection of 1.5 ml of normal saline and 1.5 ml of platelet-rich plasma will be performed under ultrasound guidance in the subacromial space during two periods with an interval of 3 weeks. The preparation method of PRP is similar to the procedure mentioned in the intervention group, with the difference that for the control group, after preparation, PRP mixed with normal saline is used for injection to the patients of the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic specialist office
Full name of responsible person
Dr. Amirreza Sadeghifar
Street address
Unit 409, 4th floor, Baran doctors complex, Jahad Boulevard, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619817189
Phone
+98 34 3223 5280
Email
drsadeghifar2000@gmail.com
2
Recruitment center
Name of recruitment center
Stem Cells and Regenerative Medicine Innovation Center
Full name of responsible person
Dr. Alireza Farsinejad
Street address
Stem Cells and Regenerative Medicine Innovation Center, Shafa Intersection, Islamic Republic Blvd., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7618747653
Phone
+98 34 3121 5683
Fax
+98 34 3121 5682
Email
info.SIC@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargoui
Street address
Vice President of Research and Technology, Shahid Sadoughi University of Medical Sciences, Imam Reza (a.s.) educational and research complex, Daneshjoo Blvd., Imam Hossein Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۱۸۸۶۳۷
Phone
+98 35 3628 8114
Email
dvc.research@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Vahedi
Position
Master Science Student of Surgical Technology, Yazd University of Medical Sciences, Yazd, Iran
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 25, The Alley No. 10, North Sheikh Ahmed Kafi Avenue., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7617759585
Phone
+98 34 3251 0435
Email
fatemehmohammadi.v98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirreza Sadeghifar
Position
Associate Professor of Orthopaedics
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Unit 409, 4th floor, Baran Doctors Complex, Jahad Boulevard, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619817189
Phone
+98 34 3223 5280
Email
drsadeghifar2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Vahedi
Position
Master Science Student of Surgical Technology, Yazd University of Medical Sciences, Yazd, Iran
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 25, The Alley No. 10, North Sheikh Ahmed Kafi Avenue., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7617759585
Phone
+98 34 3251 0435
Email
fatemehmohammadi.v98@gmail.com
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