In this study we are aiming to investigate the therapeutic effect of Adipose-derived Stromal Vascular Fraction on the management of lateral epicondylitis (tennis elbow).
Design
A randomized controlled trial with two parallel groups
Settings and conduct
In this randomized clinical trial 54 people diagnosed with chronic external epicondylitis according to the inclusion and exclusion of the study, will be randomly assigned in two groups of SVF (intervention) and the control group with a ratio of 1:1. Injections will be performed in the external epicondyle area. The person assessing the results and the statistical analyst will be blinded to the patient groups.
Participants/Inclusion and exclusion criteria
The main inclusion criteria include: a minimum of four months must have passed since the onset of pain and conservative treatment must have proven ineffective. A minimum of two months must have passed since the last corticosteroid injection.
Main exclusion criteria include history of cardiovascular disease such as previous Myocardial Infarction or heart failure; Coagulopathies such as disrupted PT, PTT, INR and elbow pain caused by other musculoskeletal diseases such as rheumatoid arthritis.
Intervention groups
From group A patients, first about 100 mL of adipose tissue is taken in a sterile form through liposuction of the abdominal area. Then, after the cell separation process, the obtained nano fat will be used for injection. Group B patients will receive corticosteroids and normal saline as a control group.
Main outcome variables
The main variable will be elbow function, which is measured based on the QuickDASH (Disabilities of the Arm, Shoulder and Hand) and Mayo Elbow Performance Index questionnaires.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221104056393N3
Registration date:2024-01-11, 1402/10/21
Registration timing:registered_while_recruiting
Last update:2024-01-11, 1402/10/21
Update count:0
Registration date
2024-01-11, 1402/10/21
Registrant information
Name
Pooya Hosseini-Monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 1072
Email address
pomonfared@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of Adipose-derived Stromal Vascular Fraction on Lateral Epicondylitis (Tennis Elbow) disease, A randomized controlled trial
Public title
Therapeutic effect of Adipose-derived Stromal Vascular Fraction on Lateral Epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 4 months passed since onset of pain
not responding to conservative therapy for 3 months
A history of one unsuccessful corticosteroid or PRP injection in the past 3 months (at least 2 months have passed since the injection)
The patient has the ability to understand the explanations and registers his oral and written desire in the informed consent form.
Exclusion criteria:
Any history of an injection in the elbow during the past 2 months
History of cardiovascular disease such as previous myocardial infarction or heart failure
Coagulopathies such as disrupted PT, PTT, INR
Pregnancy or breastfeeding
Drug users or alcoholics
Elbow pain due to other musculoskeletal diseases such as rheumatoid arthritis, fibromyalgia, etc.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized clinical trial study, randomization is carried out by the 4-way box method in which 2 chances are considered for each group, and 2 out of 4 people are randomly entered into each group by the order of visiting the clinic.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, due to the need for liposuction in the Stromal Vascular Fraction (SVF) group, it is not possible to blind the patients to the type of treatment, but the person who collects the patient's information and also the person who analyzes the final data will be blinded to the group allocation.
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
Azar dead end alley, Sharifi Manesh street., Pole Roomi, Tajrish
City
Tehran
Province
Tehran
Postal code
1964714953
Approval date
2023-11-01, 1402/08/10
Ethics committee reference number
IR.SBMU.SRC.REC.1402.020
Health conditions studied
1
Description of health condition studied
Lateral epicondylitis
ICD-10 code
M77.10
ICD-10 code description
Lateral epicondylitis, unspecified elbow
Primary outcomes
1
Description
Elbow function
Timepoint
Before the intervention, 1, 3, 6 months after the intervention
Method of measurement
QuickDASH and MEPI questionnaire
Secondary outcomes
1
Description
The patient's pain level
Timepoint
Before the intervention, 1, 3, 6 months after the intervention
Method of measurement
VAS questionnaire
2
Description
Radiological evaluation of the lesion in the form of CEO tendon lesion measurement
Timepoint
Before the intervention, 6 months after the intervention
Method of measurement
MRI examination by a radiologist
Intervention groups
1
Description
About 100 mL of adipose tissue is taken under sterile condition through liposuction of the abdomen. The obtained fat will be emulsified by passing through 2.4 mm, 1.2 mm filters and finally a 400 and 600 micrometer filter (25-30 passes). In order to separate free fatty acids, these nanofats are centrifuged (for 2 minutes at 1200 rpm) and the separated fatty acids will be discarded. The number of cells in the remaining substance will be counted under the microscope. The obtained nanofat will be used for injection. The injection will be done for all patients in the external epicondyle area.
Category
Treatment - Other
2
Description
Control group: Patients in the control group will receive corticosteroids and normal saline.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Reza Robati
Street address
Shohada Tajrish Educational Medical Center, Shahrdari St, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
rezarobati@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Third floor, School of Medicine, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2243 9951
Email
rezarobati@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
Reza Robati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohada Tajrish Educational Medical Center, Shahrdari St, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
rezarobati@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Robati
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Shohada Tajrish Educational Medical Center, Shahrdari St, Tajrish Sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1507
Email
rezarobati@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pooya Hosseini-Monfared
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Clinical Research and Development Unit, Akhtar Orthopedic Hospital, Shahid Beheshti University of Medial Science, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Fax
Email
pomonfared@sbmu.ac.ir
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
Undecided - It is not yet known if there will be 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
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared after
making the individuals undetectable
When the data will become available and for how long
Access will be granted 6 months after the results of the
study are published.
To whom data/document is available
Researchers and medical specialist
Under which criteria data/document could be used
based on the Ministry of Health and Medical Education
criteria for clinical trials
From where data/document is obtainable
Dr. Reza Robati, Dermatology research center, Tajrish, Tehran
What processes are involved for a request to access data/document
The data that support the findings of this study will be available on request from the corresponding author. The data will not be publicly available due to privacy and ethical considerations.