Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis
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Protocol summary
Inclusion criteria: People aged 40 to 70 years with a BMI between 18 and 30, based on history and physical examination, knee osteoarthritis is diagnosed and confirmed by using knee x-rays (Kellgren-Lawrence grade 2-3) and the duration of symptoms is more than 3 months. Exclusion criteria : History of diabetes, immunodeficiency and collagen disorders; Use of NSAIDs within 2 days before injection; Pregnancy or breastfeeding; Geneva valgum/varom more than 20 degrees and Clinical or paraclinical symptoms in favor of spinal canal narrowing, neuropathy or lumbar radiculopathy
Inclusion criteria: People aged 40 to 70 years with a BMI between 18 and 30, based on history and physical examination, knee osteoarthritis is diagnosed and confirmed by using knee x-rays (Kellgren-Lawrence grade 2-3) and the duration of symptoms is more than 3 months. Exclusion criteria : History of uncontrolled diabetes, immunodeficiency, and collagen disorders; Use of NSAIDs within 2 days before injection; Pregnancy or breastfeeding; Geneva valgum/varom more than 20 degrees and Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy, active lumbar radiculopathy
Inclusion criteria: People aged 40 to 70 years with a BMI between 18 and 30, based on history and physical examination, knee osteoarthritis is diagnosed and confirmed by using knee x-rays (Kellgren-Lawrence grade 2-3) and the duration of symptoms is more than 3 months. Exclusion criteria : History of uncontrolled diabetes, immunodeficiency, and collagen disorders; Use of NSAIDs within 2 days before injection; Pregnancy or breastfeeding; Geneva valgum/varom more than 20 degrees and Clinical or paraclinicalpara-clinical symptoms in favor of spinal canal narrowing, neuropathy or, active lumbar radiculopathy
افراد با سن 40 تا 70 سال با BMI بیمار بین 18 تا 30 که براساس شرح حال و معاینه فیزیکی تشخیص استئوآرتریت زانو مطرح و با استفاده از گرافی زانو تایید شده (Kellgren–Lawrence درجه 2-3) و طول مدت علائم بیش از 3 ماه باشد.معیارهای خروج از مطالعه شامل: سابقه دیابت ، نقص ایمنی و اختلالات کلاژن; استفاده ازNSAID ها طی 2 روز قبل از تزریق; بارداری یا شیردهی; ژنو والگوم/واروم بیشتر از 20 درجه; علایم بالینی یا پاراکلینیک به نفع تنکی کانال نخاعی ، نوروپاتی یا رادیکولوپاتی کمری
افراد با سن 40 تا 70 سال با BMI بیمار بین 18 تا 30 که براساس شرح حال و معاینه فیزیکی تشخیص استئوآرتریت زانو مطرح و با استفاده از گرافی زانو تایید شده (Kellgren–Lawrence درجه 2-3) و طول مدت علائم بیش از 3 ماه باشد.معیارهای خروج از مطالعه شامل: سابقه دیابت کنترل نشده ، نقص ایمنی و اختلالات کلاژن; استفاده ازNSAID ها طی 2 روز قبل از تزریق; بارداری یا شیردهی; ژنو والگوم/واروم بیشتر از 20 درجه; علایم بالینی یا پاراکلینیک به نفع تنکی کانال نخاعی ، نوروپاتی یا رادیکولوپاتی فعال کمری
افراد با سن 40 تا 70 سال با BMI بیمار بین 18 تا 30 که براساس شرح حال و معاینه فیزیکی تشخیص استئوآرتریت زانو مطرح و با استفاده از گرافی زانو تایید شده (Kellgren–Lawrence درجه 2-3) و طول مدت علائم بیش از 3 ماه باشد.معیارهای خروج از مطالعه شامل: سابقه دیابت کنترل نشده ، نقص ایمنی و اختلالات کلاژن; استفاده ازNSAID ها طی 2 روز قبل از تزریق; بارداری یا شیردهی; ژنو والگوم/واروم بیشتر از 20 درجه; علایم بالینی یا پاراکلینیک به نفع تنکی کانال نخاعی ، نوروپاتی یا رادیکولوپاتی فعال کمری
Intervention group 1: includes 40 patients who are treated with CHondroGrid (Bioteck) made of low molecular weight hydrolyzed collagen.
