<?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>IRCT138903094052N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2008-10-21</date_registration>
      <primary_sponsor>Vice chancellor for research, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of physiotherapy on symptoms of nerve entrapment syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of neuromobilization on hand symptoms in patients with carpal tunnel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4233</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal tunnel syndrome (CTS).</hc_freetext>
      <i_freetext>Intervention 1: The patients in control group receive the physiotherapy routine including rest splint, TENS, and therapeutic ultrasound for 4 weeks. The patients were asked to avoid any activities that exacerbate hand symptoms. The treatment will be performed 3 days weekly. In each session, conventional TENS (80 Hz frequency, 60 microsecond pulse duration, and intensity at the level of tingling) will be used 20 minutes. Also, in each session, pulsed ultrasound (1 megahertz frequency, 1 W/cm2 intensity, and 20% duty cycle) will be used for 5 minutes. Intervention 2: The participants in group 2 (treatment group) receive the neuromobilization in addition to the physiotherapy routine mentioned in group 1 (control group). The neuromibilization will be used for 4 weeks, 3 sessions weekly. In this study, the neuromobilization includes: 1) transverse extension of the wrist accompanied by extension and radial deviation of the thumb, 2) flexor tendon gliding, and 3) the nerve mobilization by elbow flexion- extension oscillatory movement in upper limb tension test position 1. In each session, the neuromobilization will be performed 3 sets including 10 repetitions. These techniques will be performed passively by a physiotherapist.</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. Ghdamali Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tavanir street, Faculty of rehabilitation</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1331 1293</telephone>
        <email>talebig@tbzmed.ac.ir</email>
        <affiliation>Tabriz Univercity of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ghadamali Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tavanir street, Faculty of rehabilitation</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1331 1293</telephone>
        <email>talebig@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:              &#13;
1- Diagnosis of carpal tunnel syndrome based on clinical and electrophysiological findings (median nerve motor distal latency &gt;4.2 ms; median nerve sensory distal latency &gt;3.7 ms)&#13;
2- Patients with 18-60 old years and mild to moderate carpal tunnel syndrome&#13;
&#13;
Exclusion criteria:&#13;
1- Entrapment at proximal sites&#13;
2- Systemic peripheral neuropathy&#13;
3- Surgical release of carpal tunnel&#13;
4- Metabolic disorders such as diabetics&#13;
5- Pregnancy&#13;
6- Steroid injection in carpal tunnel&#13;
7- Severe atrophy in hand muscles</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The patients in control group receive the physiotherapy routine including rest splint, TENS, and therapeutic ultrasound for 4 weeks. The patients were asked to avoid any activities that exacerbate hand symptoms. The treatment will be performed 3 days weekly. In each session, conventional TENS (80 Hz frequency, 60 microsecond pulse duration, and intensity at the level of tingling) will be used 20 minutes. Also, in each session, pulsed ultrasound (1 megahertz frequency, 1 W/cm2 intensity, and 20% duty cycle) will be used for 5 minutes.</i_keyword>
      <i_keyword>The participants in group 2 (treatment group) receive the neuromobilization in addition to the physiotherapy routine mentioned in group 1 (control group). The neuromibilization will be used for 4 weeks, 3 sessions weekly. In this study, the neuromobilization includes: 1) transverse extension of the wrist accompanied by extension and radial deviation of the thumb, 2) flexor tendon gliding, and 3) the nerve mobilization by elbow flexion- extension oscillatory movement in upper limb tension test position 1. In each session, the neuromobilization will be performed 3 sets including 10 repetitions. These techniques will be performed passively by a physiotherapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Subjective findings. Timepoint: Before and after the treatment period, by 4 weeks interval. Method of measurement: Boston Questionnaire (symptom severity scale and functional status scale) and visual analogue scale.</prim_outcome>
      <prim_outcome>Findings of physical examination. Timepoint: Before and after the treatment period, by 4 weeks interval. Method of measurement: Phalen's sign and median nerve tension test.</prim_outcome>
      <prim_outcome>Electrophysiological findings. Timepoint: Before and after the treatment period, by 4 weeks interval. Method of measurement: Nerve conduction study including the median nerve motor and sensory distal latency.</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, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-10-18</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Golgasht street Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
