<?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>IRCT20210913052456N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-02</date_registration>
      <primary_sponsor>The University  of Lahore</primary_sponsor>
      <public_title>Immediate and prolong effects of manual therapy on Jaw</public_title>
      <acronym>TMJ</acronym>
      <scientific_title>IMMEDIATE AND PROLONGED EFFECTS OF TEMPOROMANDIBULAR JOINT MOBILIZATION ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN HYPOMOBILE TEMPOROMANDIBULAR JOINT PATIENTS; A RANDOMIZED CONTROLLED TRIAL</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59567</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization with Sealed Envelops will be given by the assessor after pre-treatment assessment Odd number will be given to the control group and Even numbers will be given to the treatment
group, Blinding description: The outcome assessor have been blinded by simply not informing him of the group allocation of the participants. After Assessment the assessor will be asked to handover the sealed envelope with a number written on the envelope. The Assessor was not aware of the random numbers and group allocation. Every odd number will be then allocated to control group by the therapist and every even number will be allocated to intervention group by the therapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>temporomandibular joint disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group will get on spot session of 30 minutes session of manual therapy. Mulligan technique will be applied. Intervention 2: Control group: Transcutaneous Electrical Neuromuscular Stimulation, Hot pack and soft tissue technique will be applied to the patients.</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:
IMMEDIATE AND PROLONGED EFFECTS OF TEMPOROMANDIBULAR JOINT MOBILIZATION ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN HYPOMOBILE TEMPOROMANDIBULAR JOINT PATIENTS; A RANDOMIZED CONTROLLED TRIAL

When:
After Publication the data will be available for 5 years

To whom:
To researcher

Conditions:
Data will be accessible to the researchers on request at naveeda.ashraf@uipt.uol.edu.pk

Where to obtain:
communication and clear contact information such as
email addresses mentioned previously along with cover
letter and resume and purpose of the data need.

How to obtain:
Requested email to the following addresses: 
naveeda.ashraf@uipt.uol.edu.pk
umber.nawaz@uipt.uol.edu.pk

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Naveeda Ashraf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54700</zip>
        <telephone>+92 333 4888279</telephone>
        <email>naveeda.ashraf@uipt.uol.edu.pk</email>
        <affiliation>The University  of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Umber Nawaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54700</zip>
        <telephone>+92 42 35440889</telephone>
        <email>umber.nawaz@uipt.uol.edu.pk</email>
        <affiliation>The University  of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Pain in the region of the Temporomandibular joints and masticatory
•	Associated muscles and limited mandibular movement for at least six months
•	Complete dentition to provide stable and repeatable base points for jaw measurements.
•	Diagnosed by an experienced clinician as suffering from Temporomandibular disorders
•	Decreased mandibular opening</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	History of severe head trauma or surgery
•	Known cervical pathology
•	Taking any medication except for occasional analgesics.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint disorders</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: Patients in this group will get on spot session of 30 minutes session of manual therapy. Mulligan technique will be applied</i_keyword>
      <i_keyword>Control group: Transcutaneous Electrical Neuromuscular Stimulation, Hot pack and soft tissue technique will be applied to the patients</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>•	Pain. Timepoint: 4 weeks. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>•	Range of Motion. Timepoint: 4 weeks. Method of measurement: Goniometer, Vernier Calliper.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: 4 weeks. Method of measurement: Jaw disability index.</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>The University  of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-27</approval_date>
        <contact_name>The University of Lahore, Faculty of Allied health Science, Institutional Review Board</contact_name>
        <contact_address>1 KM- Raiwind Road, Bhoptian Chowk, Main Campus, Lahore, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
