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The effect of local injection of ozone, corticosteroid and prothorectropy under ultrasound guidance in the treatment of inflammation of shoulder tendons: a randomized, prospective, multicentre double blind clinical trial with positive control group

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History
# Registration date Revision Id
3 2025-05-06, 1404/02/16 339844
2 2023-08-25, 1402/06/03 276755
1 2018-07-12, 1397/04/21 52404
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  • Protocol summary

    Phase 3, multi-center, double blind randomized controlled clinical trial, with parallel group design. The study will be done on 75 patients (25 in each group), and follow-up will be done one week and two months after injection
    Phase 3, multi-center, double blind randomized controlled clinical trial, with parallel group design. The study will be done on 45 patients (15 in each group), and follow-up will be done one week and two months after injection
    کارآزمایی بالینی فاز سه، چندمرکزی، تصادفی شده ، دارای گروه کنترل مثبت، دو سویه کور با گروه های موازی، در کل روی 75 بیمار (25 نفر در هر گروه) با پیگیری یک هفته و دو ماه پس از تزریق
    کارآزمایی بالینی فاز سه، چندمرکزی، تصادفی شده ، دارای گروه کنترل مثبت، دو سویه کور با گروه های موازی، در کل روی 45 بیمار (15 نفر در هر گروه) با پیگیری یک هفته و دو ماه پس از تزریق
    Department of Physical Medicine and Rehabilitation of Shohada Hospital and Imam Reza Hospital affiliated to Tabriz University of Medical Sciences and Physiotherapy and Rehabilitation Physics Department of Rasoul Akram Medical Center affiliated to Iran University of Medical Sciences
    Department of Physical Medicine and Rehabilitation of Firoozgar Hospital and Physiotherapy and Rehabilitation Physics Department of Rasoul Akram Medical Center affiliated to Iran University of Medical Sciences
    بخش طب فیزیکی و توانبخشی مرکز آموزشی درمانی شهداء و امام رضا (ع) وابسته به دانشگاه علوم پزشکی تبریز و بخش طب فیزیکی و توانبخشی مرکز آموزشی درمانی حضرت رسول اکرم (ص) وابسته به دانشگاه علوم پزشکی ایران
    بخش طب فیزیکی و توانبخشی مرکز آموزشی درمانی فیروزگر و بخش طب فیزیکی و توانبخشی مرکز آموزشی درمانی حضرت رسول اکرم (ص) وابسته به دانشگاه علوم پزشکی ایران
    Inclusion criteria: Tendinopathy in patients with positive one of the shoulder tests including Neer test or Hawkins test, VAS greater than 4, Patient's desire to attend the research project. Exclusion criteria: rotator cuff tear, diabetes, coagulation disorders, fracture, hematological diseases, tumors and infection,history of Injection in the shoulder joint in the last 3 months, Frozen Shoulder, Presence of c6-c5 Concomitant radiculopathy.
    Inclusion criteria: Tendinopathy in patients with positive one of the shoulder tests including Neer test or Hawkins test, VAS greater than 4, Patient's desire to attend the research project. Exclusion criteria: rotator cuff tear, diabetes, coagulation disorders, fracture, rheumatologic diseases, tumors and infection,history of Injection in the shoulder joint in the last 3 months, Frozen Shoulder, Presence of c6-c5 Concomitant radiculopathy.
    Topical ozone injection group: 5cc ozone 20μg/L Corticosteroid injection group: 1cc triamcinolone 40mg + 1cc normal slain and prolotherapy group: 5cc dextrose 50%
    Topical ozone injection group: 5cc ozone 20μg/L Corticosteroid injection group: 1cc triamcinolone 40mg + 1cc  lidocaine and prolotherapy group: 5cc dextrose  20%
    گروه تزريق موضعي ازون: 5 سی سی اوزون 20 میلی گرم بر لیتر، گروه تزریق كورتيكو استروئيد: یک سی سی نرمال سالین 40 میلی گرم به همراه یک سی سی نرمال سالین و گروه پرلوتراپی: 5 سی سی دکستروز 50 درصد.
    گروه تزريق موضعي ازون: 5 سی سی اوزون 20 میلی گرم بر لیتر، گروه تزریق كورتيكو استروئيد: یک سی سی تریامسینولون 40 میلی گرم به همراه یک سی سی لیدوکایین و گروه پرلوتراپی: 5 سی سی دکستروز 20 درصد.

