Design and construction of Dorsal forearm- wrist splint and compare with Dorsal Wrist cock-up splint and theirs effects on pain and grip force and function in patients with tennis elbow
Design and construction of Dorsal forearm- wrist splint and compare with Dorsal Wrist cock-up splint and theirs effects on pain and grip force and function in patients with tennis elbow
Design
This prospective study is a randomized clinical trial with parallel groups.
Settings and conduct
Sampling will be done in a simple and accessible way among the people who have the conditions to enter our study who have referred to the technical orthopedic clinics in Isfahan and the orthopedic specialist.
Participants/Inclusion and exclusion criteria
Pain rate, grip strength, function by VAS test, dynamometer, (Nine hole peg test) on patients with eligible patients who have referred to technical orthopedic clinics in Isfahan and orthopedic physicians, respectively. it is going to happen. The study will be performed on 28 people, which has been calculated according to a similar study in G-Power software. They will be divided into two groups of 14 people, each group will use an orthosis and will be evaluated before and after 4 weeks of follow-up.
Inclusion criteria for the present study:
1. Includes being in the age range of 30 to 55 years.
2. Report of chronic pain in the external epicondyle of the humerus
3. Ability to respond and participate consciously in research
Exclusion criteria:
1. Existence of any disorders and abnormalities in the hands, forearms, shoulders and neck area of people
2. History of fracture, dislocation, surgery on the elbow joint
3. History of corticosteroid injection (corticosteroids) in the period of six months before the study
Intervention groups
Subjects with tennis elbow syndrome separate into two groups. The control group used a short dorsal splint and the intervention group used a dorsal-forearm splint.
Main outcome variables
pain - grip force - function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047459N4
Registration date:2021-06-23, 1400/04/02
Registration timing:registered_while_recruiting
Last update:2021-06-23, 1400/04/02
Update count:0
Registration date
2021-06-23, 1400/04/02
Registrant information
Name
Masoud Rafiaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5043
Email address
ma.rafiaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and construction of Dorsal forearm- wrist splint and compare with Dorsal Wrist cock-up splint and theirs effects on pain and grip force and function in patients with tennis elbow
Public title
effect of wrist hand orthosis on subjects with tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 30 to 55 years
Report of chronic pain in the lateral epicondyle of the humerus, which increases with active movement of the wrist and third finger, supination, and strong force in the hand, and indicates the presence of dissatisfaction or tennis elbow, which should be mild to moderate symptoms (vas≥3).
Ability to respond and participate consciously in research
Exclusion criteria:
1. Existence of any disorders and abnormalities in the hands, forearms, shoulders and neck area
2. History of fracture, dislocation, surgery on the elbow joint
3. History of corticosteroid injection in the period of six months before the study.
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly divided into 2 groups. The order of the tests at each stage is determined randomly by removing the closed pocket. In this way, orthoses are held between the two main groups, which are dorsal wrist - forearm orthosis and cock up and one of these two orthoses is delivered to the first person and the second to the second person and evaluated, and thus subjects will be divided into two groups.
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 medial university of isfahan
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.014
Health conditions studied
1
Description of health condition studied
tennis elbow
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
pain
Timepoint
4 weeks
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
grip force
Timepoint
4 weeks
Method of measurement
dynamometer
Intervention groups
1
Description
The control group includes subjects who use cock-up orthosis which cover the palmar surface of the hand and wrist area and cause stability in this area. This orthosis is made of polyethylene and its use time is 4 weeks. Subjects will be taught how to use the orthosis correctly by the researcher.
Category
Rehabilitation
2
Description
The intervention group includes subjects using dorsal wrist forearm orthoses which cover the dorsal surface of the hand, forearm and wrist area and cause stability in this area. This orthosis is made of polyethylene and its use time is 4 weeks. Subjects will be taught how to use the orthosis correctly by the researcher.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital, Isfahan
Full name of responsible person
Masoud Rafiaei
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences
Full name of responsible person
shaghayegh Haghjooyejavanmard
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
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 and Technology, Isfahan 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
Masoud Rafiaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
ma.rafiaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
ma.rafiaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Hezarjerib
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
ma.rafiaei@gmail.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
data will be published from university.
When the data will become available and for how long
one year
To whom data/document is available
researchers
Under which criteria data/document could be used
future research
From where data/document is obtainable
The main performer
What processes are involved for a request to access data/document