Protocol summary

Summary
Lateral epicondylitis or tennis elbow is a common problem in orthopedic clinics. The aim of this study was to compare treatment effects of autologous blood injection with local corticosteroid injection in patients with lateral epicondylitis. 60 patients suffering from lateral epicondylitis who admitted to the army hospital No: 501 during years 2007-2008 (1386-1387) were randomly assigned into two equal groups. The treatment protocol was single local injection of Methyl Prednisolone (20mg) and 2% Lidocaine (1cc) for group I and local injection of 2cc of autologous blood (which obtained from distal site of the same hand) in conjunction with 1cc of 2%, lidocaine for group II. The demographic data, upper limb pain during last 24 hours, upper limb function during last 24 hours and maximum pain while gripping (VAS) and Pain threshold in examination site was measured and maximum strength of gripping was assessed, the Modified Nirscle stage and the Quick DASH questionnaire was completed at the admission time, 4 and 8 weeks after treatment session.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138711191658N1
Registration date: 2009-04-05, 1388/01/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-04-05, 1388/01/16
Registrant information
Name
Ali Panahi
Name of organization / entity
Army Medical University
Country
Iran (Islamic Republic of)
Phone
+98 669436822198
Email address
drpanahi@irimc.org
Recruitment status
Recruitment complete
Funding source
Army University of Medical Scince
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2008-09-22, 1387/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of local corticosteroid injection with autologous blood injection in the treatment of Lateral epicondylitis
Public title
Comparison of effectiveness of local corticosteroid injection with autologous blood injection in the treatment of Lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:new episode of disease, severe limitation of activity, pain in lateral epicondyle on working, maximum tenderness at ECRB muscle near lat epicondyle(10-15 mm distance), positive coffee test, presence of tenderness distal to lateral epicondyle Exclusion criteria:history of inflammatory diseases. pregnancy or lactation, history of surgery for the present problem, articular deformity, steroid injection(during last 3 month), history of trauma to elbow, use of brace, recieving NSAID
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Army University of Medical Scinces, 501 Hospital
Street address
Army University of Medical Scince, 501 Hospital, Etemad zadeh st. Fatemi Ave.
City
Tehran
Postal code
1411846355
Approval date
2008-01-27, 1386/11/07
Ethics committee reference number
48/1/9158/2ج/الف

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 of upper limb during 24 hr prior to intervention
Timepoint
Before intervention ,1 and 2 month(s) after intervention
Method of measurement
VAS

2

Description
Upper limb function in 24 hr prior to intervention
Timepoint
Before intervention ,1 and 2 month(s) after intervention
Method of measurement
Quick DASH

3

Description
Maximum pain in powerful grip
Timepoint
Before intervention ,1 and 2 month(s) after intervention
Method of measurement
VAS

4

Description
Pain threshold on examination site
Timepoint
Before intervention ,1 and 2 month(s) after intervention
Method of measurement
Algometer

5

Description
Maximum power of hand grip
Timepoint
Before intervention ,1 and 2 month(s) after intervention
Method of measurement
Dynamometer

6

Description
Upper limb function on manual works
Timepoint
Before intervention ,1 and 2 month(s) after intervention
Method of measurement
Modified Nirschl stage

Secondary outcomes

empty

Intervention groups

1

Description
Single local injection of Methyl Prednisolone (20mg) and Lidocaine 2%(1cc)
Category
Treatment - Drugs

2

Description
Local injection of 2cc of autologous blood with 1cc of lidocaine2%
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Army University of Medical Scince, 501 Hospital
Full name of responsible person
Dr. Marzieh Kazemi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Army University of Medical Scince
Full name of responsible person
Dr marziyeh kazemi
Street address
Army University of Medical Scince, 501 Hospital, Etemad zadeh st. Fatemi Ave.
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Army University of Medical Scince
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
Army University of Medical Scinces, 501 Hospital
Full name of responsible person
Dr. Marzieh Kazemi
Position
Resident of Physical Medicine And Rehabilitaiton
Other areas of specialty/work
Street address
No. 5 Babak alley North Sindokht St. West Fatemi Ave.
City
Tehran
Postal code
1411846355
Phone
Fax
Email
mkazemi77@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Army University of Medical Scince, 501 Hospital
Full name of responsible person
Dr. Marzieh Kazemi
Position
Resident of Physical Medicine And Rehabilitaiton
Other areas of specialty/work
Street address
No. 5, babak alley ,north sindokht St. ,west fatemi Ave.
City
Tehran
Postal code
1411846355
Phone
Fax
Email
mkazemi77@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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