Protocol summary

Study aim
Determining the effect of corticosteroid injection with and without needling in the treatment of patients with external epicondylitis (tennis elbo)
Design
A clinical trial with two parallel, double-blind, randomized groups was performed on 90 patients using a random number table.
Settings and conduct
A clinical trial with two parallel, double-blind, randomized groups was performed on 90 patients using a random number table.This study is performed in Yazd. In this study, people are divided into two groups of injection with needling and injection alone. In the intervention group, corticosteroid injection is performed along with needling that with the same needle head as the injection intermittent movements of the needle in and out injure the bone cortex to cause local bleeding at the site.This operation was continued for one minute . In the injection group, injection was performed within 15 seconds without needling. The patient's pain is assessed three months and six months after the injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all people who are ill and suffering from tennis elbow; Eligible for the injection of cortico steroids Exclusion criteria: history of rheumatic disease; upper limb problems
Intervention groups
In this study, people are divided into two groups of injection with needling and injection alone. In the intervention group, corticosteroid injection is performed along with needling that with the same needle head as the injection intermittent movements of the needle in and out injure the bone cortex to cause local bleeding at the site.This operation was continued for one minute . In the injection group, injection was performed within 15 seconds without needling .
Main outcome variables
The patient's pain during 3 months and 6 months after injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161225031559N4
Registration date: 2021-10-09, 1400/07/17
Registration timing: retrospective

Last update: 2021-10-09, 1400/07/17
Update count: 0
Registration date
2021-10-09, 1400/07/17
Registrant information
Name
Seyed Hossein Saeed-Banadaky
Name of organization / entity
Shahid Sadoughi Medical University
Country
Iran (Islamic Republic of)
Phone
+98 35 3626 0001
Email address
saeed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
2020-05-21, 1399/03/01
Actual recruitment end date
2021-03-10, 1399/12/20
Trial completion date
2021-03-10, 1399/12/20
Scientific title
The effect of corticosteroid injection with and without needle on pain intensity in patients with tennis elbow
Public title
The effect of corticosteroid injection with and without needle on pain intensity in patients with tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people using active resisted extension painful wrist test and local tendernes in latral condyle of humerus that have been given a clinical diagnosis of Albo tennis disease And did not respond to conservative treatment
Exclusion criteria:
Concomitant diseases such as radiculopathy History of previous surgery or limb trauma Positive radiographic evidence such as DJD
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Using table of random numbers, 45 patients will be allocated to each of the intervention and control groups. Each participant will be given a number from 1 to 90. One row and one column will be randomly chosen from the table of random numbers; the intersection between this row and column will be the starting point for sampling. A finger will be put on the starting point and will be moved downwards through the table. Because there should be 45 participants in the intervention group and 45 participants in the control group, the two digits at the right side of each number in the table will be considered. The moving of finger will be repeated until 45 participants of the intervention group will be chosen. Duplicate numbers and numbers larger than 90 will not be considered. In this way, it will be found out that which 45 numbers among all of the 90 numbers given to the whoke participants will be allocated to the intervention group (e.g. numbers 3, 4, 9, 11, 13, 14, ...). The remaining 45 participants will be automatically put in the control group. After randomization, each of the 90 numbers will be matched with one of the treatment arms. Each treatment arm will be allocated the letter A or B and these letters will be put in an opaque and sealed pocket. The researcher and the patient will not know any type of injection and only the injecting physician will be aware of the contents of the envelopes and the type of injection.
Blinding (investigator's opinion)
Double blinded
Blinding description
The type of treatment assigned will be indicated by the letters A or B. Only the injecting physician knows the type of treatment. The researcher and the patient are unaware of the type of injection
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Sq, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.051

Health conditions studied

1

Description of health condition studied
latral epicondylitis (tennis elbow)
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
Patient pain rate
Timepoint
3 months and 6 months after injection
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Local corticosteroid injection +1 cc lidocain at the lateral epicondyle of humerus with in sito needling as long as one minute.
Category
Treatment - Other

2

Description
Control group: Local corticosteroid injection +1 cc lidocain at the lateral epicondyle of humerus
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sadra Clinic
Full name of responsible person
Mohammad Hosein Besharati
Street address
Hana Street, Taleghani Aveniue
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3626 0000
Email
saeed@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Hosein Besharati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Email
besharati.mm@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Hossein Saeed Banadaki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Email
h.saeed.b@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Hossein Saeed Banadaki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Email
h.saeed.b@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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