Intervention group 2: Includes 40 patients who are treated with PRP in three injections with two-week intervals intra-articularly.
Intervention group 3: Includes 40 patients who are treated with HA injection in three injections with two weeks intervals intra-articularly
Intervention group 1: includes 40 patients who are treated with CHondroGrid made of low molecular weight hydrolyzed collagen.
Intervention group 2: Includes 40 patients who are treated with PRP in three injections with two-week intervals intra-articularly.
Intervention group 3: Includes 40 patients who are treated with HA injection in three injections with two weeks intervals intra-articularly
Intervention group 1: includes 40 patients who are treated with CHondroGrid (Bioteck) made of low molecular weight hydrolyzed collagen. Intervention group 2: Includes 40 patients who are treated with PRP in three injections with two-week intervals intra-articularly. Intervention group 3: Includes 40 patients who are treated with HA injection in three injections with two weeks intervals intra-articularly
Assessment of knee pain and stiffness, assessment of patient's performance in daily tasks and degree of patient's satisfaction.
Assessment of knee pain and stiffness, assessment of patient's function in daily tasks and degree of patient's satisfaction.
Assessment of knee pain and stiffness, assessment of patient's performancefunction in daily tasks and degree of patient's satisfaction.
General information
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With the aim of more accurately and completely determining the exclusion criteria and clarifying the title of the research project and specifying the brand and characteristics of hyaluronic acid used in this research project, an update was made.
With the aim of more accurately and completely determining the exclusion criteria and clarifying the title of the research project and specifying the brand and characteristics of hyaluronic acid used in this research project, an update was made.
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با هدف تعیین دقیق تر و کامل تر معیارهای خروج از مطالعه و شفاف تر نمودن عنوان طرح تحقیقاتی و مشخص نمودن برند و مشخصات هیالورونیک اسید مورد استفاده در این طرح تحقیقاتی به روز رسانی انجام گردید.
با هدف تعیین دقیق تر و کامل تر معیارهای خروج از مطالعه و شفاف تر نمودن عنوان طرح تحقیقاتی و مشخص نمودن برند و مشخصات هیالورونیک اسید مورد استفاده در این طرح تحقیقاتی به روز رسانی انجام گردید.
History of diabetes, immunodeficiency and collagen disorders
History or presence of malignant disorders, infection or active wound in the knee area
Recent history of severe knee injury
Autoimmune and platelet disorders
Treatment with anticoagulant and antiplatelet drugs within 10 days before injection
Use of NSAIDs within 2 days before injection
History of intramuscular injection or oral use of systemic corticosteroids 2 weeks before injection
History of any intra-articular injection of the knee during the last 6 months
Hemoglobin less than 12 g/dL
Platelet count less than 150,000/ml
History of vasovagal shock
Pregnancy or breastfeeding
Geneva valgum/varom more than 20 degrees
Hypersensitivity to hyaluronate
Allergy to bovine proteins and collagen
Hemarthrosis, erythema and psoriatic lesions
Clinical or paraclinical symptoms in favor of spinal canal narrowing, neuropathy or lumbar radiculopathy
History of immunodeficiency and collagen disorders and uncontrolled diabetes
History or presence of malignant disorders, infection or active wound in the knee area
Recent history of severe knee injury
Autoimmune and platelet disorders
Treatment with anticoagulant and antiplatelet drugs within 10 days before injection
Use of NSAIDs within 2 days before injection
History of intramuscular injection or oral use of systemic corticosteroids 2 weeks before injection
History of any intra-articular injection of the knee during the last 6 months
