<?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>IRCT20150210021034N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-17</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The sensori-motor effects of elbow orthoses in tennis elbow</public_title>
      <acronym></acronym>
      <scientific_title>The immediate sensori-motor effects of elbow orthoses in people with lateral elbow tendinopathy: A randomized cross-over study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30809</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: The order of intervention and testing conditions were randomized and determined by taking a concealed draw from a bag.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tennis elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The forearm band was an 8-cm-wide neoprene band fitted 2.5 cm below the elbow. A double layered neoprene pad was incorporated in the forearm band to apply a direct pressure to the origin of the extensor muscles. The elbow strap had a 5-cm-wide non-elastic strap to adjust the pressure on the pad. Intervention 2: Intervention group: The elbow sleeve was a neoprene support circumferentially contained the arm approximately 15 cm above and below the elbow. The elbow sleeve was fitted on the arm using two 5-cm-wide non-elastic straps above and below the elbow. Both types of counterforce orthoses had a range of available sizes to accommodate different participants’ sizes. Intervention 3: Control group: No orthosis.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The finding will be submitted for publication in a scientific journal.

When:
The finding will be submitted for publication in a scientific journal.

To whom:
The finding will be submitted for publication in a scientific journal.

Conditions:
The finding will be submitted for publication in a scientific journal.

Where to obtain:
The finding will be submitted for publication in a scientific journal.

How to obtain:
The finding will be submitted for publication in a scientific journal.

Comments:
The finding will be submitted for publication in a scientific journal.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jerib St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5053</telephone>
        <email>sadeghi@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ebrahim Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib St.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 5053</telephone>
        <email>sadeghi@rehab.mui.ac.ir</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pain on palpation of the lateral epicondyle.
Elbow pain aggravated with resisted wrist extension.
Pain on resistive middle finger extension</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with history of surgery, fracture, dislocation, or injection to the elbow less than 6 weeks prior were excluded</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M77.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lateral epicondylitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The forearm band was an 8-cm-wide neoprene band fitted 2.5 cm below the elbow. A double layered neoprene pad was incorporated in the forearm band to apply a direct pressure to the origin of the extensor muscles. The elbow strap had a 5-cm-wide non-elastic strap to adjust the pressure on the pad.</i_keyword>
      <i_keyword>Intervention group: The elbow sleeve was a neoprene support circumferentially contained the arm approximately 15 cm above and below the elbow. The elbow sleeve was fitted on the arm using two 5-cm-wide non-elastic straps above and below the elbow. Both types of counterforce orthoses had a range of available sizes to accommodate different participants’ sizes.</i_keyword>
      <i_keyword>Control group: No orthosis</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 5 minutes after each intervention was applied. Method of measurement: The pain severity was measured using a 10-cm visual analogue scale (VAS) in which 0 represented “no pain” and 10 indicated “the most severe pain” .</prim_outcome>
      <prim_outcome>Hand grip strength. Timepoint: 5 minutes after each intervention was applied. Method of measurement: Pain-free grip on the involved side was measured using a digital handgrip dynamometer (YDM-110, Yagami Ltd, Tokyo, Japan). Each participant stood with shoulder in neutral, elbow in extension and forearm in neutral position of supination/pronation then slowly squeeze the dynamometer handle until they felt pain at elbow.</prim_outcome>
      <prim_outcome>Elbow joint position sense. Timepoint: 5 minutes after each intervention was applied. Method of measurement: Elbow proprioception was evaluated by the measurement of joint position sense. For this purpose, the ability of active angle reproduction was measured at the involved elbow. The participant sat on a chair and the arm is kept undisturbed and parallel to the floor using an adjustable arm support attached to the chair’s handle. The participant’s eyes were closed during proprioception testing. The examiner kept the forearm and started slowly moving the elbow from 90º toward extension until elbow reached in 70º of flexion. The elbow was kept at 70º for 20 seconds and participant was asked to memorize this position. The elbow returned to 90º and participant was asked to reproduce the target angle (70º of flexion). The active angle reproduction test was also employed when elbow moving toward flexion direction. Participants were asked to move their elbow from 90º toward further flexion until reached target angle was set at 110º of flexion.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Finger dexterity. Timepoint: 5 minutes after intervention was applied. Method of measurement: The finger dexterity was evaluated using “nine-hole peg test”. The testing instrument consist of a wooden board with nine hole and a counterpart has a shallow round dish contained nine pegs. The hole-board was centered in front of participant and shallow dish was on the involved side. Participant took the pegs one by one and put them in the holes, as quickly as could. They then removed the pegs one by one and replaced them in the shallow round dish. The time was recorded using a stopwatch from the moment participant reach the first peg until the last peg was put back in the dish.</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>2017-06-17</approval_date>
        <contact_name>ُthical committee of Isfahan University of Medical Sciences, Isfahan, Iran</contact_name>
        <contact_address>Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