  • General information

    empty
    20
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    Year
    Yes
    No
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    80
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    Year
    Yes
    No
    75
    45
    2019-06-22, 1398/04/01
    2024-06-22, 1403/04/02
    empty
    Modifications are needed in the execution method, date and place.
    empty
    اصلاحاتی در روش اجرا، تاریخ و محل انجام مورد نیاز است.
    empty
    empty

  • Primary outcomes

    #1
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    #2
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق

  • Secondary outcomes

    #1
    Before injection, 1 weeks and 8 weeks after injection
    Before injection, 2 weeks and 8 weeks after injection
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    #2
    Before injection, 1 weeks and 8 weeks after injection
    Before injection, 2 weeks and 8 weeks after injection
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    #3
    Before injection, 1 weeks and 8 weeks after injection
    Before injection, 2 weeks and 8 weeks after injection
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    #4
    Before injection, 1 weeks and 8 weeks after injection
    Before injection, 2 weeks and 8 weeks after injection
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    #5
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    #6
    Before injection, 1 weeks and 8 weeks after injection
    Before injection, 2 weeks and 8 weeks after injection
    قبل از تزریق، 1 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق

  • Intervention groups

    #1
    Intervention group (porlotherapy): 5cc dextrose 50%, in subacromial space with lateral aperture under ultrasound guidance.
    Intervention group (porlotherapy): 5cc dextrose 20%, in subacromial space with lateral aperture under ultrasound guidance.
    گروه مداخله: (گروه پرلوتراپی): 5cc dextrose 50% ، در فضای ساب آکرومیال با اپروچ لترال تحت هدایت سونوگرافی
    گروه مداخله: (گروه پرلوتراپی): 5cc dextrose 20% ، در فضای ساب آکرومیال با اپروچ لترال تحت هدایت سونوگرافی
    #2
    Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc normal slain, in subacromial space with lateral aperture under ultrasound guidance.
    Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc lidocaine , in subacromial space with lateral aperture under ultrasound guidance.
    گروه کنترل (گروه تزریق کورتیکواستروئید): 1cc triamcinolone 40mg + 1cc normal slain، در فضای ساب آکرومیال با اپروچ لترال تحت هدایت سونوگرافی
    گروه کنترل (گروه تزریق کورتیکواستروئید): 1cc triamcinolone 40mg + 1cc lidocaine، در فضای ساب آکرومیال با اپروچ لترال تحت هدایت سونوگرافی

