Determine the effectiveness of shock wave combination therapy and local corticosteroid with shock wave alone on severity of pain and grip strength in patients with lateral epicondylitis
Design
A clinical trial with a control group, with a parallel group, double blind, randomized
Settings and conduct
This study is performed on 70 people in Physical medicine clinics affiliated to Isfahan University of Medical Sciences. Patients are initially examined by a physical medicine specialist and, if there is a typical biography, tenderness is placed at the site of the extensor tendons to the lateral epicondyl, and at least one of the relevant tests (Thamsen test and Maudsley, s test) is diagnosed. Both groups of patients receive routine lateral epicondylitis treatment with Scan View 3 sessions per week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years؛ Duration of the disease is more than 3 months؛ Failure to respond to a non-invasive conservative treatment؛ Exclusion criteria: Patient dissatisfaction; pregnancy during the course of treatment; malignant infections or need surgery in the arterial region; arthritis; generalized polyarthritis; dysfunction of the shoulder on the same side
Intervention groups
In the study, one group received topical clobutazol ointment and another group received a vaseline.
Main outcome variables
Pain intensity; grip strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N8
Registration date:2019-05-04, 1398/02/14
Registration timing:prospective
Last update:2019-05-04, 1398/02/14
Update count:0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of shock wave therapy combined with topical corticostreroid on severity of pain and grip strenght of patient with lateral epicondylitis.
Public title
Effect of sockwave and corticosteroid on epicondylitis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Duration of the disease is more than 3 months
Failure to respond to a non-invasive conservative treatment
Exclusion criteria:
Patient dissatisfaction
pregnancy during the course of treatment
malignant infections or need surgery in the arterial region
arthritis
eneralized polyarthritis
dysfunction of the shoulder on the same side
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of the two groups by selecting the cards named A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The topical clobetasol ointment and vaseline are coded by similar collaborators in the same packages, and the first group is packed with the code A and the second group receives the packet B of the packet with closed bandages, so that the participants and the researchers are blind to the contents of the packets.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-03-18, 1397/12/27
Ethics committee reference number
IR.MUI.MED.REC.1398.011
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 intensity
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Graded line of Visual Analogue Scale (VAS)
2
Description
Grip strength
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: treated with shockwave with topical clobutazol half an hour before the shockwave meetings. Patients undergoing lateral epicondylitis routine treatment with shockwave receive 3 sessions per week.ointment
Category
Treatment - Devices
2
Description
Control group: Treated a shockwave with vaseline half an hour before the shockwave meetings. Patients undergoing lateral epicondylitis routine treatment with shockwave receive 3 sessions per week.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy and Rehabilitation Clinics of Isfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Street address
Office of Physical Medicine and Rehabilitation, Al-Zahra Educational Center, ,Sofe St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
vahdatpour@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
Farajzadegan@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
Babak Vahdatpour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
vahdatpour@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
vahdatpour@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
vahdatpour@med.mui.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Department of Physical Medicine and Rehabilitation
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.