Determine the effectiveness of TECAR therapy on clinical and neuroelectrophysiological symptoms of patients with mild to moderate carpal tunnel syndrome.
Design
The present study is a blind clinical trial study with parallel, randomized groups that will be performed on 50 samples.
Settings and conduct
Patients with mild to moderate carpal tunnel syndrome who have will diagnosed in physical medicine clinics of Isfahan University of Medical Sciences will be referred to Amin Hospital for TECAR therapy. In the control group, patients will treat with TECAR off device. Both groups will also receive splints and vitamin B1 for four weeks.
Participants/Inclusion and exclusion criteria
A patient over 18 years of age with unilateral or bilateral idiopathic mild and moderate carpal tunnel syndrome confirmed by EMG-NCS and clinical examination and lasting more than one month will be referred. If the patient has a systemic disease such as diabetes, etc., or has a fracture of the hand and wrist, or has neuropathy, or vascular disease, or is pregnant, or has a pacemaker or prosthesis, he will not be included in the plan.
Intervention groups
In the intervention group, patients will have eight sessions of 15-minute TECAR therapy with a TECAR device in the patients' wrist area of the carpal tunnel. In the control group, TECAR device will be used off.
Main outcome variables
ُTeatment; Severity of symptoms; Functional status; Pain; SNAP latency; CMAP latency;
SNAP amplitude; NCV across wrist; sex; Age; Tinnel test; Fallen test; Reverse phalen's test; Compression test
Evaluation of the effectiveness of TECAR therapy in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with unilateral or bilateral idiopathic mild and moderate carpal tunnel syndrome confirmed by EMG-NCS and clinical test and lasting more than one month.
Exclusion criteria:
Systemic and local diseases (diabetes, RA, wrist arthritis, hypothyroidism, etc.)
Cancer
Pregnancy
Burns on the hands and forearms
IUD, Pacemaker, prosthesis
Peripheral vascular diseases
Fractures in the wrist and hand area
Corticosteroid injection in the last trimester in the carpal tunnel
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by double block randomization method. Thus, the first client with a diagnosis of CTS will be placed in a group (treatment or control) by lottery. Then the second person will be in the opposite group. The lottery will be held again by referring to the third person and will be placed in a group (trick or control). Then the fourth person will be in the opposite group. Thus, the last person will be in the treatment and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is not aware that the tecar is actively performed or the test is off.
Placebo
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
Hezar jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.MUI.MED.REC.1400.340
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
Symptom severity scale
Timepoint
At the beginning of the study and 1 and 2 months after treatment
Method of measurement
Boston Carpal Tunnel Syndrome Questionnaire
2
Description
Functional status
Timepoint
At the beginning of the study and 1 and 2 months after treatment
Method of measurement
Boston Carpal Tunnel Syndrome Questionnaire
3
Description
Pain
Timepoint
At the beginning of the study and 1 and 2 months after treatment
Method of measurement
Visual Analogue Scale
4
Description
Median SNAP peak latency
Timepoint
At the beginning of the study and 2 months after treatment
Method of measurement
EMG machine
5
Description
Median motor onset latency
Timepoint
At the beginning of the study and 2 months after treatment
Method of measurement
EMG machine
6
Description
Median SNAP amplitude
Timepoint
At the beginning of the study and 2 months after treatment
Method of measurement
EMG machine
7
Description
Median sensory NCV across wrist
Timepoint
At the beginning of the study and 2 months after treatment
Method of measurement
EMG machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: TECAR therapy for 15 minute in 8 session + wrist splint (one month) + vitamin B 1 300 mg daily
Category
Treatment - Devices
2
Description
Control group: TECAR therapy ( device off)for 15 minutes in 8 session + wrist splint (one month) + vitamin B 1 300 mg daily
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Hamid reza Ghasemi
Street address
EBN E SINA street
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Email
dr.ghasemi85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour siavash
Street address
Hezar jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
siavash@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
Hamid reza Ghasemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hezar jerib Ave, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
dr.ghasemi@resident.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
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Hezar jerib Ave, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
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
Hamid reza Ghasemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hezar jerib Ave, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
dr.ghasemi@resident.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
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
Collected data, data analysis and results
When the data will become available and for how long
Six months after the publication of the results
To whom data/document is available
Employees of scientific institutes and physicians
Under which criteria data/document could be used
To use the results for treatment or re-research
From where data/document is obtainable
Email the person in charge of the research project, Mr. Hamidreza Ghasemi
dr.ghasemi85@gmail.com
What processes are involved for a request to access data/document
Information will be sent within a month after the call.