The comparison of the immediate effects of two types of Thumb splint on pain, grip strength and hand function of people with de quervain’s disease: a randomised crossover study
The aim of this study was to compare the effect of two types of Palmar abduction and radial abduction splints
On pain, hand function and hand grip in people with dequervain disease
Design
This is a crossover clinical trial. The sample size was
determined based on the previous similar studies and set
at 30 participants. All participants were put in a single
group and received interventions in a random order.
Randomization of intervention was determined by
drawing a concealed envelop from a bag.
Settings and conduct
Participants will be recruited from outpatient clinic in
Alzahra hospital, Isfahan, Iran through a convenience
sampling method
Participants/Inclusion and exclusion criteria
The inclusion criteria for people with dequervain disease with pain in the radial said of the wrist and positive Finkelstein test and the average pain in the acute phase is 3 . the exclusion criteria for people with arthritis and those who have undergone surgery or injection in the last 6 months to treat the disease
Intervention groups
In this study, for each person, three conditions are allocated to each
participants without splint, with Palmar abduction splint and with radial abduction splint
Main outcome variables
Pain,Hand function and hand grip strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190925044885N1
Registration date:2020-10-06, 1399/07/15
Registration timing:registered_while_recruiting
Last update:2020-10-06, 1399/07/15
Update count:0
Registration date
2020-10-06, 1399/07/15
Registrant information
Name
Hanieh Mohammadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2671 3572
Email address
haniehmohammadzadeh927@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-05, 1398/04/14
Expected recruitment end date
2020-12-19, 1399/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the immediate effects of two types of Thumb splint on pain, grip strength and hand function of people with de quervain’s disease: a randomised crossover study
Public title
Effects of splint on dequervain’s disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Positive result of finkelstine
Pain on radial said of wrist
Average of pain should be 3 and people should be in acute situation
Exclusion criteria:
People with osteoarthritis and different arthritis
Corticosteroid injection and surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The order of intervention and testing conditions were randomized and determined by taking a concealed draw from a bag
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
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
Hezarjarib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-02-06, 1397/11/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.379
Health conditions studied
1
Description of health condition studied
De Quervain Disease
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
Intensity of pain
Timepoint
All interventions are given to the participant in one session and result of the study situations result are record after 20 minutes.
Method of measurement
Pain intensity is measured with a visual pain scale. People show their pain intensity on a 10 cm ruler.
2
Description
Strength of the hand grip
Timepoint
All interventions are given to the participant in one session and result of the study situations result are record after 20 minutes.
Method of measurement
The power of holding objects in the hand is measured by a hand-held dynamometer
3
Description
Hand function
Timepoint
All interventions are given to the participant in one session and result of the study situations result are record after 20 minutes.
Method of measurement
Hand function measure with Jebson Taylor test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Palmar abduction splint, thumb is abducted from the palm of the hand and covers the end of the metacarpal of the fingers, the end of the thumb is free and extends up to two thirds of the forearm, which is made of thermoplastic and custom-made for people. To each participant about ten minutes is given to get used to the device then Measurements are made while the device is covered.
Category
Treatment - Devices
2
Description
Intervention group: Radial abduction splint, thumb is abducted from the fingers and covers the end of the metacarpal of the fingers, the end of the thumb is free and extends up to two thirds of the forearm, which is made of thermoplastic and is custom made for people. Each participant about ten minutes is given to get used to the device then Measurements are made while the device is covered.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Abolghasem Zarezadeh
Street address
Alzahra hospital, Hezarjarib street
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
r.ac.mui@a
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahdi Nematbakhsh
Street address
Hezajarib street
City
Esfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
https://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
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
Ebrahim Sadeghi-Demne
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Hezarjarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
sadeghi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi-Demne
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Hezarjarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
sadeghi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ebrahim Sadeghi-Demneh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Hezarjarib Street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
sadeghi@rehab.mui.ac.ir
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study information (other than personal information) with other researchers
Will be shared
When the data will become available and for how long
There are no specific restrictions
To whom data/document is available
There are no specific restrictions
Under which criteria data/document could be used
No condition is specified
From where data/document is obtainable
People can sent their request to the correspondence and
obtain the data
What processes are involved for a request to access data/document