<?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>IRCT2017012732221N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-13</date_registration>
      <primary_sponsor>The University of Social Welfare and Rehabilitation Sciences (USWRS)</primary_sponsor>
      <public_title>The effect of Temporomandibular joint manual therapy on the improvement of patients with non-specific chronic neck pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding Temporomandibular joint manual therapy to routine physiotherapy on the improvement of patients with non-specific chronic neck pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25150</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Temporomandibular joint disorders. Condition 2: non-specific chronic neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Common physical therapy treatment interventions for neck pain, which is the same for both groups, include the following: &#13;
Soft tissue release, muscle energy techniques and exercise therapy. Intervention 2: In the intervention group, manual therapy of the temporomandibular joint includes the following:  &#13;
Muscle energy techniques, mobilization and tongue movements and related training in the TMJ.</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>Maryam Ghodrati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 16, No 23, Abbasi St , karimi St, Andarzgoo Blvd., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+212 2203652</telephone>
        <email>mary.gh1372@yahoo.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zahra mosallanezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation Sciences (USWR) Koodakyar St., Daneshjoo Blvd, Velenjak,  Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+212 2180039</telephone>
        <email>zmosallanezhad@yahoo.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: People with non-specific chronic neck pain, which they are also suffering from the Temporomandibular joint disorders. In this case, there are the pain and limitations in range of motion of the Temporomandibular joint and pain and tenderness in at least two related muscles.&#13;
Exclusion criteria: Neurological disorders; Absence of pain in the Temporomandibular joint; Malignancy and infection; Acute muscle trauma</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K07.6</hc_code>
      <hc_code>R52.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint disorders</hc_keyword>
      <hc_keyword>Other chronic pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Common physical therapy treatment interventions for neck pain, which is the same for both groups, include the following: &#13;
Soft tissue release, muscle energy techniques and exercise therapy</i_keyword>
      <i_keyword>In the intervention group, manual therapy of the temporomandibular joint includes the following:  &#13;
Muscle energy techniques, mobilization and tongue movements and related training in the TMJ</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neck disability index (NDI). Timepoint: At the first session, at the last session and one month after. Method of measurement: Neck disability index (NDI).</prim_outcome>
      <prim_outcome>The pain. Timepoint: At the first session, at the last session and one month after. Method of measurement: Visual Analogue Scale(VAS).</prim_outcome>
      <prim_outcome>The range of motion of neck flexion. Timepoint: At the first session, at the last session and one month after. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>The range of motion of neck extention. Timepoint: At the first session, at the last session and one month after. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>The range of motion of neck side bending. Timepoint: At the first session, at the last session and one month after. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>The range of motion of neck rotation. Timepoint: At the first session, at the last session and one month after. Method of measurement: Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General questionnaire. Timepoint: At the first assessment session. Method of measurement: questionnaire.</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>The University of Social Welfare and Rehabilitation Sciences (USWRS)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-02</approval_date>
        <contact_name>The University of Social Welfare and Rehabilitation Sciences (USWRS)</contact_name>
        <contact_address>kodakyar Ave., Daneshjo Blvd.,Evin Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
