1. Home
  2. Approved trials
  3. » فارسی

A comparison between corticosteroid injection versus local anaesthetic in treatment of lateral epicondylitis

Protocol summary

Summary
1) objectives: A comparison between corticosteroid injection versus loanaesthetic in treatment of lateral epicondylitis. 2) Design: Randomizedcal clinical trial. 3) Setting and conduct: Group A will receive Corticosteroid injection (Methyl-prednisolon acetate 1 ml) single dose into the painfull zone, Group B will receive a local anesthesia (procaine 2% 1 ml). VAS and Quick DASH questionnaires will completed at the baseline, and then 3, 6, 12 weeks after treatment. Also, each patient will fill demographic questionnaire including age, gender, first refer time, involved hand, dominant hand and characteristic of disease.4) Inclusion criteria: chronic pain in lateral zone of elbow, definite tenderness in lateral epicondylitis, age more than 15 years, and VAS score more than 6. exclusion criteria: radicular pain to the upper limbs, established Carpal Tunnel Syndrome, and past history of tennis elbow treatment. 5) Intervention: Group A will receive Corticosteroid injection (Methyl-prednisolon acetate 1 ml) single dose into the painfull zone, Group B will receive a local anesthesia (procaine 2% 1 ml). 6) Main outcome measures: primary outcome is Survey of the elbow inability level measured with DASH questionnaire and secondary outcome is pain score that measured with VAS questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205127274N4
Registration date: 2012-05-30, 1391/03/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-30, 1391/03/10
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-07-23, 1391/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between corticosteroid injection versus local anaesthetic in treatment of lateral epicondylitis
Public title
A comparison between corticosteroid injection versus local anaesthetic in treatment of elbow tendinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:chronic pain in lateral zone of elbow; definite tenderness in lateral epicondylitis; age more than 15 years and VAS score more than 6. Exclusion criteria: radicular pain to the upper limbs; established Carpal Tunnel Syndrome and past history of tennis elbow treatment.
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Guilan University of Medical Science
Street address
Vice Chancellor for Research, Guilan University of Medical Sciences, Namjou Avenue
City
Rasht
Postal code
Approval date
2012-04-17, 1391/01/29
Ethics committee reference number
1910051505

Health conditions studied

1

Description of health condition studied
Lateral epicondylitis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Disability of elbow score
Timepoint
At baseline, and 3, 6, 12 weeks after treatment
Method of measurement
The Disabilities of the Arm, Shoulder and Hand Score(QuickDash)

Secondary outcomes

1

Description
Pain severity
Timepoint
At baseline, and 3, 6, 12 weeks after treatment
Method of measurement
Value-added service (VAS) score

Intervention groups

1

Description
Group 2: Corticosteroid (Methyl-prednisolon acetate 1 ml) injection single dose into the painful zone
Category
Treatment - Drugs

2

Description
Group 1: injection of a local anesthesia (procaine 2% 1 ml)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam-Reza Clinic of Poursina Hospital
Full name of responsible person
Dr Mohsen Mardani Kivi
Street address
Imam-Reza Clinic, Poursina Hospital, Parastar Avenue
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasoul Sobhani, Research Chancellor of Guilan University of Medical Science
Street address
Vice Chancellor for Research, Guilan University of Medical Sciences, Namjou Avenue
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Guilan University of Medical Sciences
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
Guilan University of Medical Science
Full name of responsible person
Dr. Mohsen Mardani Kivi
Position
Assistant Professor
Other areas of specialty/work
Street address
Orthopedic Department, Poursina Hospital, Parastar Avenue.
City
Rasht
Postal code
Phone
+98 13 1321 1470
Fax
Email
dr_mohsen_mardani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Dr. Mohsen Mardani Kivi
Position
Assistant Professor
Other areas of specialty/work
Street address
Orthopedic Department, Poursina Hospital, Parastar avenue.
City
Rasht
Postal code
Phone
+98 13 1321 1470
Fax
Email
dr_mohsen_mardani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Mardani Kivi
Position
Orthopedic Surgeon, Assistant Professor
Other areas of specialty/work
Street address
Orthopedic Department, Poursina Hospital, Parastar Avenue
City
Rasht
Postal code
Phone
00
Fax
Email
dr_mohsen_mardani@yahoo.com
Web page address

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
Loading...