Evaluation of the effectiveness of autologous blood transfusion and dry needling in the treatment of refractory tennis elbow
Design
Clinical trial with control group with parallel, randomized groups, phase 3 on 34patients. The random number table was used for randomization
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. Patients are randomly divided into two groups. The first group will be treated with dry needling method and the second group will be treated with Autologus Blood Injection method. Patients' pain will be measured and compared 1 month and 3 months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients 18-70 years old, Pain in the external epicondyle with local tenderness, Positive one of cozen's or middle finger extention tests, History of lateral conservative treatment of epicondylitis and failure to respond to treatment. Exclusion criteria: History of lateral elbow surgery, Patients with chronic regional pain syndrome Inflammatory arthritis or autoimmune diseases, Patients with lateral collateral ligament rupture, Patients with a history of elbow and forearm fractures.
Intervention groups
Intervention group: Patients in this group will be treated with dry needling method. This technique is performed using Hong’s fast-in, fast out method and using filament needles 0.30 in 50 mm 20 times in the specified position. Patients in the other group will be treated with the Autologus Blood Injection method. 3 ml of patients' blood is taken from the contralateral antecubital area. The patients 'blood is shaken gently to prevent clotting, and then the same 3 ml of the patients' autologous whole blood is injected at the tenderness site. Patients' pain is measured 1 month and 3 months later by a questionnaire.
Main outcome variables
Elbow pain in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N3
Registration date:2020-08-21, 1399/05/31
Registration timing:registered_while_recruiting
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of autologous blood injection and dry needling in the treatment of refractory tennis elbow
Public title
Treatment of refractory tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in the external epicondyle with local tenderness
Positive one of cozen's or middle finger extention tests
History of lateral conservative treatment of epicondylitis and failure to respond to treatment
Exclusion criteria:
History of lateral elbow surgery
Patients with chronic regional pain syndrome Inflammatory arthritis or autoimmune diseases
Patients with lateral collateral ligament rupture
Patients with a history of elbow and forearm fractures
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, table of random numbers. In this study, reading the table of predefined random numbers (eg, up or down) and the researcher's second default is to consider even numbers for intervention group .
The researcher begins to read the numbers in a predetermined manner and the patients are divided.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of Medical sciences
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۳۷۸۶۶۵۱۵
Approval date
2020-04-19, 1399/01/31
Ethics committee reference number
IR.MUI.MED.REC.1399.060
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
1 month and 3 months after intervention
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group will be treated with dry needling method. This technique is performed using Hong’s fast-in, fast out method and using filament needles 0.30 in 50 mm 20 times in the specified position. Patients' pain is measured 1 month and 3 months later by a questionnaire.
Category
Treatment - Devices
2
Description
Intervention group: Patients in this group will be treated with the Autologus Blood Injection method. 3 ml of patients' blood is taken from the contralateral antecubital area. The patients 'blood is shaken gently to prevent clotting, and then the same 3 ml of the patients' autologous whole blood is injected at the tenderness site. Patients' pain is measured 1 month and 3 months later by a questionnaire.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Razieh Maghroori
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
ramaghroori@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Razieh Maghroori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3337 7986
Email
ramaghroori@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Razieh Maghroori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Phone
+98 31 3337 7986
Email
ramaghroori@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Razieh Maghroori
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8137866515
Phone
+98 31 3337 7986
Email
ramaghroori@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.