  • Recruitment centers

    #1
    Name of recruitment center - English: Department of Physical Medicine and Rehabilitation of Rasoul-e-Akram Medical Education Center affili
    Name of recruitment center - Persian: بخش طب فیزیکی و توانبخشی مرکز آموزشی درمانی حضرت رسول اکرم (ص) وابسته به دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Arash babaee
    Full name of responsible person - Persian: آرش بابائی
    Street address - English: Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
    Street address - Persian: بیمارستان رسول اکرم (ص)، خیابان مازیار منصوری، خیابان ستارخان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 86701
    Fax:
    Email: babaei-ghazani.a@iums.ac.ir
    Web page address:
    Name of recruitment center - English: Department of Physical Medicine and Rehabilitation of Rasoul-e-Akram Medical Education Center affili
    Name of recruitment center - Persian: بخش طب فیزیکی و توانبخشی مرکز آموزشی درمانی حضرت رسول اکرم (ص) وابسته به دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Arash Babaee
    Full name of responsible person - Persian: آرش بابائی
    Street address - English: Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
    Street address - Persian: بیمارستان رسول اکرم (ص)، خیابان مازیار منصوری، خیابان ستارخان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۴۹۶۱۴۵۳۵
    Phone: +98 21 86701
    Fax:
    Email: babaei-ghazani.a@iums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Shohada Medical Research and Training Hospital,Tabriz University of Medical Sciences
    Name of recruitment center - Persian: بخش طب فیزیکی مرکز آموزشی درمانی امام رضا وابسته به دانشگاه علوم پزشكي تبريز
    Full name of responsible person - English: Dr. Babak Kolahi
    Full name of responsible person - Persian: بابک کلاهی
    Street address - English: Imam Reza hospital, University Ave.
    Street address - Persian: خيابان دانشگاه- مركز آموزشي درماني امام رضا (ع)
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614756
    Phone: +98 41 3336 3161
    Fax:
    Email: dr.kolahi@gmail.com
    Web page address:
    Name of recruitment center - English: Shohada Medical Research and Training Hospital,Tabriz University of Medical Sciences
    Name of recruitment center - Persian: بخش طب فیزیکی مرکز آموزشی درمانی فیروزگر وابسته به دانشگاه علوم پزشكي ایران
    Full name of responsible person - English: Dr. arash babaei
    Full name of responsible person - Persian: ارش بابایی
    Street address - English: Firoozgar hospital, Beh afarinAve.
    Street address - Persian: خيابان یه افرین- مركز آموزشي درماني فیروزگر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1593747811
    Phone: +98 21 8214 1000
    Fax:
    Email: babaei-ghazani.a@iums.ac.ir
    Web page address:
    #3
    Name of recruitment center - English: Physical medicine and rehabilitation research center of Shohada Hospital affiliated to Tabriz Univer
    Name of recruitment center - Persian: بخش طب فیزیکی مرکز آموزشی درمانی شهدا وابسته به دانشگاه علوم پزشكي تبريز
    Full name of responsible person - English: Dr. Bina Eftekharsaadat
    Full name of responsible person - Persian: دكتر بينا افتخارالسادات
    Street address - English: Shohada hospital, GolshahrAve.
    Street address - Persian: خیابان گلشهر، مرکز آموزشی درمانی شهدا
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614756
    Phone: +98 21 3336 3161
    Fax:
    Email: binasadat@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Bina Eftekhar sadat
    Full name of responsible person - Persian: بینا افتخار سادات
    Street address - English: Gulgasht Street
    Street address - Persian: خیابان گلگشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614766
    Phone: +98 41 3336 3161
    Fax:
    Email: binasadat@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Arash babaei
    Full name of responsible person - Persian: دکتر ارش بابایی
    Street address - English: Niyayesh Street
    Street address - Persian: خیابان نیایش
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1445613131
    Phone: +98 21 6435 1000
    Fax:
    Email: babaei-ghazani.a@iums.ac.ir
    Web page address:
    Yes
    empty
    Tabriz University of Medical Sciences
    Iran University of Medical Sciences
    دانشگاه علوم پزشکی تبریز
    دانشگاه علوم پزشکی ایران
    #2

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر سید کاظم ملکوتی
    Full name of responsible person - Persian: Dr. Seyed Kazem Malakouti
    Street address - English: مرکز تحقیقات بیماریهای عصبی، عضلانی و اسکلتی، دانشکده طب فیزیکی و توانبخشی، دانشگاه علوم پزشکی ایران
    Street address - Persian: Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 41 1331 1147
    Fax:
    Email: rashbabaie@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Seyed Kazem Malakouti
    Full name of responsible person - Persian: دکتر سید کاظم ملکوتی
    Street address - English: Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences
    Street address - Persian: مرکز تحقیقات بیماریهای عصبی، عضلانی و اسکلتی، دانشکده طب فیزیکی و توانبخشی، دانشگاه علوم پزشکی ایران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1449614535
    Phone: +98 41 1331 1147
    Fax:
    Email: rashbabaie@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of Sono-guided Oxygen-ozone/ corticosteroid and prothorectropy local injection in the treatment of Shoulder tendonitis
Design
Phase 3, multi-center, double blind randomized controlled clinical trial, with parallel group design. The study will be done on 45 patients (15 in each group), and follow-up will be done one week and two months after injection
Settings and conduct
Department of Physical Medicine and Rehabilitation of Firoozgar Hospital and Physiotherapy and Rehabilitation Physics Department of Rasoul Akram Medical Center affiliated to Iran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: Tendinopathy in patients with positive one of the shoulder tests including Neer test or Hawkins test, VAS greater than 4, Patient's desire to attend the research project. Exclusion criteria: rotator cuff tear, diabetes, coagulation disorders, fracture, rheumatologic diseases, tumors and infection,history of Injection in the shoulder joint in the last 3 months, Frozen Shoulder, Presence of c6-c5 Concomitant radiculopathy.
Intervention groups
Topical ozone injection group: 5cc ozone 20μg/L Corticosteroid injection group: 1cc triamcinolone 40mg + 1cc  lidocaine and prolotherapy group: 5cc dextrose  20%
Main outcome variables
Visual Analogue Scale (VAS); shoulder pain and disability index (SPADI)

General information

Reason for update
Modifications are needed in the execution method, date and place.
Acronym
IRCT registration information
IRCT registration number: IRCT20151017024572N17
Registration date: 2018-07-12, 1397/04/21
Registration timing: registered_while_recruiting