Hemoglobin less than 11 g/dL
Platelet count less than 150,000/ml
History of vasovagal shock
Pregnancy or breastfeeding
Geneva valgum/varum more than 20 degrees
Hypersensitivity to hyaluronate
Allergy to bovine proteins, poultry products, eggs and collagen
Hemarthrosis, erythema and psoriatic lesions
Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy or active lumbar radiculopathy
History of diabetes, immunodeficiency and collagen disorders and uncontrolled diabetes History or presence of malignant disorders, infection or active wound in the knee area Recent history of severe knee injury Autoimmune and platelet disorders Treatment with anticoagulant and antiplatelet drugs within 10 days before injection Use of NSAIDs within 2 days before injection History of intramuscular injection or oral use of systemic corticosteroids 2 weeks before injection History of any intra-articular injection of the knee during the last 6 months Hemoglobin less than 1211 g/dL Platelet count less than 150,000/ml History of vasovagal shock Pregnancy or breastfeeding Geneva valgum/varomvarum more than 20 degrees Hypersensitivity to hyaluronate Allergy to bovine proteins, poultry products, eggs and collagen Hemarthrosis, erythema and psoriatic lesions Clinical or paraclinicalpara-clinical symptoms in favor of spinal canal narrowing, neuropathy or active lumbar radiculopathy
سابقه دیابت ، نقص ایمنی و اختلالات کلاژن
سابقه یا وجود اختلالات بدخیم، عفونت یا زخم فعال در ناحیه زانو
سابقه اخیر ضربه شدید به زانو
اختلالات خودایمنی و پلاکتی
درمان با داروهای ضد انعقاد و ضد پلاکت در طی 10 روز قبل از تزریق
استفاده ازNSAID ها طی 2 روز قبل از تزریق
سابقه تزریق عضلانی یا مصرف خوراکی کورتیکواستروئیدهای سیستمیک 2 هفته قبل از تزریق
سابقه هرگونه تزریق داخل مفصلی زانو طی 6 ماه گذشته
هموگلوبین کمتر از 12 گرم در دسی لیتر
تعداد پلاکت کمتر از 150 هزار در میلی لیتر
سابقه شوک وازوواگال
بارداری یا شیردهی
ژنو والگوم/واروم بیشتر از 20 درجه
حساسیت به هیالورونات
حساسیت به پروتئین های گاوی و کلاژن
همارتروز ، اریتم و ضایعات پسوریاتیک
علایم بالینی یا پاراکلینیک به نفع تنکی کانال نخاعی ، نوروپاتی یا رادیکولوپاتی کمری
سابقه نقص ایمنی و اختلالات کلاژن و دیابت کنترل نشده
سابقه یا وجود اختلالات بدخیم، عفونت یا زخم فعال در ناحیه زانو
سابقه اخیر ضربه شدید به زانو
اختلالات خودایمنی و پلاکتی
درمان با داروهای ضد انعقاد و ضد پلاکت در طی 10 روز قبل از تزریق
استفاده ازNSAID ها طی 2 روز قبل از تزریق
سابقه تزریق عضلانی یا مصرف خوراکی کورتیکواستروئیدهای سیستمیک 2 هفته قبل از تزریق
سابقه هرگونه تزریق داخل مفصلی زانو طی 6 ماه گذشته
هموگلوبین کمتر از 11 گرم در دسی لیتر
تعداد پلاکت کمتر از 150 هزار در میلی لیتر
سابقه شوک وازوواگال
بارداری یا شیردهی
ژنو والگوم/واروم بیشتر از 20 درجه
حساسیت به هیالورونات
حساسیت به پروتئین های گاوی، محصولات پرندگان تخم مرغ و کلاژن
همارتروز ، اریتم و ضایعات پسوریاتیک
علایم بالینی یا پاراکلینیک به نفع تنکی کانال نخاعی ، نوروپاتی یا رادیکولوپاتی فعال کمری
سابقه دیابت ، نقص ایمنی و اختلالات کلاژن و دیابت کنترل نشده سابقه یا وجود اختلالات بدخیم، عفونت یا زخم فعال در ناحیه زانو سابقه اخیر ضربه شدید به زانو اختلالات خودایمنی و پلاکتی درمان با داروهای ضد انعقاد و ضد پلاکت در طی 10 روز قبل از تزریق استفاده ازNSAID ها طی 2 روز قبل از تزریق سابقه تزریق عضلانی یا مصرف خوراکی کورتیکواستروئیدهای سیستمیک 2 هفته قبل از تزریق سابقه هرگونه تزریق داخل مفصلی زانو طی 6 ماه گذشته هموگلوبین کمتر از 1211 گرم در دسی لیتر تعداد پلاکت کمتر از 150 هزار در میلی لیتر سابقه شوک وازوواگال بارداری یا شیردهی ژنو والگوم/واروم بیشتر از 20 درجه حساسیت به هیالورونات حساسیت به پروتئین های گاوی، محصولات پرندگان تخم مرغ و کلاژن همارتروز ، اریتم و ضایعات پسوریاتیک علایم بالینی یا پاراکلینیک به نفع تنکی کانال نخاعی ، نوروپاتی یا رادیکولوپاتی فعال کمری
Intervention groups
#1
Intervention group: includes 40 patients who are treated with 2.5 cc of hyaluronic acid with a molecular weight of 1800-2200 in three injections with two weeks intervals intra-articularly.
