<?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>IRCT20151128025265N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-12</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of 4 weeks of cuping and kinesiotype in patients with carpal tunnel syndrome during pregnancy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of 4 weeks of caping and kinesiotype on reducing the symptoms of carpal tunnel syndrome during pregnancy (ultrasonography)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54775</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Pregnant women with CTS in the third trimester of pregnancy were selected by simple and available sampling and randomly divided into two groups: 
kinesiotype (n: 15) and group (n: 15). In this study, for random allocation, the coin tossing method was used in such a way that one group is considered a lion and one group is considered a line and the number of coin samples is tossed and individuals are randomly assigned to two groups, Blinding description: Patients did not know the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the caping group, air cupping will be used in the anterior region of the hand, and to create a vacuum, a hand pump equipped with a monitor (Gauge) will be used to adjust the pressure in millimeters of mercury. These treatments will be performed for 8 sessions two days a week for a total of 4 weeks. Under the edge of the cup, ultrasound gel without therapeutic properties will be used for better adaptation of the cup for patients. Intervention 2: In this group, the treatment will be done for 4 weeks, so that in each week, subjects will receive 3 days of kinesiotype as fascia technique. Then they will receive one day without kinesiotype and then another 3 days of kinesiotype. The I-shaped kinesiotype tape will be measured from the proximal palmar fold to the medial epicondyle of the humerus, then a Y-shaped cut will be made on the kinesiotype tape. The patient's elbow and wrist will be extended (complete stretch with the patient's other hand). The base of Y-shaped cut will be attached to the proximal palmar fold and the medial proximal tail will be attached in the direction of the medial epicondyle of the humerus with moderate tension (50% initial tension). Then, another I kinesiotype I tape with technique space with 25% tension will be used for dorsal wrist above the ulnar and radius.</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 Study participants should be interviewed and given permission</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedighe Sadat Naimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>naimi.se@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Sadat Naimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran - Imam Hossein Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Science</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7754 8496</telephone>
        <email>naimi.se@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The  subjects are in the third trimester of pregnancy
The subjects are in the age range of 20 to 35 years
Dominant hand with carpal tunnel syndrome
Ultrasonographic findings should be positive in all subjects (increase in median cross-sectional area of ​​more than 9 mm2)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of trauma to the median nerve or wrist  such as bruises, fractures
Pre-pregnancy test takers have CTS
Multiple births
Skin sensitivity to kinesiotype in some subjects
Diabetes
Rheumatoid Arthritis
Hypothyroidism
Premature delivery of a volunteer
Discontinue patient cooperation
Irregularities in referrals</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the caping group, air cupping will be used in the anterior region of the hand, and to create a vacuum, a hand pump equipped with a monitor (Gauge) will be used to adjust the pressure in millimeters of mercury. These treatments will be performed for 8 sessions two days a week for a total of 4 weeks. Under the edge of the cup, ultrasound gel without therapeutic properties will be used for better adaptation of the cup for patients.</i_keyword>
      <i_keyword>In this group, the treatment will be done for 4 weeks, so that in each week, subjects will receive 3 days of kinesiotype as fascia technique. Then they will receive one day without kinesiotype and then another 3 days of kinesiotype. The I-shaped kinesiotype tape will be measured from the proximal palmar fold to the medial epicondyle of the humerus, then a Y-shaped cut will be made on the kinesiotype tape. The patient's elbow and wrist will be extended (complete stretch with the patient's other hand). The base of Y-shaped cut will be attached to the proximal palmar fold and the medial proximal tail will be attached in the direction of the medial epicondyle of the humerus with moderate tension (50% initial tension). Then, another I kinesiotype I tape with technique space with 25% tension will be used for dorsal wrist above the ulnar and radius.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of symptoms. Timepoint: Immediately before and immediately after the intervention. Method of measurement: Boston Questionnaire.</prim_outcome>
      <prim_outcome>Functional status. Timepoint: Immediately before and immediately after the intervention. Method of measurement: Boston Questionnaire.</prim_outcome>
      <prim_outcome>Transverse cross section of median nerve. Timepoint: Immediately before and immediately after the intervention. Method of measurement: ultrasonography.</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>Dr. Afshin Zarghi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-28</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Tehran - Imam Hossein (AS) Square - Damavand St. (New Tehran) - in front of Bouali Hospital - Faculty of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
