1. Home
  2. Approved trials
  3. » فارسی

Comparing ultrasound guided injection of oxygen-ozone vs. corticosteroid vs. prolotherapy in the treatment of shoulder tendinopathy : a randomized, prospective, multicenter randomized clinical trial

View the latest revision

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
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    The effect of Sono-guided Oxygen-ozone/ corticosteroid and prothorectropy local injection in the treatment of Shoulder tendonitis
    The effect of Sono-guided Oxygen-ozone/ corticosteroid and prolotherapy local injection in the treatment of Shoulder tendonitis
    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
    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 two week , two months and six months after the injection
    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
    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 دو هفته , دوماه و شش ماه پس از تزریق

  • General information

    empty
    45
    2017-08-23, 1396/06/01
    2019-05-10, 1398/02/20
    empty
    2019-05-10, 1398/02/20
    empty
    2024-06-22, 1403/04/02
    empty
    2024-12-22, 1403/10/02
    اصلاحاتی در روش اجرا، تاریخ و محل انجام مورد نیاز است.
    اصلاحاتی در عنوان ( به علت خطای تایپی) ، تاریخ ( تاریخ شروع قبل از ثبت خورده است ) مورد نیاز است
    The effect of local injection of ozone, corticosteroid and prothorectropy under ultrasound guidance in the treatment of inflammation of shoulder tendons
    Comparing local injection of ozone, corticosteroid and prolotherapy under ultrasound guidance in the treatment of inflammation of shoulder tendons
    اثر تزريق موضعي ازون، كورتيكواستروئيد و پرولوتراپی تحت هدايت سونوگرافي در درمان التهاب تاندونهای شانه
    مقایسه ی تزريق موضعي ازون، كورتيكواستروئيد و پرولوتراپی تحت هدايت سونوگرافي در درمان التهاب تاندونهای شانه
    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
    Comparing ultrasound guided injection of oxygen-ozone vs. corticosteroid vs. prolotherapy in the treatment of shoulder tendinopathy : a randomized, prospective, multicenter randomized clinical trial
    بررسي اثر تزريق موضعي ازون، كورتيكواستروئيد و پرولوتراپی تحت هدايت سونوگرافي در درمان التهاب تاندونهای شانه: یک کارآزمایی بالینی تصادفی آینده‌نگر، دو سو کور چندمرکزی با گروه کنترل مثبت
    مقایسه ی اثر تزريق موضعي ازون، كورتيكواستروئيد و پرولوتراپی تحت هدايت سونوگرافي در درمان التهاب تاندونهای شانه: یک کارآزمایی بالینی تصادفی آینده‌نگر، دو سو کور چندمرکزی
    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.
    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, two week , two months and six months after the injection.
    برای کور سازی بیمار، پزشک به دور از چشم بیمار، ماده تزریقی مورد نظر را در سرنگ آماده کرده و برای عدم اطلاع فرد از نوع ماده تزریقی، سرنگ‌ها را با یک ورق آلومنیومی خواهد پوشاند. لازم به ذکراست که رقیق کردن کورتیکواستروئید و نرمال سالن جهت برابر کردن حجم هر سه محلول تزریقی صورت خواهد گرفت. بيماران هر گروه توسط دستيار طب فيزيكي وتوان بخشي كه از نوع تزريق آگاه نيست قبل از تزريق، یک هفته بعد و دوماه پس از تزریق مورد ارزیابی قرار خواهند گرفت.
    برای کور سازی بیمار، پزشک به دور از چشم بیمار، ماده تزریقی مورد نظر را در سرنگ آماده کرده و برای عدم اطلاع فرد از نوع ماده تزریقی، سرنگ‌ها را با یک ورق آلومنیومی خواهد پوشاند. لازم به ذکراست که رقیق کردن کورتیکواستروئید و نرمال سالن جهت برابر کردن حجم هر سه محلول تزریقی صورت خواهد گرفت. بيماران هر گروه توسط دستيار طب فيزيكي وتوان بخشي كه از نوع تزريق آگاه نيست قبل از تزريق، دو هفته , دوماه و شش ماه پس از تزریق مورد ارزیابی قرار خواهند گرفت.

