Study of the long term 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
Chronic lateral elbow epicondylitis known as tennis elbow is an angiofibrolastic tendinosis involving the origin of wrist extensor muscles. Healing of this lesion is reported with the use of Autologous whole blood (AWB) and Platelet-rich plasma (PRP). We conducted this study to compare the effects of PRP with AWB local injection in patients with chronic tennis elbow.Fifty five patients with chronic lateral epicondylitis with duration of symptoms more than 3 months were randomly divided into 2 groups. Group 1 subjects received a single injection of 2mL of Autologous PRP and group 2 injected with 2mL of Autologous blood. Tennis elbow strap, stretching and strengthening exercises were administered for both groups during 2 month follow up. Pain and functional improvements were assessed using visual analog scale (VAS), Modified Mayo Clinic Performance Index (MMCPI) for the elbow and pressure pain threshold (PPT) at baseline and then at the end of 1,2,6 and 12months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100513442N3
Registration date:2013-11-05, 1392/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-05, 1392/08/14
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
Faculty of Medicine, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the long term 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 long term 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; patients with Hb values of 10; 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; radial neuropathy.
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
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 Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman St, Shahid Chamran Highway, Tehran,Iran
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
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
0,1,2,6,12 months
Method of measurement
VAS Questionnaire
Secondary outcomes
1
Description
elbow function
Timepoint
0,1,2 ,6,12 months
Method of measurement
Modified Mayo clinic performance index for the elbow Questionnaire
Intervention groups
1
Description
Tennis Elbow strap and wrist extensor strengthening exercises,2/day and 5times for each exercise and wrist extensors stretching exercises,2/day and 30sec for each exercise and 500mg/8h Acetaminophen PRN and an injection of 2cc autologous blood in control group
Category
Treatment - Drugs
2
Description
Tennis Elbow strap and wrist extensor strengthening exercises,2/day and 5times for each exercise and wrist extensors stretching exercises,2/day and 30sec for each exercise and 500mg/8h Acetaminophen PRN and an Injection of 2cc PRP in intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Rosa Rahimi
Street address
Saadat Abad, Yadegar e Emam Highway, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ethic Committe of Faculty of Medicine,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Dr. Rahmati Roodsari
Street address
Shahid Beheshti University of Medical Siences, Yaman St, Shahid Cjamran High Way, Tehran, Iran
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 Sciences