<?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>IRCT20240326061368N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-31</date_registration>
      <primary_sponsor>The University Of Arak</primary_sponsor>
      <public_title>Investigating the effect of neuromuscular and pelvic floor dynamic stability exercises on non-specific chronic back pain and stress urinary incontinence in women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Dynamic Neuromuscular Stabilization and Pelvic Floor Training on pain and pelvic floor muscle function in women with Non-Specific Chronic Low Back Pain and Stress Urinary Incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76135</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Other design features: Using neuromuscular and pelvic floor dynamic stability exercises, Randomization description: We prepare a list of people who have the conditions to enter the study. People are placed in blocks of three and a lottery is done for each block. The first person of each block is in the control group, the second person is in the group of neuromuscular dynamics exercises and the third person is in the group of neuromuscular dynamics stability exercises along with pelvic floor exercises.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific back pain and stress urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Group 1:Dynamic Neuromuscular Stabilization Exercises: One of the newest sports rehabilitation techniques is Dynamic Neuromuscular Stabilization (DNS). The DNS treatment method is based on a detailed assessment of the quality of stability and movement, and the purpose of these exercises is to restore the spinal integration system (ISSS) through specific functional exercises based on evolved kinesiology positions. These exercises should activate the optimal patterns necessary for stabilization (support) in the closed kinetic chain as well as dynamic movements in the open kinetic chain. The ultimate strategy in these exercises is to maintain central control, joint stability, and ideal quality of movement. By repeating the exercises, an automatic pattern is created, which becomes an essential part of everyday movement and skills. The exercises will be done for 8 weeks, 3 times a week for 45 to 60 minutes. Intervention 2: Group 2: A combination of neuromuscular dynamic stability exercises and pelvic floor exercises: pelvic floor or Kegel exercises are those exercises that strengthen the pelvic floor muscles and help control the flow of urine and prevent involuntary leakage of urine. to be Kegel exercises include movements that help strengthen the muscles of the pelvic floor by tightening and then relaxing them and make them maintain their strength, just as other muscles in the body are strengthened by lifting weights. Doing Kegel exercises is a way to be strong. Keeping the pelvic floor muscles. These exercises will be done 3 times a week for 45 to 60 minutes for 8 weeks. Intervention 3: Intervention group: pelvic floor exercises: the control group will only perform pelvic floor exercises. These exercises will be performed for 8 weeks, 3 sessions per week for 45 to 60 minutes.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.shahnaz shahrjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences, Arak University, Karbala Boulevard, Basij Square, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۴۸۱۷۷۵۸۴</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>shahrjerdishahnaz@gmail.com</email>
        <affiliation>The University of Arak</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.shahnaz shahrjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences , Arak University , Karbala Boulevard , Basij Square , Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۸۴۸۱۷۷۵۸۴</zip>
        <telephone>+98 86 3417 3492</telephone>
        <email>shahrjerdishahnaz@gmail.com</email>
        <affiliation>The University of Arak</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Maximum of 2 natural births
Age range 30 to 40 years
Body mass index up to 35
Having non-specific chronic back pain with mild to moderate intensity
Has stress urinary incontinence</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with persistent back pain and a pain score of more than 8
History of urinary and kidney infection and spinal inflammation and infection
Dislocations
Neurological bladder
Hormonal treatments
Excessive obesity (grade 2)
Spinal stenosis or nerve compression or disc herniation
Inflammatory rheumatic diseases
History of hip or spine fracture
Osteoporosis
Ankylosing spondylitis
Spondylosis
Neoplasm
Spondylolisthesis
Sacroiliac joint disorder
Smoking or alcohol consumption
Diabetes
Those who cannot do the exercises or do not want to do the exercises
Spine or pelvic floor surgeries</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1:Dynamic Neuromuscular Stabilization Exercises: One of the newest sports rehabilitation techniques is Dynamic Neuromuscular Stabilization (DNS). The DNS treatment method is based on a detailed assessment of the quality of stability and movement, and the purpose of these exercises is to restore the spinal integration system (ISSS) through specific functional exercises based on evolved kinesiology positions. These exercises should activate the optimal patterns necessary for stabilization (support) in the closed kinetic chain as well as dynamic movements in the open kinetic chain. The ultimate strategy in these exercises is to maintain central control, joint stability, and ideal quality of movement. By repeating the exercises, an automatic pattern is created, which becomes an essential part of everyday movement and skills. The exercises will be done for 8 weeks, 3 times a week for 45 to 60 minutes.</i_keyword>
      <i_keyword>Group 2: A combination of neuromuscular dynamic stability exercises and pelvic floor exercises: pelvic floor or Kegel exercises are those exercises that strengthen the pelvic floor muscles and help control the flow of urine and prevent involuntary leakage of urine. to be Kegel exercises include movements that help strengthen the muscles of the pelvic floor by tightening and then relaxing them and make them maintain their strength, just as other muscles in the body are strengthened by lifting weights. Doing Kegel exercises is a way to be strong. Keeping the pelvic floor muscles. These exercises will be done 3 times a week for 45 to 60 minutes for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: pelvic floor exercises: the control group will only perform pelvic floor exercises. These exercises will be performed for 8 weeks, 3 sessions per week for 45 to 60 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chronic non-specific back pain. Timepoint: The beginning and end of the study. Method of measurement: VAS questionnaire and electromyography device Myotrac Infinity model made in Canada.</prim_outcome>
      <prim_outcome>Stress urinary incontinence. Timepoint: The beginning and end of the study. Method of measurement: Brawley's Urinary Incontinence Questionnaire(QUID) and one-hour test pad.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before starting the intervention, 8 weeks after the intervention. Method of measurement: Visual Analog Scale 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 Arak</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-13</approval_date>
        <contact_name>Ethics Committee of Arak University</contact_name>
        <contact_address>The University of Arak , Karbala BLV , Basij Square , Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
