<?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>IRCT20240120060742N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-15</date_registration>
      <primary_sponsor>The University of Faisalabad.</primary_sponsor>
      <public_title>Trigger point release on temporomandibular dysfunction by ischemic compression therapy and shock wave therapy.</public_title>
      <acronym>Shock wave therapy (SWT)             Ischemic compression therapy(ISC)                    Temporomandibular dysfunction(TMD)</acronym>
      <scientific_title>Analgesic effect of ischemic compression therapy and shock wave therapy for trigger point release on temporomandibular dysfunction.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75129</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: sampling technique, Randomization description: Randomization through sealed envelope. Non-probability convenient sampling will use for the study. Groups allocation will be accomplished using simple randomization sampling technique. The participants will
be recruited into this study, allocation to groups will be done by chit and draw method, Blinding description: It is a single blind study, participants will be blinded as they will not known the treatment which they will receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients who will have experience orofascial pain, pain in the muscles of mastication due to trigger points on the temporomandibular joint will include in this study..</hc_freetext>
      <i_freetext>Intervention 1: Interventional Group 1 will receive ischemic compression therapy.  *Baseline treatment was relaxation exercise. *Fist of all patients were relaxation on treatment bed in supine line position* There were 6 treatment session in one month. *There were three consecutive treatment sessions for three days. * There was relaxation period of one week. After relaxation of one week there were three consecutive treatment session for next three days. *The time of treatment in one session was five to eight minutes per patient. In this group of treatment therapist applied compression by thumb on active trigger points for 90 seconds. *Then relax for thirty seconds. *This type of compression was applied for three time in one session and continues for three consecutive days. Intervention 2: Intervention group B:  will receive shock wave therapy *Baseline treatment was relaxation exercises. *Patients were relaxed on the treatment bed and treated in supine line position. *Patient lying on supine line position with slightly open mouth that will reflex the jaw muscles. *After localizing and palpating the pain region shock wave was applied with energy flux density of 1500 with shock wave frequency of 2000 strokes per therapy session. *About 2000 shock wave delivered per session on the active trigger points of masseter muscles. *There was 3 session of treatment in one week. *After that there was relaxation period of one week. *After relaxation period of one week Shock wave was applied for consecutive three days. *There were 3 session of treatment in one week. There were two weeks of treatment session. Intervention 3: Intervention group C: Interventional Group 3 will receive the combination effect of ischemic compression therapy and shock wave therapy. *Baseline treatment was relaxation exercise. *Patients were in relaxation in supine line. *Patients received 6 session in one month, 3 days consecutive treatment after one week of relaxation again 3 days consecutive treatment.*Patients received ischemic compression therapy first. *compression of 60 second with thumb on trigger point then relaxation of 30 second.*Time of treatment was 5 to 8 minutes.*After localizing and palpating the pain region shock wave was applied with energy flux density of 1500 with shock wave frequency of 2000 strokes per therapy session. *About 2000 shock wave delivered per session on the active trigger points of masseter muscles. There were total 6 treatment sessions with one week relaxation period. There were two weeks of treatment session.*.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is For concealing participants identity</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>kinza Ihsan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Medina teaching hospital Sargodha road Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 333 7653094</telephone>
        <email>dr.kinzaimran95@gmail.com</email>
        <affiliation>University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>kinza Ihsan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>madina teaching hospital Sargodha road Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 333 7653094</telephone>
        <email>dr.kinzaimran95@gmail.com</email>
        <affiliation>University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender both male and female.
Patient age ranges from 20 to 60 year.
Patients suffer from painful functional disorder within the masticatory muscles of myofascial characteristics.
Chief complaint of acute pain in the joint on at least one side (duration less than 6months).
Presence of joint clicking during opening that was eliminated on protrusive opening.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If individual have diabetes, cardiovascular problem, sensory deficient, skin lesion in thearea of trigger point, fibromyalgia and tuberculosis
Pregnant women, history of fascial trauma, fracture of facial bone and facial palsy
Presence of systemic disease and history of recent trauma</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K07.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Temporomandibular joint-pain-dysfunction syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventional Group 1 will receive ischemic compression therapy.  *Baseline treatment was relaxation exercise. *Fist of all patients were relaxation on treatment bed in supine line position* There were 6 treatment session in one month. *There were three consecutive treatment sessions for three days. * There was relaxation period of one week. After relaxation of one week there were three consecutive treatment session for next three days. *The time of treatment in one session was five to eight minutes per patient. In this group of treatment therapist applied compression by thumb on active trigger points for 90 seconds. *Then relax for thirty seconds. *This type of compression was applied for three time in one session and continues for three consecutive days.</i_keyword>
      <i_keyword>Intervention group B:  will receive shock wave therapy *Baseline treatment was relaxation exercises. *Patients were relaxed on the treatment bed and treated in supine line position. *Patient lying on supine line position with slightly open mouth that will reflex the jaw muscles. *After localizing and palpating the pain region shock wave was applied with energy flux density of 1500 with shock wave frequency of 2000 strokes per therapy session. *About 2000 shock wave delivered per session on the active trigger points of masseter muscles. *There was 3 session of treatment in one week. *After that there was relaxation period of one week. *After relaxation period of one week Shock wave was applied for consecutive three days. *There were 3 session of treatment in one week. There were two weeks of treatment session.</i_keyword>
      <i_keyword>Intervention group C: Interventional Group 3 will receive the combination effect of ischemic compression therapy and shock wave therapy. *Baseline treatment was relaxation exercise. *Patients were in relaxation in supine line. *Patients received 6 session in one month, 3 days consecutive treatment after one week of relaxation again 3 days consecutive treatment.*Patients received ischemic compression therapy first. *compression of 60 second with thumb on trigger point then relaxation of 30 second.*Time of treatment was 5 to 8 minutes.*After localizing and palpating the pain region shock wave was applied with energy flux density of 1500 with shock wave frequency of 2000 strokes per therapy session. *About 2000 shock wave delivered per session on the active trigger points of masseter muscles. There were total 6 treatment sessions with one week relaxation period. There were two weeks of treatment session.*</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual analogous scale. Timepoint: At the time of enrollment, later after 3rd and last after the 6th session. Method of measurement: 1-10 Points on paper.</prim_outcome>
      <prim_outcome>Visual analogous scale. Timepoint: At the time of enrollment, later after 3rd and last after the 6th session. Method of measurement: 1-10 Points on paper.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Temporomandibular dysfunction questionnaire before and after treatment. Timepoint: At the time of enrollment, later after 3rd and last after the 6th 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 Faisalabad.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-27</approval_date>
        <contact_name>The Ethics committee of University of Faisalabad</contact_name>
        <contact_address>No.P-11,Zeenat Block, Muslim Town1: Faisalabad, Pakistan Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