Last update: 2023-08-27, 1402/06/05
Update count: 2
Registration date
2018-07-12, 1397/04/21
Registrant information
Name
Arash Babaei-Ghazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2683
Email address
babaei-ghazani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2024-06-22, 1403/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local injection of ozone, corticosteroid and prothorectropy under ultrasound guidance in the treatment of inflammation of shoulder tendons: a randomized, prospective, multicentre double blind clinical trial with positive control group
Public title
The effect of local injection of ozone, corticosteroid and prothorectropy under ultrasound guidance in the treatment of inflammation of shoulder tendons
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of tandinopathy in patients as a positive one in a special shoulder test, including: Neer test, Hawkins test Visual Analog Scale (VAS) above 4 Patient's desire to attend research project
Exclusion criteria:
Existence of a history and examination of rotator cuff tears, diabetes, coagulation disorders, fractures, rheumatologic diseases, tumors and infection Receiving injection in the shoulder joint in the last 3 months Frozen Shoulder Presence of c6-c5 synchronous radiculopathy
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method for randomization will be used and individuals (patients) will form random units. A random sequence will be generated using RAS software. A central randomization method will be used to conceal random allocation. The random sequence will be created by the statistician and will be available to her. The doctor will be connected to the statistician by telephone or text message and will ask him or her about the random allocation of the participant to the specific group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the patient, the doctor will prepare the injection material in the syringe, and will cover the syringes with an aluminum sheet to avoid being aware of the type of injection. It should be noted that dilution of corticosteroid and normal salin will be done to equalize the volume of all three injectable solutions. Patients in each group will be evaluated by a physical medicine and rehabilitation specialist, who is not aware of the type of injection, before the injection, one week after the injection and two months after the injection.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences,Hemat Highway next to Milad Tower,Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.IUMS.REC 1396.30322

Health conditions studied

1

Description of health condition studied
Inflammation of the shoulder tendons
ICD-10 code
G59
ICD-10 code description
Mononeuropathy in diseases classified elsewhere

Primary outcomes

1

Description
Pain score based on Visual Analogue Scale
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Visual Analog Scale (VAS)

2

Description
Shoulder pain and disability
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Shoulder pain and disability index (SPADI)

Secondary outcomes

1

Description
Clinical Global Impression
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Clinical Global Impression Questionnaire

2

Description
Patient Global Impression of Improvement
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
Patient Global Impression of Improvement Questionnaire

3

Description
shoulder rang of motiom
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
goniometer

4

Description
synovial thickness
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
sonography

5

Description
Partial tearing
Timepoint
Before injection, 1 weeks and 8 weeks after injection
Method of measurement
sonography

6

Description
Liquid Thickness
Timepoint
Before injection, 2 weeks and 8 weeks after injection
Method of measurement
sonography

Intervention groups

1

Description
Intervention group (ozone therapy): 5cc ozone 20μg / L, in subacromial space with lateral aperture under ultrasound guidance.
Category
Treatment - Drugs

2

Description
Intervention group (porlotherapy): 5cc dextrose 20%, in subacromial space with lateral aperture under ultrasound guidance.
Category
Treatment - Drugs

3

Description
Control group (corticosteroid therapy ): 1cc triamcinolone 40mg + 1cc lidocaine , in subacromial space with lateral aperture under ultrasound guidance.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Physical Medicine and Rehabilitation of Rasoul-e-Akram Medical Education Center affili
Full name of responsible person
Arash Babaee
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
babaei-ghazani.a@iums.ac.ir

2

Recruitment center
Name of recruitment center
Shohada Medical Research and Training Hospital,Tabriz University of Medical Sciences
Full name of responsible person
Dr. arash babaei
Street address
Firoozgar hospital, Beh afarinAve.
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1000
Email
babaei-ghazani.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Arash babaei
Street address
Niyayesh Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
babaei-ghazani.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
70
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

2

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malakouti
Street address
Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 41 1331 1147
Email
rashbabaie@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
30
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
Iran University of Medical Sciences
Full name of responsible person
Arash Babaie
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical medicine and rehabilitation ward, Firoozgar Hospital, Behafarin Avenue, Valiasr Square, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
arashbabaie@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Arash Babaei
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
babaei-ghazani.a@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Arash Babaei
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Fax
Email
babaei-ghazani.a@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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