Study of the effects of local platelet-rich plasma (PRP) injection versus autologous blood injection in patients with lateral epicondylitis in PM & R clinic of Modarres hospital from 2011 to 2013
This study was designed to compare the effects of PRP and autologous blood injection in patients with chronic lateral epicondylitis .45 patients with chronic lateral epicondylitis and intractable pain were divided equally into 2 groups,group A and group B.Group A was treated with a single injection of 2 ml of PRP and group B with 2 ml autologous blood . Both groups used tennis elbow band and did stretching and strengthening exercises during 2 months of follow up. Pain visual analog scale (VAS), Mayo score (Modified Mayo clinic performance index for the elbow ) and Pressure pain threshold (PPT) were evaluated at the beginning ,4 and 8 weeks after treatments .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052313442N1
Registration date:2013-06-06, 1392/03/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-06, 1392/03/16
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of faculty of medicine,Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of local platelet-rich plasma (PRP) injection versus autologous blood injection in patients with lateral epicondylitis in PM & R clinic of Modarres hospital from 2011 to 2013
Public title
Study of the effects of local platelet-rich plasma (PRP) injection versus autologous blood injection in patients with lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of chronic (at least 3months) pain or swelling of the lateral epicondyle and pain more than 5 of 10 according to visual analogue scale. Exclusion criteria: systemic disorders such as diabetes, rheumatoid arthritis, hematological diseases (coagulopathy), severe cardiovascular diseases, infections, immunosuppression, patients in therapy with anticoagulants or antiaggregants, the use of NSAIDs in the 2 days before blood donation and patients with Hb values of 10 and platelet values of 100,000/mmc; Pregnancy; vasovagal shock; injection of corticosteroid in since 2 weeks ago;any injection in site of tenderness since 1 month ago;malignancy;history of CTS,cervical radiculopathy or radial neuropathy.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of faculty of medicine,Shahid beheshti University of Medical siences
Street address
Shahid beheshti University of Medical siences,Velenjak
City
Tehran
Postal code
1985717443
Approval date
2012-11-28, 1391/09/08
Ethics committee reference number
12007
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
0,1,2 month
Method of measurement
VAS Questionnaire
Secondary outcomes
1
Description
elbow function
Timepoint
0,1,2 month
Method of measurement
Modified Mayo clinic performance index for the elbow Questionnaire
2
Description
Pressure pain threshold
Timepoint
0,1,2 month
Method of measurement
Algometer sundoo
Intervention groups
1
Description
An Injection of 2cc PRP or autologous blood
Category
Treatment - Drugs
2
Description
Rest,Tennis elbow strap,Acetaminophen,Wrist extensors stretching and strengthening exercises
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Rosa Rahimi
Street address
Saadat Abad-Kaj sqr-Shahid Modarres Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ethic committe of faculty of medicine,Shahid beheshti University of Medical siences
Full name of responsible person
Vice chancellor for research, Dr. Rahmati Roodsari
Street address
Tehran-Shahid Chamran highway-Velenjak-Shahid Beheshti university of Medical siences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ethic committe of faculty of medicine,Shahid beheshti University of Medical siences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Modarres hospital
Full name of responsible person
Rosa Rahimi
Position
Resident
Other areas of specialty/work
Street address
Saadat abad-Kaj sqr-Shahid Modarres hospital
City
Tehran
Postal code
Phone
+98 21220740909
Fax
Email
rosarahimi@gmal.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Modarres hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Position
assistant professor
Other areas of specialty/work
Street address
Saadat Abad-Kaj sqr-Shahid Modarres hospital
City
Tehran
Postal code
Phone
+98 21220740909
Fax
Email
a_raeissadat@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)