Comparison of Ultrasound-Guided Local Corticosteroid Injection versus Mesenchymal Stem Cell Origin of Adipocytes ( Allogeneic ) in patient with Rotator Cuff Tendinopathy
Comparison of the effect of ultrasound-guided corticosteroid injections with allogeneic mesenchymal stem cell in patients with rotator cuff tendonitis in the shoulder
Design
Subacromial injection of 1 cc equivalent of forty mg triamcinolone with 1 cc lidocaine is performed in a bursa near the parietal rupture, gage 22 and ultrasound guidance.In the other group allogeneic mesenchymal stem cells are injected 30 × 106 mesenchymal stem cells are injected 1 cc with 1 cc lidocaine in sterile conditions in the area with partial rupture.
Settings and conduct
Patients with shoulder tendonopathy are selected from referrals to physical medicine clinics of Iran University of Medical Sciences.Patients were randomly divided into two groups, each with a closed envelope method.
Participants/Inclusion and exclusion criteria
Main Inclusion Criteria: Tendinopathy in patients with positive shoulder specific tests including: Neer test, Hawkins test
VAS more than 4; no history of poor control of diabetes, coagulopathy, fractures, rheumatologic diseases, tumors and systemic infections , Not having shoulder injection in last 4 months.
Main Exclusion Criteria: Patients who cannot be referred for follow-up by any other means, complete rotator cuff rupture, possibility of cervical radiculopathy, myofacial trigger point
Intervention groups
Intervention group: Allogeneic Stem Cell Injection in the area with partial rupture with Ultrasound-guided Lateral Approach. Control group: Ultrasound-guided injection of corticosteroid in the subacromial space with the lateral approach.
Main outcome variables
The severity of symptoms by Visual Analog Scale (VAS) , Shoulder Disability by
Quick Disabilities of Arm, Shoulder & Hand (Quick DASH)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151017024572N21
Registration date:2020-01-09, 1398/10/19
Registration timing:prospective
Last update:2020-01-09, 1398/10/19
Update count:0
Registration date
2020-01-09, 1398/10/19
Registrant information
Name
Arash Babaei-Ghazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 8991
Email address
babaei-ghazani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ultrasound-Guided Local Corticosteroid Injection versus Mesenchymal Stem Cell Origin of Adipocytes ( Allogeneic ) in patient with Rotator Cuff Tendinopathy
Public title
Effect of Mesenchimal Stem Cell in Rotator Cuff Tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of tendinopathy in patients with positive shoulder specific tests including: Neer test, Hawkins test
Visual Analogue Scale more than 4
Lack of history of poor control Diabetes, coagulopathy, fractures, rheumatologic diseases, tumors and systemic disease infection
No history of shoulder injections in the last 4 months
Patient's age 18 to 65 years
No pregnancy or decision to become pregnant
Lack of risk factor for intra articular injection such as coagulation disorders or Use of anticoagulants
Lack of mental disorder
Patient willingness to participate in research project
Exclusion criteria:
Patients who have not been followed for any reason
Changes in the patient's treatment according to the physician or Other treatment by the patient during the study
History of shoulder surgery
Complete rotator cuff rupture
History of cervical radiculopathy
Myofascial trigger points
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: block,
Unit of randomization: individual,
Tools used in randomization: table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study in which patients and outcomes analyzer are blinded.
In order to blind the patient, it is said that both materials are effective for treatment, but the type of substance is not mentioned for patients when its injected. In order to blind the analyzer, the persons responsible for injection and data collection are different from the outcome assessors.
Placebo
Not used
Assignment
Parallel
Other design features
Block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran Universiy of Medical Science
Street address
Medical faculty, Iran University of Medical Sience, Hemmat High way
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.IUMS.REC.1398.081
Health conditions studied
1
Description of health condition studied
Shoulder tendinopathy
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
The severity of symptoms
Timepoint
Zero, two weeks , three months , six months later (Since the injection)
Method of measurement
Visual Analog Scale (VAS)
2
Description
Shoulder Pain and Disability
Timepoint
Zero, two weeks , three months , six months later (Since the injection)
Method of measurement
Quick Disabilities of Arm, Shoulder & Hand (Quick DASH)
Secondary outcomes
1
Description
Side effects
Timepoint
30 minutes and tow weeks (Since the injection)
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Allogeneic Stem Cell Injection in the area with partial rupture with Ultrasound-guided Lateral Approach
Category
Treatment - Other
2
Description
Control group: Ultrasound-guided injection of corticosteroid in the subacromial space with the lateral approach.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Nariman samadaeian
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
Nariman.samadaeian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakooti
Street address
5th floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8862 2553
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nariman samadaeian
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
nariman.samadaeian@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 82141229
Email
babaei-ghazani.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nariman Samadaeian
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 82141201
Email
nariman.samadaeian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD