<?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>IRCT20240107060646N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-20</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Effects of dynamic neuromuscular stabilization exercises on chronic low back pain</public_title>
      <acronym>DNS</acronym>
      <scientific_title>Effect of Dynamic Neuromuscular Stabilization exercises on pain, functional tests scores, respiratory function, and quality of life in individuals with chronic non-specific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: Participants are assigned to one of two groups: the control group and the experimental group. The control group follows their regular daily routine, while the experimental group follows a specific exercise protocol, Randomization description: The participants' names are entered in the first column of the Excel spreadsheet. Using the online website https://www.random.org, a random number between 1 and 36 is generated, and the generated numbers are entered in the second column of the spreadsheet in order (corresponding to the participants' names). Then, the sort command is used to sort the second column in ascending order. This way, individuals with numbers 1 to 18 in the second column are assigned to the control group, and individuals with numbers 19 to 36 are assigned to the exercise group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Exercise group. Intervention 2: Control group: Control group.</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:
If requested by the principal investigator, information regarding the primary outcomes can be shared.

When:
The access period will begin 6 months after the publication of the results.

To whom:
Researchers employed in academic and scientific institutions, as well as individuals working in industry, can proceed to obtain them upon request.

Conditions:
For scientific and practical purposes.

Where to obtain:
To request the information from the principal investigator, you can either make an in-person visit to the Faculty of Sports Sciences at Isfahan University or correspond via email to r.mahdavinejad@spr.ui.ac.ir.

How to obtain:
After verifying the appropriateness of data usage, it will be shared within one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Mahdavinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences, University of Isfahan, Azadi Square, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3793 2128</telephone>
        <email>r.mahdavinejad@spr.ui.ac.ir</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Mahdavinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences, University of Isfahan, Azadi Square, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3793 2128</telephone>
        <email>r.mahdavinejad@spr.ui.ac.ir</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a minimum of three months of non-specific chronic low back pain
The ability to sit, stand, and walk without using assistive devices
Not engaging in regular exercise</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any specific pathology such as disc protrusion, spinal injury or surgery history, neurological disorders, tumors, osteoarthritis, and rheumatoid arthritis diagnosed by a specialist physician
Being diagnosed with any medical condition that restricts physical activity by a physician
Experiencing unbearable pain and inability to perform exercises
Potential lung tissue damage in case of COVID-19 infection
Absenteeism of more than one-third of exercise sessions irregularly or absenteeism of three consecutive sessions
Lack of willingness to continue participation in the study</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Exercise group</i_keyword>
      <i_keyword>Control group: Control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain is measured using the Visual Analog Scale (VAS). Functional disability is assessed using the Oswestry Disability Index questionnaire. Motor function is measured through Functional Movement Screen (FMS) tests. Spirometry is used to evaluate respiratory performance (FVC, FEV1, and FEV1/FVC). The SF-36 Quality of Life questionnaire is employed for assessing the quality of life. Timepoint: At the beginning of the study (prior to intervention), 8 weeks after the intervention (posttest), and after 2 months of detraining following the posttest. Method of measurement: Pain is measured using the Visual Analog Scale. Functional disability is assessed using the Oswestry Disability Index questionnaire. Motor function is measured through Functional Movement Screen tests. Spirometry is used to evaluate respiratory performance (forced vital capacity, forced expiratory volume in the first second, and the ratio of forced expiratory volume in the first second to forced vital capacity). The Short Form 36-item questionnaire is employed for assessing the quality of life.</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>University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-13</approval_date>
        <contact_name>University of Isfahan - Research Ethics Committees Certificate</contact_name>
        <contact_address>Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Services,  Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
