Comparing the effects of Platelet-Rich Plasma with Corticosteroid injection in resistant tennis elbow patients to Nonsurgical treatment
Design
Two arm parallel group randomised trial without blinded postoperative care and outcome assessment.sampling size is 36 patients that is divided to 2 group of 18 patients
Settings and conduct
Shahid Madani academic medicinal center
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with lateral epicondylitis and related functional impairments diagnosed.That is patients who after six weeks of *non - surgical care such as resting, avoiding severe activities, Behavior reform, physical therapy, Non Steroid Anti Inflammatory Drug (NSAID)
by resisted wrist extension test in forearm pronation and elbow extension VAS score=5 or more symptoms lasting for at least 3 months
Exclusion criteria:
Age of 70 years old or more
History of infectious diseases or fever in recent days
History of any malignancies
Diagnosed carpal tunnel syndrome or any other peripheral nerve lesions or cervical radiculopathy
Systemic diseases such as ischemic heart disease, diabetes mellitus, rheumatoid arthritis or hepatitis
Any bone malformations or bone injuries in humerus or elbow joint
History of autoimmune diseases
History of Platelet dysfunction
using anti platelet medications during last 10 days or using NSAIDs during last 48 hours before injection
Using steroids during last 3 weeks
Hb=10 or less
patients with platelet count less than 150000
History of vasovagal reaction
Pregnency or breast feeding
Intervention groups
The injection of 40 mg of Prednisolone acetate in the control group and the injection of two mL of Platelet - Rich Plasma obtained from the patient's blood centrifuge (intervention group)) at the maximum tenderness point in the peppering method
Main outcome variables
Pain؛ function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191105045335N1
Registration date:2020-05-29, 1399/03/09
Registration timing:registered_while_recruiting
Last update:2020-05-29, 1399/03/09
Update count:0
Registration date
2020-05-29, 1399/03/09
Registrant information
Name
Fatemeh Ochi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3350 9825
Email address
lamy@chmail.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Platelet-rich plasma (PRP) with Corticosteroid injection in resistant tennis Elbow patients to non-surgical treatment
Public title
Comparing the effects of Platelet-rich plasma (PRP) with Corticosteroid injection in resistant tennis Elbow patients to non-surgical treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with lateral epicondylitis and related functional impairments after six weeks of *non - surgical care such as resting, avoiding severe activities, Behavior reform, physical therapy, Non Steroid Anti Inflammatory Drug (NSAID)
In physical examination, resisted wrist extension test in forearm pronation and elbow extension, VAS score=5 or more symptoms lasting for at least 3 months
Exclusion criteria:
Age of 70 years old or more
History of infectious diseases or fever in recent days
History of any malignancies
Diagnosed carpal tunnel syndrome or any other peripheral nerve lesions or cervical radiculopathy
Systemic diseases such as ischemic heart disease, diabetes mellitus, rheumatoid arthritis or hepatitis
Any bone malformations or bone injuries in humerus or elbow joint
History of autoimmune diseases
History of Platelet dysfunction
using anti platelet medications during last 10 days or using NSAIDs during last 48 hours before injection
Using steroids during last 3 weeks
Hb=10 or less
patients with platelet count less than 150000
History of vasovagal reaction
Pregnency or breast feeding
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups based on random numbers. In (random digits table) the numbers are rounded up to 9 in row and columns.The order to extract and adjust these numbers is made entirely by the computer.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Deputy of research and technology ,Shahid Saffarian Ave, Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.ABZUMS.REC.1399.036
Health conditions studied
1
Description of health condition studied
Lateral epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
pain
Timepoint
before injection, 2week ,1 and 3 months after injection
Method of measurement
Visual analogue scale (VAS)
2
Description
function
Timepoint
before injection, 2week ,1 and 3 months after injection
Method of measurement
Disabilities of the Arm, Shoulder and Hand (DASH) score
Secondary outcomes
1
Description
side effects of injection
Timepoint
2week,1 and 3 months after injection
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: the injection of two mL Platelet - Rich Plasma, obtained from the patient's blood centrifuge, at the maximum tenderness point by peppering method.
Category
Treatment - Drugs
2
Description
Control group: The injection of 40 mg of Prednisolone acetate at the maximum tenderness point using peppering method.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani hospital
Full name of responsible person
Salman Azarsina
Street address
Jahanshahr
City
Karaj
Province
Alborz
Postal code
3198688381
Phone
+98 26 3441 2841
Email
azarsina1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Noori Sepehr
Street address
Deputy of research and technology ,Shahid Saffarian Ave, Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Ochi Ardebili
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No,74-Shahid Ali Hatami Ave-Golshahr
City
Karaj
Province
Alborz
Postal code
3198688381
Phone
+98 26 3350 9825
Email
lamy@chmail.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Arvin Najfi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Shahid Madani hospital-Jahanshahr
City
Karaj
Province
Alborz
Postal code
3198688381
Phone
+98 26 3441 2841
Email
Parsmedicine@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Ochi Ardebili
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No,74-Shahid Ali Hatami Ave-Golshahr
City
Karaj
Province
Alborz
Postal code
3198688381
Phone
+98 26 3350 9825
Email
lamy@chmail.ir
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