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Sensory-motor effects of the dorsal splint which restricts the wrist and finger flexion on patients with carpal tunnel syndrome: a study with parallel groups

Protocol summary

Study aim
The effect of dorsal splint which restricts wrist and finger flexion in carpal tunnel syndrome on pain relief, symptoms, function, time of patient's symptoms are reproduced in Phalen Test, sense of two-point discrimination, hand dexterity, grip and pinch strength
Design
A randomized controlled clinical trial with parallel groups, single-blind
Settings and conduct
The target population includes those with mild and moderate carpal tunnel syndrome referred to the Al-Zahra Hospital، diagnosed by an orthopedist. split and study for six weeks. Participants are randomly divided into intervention and control groups. Before and after the interventions, the time of patient's symptoms are reproduced in Phalen Test, pain, symptoms, and function, sense of two-point distinction, hand dexterity, grip, and pinch strength will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being over 18 years of age, having positive Phalen maneuvers, didn't have a steroid injection into the carpal canal within the previous 3 months, didn't use any splint before the study, didn't have carpal tunnel release procedure. Exclusion criteria: pregnancy, patients in urgent need of surgery existence of Thenar atrophy or severe carpal tunnel syndrome
Intervention groups
Intervention group: Patients who use dorsal splint which restricts the wrist and finger flexion for six weeks. Control group: Patients who use a dorsal splint which restricts wrist flexion for six weeks.
Main outcome variables
Time of patient's symptoms are reproduced in Phalen Test, Pain, Symptoms, Function, Sense of two-point distinction, hand dexterity, Grip and Pinch strength

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201116049402N1
Registration date: 2020-11-20, 1399/08/30
Registration timing: prospective

Last update: 2020-11-20, 1399/08/30
Update count: 0
Registration date
2020-11-20, 1399/08/30
Registrant information
Name
Zahra Soltani hanafi por
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 5062
Email address
porya.sol85@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-21, 1399/11/02
Expected recruitment end date
2021-05-23, 1400/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Sensory-motor effects of the dorsal splint which restricts the wrist and finger flexion on patients with carpal tunnel syndrome: a study with parallel groups
Public title
Effect of dorsal splint which restricts wrist and finger flexion on mild and moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a positive Phalen maneuver diagnosed with CTS by the physiatrist Being over 18 years of age with mild to moderate symptoms of CTS Didn't use any splints before the study Didn't have a steroid injection into the carpal canal within the previous 3 months Didn't have a carpal tunnel release procedure
Exclusion criteria:
Pregnancy Patients in urgent need of surgery Existence of Thenar atrophy or sever carpal tunnel syndrome
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random sample is a subset of a statistical population in which each member of the subset has an equal probability of being chosen
Blinding (investigator's opinion)
Single blinded
Blinding description
A single-blind randomized control trial is when the investigator but not the study participants know which treatment has been allocated.
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
Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-08, 1399/08/18
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.547

Health conditions studied

1

Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome

Primary outcomes

1

Description
Symptoms and Function
Timepoint
At baseline and after six weeks
Method of measurement
Boston Questionnaire

2

Description
Pain
Timepoint
At baseline and after six weeks
Method of measurement
Visual Analog Scale (VAS)

3

Description
The time it takes to make the Palen Test positive
Timepoint
At baseline and after six weeks
Method of measurement
Chronometer

4

Description
Two point discrimination
Timepoint
At baseline and after six weeks
Method of measurement
Collis

5

Description
Grip and Pinch strength
Timepoint
At baseline and after six weeks
Method of measurement
Dynamometer

6

Description
Hand dexterity
Timepoint
At baseline and after six weeks
Method of measurement
Nine Hole Peg Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients who use a dorsal splint which restricts wrist and finger for six weeks
Category
Treatment - Devices

2

Description
Control group: Patients who use a dorsal splint which restricts wrist for six weeks
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Ibrahim Sadeghi Demneh
Street address
Shahid Keshvari Highway
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sadeghi@rehab.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ibrahim Sadeghi Demneh
Street address
Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sadeghi@rehab.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
Ibrahim Sadeghi Demneh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Technical orthopedics
Street address
Hezarjarib Avenue
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
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
Zahra Soltani Hanafipour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Technical orthopedics
Street address
Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
nesa.soltani.hp@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Soltani Hanafipour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Technical orthopedics
Street address
Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
nesa.soltani.hp@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
A major part of the information will be available for the population.
When the data will become available and for how long
12 months after the publication
To whom data/document is available
Available for people working in academic Institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
Dr. Ebrahim Sadeghi Demneh sadeghi@rehab.mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible، after receiving the request.
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