comparision of the effect of the carpal lock splint and neoprene splint with anterior (palmar)bar on pain and muscle strength in patients with carpal tunnel syndrome.
The present study is a comparative clinical trial that uses the VAS table to achieve changes in pain score and the SAEHAN SH5001 dynamometer to measure hand muscle strength. 26 patients will be admitted according to the inclusion criteria.
Settings and conduct
Patients with carpal tunnel syndrome referred to Kashani and Al-Zahra Hospital in Isfahan،They will enter the study if they are eligible.
Participants/Inclusion and exclusion criteria
Patients 25 to 65 years old, of both sexes، with EMG findings of mild to moderate idiopathic cts ،Fallen or positive tunnel test with symptoms such as Pain, numbness, paresthesia, hypostasis in median nerve disorder
and Exclusion criteria: Acute hand trauma fracture، Rheumatoid arthritis, diabetes, MS, kidney and thyroid diseases، History of carpal tunnel syndrome surgery، History of steroid injection in the carpal tunnel in the last 3 months
، Pregnancy، History of using orthosis، Neuromuscular diseases
Intervention groups
We have two intervention groups. In the intervention group, they use "Carpal Lock splint" and in the control group, they use "Neoprene splint with anterior bar", which are our two interventions in the study. In our study, both groups use splints for 4 weeks. Finally, the effect of these two therapies on the mentioned variables is examined and compared.
Main outcome variables
"Pain score" and "muscle strength" are our two main variables in the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211018052800N1
Registration date:2022-01-03, 1400/10/13
Registration timing:registered_while_recruiting
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Fatemeh zahra Bahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 3372
Email address
fzbahmanii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparision of the effect of the carpal lock splint and neoprene splint with anterior (palmar)bar on pain and muscle strength in patients with carpal tunnel syndrome.
Public title
Comparison of the effect of two therapies (dorsal wrist brace and volar wrist brace) on pain and muscle strength in patients with carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 25 to 65 years old,of both sexes
Patients with mild to moderate idiopathic carpal tunnel syndrome lesion EMG findings
Fallen or Tinnel positive test
Pain,numbness,paresthesia,hypostasis in median nerve disorder
Exclusion criteria:
Acute trauma and hand fracture
Rheumatoid arthritis, diabetes, MS, kidney and thyroid
History of carpal tunnel syndrome surgery
History of steroid injection in the carpal tunnel in the last 3 months
Pregnancy
History of orthosis use
Neuromuscular diseases
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequencing was performed using a random number table.
messy numbers and without a special pattern provide to patients and we ask them to choose a number from the right, we consider even numbers for the intervention group and odd numbers for the control group,they choose a number if they are even in the intervention group and if they are an individual they are randomly placed in the control group.
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 Isfahan University of Medical Sciences
Street address
Isfahan, Hezar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.136
Health conditions studied
1
Description of health condition studied
carpal tunnel syndrome (CTS)
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Pain score
Timepoint
4 weeks
Method of measurement
VAS Pain video questionnaire
2
Description
Muscle strength
Timepoint
4 weeks
Method of measurement
SAEHAN SH5001 dynamometer device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Carpal lock splint, for 4 weeks, use at night during sleep and day during activity, tying on the patient's hand by the researcher (student), construction by the researcher (student), made of hard thermoplastic and soft foam.
Category
Treatment - Devices
2
Description
Control group: Neoprene splint with anterior bar, for 4 weeks, use at night during sleep and day during activity, tied on the patient's hand by the researcher (student), made by "Sama Teb Pakan" company, its surface is made of neoprene and its bar is made of hard thermoplastic .
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Fatemeh Zahra Bahmani
Street address
hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8007
Email
fzbahmanii@gmail.com
Web page address
http://www.mui.ac.ir
2
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Fatemeh Zahra Bahmani
Street address
hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8007
Email
fzbahmanii@gmail.com
Web page address
http://www.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Tahmoores Tahmasbi
Street address
hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5016
Email
t_tahmasbi@yahoo.com
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
Fatemeh Zahra Bahmani
Position
post graduate student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 71 3725 3372
Email
fzbahmanii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Bahmani
Position
post graduate student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8146673461
Phone
+98 71 3725 3372
Email
fzbahmanii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Zahra Bahmani
Position
post graduate student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 71 3725 3372
Email
fzbahmanii@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Numerical data of patients can be published
When the data will become available and for how long
September 2021
To whom data/document is available
researchers
Under which criteria data/document could be used
researchers
From where data/document is obtainable
Through the university website, research section
What processes are involved for a request to access data/document