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Comparative effect of tecar therapy versus phonophoresis on improvement of symptoms, function and electrodiagnostic and sonographic findings in patients with mild to moderate carpal tunnel syndrome

Protocol summary

Study aim
Determining and comparing the effect of tecar therapy and phonophoresis on the improvement of carpal tunnel syndrome
Design
The randomized, double-blind clinical trial, with the parallel groups, on 50 patients
Settings and conduct
In this randomized double-blind clinical trial study, 50 eligible patients referred to Amin Hospital in Isfahan will be included in the study and randomly divided into 2 groups. Patients in the first group will undergo Tecar therapy, and patients in the second group will undergo phonophoresis. The intervention will be performed in such a way that the patient, the investigator, and the data analyst will not have any knowledge of the type of intervention and the conditions will be double-blind. Patients' symptoms and function will then be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include a mild to moderate carpal tunnel syndrome diagnosis by nerve and muscle strips and consent to participate in the study. Exclusion criteria include rheumatoid arthritis, diabetes, hypothyroidism, peripheral vascular disease, active cancer, cervical radiculopathy and polyneuropathy, pregnancy, a cardiac pacemaker, having a history of corticosteroid injection in the carpal tunnel area in the last quarter, and having a history of carpal tunnel syndrome surgery.
Intervention groups
Intervention group 1: Patients in this group will receive standard treatments. In addition, patients will receive Tecar therapy. Intervention group 2: Patients in this group will receive standard treatments. In addition, patients will be treated with phonophoresis.
Main outcome variables
Symptoms and function of the syndrome; Cross-sectional area (CSA) of the median nerve; Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220305054198N1
Registration date: 2022-04-03, 1401/01/14
Registration timing: prospective

Last update: 2022-04-03, 1401/01/14
Update count: 0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Zahra Abbasian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 8907
Email address
zahraabbasian@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of tecar therapy versus phonophoresis on improvement of symptoms, function and electrodiagnostic and sonographic findings in patients with mild to moderate carpal tunnel syndrome
Public title
Comparison oftecar therapy versus phonophoresis on improvement of symptoms of patients with mild and moderate carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of mild to moderate carpal tunnel syndrome by nerve and muscle tape Satisfaction to participate in the study
Exclusion criteria:
Rheumatoid arthritis, diabetes, hypothyroidism, peripheral vascular disease, active cancer, cervical radiculopathy and polyneuropathy Pregnancy Having a Heart Pacemaker Having a history of corticosteroid injection in the carpal tunnel area in the last quarter Having a history of carpal tunnel syndrome surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 50 eligible patients are randomly selected. For this, the letter A is written on 25 sheets and the letter B is written on 25 sheets and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Given the type of intervention used in each of the two groups, the researcher is aware of the type of intervention in each group. But the patient, the investigator and the data analyser will not be aware of the type of intervention.
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
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2022-01-23, 1400/11/03
Ethics committee reference number
IR.MUI.MED.REC.1400.767

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
Severity of symptoms
Timepoint
Before, immediately, one month and three months after the intervention
Method of measurement
Boston Questionnaire

2

Description
Function score
Timepoint
Before, immediately, one month and three months after the intervention
Method of measurement
Boston Questionnaire

3

Description
Cross-sectional area (CSA) of the median nerve
Timepoint
Before and three months after the intervention
Method of measurement
Sonography

4

Description
Pain
Timepoint
Before, immediately, one month and three months after the intervention
Method of measurement
Visual Analogue Scale

5

Description
Nerve Conduction Velocity (NCV) across wrist
Timepoint
Before and three months after the intervention
Method of measurement
Nerve and muscle strip

6

Description
Sensory nerve action potential (SNAP) latency from median nerves
Timepoint
Before and three months after the intervention
Method of measurement
Nerve and muscle strip

7

Description
Compound Muscle Action Potential (CMAP) Amplitude from median nerves
Timepoint
Before and three months after the intervention
Method of measurement
Nerve and muscle strip

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients in this group will receive standard treatments. In addition, patients will receive Tecar therapy(TECAR WINBACK made in France). In this way, the patient is sitting. The dorsal surface of the patient's hand will be placed on the insulating pad of the implant and the active pad on the patient's wrist will be placed on the volar surface. After rubbing the conductive cream on the volar surface of the wrist, using the capacitive model (CET) (frequency 500 kHz), in the path of the median nerve from the wrist to the palm for 15 minutes with an intensity of at least 20 and maximum 40, is moved. Eight sessions will be performed twice a week for patients.
Category
Treatment - Other

2

Description
Intervention group 2: Patients in this group will receive standard treatments. In addition, patients will be treated with phonophoresis. Following the use of the gel, the ultrasound probe will be placed perpendicular to the wrist. In each session, 15 minutes of pulse phonophoresis (1 to 4) with a frequency of 3 MHz and an intensity of one w/cm2 will be performed with hydrocortisone. Eight sessions of phonophoresis treatment will be performed twice a week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Saeid Khosrawi
Street address
Ibn Sina Street
City
Isfahan
Province
Isfehan
Postal code
5314181486
Phone
+98 31 3445 5051
Fax
Email
khosrawi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
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
Saeid Khosrawi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physical Medicine
Street address
Department of physical medicine, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
khosrawi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Saeid Khosrawi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Physical Medicine
Street address
Department of physical medicine, Al-Zahra Hospital, Hezar Jarib Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
khosrawi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Abbasian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Ibn Sina St., Sanbolistan Alley, Amin Hospital
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3445 5051
Fax
Email
zahraabbasian@resident.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
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