<?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>IRCT20221006056105N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-06</date_registration>
      <primary_sponsor>The University Of Faisalabad</primary_sponsor>
      <public_title>Rocabado exercises vs. Myofascial Release: Comparative effects in patients with Temporomandibular Joint Dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>Rocabado exercises vs. Myofascial Release: Comparative effects in patients with Temporomandibular Joint Dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization process was done using chit and draw or lottery method. Thirty chits were made in order to allocate the participants in both groups. Thirty chits were made and with every participant coming, one chit was drawn and it happened in a way that all even numbered chits were allocated into group A while all odd ones into group B, Blinding description: The treatment techniques used in this study are soft tissue techniques out of which one was manual and the other was exercise based. Both groups received a baseline treatment in which therapeutic ultrasound was used so the groups were similar and comparable in order to blind the participants. The groups were homogenous at baseline i.e. of same age group and of similar levels of pain and severity of dysfunction. The interventions in the two groups were sufficiently similar in terms of implementation without the use of any kind of insttument in either group.</study_design>
      <phase>3</phase>
      <hc_freetext>Temporomandibular Joint Dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants of group  A received therapeutic ultrasound (3 MHz, 1.2 W/cm2 for 3 minutes) over TMJ and simple jaw exercises as a baseline treatment. then they were given an exercise protocol which was named as Rocabado exercises which included a set of six different exercises. each exercise was repeated for 6 six times. the treatment was given thrice a week over a period of 4 weeks. Intervention 2: Intervention group: The participants of group  B received therapeutic ultrasound (3 MHz, 1.2 W/cm2 for 3 minutes) over TMJ and simple jaw exercises as a baseline treatment. then they were given myofascial release technique for masseter and temporalis muscles. the participants were made to assume the side-lying position with affected TMJ on the top. gel was applied over these areas and then the muscles were slowly released. the treatment was given thrice a week over a period of 4 weeks.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saman Salahuddin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P 175 Shadman Town Sargodha Road</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 337 7002916</telephone>
        <email>hashmisaman5@gmail.com</email>
        <affiliation>Madinah Teaching Hospital Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saman Salahuddin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P 175 Shadman Town Sargodha Road</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 337 7002916</telephone>
        <email>hashmisaman5@gmail.com</email>
        <affiliation>Madinah Teaching Hospital Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 30 years
Mild to Moderate temporomandibular joint dysfunction according to fonseca questionnaire
Decreased mouth opening
Mild to moderate pain on NPRS
Male and female participants
Willingness to participate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any recent surgery
Unhealed fracture of mandible
Severe osteoporosis
TMJ hypermobility
Advanced diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M26.60</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint disorder, unspecified</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: The participants of group  A received therapeutic ultrasound (3 MHz, 1.2 W/cm2 for 3 minutes) over TMJ and simple jaw exercises as a baseline treatment. then they were given an exercise protocol which was named as Rocabado exercises which included a set of six different exercises. each exercise was repeated for 6 six times. the treatment was given thrice a week over a period of 4 weeks.</i_keyword>
      <i_keyword>Intervention group: The participants of group  B received therapeutic ultrasound (3 MHz, 1.2 W/cm2 for 3 minutes) over TMJ and simple jaw exercises as a baseline treatment. then they were given myofascial release technique for masseter and temporalis muscles. the participants were made to assume the side-lying position with affected TMJ on the top. gel was applied over these areas and then the muscles were slowly released. the treatment was given thrice a week over a period of 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mouth Opening Range of Motion. Timepoint: It was measured before and after intervention. Method of measurement: A ruler calibrated in millimeters was used to measure this outcome.</prim_outcome>
      <prim_outcome>Functional Limitation of Jaw. Timepoint: it was measured before and after treatment i.e. at baseline and at 4th week. Method of measurement: Jaw Functional Limitation Scale was used to measure it.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: it was measured before treatment and after treatment. Method of measurement: Numeric pain rating scale was used.</sec_outcome>
      <sec_outcome>Severity of dysfunction. Timepoint: before and after treatment. Method of measurement: Fonseca Anamnestic Index Questionnaire was used.</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>Madinah Teaching Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-17</approval_date>
        <contact_name>Ethics Committee of the university of Faisalabad</contact_name>
        <contact_address>P 175 Shadman Town Sargodha Road Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
