<?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>IRCT20230724058902N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-29</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The comparative evaluation of the effects of TECAR therapy and conventional physical therapy treatments on pain and function in people with Carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The comparative evaluation of the effects of TECAR therapy and conventional physical therapy treatments on pain and function in people with Carpal tunnel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71565</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized clinical trial in a three-way blind method. The sampling method of this research project is simple, non-random, continuous and goal-based, but the grouping of participants is done in random blocks (4 blocks of 11 numbers). Half of the total sample numbers are randomly selected (through the table of random numbers) and are considered as the first group, and the remaining numbers are included in the second group, Blinding description: The study is considered triple-blind because the evaluator, statistical consultant, and participants are unaware of the type of treatment and treatment groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 10 sessions routine physiotherapy  - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of 21 W/cm on the palmar surface of the wrist / 5 minutes of non-continuous ultrasound (1:4) (manufactured by the company Novin Medical Engineering Model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the palmar surface of the wrist / - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the surface Palmar wrist/ therapy exercise program/ along with 5 sessions of TECAR therapy, each session will be 10 minutes (5 minutes of capacitance and 5 minutes of resistance) with a frequency of 500 KHz. Intervention 2: Control group: 10 sessions routine physiotherapy  - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of 21 W/cm on the palmar surface of the wrist / 5 minutes of non-continuous ultrasound (1:4) (manufactured by the company Novin Medical Engineering Model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the palmar surface of the wrist / - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the surface Palmar wrist/ therapy exercise program/ along with 5 sessions of   placebo TECAR therapy.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Navid Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 13 3792 5049</telephone>
        <email>n_taheri@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jarib</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5049</telephone>
        <email>n_taheri@mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Moderate to severe carpal tunnel syndrome based on electrodiagnostic findings
25-65 years old people
Tingling pain with pins and needle sensation and numbness in thumb, index, middle and radial half of ring finger
Presence of symptoms more than 3 months</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Metabolic and systemic disorder: hypothyroidism, diabetes, rheumatoid arthritis
Polyneuropathy
Corticosteroid injection in the subject hand in the past 3 months
Trauma history to the subject hand in past 12 months
Past carpal tunnel syndrome surgery history in the affected hand
Pace maker
Severe neurologic disorder
Pregnancy in study process
Deformity in wrist or hand</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 10 sessions routine physiotherapy  - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of 21 W/cm on the palmar surface of the wrist / 5 minutes of non-continuous ultrasound (1:4) (manufactured by the company Novin Medical Engineering Model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the palmar surface of the wrist / - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the surface Palmar wrist/ therapy exercise program/ along with 5 sessions of TECAR therapy, each session will be 10 minutes (5 minutes of capacitance and 5 minutes of resistance) with a frequency of 500 KHz.</i_keyword>
      <i_keyword>Control group: 10 sessions routine physiotherapy  - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of 21 W/cm on the palmar surface of the wrist / 5 minutes of non-continuous ultrasound (1:4) (manufactured by the company Novin Medical Engineering Model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the palmar surface of the wrist / - 5 minutes of non-continuous ultrasound (1:4) (manufactured by Novin Medical Engineering Company, model 215M) with a frequency of 1 MHz and an intensity of W/cm21 on the surface Palmar wrist/ therapy exercise program/ along with 5 sessions of   placebo TECAR therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Beginning, after 10 sessions and 4 weeks later. Method of measurement: NPRS.</prim_outcome>
      <prim_outcome>Function. Timepoint: Beginning, after 10 sessions and 4 weeks later. Method of measurement: Boston questionnaire.</prim_outcome>
      <prim_outcome>Hand grip strength. Timepoint: Beginning, after 10 sessions and 4 weeks later. Method of measurement: Dynamometer.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-24</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>East namdaran Fooladshahr Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
