<?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>IRCT20241107063631N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pelvic physiotherapy in reducing pain in patients with endometriosis</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Dienogest with and without pelvic floor physiotherapy on the pain level of endometriosis sufferers.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Sequence Generation will be done by simple randomization and by shuffling the cards. A number of cards will be prepared as the first group and the same number of cards for the next groups. Then, by shuffling them, one card will be removed and its assignment will be recorded, and that card will be returned to the other cards. Then, the cards will be shuffled again and another card will be removed. This process will continue until a random sequence is reached according to the sample size.</study_design>
      <phase>3</phase>
      <hc_freetext>Endometriosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dienogest treatment with pelvic physiotherapy - Pelvic floor physiotherapy will be performed for 12 sessions of fifty minutes, repeated three times a week. It includes thirty minutes of visceral manipulation (internal vaginal and external (abdomen) and twenty minutes of pelvic floor muscle exercises. The patient is placed in a supine position with bent knees. Pelvic floor exercises are divided into four phases. The proprioceptive phase in the first week includes proprioceptive exercises for adequate understanding of the exercises and performing fast and slow contractions. The simple phase is performed in the second week with the aim of improving the control of fast and slow contractions during simple functional activities. The advanced phase is performed in the third week in which functional exercises with a greater amplitude are performed. The strength phase is performed in the last week to increase the strength of contraction. In all sessions, contractions will be performed for slow and fast fibers. Intervention 2: Control group: Dienogest treatment and sham maneuver (a dummy intervention is used as an intervention in the control group, and the practical methods are applied in a fake manner in the control group). Dienogest was also prescribed from Ati Pharmed Pharmaceutical Company at a dose of 2 mg daily.</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 we haven't decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maral Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No:33,darya staion , farahzadi blvd, Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>146974541</zip>
        <telephone>+98 21 8807 9143</telephone>
        <email>maral.hosseinzadeh65@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maral Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No:33,darya staion , farahzadi blvd, Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>146974541</zip>
        <telephone>+98 21 8807 9143</telephone>
        <email>maral.hosseinzadeh65@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 20-45 with endometriosis.
All of them have been using dinogest for at least 3 months
All of them reported symptoms of pelvic pain (CPP or dyspareunia and dysmenorrhea).</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>pregnancy
Pace maker
Reduced skin sensitivity,   , acute , cognitive impairment, and
Epilepsy,
Cardiac arrhythmia
Cancer
Acute pelvic inflammatory disease
Gel or electrode sensitivity,
difficulty understanding instructions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis of pelvic peritoneum</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: Dienogest treatment with pelvic physiotherapy - Pelvic floor physiotherapy will be performed for 12 sessions of fifty minutes, repeated three times a week. It includes thirty minutes of visceral manipulation (internal vaginal and external (abdomen) and twenty minutes of pelvic floor muscle exercises. The patient is placed in a supine position with bent knees. Pelvic floor exercises are divided into four phases. The proprioceptive phase in the first week includes proprioceptive exercises for adequate understanding of the exercises and performing fast and slow contractions. The simple phase is performed in the second week with the aim of improving the control of fast and slow contractions during simple functional activities. The advanced phase is performed in the third week in which functional exercises with a greater amplitude are performed. The strength phase is performed in the last week to increase the strength of contraction. In all sessions, contractions will be performed for slow and fast fibers.</i_keyword>
      <i_keyword>Control group: Dienogest treatment and sham maneuver (a dummy intervention is used as an intervention in the control group, and the practical methods are applied in a fake manner in the control group). Dienogest was also prescribed from Ati Pharmed Pharmaceutical Company at a dose of 2 mg daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in the questionnaire. Timepoint: Before the start of the intervention - one month after the start of physiotherapy. Method of measurement: mode Questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-10</approval_date>
        <contact_name>Ethics committee of shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>taleghani hospital . Arabi street . daneshjoo street tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
