<?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>IRCT201609178717N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-24</date_registration>
      <primary_sponsor>Vice chancellor for research of Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure in the treatment of carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on the clinical manifestations of Carpal Tunnel Syndrome (CTS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9215</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention (the use of acupressure): In this group, acupressure is performed for a period of one month. For applying acupressure, the Sea-Band button is placed at all times day and night on the P6 (Nei guan) point on the internal surface of forearm to the width of 3-2 fingers up inside groove of wrist and on the P7 (Daling) point in the inner surface of transverse groove of wristt, between the tendons of palmaris longus and flexor carpi radialis. Pressure is applied so that the patient does not feel pain or discomfort. Boston Carpal Tunnel Questionnaire (BCTQ) to evaluate the clinical signs, EMG device to measure nerve conduction velocity (NCV), distal sensory latency (DSL), the distal motor latency (DML), and hand-held dynamometer device to measure grip strength (Grip power) of patients affected hand and digital dynamometer device to measure pinch strength (power Pinch) of patients affected hand fingers are used. Assessment and measurements will be done before the intervention in the first session and after the intervention (after a month). People in this group, the routine treatment (splint and analgesic drugs) will receive. Intervention 2: The second intervention (the use of the placebo): In this group, the placebo will be used for one month. For applying placebo, the Sea-Band button is placed at all times day and night on the external surface of patient forearm, on the opposite side the PC6 and PC7 (as a false point). Pressure is applied so that the patient does not feel pain or discomfort. Boston Carpal Tunnel Questionnaire (BCTQ) to evaluate the clinical signs, EMG device to measure nerve conduction velocity (NCV), distal sensory latency (DSL), the distal motor latency (DML), and hand-held dynamometer device to measure grip strength (Grip power) of patients affected hand and digital dynamometer device to measure pinch strength (power Pinch) of patients affected hand fingers are used. Assessment and measurements will be done before the intervention in the first session and after the intervention (after a month). People in this group, the routine treatment (splint and analgesic drugs) will receive. Intervention 3: Third intervention (routine treatment in control group): People in this group, only the routine treatment (splint and analgesic drugs) will receive. Boston Carpal Tunnel Questionnaire (BCTQ) to evaluate the clinical signs, EMG device to measure nerve conduction velocity (NCV), distal sensory latency (DSL), the distal motor latency (DML), and hand-held dynamometer device to measure grip strength (Grip power) of patients affected hand and digital dynamometer device to measure pinch strength (power Pinch) of patients affected hand fingers are used. Assessment and measurements will be done in the first session and after a month.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Reza Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3344 0758</telephone>
        <email>asgari5000@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ِDr. Mohammad Reza Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of nursing and allied, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514743365</zip>
        <telephone>+98 23 3344 0758</telephone>
        <email>asgari5000@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The age of patients is 20-70 years; Carpal tunnel syndrome be diagnosed by orthopedic specialist; Symptoms lasting more than 3 months; Having no skin problem at the close Sea-Band site.&#13;
Exclusion criteria: Patients with a history of wrist or median nerve trauma; CTS that are followed pregnancy, alcoholism, systemic diseases; Patients with a history of stroke and cerebral palsy; Illiterate Patients; Obese patients; Patients with a low level of consciousness; Patients who due to intensity of disease symptoms in during the study, surgical treatment or corticosteroid injections be necessary; Patients who can not tolerate Sea-Band.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Placebo</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention (the use of acupressure): In this group, acupressure is performed for a period of one month. For applying acupressure, the Sea-Band button is placed at all times day and night on the P6 (Nei guan) point on the internal surface of forearm to the width of 3-2 fingers up inside groove of wrist and on the P7 (Daling) point in the inner surface of transverse groove of wristt, between the tendons of palmaris longus and flexor carpi radialis. Pressure is applied so that the patient does not feel pain or discomfort. Boston Carpal Tunnel Questionnaire (BCTQ) to evaluate the clinical signs, EMG device to measure nerve conduction velocity (NCV), distal sensory latency (DSL), the distal motor latency (DML), and hand-held dynamometer device to measure grip strength (Grip power) of patients affected hand and digital dynamometer device to measure pinch strength (power Pinch) of patients affected hand fingers are used. Assessment and measurements will be done before the intervention in the first session and after the intervention (after a month). People in this group, the routine treatment (splint and analgesic drugs) will receive.</i_keyword>
      <i_keyword>The second intervention (the use of the placebo): In this group, the placebo will be used for one month. For applying placebo, the Sea-Band button is placed at all times day and night on the external surface of patient forearm, on the opposite side the PC6 and PC7 (as a false point). Pressure is applied so that the patient does not feel pain or discomfort. Boston Carpal Tunnel Questionnaire (BCTQ) to evaluate the clinical signs, EMG device to measure nerve conduction velocity (NCV), distal sensory latency (DSL), the distal motor latency (DML), and hand-held dynamometer device to measure grip strength (Grip power) of patients affected hand and digital dynamometer device to measure pinch strength (power Pinch) of patients affected hand fingers are used. Assessment and measurements will be done before the intervention in the first session and after the intervention (after a month). People in this group, the routine treatment (splint and analgesic drugs) will receive.</i_keyword>
      <i_keyword>Third intervention (routine treatment in control group): People in this group, only the routine treatment (splint and analgesic drugs) will receive. Boston Carpal Tunnel Questionnaire (BCTQ) to evaluate the clinical signs, EMG device to measure nerve conduction velocity (NCV), distal sensory latency (DSL), the distal motor latency (DML), and hand-held dynamometer device to measure grip strength (Grip power) of patients affected hand and digital dynamometer device to measure pinch strength (power Pinch) of patients affected hand fingers are used. Assessment and measurements will be done in the first session and after a month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distal sensory latency (DSL). Timepoint: Before the intervention in the first session and after the intervention (after a month. Method of measurement: By EMG device.</prim_outcome>
      <prim_outcome>Nerve conduction velocity (NCV). Timepoint: Before the intervention in the first session and after the intervention (after a month). Method of measurement: By EMG device.</prim_outcome>
      <prim_outcome>Hand muscle strength (Grip power). Timepoint: Before the intervention in the first session and after the intervention (after a month). Method of measurement: By hand-held dynamometer device.</prim_outcome>
      <prim_outcome>Clinical manifestations of Carpal Tunnel Syndrome (CTS). Timepoint: Before the intervention in the first session and after the intervention (after a month). Method of measurement: By Boston Carpal Tunnel Questionnaire (BCTQ).</prim_outcome>
      <prim_outcome>Pinch power. Timepoint: Before the intervention in the first session and after the intervention (after a month). Method of measurement: by Digital dynamometer Device.</prim_outcome>
      <prim_outcome>Distal motor latency (DML). Timepoint: Before the intervention in the first session and after the intervention (after a month). Method of measurement: By EMG device.</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>Vice chancellor for research of Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-13</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences, Semnan, Semnan Province, Iran Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
