<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220305054198N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-03</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison oftecar therapy versus phonophoresis on improvement of symptoms of patients with mild and moderate carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62542</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Khosrawi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of physical medicine, Al-Zahra Hospital, Hezar Jarib Street.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>khosrawi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Khosrawi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of physical medicine, Al-Zahra Hospital, Hezar Jarib Street.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>khosrawi@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of mild to moderate carpal tunnel syndrome by nerve and muscle tape
Satisfaction to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <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</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carpal tunnel syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of symptoms. Timepoint: Before, immediately, one month and three months after the intervention. Method of measurement: Boston Questionnaire.</prim_outcome>
      <prim_outcome>Function score. Timepoint: Before, immediately, one month and three months after the intervention. Method of measurement: Boston Questionnaire.</prim_outcome>
      <prim_outcome>Cross-sectional area (CSA)  of the median nerve. Timepoint: Before and three months after the intervention. Method of measurement: Sonography.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before, immediately, one month and three months after the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Nerve Conduction Velocity (NCV) across wrist. Timepoint: Before and three months after the intervention. Method of measurement: Nerve and muscle strip.</prim_outcome>
      <prim_outcome>Sensory nerve action potential (SNAP) latency from median nerves. Timepoint: Before and three months after the intervention. Method of measurement: Nerve and muscle strip.</prim_outcome>
      <prim_outcome>Compound Muscle Action Potential (CMAP) Amplitude from median nerves. Timepoint: Before and three months after the intervention. Method of measurement: Nerve and muscle strip.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-23</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