  • Primary outcomes

    #1
    Before injection, 2 weeks and 8 weeks after injection
    Before injection, two weeks , two months and six months after the injection
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    قبل از تزریق , دو هفته , دوماه و شش ماه پس از تزریق
    #2
    Before injection, 2 weeks and 8 weeks after injection
    Before injection, two weeks , two months and six months after the injection
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، دو هفته , دوماه و شش ماه پس از تزریق

  • Secondary outcomes

    #1
    Before injection, 2 weeks and 8 weeks after injection
    Before injection, two weeks , two months and six months after the injection
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، دو هفته , دوماه و شش ماه پس از تزریق
    #2
    Before injection, 2 weeks and 8 weeks after injection
    Before injection, two weeks , two months and six months after the injection
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، دو هفته , دوماه و شش ماه پس از تزریق
    #3
    Before injection, 2 weeks and 8 weeks after injection
    Before injection, two weeks , two months and six months after the injection
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، دو هفته , دوماه و شش ماه پس از تزریق
    #4
    synovial thickness
    Subacromial bursaThickness
    ضخامت سینوویوم
    ضخامت بورس شانه
    Before injection, 2 weeks and 8 weeks after injection
    Before injection, two weeks , two months and six months after the injection
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، دو هفته , دوماه و شش ماه پس از تزریق
    #5
    Partial tearing
    Constant Score
    پاره شدگی جزئی
    معیار constant
    Before injection, 1 weeks and 8 weeks after injection
    Before injection, two weeks , two months and six months after the injection
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    قبل از تزریق، دو هفته , دوماه و شش ماه پس از تزریق
    sonography
    Constant Score Questionnaire
    سونوگرافی
    پرسشنامه
    #6
    Liquid Thickness
    empty
    ضخامت مایع
    empty
    Before injection, 2 weeks and 8 weeks after injection
    empty
    قبل از تزریق، 2 هفته و 8 هفته بعد از تزریق
    empty
    sonography
    empty
    سونوگرافی
    empty

Protocol summary

Study aim
The effect of Sono-guided Oxygen-ozone/ corticosteroid and prolotherapy 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 two week , two months and six months after the 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: prospective

Last update: 2025-05-13, 1404/02/23
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
2019-05-10, 1398/02/20
Expected recruitment end date
2024-06-22, 1403/04/02
Actual recruitment start date
2019-05-10, 1398/02/20
Actual recruitment end date
2024-06-22, 1403/04/02
Trial completion date
2024-12-22, 1403/10/02
Scientific title
Comparing ultrasound guided injection of oxygen-ozone vs. corticosteroid vs. prolotherapy in the treatment of shoulder tendinopathy : a randomized, prospective, multicenter randomized clinical trial
Public title
Comparing local injection of ozone, corticosteroid and prolotherapy 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
Actual sample size reached: 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, two week , two months and six 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, two weeks , two months and six months after the injection
Method of measurement
Visual Analog Scale (VAS)

2

Description
Shoulder pain and disability
Timepoint
Before injection, two weeks , two months and six months after the injection
Method of measurement
Shoulder pain and disability index (SPADI)

Secondary outcomes

1

Description
Clinical Global Impression
Timepoint
Before injection, two weeks , two months and six months after the injection
Method of measurement
Clinical Global Impression Questionnaire

2

Description
Patient Global Impression of Improvement
Timepoint
Before injection, two weeks , two months and six months after the injection
Method of measurement
Patient Global Impression of Improvement Questionnaire

3

Description
shoulder rang of motiom
Timepoint
Before injection, two weeks , two months and six months after the injection
Method of measurement
goniometer

4

Description
Subacromial bursaThickness
Timepoint
Before injection, two weeks , two months and six months after the injection
Method of measurement
sonography

5

Description
Constant Score
Timepoint
Before injection, two weeks , two months and six months after the injection
Method of measurement
Constant Score Questionnaire

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
Loading...