Intervention group: includes 40 patients who are treated with 2 cc of hyaluronic acid (Hyalgan) with a molecular weight of 500000-730000 daltons in three injections with two-week intervals intra-articularly.
Intervention group: includes 40 patients who are treated with 2.52 cc of hyaluronic acid (Hyalgan) with a molecular weight of 1800500000-2200730000 daltons in three injections with two weeks-week intervals intra-articularly.
گروه مداخله: شامل 40 نفر از بيماران مي باشد كه تحت درمان با 2.5 سی سی هیالورونیک اسید با وزن مولکولی 1800-2200 بصورت سه نوبت تزريق با فواصل دو هفته قرار ميگيرند.
گروه مداخله: شامل 40 نفر از بيماران مي باشد كه تحت درمان با 2 سی سی هیالورونیک اسید با نام تجاری هیالگان با وزن مولکولی 730000-500000 دالتون بصورت سه نوبت تزريق با فواصل دو هفته قرار ميگيرند.
گروه مداخله: شامل 40 نفر از بيماران مي باشد كه تحت درمان با 2.52 سی سی هیالورونیک اسید با نام تجاری هیالگان با وزن مولکولی 1800730000-2200500000 دالتون بصورت سه نوبت تزريق با فواصل دو هفته قرار ميگيرند.
Protocol summary
Study aim
The purpose of this study is comparing the effectiveness of intra-articular injection of hyaluronic acid, hydrolyzed collagen, and platelet-rich plasma in reducing pain, improving function, and the level of satisfaction with treatment of knee osteoarthritis.
Design
A controlled, parallel-group, double blind, randomized, phase 3 clinical trial on 120 patients. Random allocation software is used for randomization.
Settings and conduct
Subjects, interventionist, outcome assessor, statistician and the researcher are all blind to treatment groups allocation; using pre-filled syringes and sealed envelopes. Subjects will be randomly allocated in 3 groups. The study will take place in Modarres hospital, Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged 40 to 70 years with a BMI between 18 and 30, based on history and physical examination, knee osteoarthritis is diagnosed and confirmed by using knee x-rays (Kellgren-Lawrence grade 2-3) and the duration of symptoms is more than 3 months. Exclusion criteria : History of uncontrolled diabetes, immunodeficiency, and collagen disorders; Use of NSAIDs within 2 days before injection; Pregnancy or breastfeeding; Geneva valgum/varom more than 20 degrees and Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy, active lumbar radiculopathy
Intervention groups
Intervention group 1: includes 40 patients who are treated with CHondroGrid made of low molecular weight hydrolyzed collagen.
Intervention group 2: Includes 40 patients who are treated with PRP in three injections with two-week intervals intra-articularly.
Intervention group 3: Includes 40 patients who are treated with HA injection in three injections with two weeks intervals intra-articularly
Main outcome variables
Assessment of knee pain and stiffness, assessment of patient's function in daily tasks and degree of patient's satisfaction.
General information
Reason for update
With the aim of more accurately and completely determining the exclusion criteria and clarifying the title of the research project and specifying the brand and characteristics of hyaluronic acid used in this research project, an update was made.
