<?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>IRCT20220626055285N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-21</date_registration>
      <primary_sponsor>Rashid Latif Medical College</primary_sponsor>
      <public_title>Effect of Therapeutic Ultrasound versus Muscle Energy Techniques on coccydynia in pregnant females</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Therapeutic Ultrasound versus Muscle Energy Techniques of piriformis and iliopsoas for coccydynia in pregnant females</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67950</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 35 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 26 cards were taken out, 13 participants in each group, Blinding description: The blinding is achieved by concealment in which the treatment allocation for each patient is not revealed to the patient. This is done to avoid biasness.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coccydynia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A will receive Therapeutic ultrasound. Therapeutic ultrasound is used with the intensity of 1.5W/cm2 for 3-5 min with the use of ultrasonic gel and this procedure is done by approaching the patient posteriorly using irregular probe. Intervention 2: Intervention group: Group B will receive muscle energy techniques of piriformis and iliopsoas. For piriformis MET, ask patient to Lay the patient in the supine position  and bend the knee of affected side and place the foot of that side on the lateral aspect of the opposite knee. The therapist was at the side of the patient. The therapist will push the knee medially until meeting the restrictive barrier.	Ask the patient push against the therapist’s resistance for 3 to 5 sec, allow for a period of isometric relaxation, then engage a new barrier and repeat three times. Then, return the patient to a neutral position. For Iliopsoas MET, Patient position is Supine lying with lower leg hanging off the end of the plinth. The patient flexes the contralateral hip and knee to hug the lower extremity to the chest. Therapist position is Standing on the ipsilateral side of the dysfunction. By Using one hand to keep the contralateral leg flexed, the other hand will provide a downward force immediately proximal to knee until reaching the restrictive barrier. Continue to engage the restrictive barrier and instruct the patient to bring the knee up toward the ceiling to achieve hip flexion for 3 to 5 sec. Instruct the patient to relax and move the hip further into extension by providing a downward force proximal to the knee. Repeat the last two steps 3 to 5 times. After last repetition passively return the patient’s leg to a neutral position.</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>Amber Iqbal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 321 4632209</telephone>
        <email>iqbalamber50@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rehana Niazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 333 4734783</telephone>
        <email>rehana.niazi@rlmc.edu.pk</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Idiopathic coccydynia
Subjects willing to undergo muscle energy techniques of piriformis and iliopsoas
Age 20-40 years pregnant females</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Tumors
Trauma
Subjects with history of spinal surgery
Lumbar disc prolapse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M53.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sacrococcygeal disorders, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A will receive Therapeutic ultrasound. Therapeutic ultrasound is used with the intensity of 1.5W/cm2 for 3-5 min with the use of ultrasonic gel and this procedure is done by approaching the patient posteriorly using irregular probe.</i_keyword>
      <i_keyword>Intervention group: Group B will receive muscle energy techniques of piriformis and iliopsoas. For piriformis MET, ask patient to Lay the patient in the supine position  and bend the knee of affected side and place the foot of that side on the lateral aspect of the opposite knee. The therapist was at the side of the patient. The therapist will push the knee medially until meeting the restrictive barrier.	Ask the patient push against the therapist’s resistance for 3 to 5 sec, allow for a period of isometric relaxation, then engage a new barrier and repeat three times. Then, return the patient to a neutral position. For Iliopsoas MET, Patient position is Supine lying with lower leg hanging off the end of the plinth. The patient flexes the contralateral hip and knee to hug the lower extremity to the chest. Therapist position is Standing on the ipsilateral side of the dysfunction. By Using one hand to keep the contralateral leg flexed, the other hand will provide a downward force immediately proximal to knee until reaching the restrictive barrier. Continue to engage the restrictive barrier and instruct the patient to bring the knee up toward the ceiling to achieve hip flexion for 3 to 5 sec. Instruct the patient to relax and move the hip further into extension by providing a downward force proximal to the knee. Repeat the last two steps 3 to 5 times. After last repetition passively return the patient’s leg to a neutral position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre and Post 1 Month. Method of measurement: Pain is measured before the application of techniques using Numeric Pain Rating Scale (NPRS).</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>Rashid Latif Medical College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-05</approval_date>
        <contact_name>Institutional Review Board of Rashid Latif Medical College</contact_name>
        <contact_address>35-Km Ferozepur road Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
