<?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>IRCT20210909052421N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-09</date_registration>
      <primary_sponsor>Prince Sattam bin Abdul-Aziz university</primary_sponsor>
      <public_title>Efficacy of a Modified Active Physical Therapy Program in athletes with Osteitis Pubis</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of a Modified Active Physical Therapy Program on Pain, Muscle Strength, and Function in Adolescent Football Players with Osteitis Pubis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68946</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: - A researcher who was not involved in the study performed the randomization using enclosed envelopes.
- The researcher prepared the enclosed envelopes, each envelope with a labeled card as either a modified active physical therapy (MAPT)  or traditional physical therapy (TPT) group. 
- Each patient was requested to choose an enclosed envelope, 1:1 simple randomization, that determined whether he was allocated randomly to the MAPT group or TPT group, Blinding description: The examining researcher was not included in the randomization process and still unaware of the group allocation. During their assessment, patients were asked not to report their  treatment allocation to the examiner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>osteitis pubis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group. The modified active physical therapy (MAPT) group consisted of four stages. Each stage lasted for three weeks.  Stage 1:  Pain control &amp; lumbopelvic stability - Stage 2:  Strengthening and core stability exercises., Stage 3;Closed kinetic chain exercises and balance training, Stage 4:Plyometrics and sports specific training. Intervention 2: Control group: The traditional physical therapy (TPT) group used basic physiotherapy methods.</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:
Patient information sheet , raw data , results

When:
After publication

To whom:
public

Conditions:
statistical analysis

Where to obtain:
Research gate

How to obtain:
via email. research gate

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nadia Lotfy Radwan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ALmanifeia, Alraghi building</address>
        <city>Alkharj</city>
        <country1>Saudi Arabia</country1>
        <zip>00966</zip>
        <telephone>+966 56 172 8094</telephone>
        <email>n.radwan@psau.edu.sa</email>
        <affiliation>Prince Sattam bin Abdulaziz University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marwa Mohamed Ibrahim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Albatha</address>
        <city>Alkharj</city>
        <country1>Saudi Arabia</country1>
        <zip>00966</zip>
        <telephone>+966 11 588 6553</telephone>
        <email>assprofpnu@gmail.com</email>
        <affiliation>prince sattam bin Abdul-Aziz university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Saudi Arabia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male adolescent football players suffering from osteitis pubis (OP).
The player’s age ranged from 12 to 18 years, with a history of OP pain extended more than 3 months.
If they have unilateral or bilateral groin pain that increases with movement as sprinting, cutting, and sit-ups and disappear by rest.
If they have positive squeeze test, positive symphysis pubis stress tests.
if they have pubic bone and pubic symphysis joint tenderness with palpation.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>All other differential diagnosis leading to groin pain (e.g. inguinal or femoral hernia, prostatitis or urinary tract disorders),
A history of lower limb surgery and/or trauma to the back or hip.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M70.85</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other soft tissue disorders related to use, overuse and pressure of thigh</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 modified active physical therapy (MAPT) group consisted of four stages. Each stage lasted for three weeks.  Stage 1:  Pain control &amp; lumbopelvic stability - Stage 2:  Strengthening and core stability exercises., Stage 3;Closed kinetic chain exercises and balance training, Stage 4:Plyometrics and sports specific training</i_keyword>
      <i_keyword>Control group: The traditional physical therapy (TPT) group used basic physiotherapy methods.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: pain will be measured at baseline and one week after the end of the treatment period for both groups. Method of measurement: Visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Hip and trunk muscle strength. Timepoint: hip and trunk muscle strength will be measured at baseline and one week after the end of the treatment period for both groups. Method of measurement: handheld dynamometer  will be used to measure muscle strength.</prim_outcome>
      <prim_outcome>Lower extremity function. Timepoint: it will be measured at baseline and one week after the end of the treatment period for both groups. Method of measurement: lower extremity functional scale.</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>Self funding</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-31</approval_date>
        <contact_name>Standing Committee of Bioethics Research (SCBR)  in the College of Applied Medical Sciences, Prince </contact_name>
        <contact_address>ALmanifeia, Alraghi building Alkharj Riyadh Saudi Arabia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