Acronym
IRCT registration information
IRCT registration number:IRCT20130523013442N34
Registration date:2023-09-23, 1402/07/01
Registration timing:registered_while_recruiting
Last update:2024-02-08, 1402/11/19
Update count:1
Registration date
2023-09-23, 1402/07/01
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis
Public title
Comparison of intra-articular injection of hydrolyzed type 1 collagen, platelet-rich plasma and hyaluronic acid on pain, stiffness and performance of patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 40 to 70 years who are diagnosed with knee osteoarthritis based on history and physical examination.
Duration of symptoms is more than 3 months.
Confirmation of diagnosis using knee x-ray (Kellgren-Lawrence grade 2-3)
The patient's BMI should be between 18 and 30.
Willingness of the patient to participate in the study
Exclusion criteria:
History of immunodeficiency and collagen disorders and uncontrolled diabetes
History or presence of malignant disorders, infection or active wound in the knee area
Recent history of severe knee injury
Autoimmune and platelet disorders
Treatment with anticoagulant and antiplatelet drugs within 10 days before injection
Use of NSAIDs within 2 days before injection
History of intramuscular injection or oral use of systemic corticosteroids 2 weeks before injection
History of any intra-articular injection of the knee during the last 6 months
Hemoglobin less than 11 g/dL
Platelet count less than 150,000/ml
History of vasovagal shock
Pregnancy or breastfeeding
Geneva valgum/varum more than 20 degrees
Hypersensitivity to hyaluronate
Allergy to bovine proteins, poultry products, eggs and collagen
Hemarthrosis, erythema and psoriatic lesions
Clinical or para-clinical symptoms in favor of spinal canal narrowing, neuropathy or active lumbar radiculopathy
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
in this clinical trial study, 60 patients with a diagnosis of frozen shoulder will be included in the study randomly .For random allocation of individuals in the study groups, the method of random allocation with block method (Block Randomization) will be used In this method, blocks with size of six (including two people in in each of the three groups) with a ratio of 1:1:1 will be used. Random Allocation software will be used to generate random sequences. For concealment, the random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified with three types of cards which are identified by the letters A (hydrolyzed collagen recipient group), B (PRP recipient group) and C (hyaluronic acid recipient group). Cards will be recorded and these cards will be placed in sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher, the patient, the data analyst and the outcome evaluator are kept blind and are not aware of the intervention performed on each group of patients, and only the final data are assigned to the first, second, and third groups of random numbers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-09-10, 1402/06/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.317
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Assessment of knee pain
Timepoint
At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
Method of measurement
Visual analogue scale (VAS), WOMAC and Lequesne index questionnaire
2
Description
Assessing the patient's performance in daily tasks
Timepoint
At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
Method of measurement
Using the WOMAC questionnaire
3
Description
Assessment of morning stiffness
Timepoint
At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
Method of measurement
Using the WOMAC and Lequesne index questionnaire
Secondary outcomes
1
Description
The degree of patient's satisfaction with the treatment
Timepoint
At the beginning of the study (before intervention) and 4 weeks and 24 weeks after the intervention
Method of measurement
5-items questionnaire
Intervention groups
1
Description
Intervention group: includes 40 patients who are treated with CHondroGrid (Bioteck) made of hydrolyzed collagen diluted in 2 cc of normal saline هn three injections with two-week intervals.
Category
Treatment - Drugs
2
Description
Intervention group: Includes 40 patients who are treated with intraarticular injection of 5 cc of PRP in three injections with two-week intervals.
Category
Treatment - Drugs
3
Description
Intervention group: includes 40 patients who are treated with 2 cc of hyaluronic acid (Hyalgan) with a molecular weight of 500000-730000 daltons in three injections with two-week intervals intra-articularly.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Modarres hospital , Kaj Square, Sa'adat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
alin7093@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
a_raeissadat@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Nazari Nodoushan
Position
Resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
alin7093@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
a_raeissadat@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Nazari Noudoshan
Position
Resident of Physical medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
alin7093@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All the data of people participating in this study can be shared after deidentifying people
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
Data of this study will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers.
From where data/document is obtainable
By sending an email to alin7093@gmail.com
What processes are involved for a request to access data/document
The given request should contain information about his/her affiliation, phone number, e-mail and the reason for his/her request. If these items are presented and the information related to the applicant's plan is registered and confirmed in the PROSPERO system, the information will be provided to the applicant.