<?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>IRCT20200823048495N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-12</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Neck strengthening exercises in anterior disc displacement with reduction</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of temporomandibular joint mobilization with &amp; without neck strengthening exercises on patients with anterior disc displacement with reduction of temporomandibular joint</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>53</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52745</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple Randomization
Sealed Envelops
Odd number to the control group and Even number 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 was 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 was then allocated to control group by the therapist and every even number was allocated to intervention group by the therapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anterior disc displacement with reduction of Temporomandibular Joint Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Manual Mobilization of temporomandibular joint will be applied in all sessions with 3-5 repetitions in 1 set. 3 sets were applied. Once a day. Soft Tissue Release of Masticatory muscles including: Masseter, lateral/ medial pterygoid &amp; Temporalis for 2 min on each muscle. Once a day. Therapeutic Exercises of temporomandibular joint including Protrusion and Lateral shifting will be given for home plan. 2 times a day with 5-6 repetitions and 10 second hold with additionally strengthening exercises of deep neck flexors muscles including:  Longus Capitus and Longus Colli muscles was given as a home plan thrice a day with 10 repetitions and 10 second hold. Intervention 2: Control group: Manual Mobilization of temporomandibular joint will be applied in all sessions with 3-5 repetitions in 1 set. 3 sets were applied. Once a day. Soft Tissue Release of Masticatory muscles including: Masseter, lateral/ medial pterygoid &amp; Temporalis for 2 min on each muscle. Once a day. Therapeutic Exercises of temporomandibular joint including Protrusion and Lateral shifting will be given for home plan. 2 times a day with 5-6 repetitions and 10 second hold.</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:
IPD collected for the primary outcome measure

When:
starting 6 months after publication

To whom:
Data will be available to all the researchers, academic institutions and common public.

Conditions:
Data will be accessible to the researchers on request at umber@kric.edu.pk or umber.nawaz@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: umber@kric.edu.pk, umber.nawaz@uipt.uol.edu.pk

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</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 35321761</telephone>
        <email>umber.nawaz@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>0092 35440889</telephone>
        <email>umber@kric.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Temporomandibular Joint Pain plus disc displacement with reduction
patient with a medical referral of Temporomandibular disorder by dentists/ maxillofacial surgeon
Symptoms for more than 1 month, at the time that the first treatment would be given</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Recent tumor
fracture or trauma in recent medical history
Any Systemic/Rheumatic disease
Degenerative changes seen
Surgical History of cervical spine Or Temporomandibular joint</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Articular disc disorder of temporomandibular joint</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:  Manual Mobilization of temporomandibular joint will be applied in all sessions with 3-5 repetitions in 1 set. 3 sets were applied. Once a day. Soft Tissue Release of Masticatory muscles including: Masseter, lateral/ medial pterygoid &amp; Temporalis for 2 min on each muscle. Once a day. Therapeutic Exercises of temporomandibular joint including Protrusion and Lateral shifting will be given for home plan. 2 times a day with 5-6 repetitions and 10 second hold with additionally strengthening exercises of deep neck flexors muscles including:  Longus Capitus and Longus Colli muscles was given as a home plan thrice a day with 10 repetitions and 10 second hold.</i_keyword>
      <i_keyword>Control group: Manual Mobilization of temporomandibular joint will be applied in all sessions with 3-5 repetitions in 1 set. 3 sets were applied. Once a day. Soft Tissue Release of Masticatory muscles including: Masseter, lateral/ medial pterygoid &amp; Temporalis for 2 min on each muscle. Once a day. Therapeutic Exercises of temporomandibular joint including Protrusion and Lateral shifting will be given for home plan. 2 times a day with 5-6 repetitions and 10 second hold.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before intervention and 4  weeks after intervention. Method of measurement: Numeric Pain Scale.</prim_outcome>
      <prim_outcome>Jaw Mobility. Timepoint: before intervention and 4  weeks after intervention. Method of measurement: Measuring Scale.</prim_outcome>
      <prim_outcome>Clicking Sounds. Timepoint: before intervention and 4  weeks after intervention. Method of measurement: Stethoscope.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Helkimo Index. Timepoint: before intervention and 4  weeks after intervention. Method of measurement: Helkimo Index.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>U1111-1262-8127</sec_id>
        <issuing_authority>World Health Organization Universal Trial Registry</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Self</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-06</approval_date>
        <contact_name>Ethic's committee of The University of Lahore, Faculty of Allied health Science,</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>
