<?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>IRCT20250113064372N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-24</date_registration>
      <primary_sponsor>Sistan and Baluchestan University of Medical Sciences</primary_sponsor>
      <public_title>Hamstring stretching exercises and core stability exercises in back pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding hamstring stretching exercises to core stability exercises on pain, range of motion, sense of position, fear of movement and function of pre-elderly women with non-specific chronic back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81726</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Through a drawing a piece of paper and in the presence of the people themselves, each person will be given a number from 1 to 30. The numbers will be written on paper, folded and placed in a container (container number 1). Then, in another container, the names of the groups (15 sheets per group) will be folded and placed inside the container (container number 2).
Then, the  "drawing a piece of paper" process will be done in the presence of the participants. One person will draw the number and group and one person will do this to record and write the numbers. All people will be grouped in the same way, Blinding description: Participants participate in the study with the assumption that they will receive a similar exercise.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: core stability exercises and hamstring stretching exercises to increase the flexibility of this muscle. Exercises will be performed three times a week for 8 weeks. Intervention 2: Control group: core stability exercises ,three times a week for 8 weeks.</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 no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asma Eshaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah street</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816745785</zip>
        <telephone>+98 54 3113 2000</telephone>
        <email>asal.es7501@gmail.com</email>
        <affiliation>Sistan and Baluchestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asma Eshaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah street</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۸۱۶۷۴۵۸۴۵</zip>
        <telephone>+98 54 3344 6251</telephone>
        <email>asal.es7501@gmail.com</email>
        <affiliation>Sistan and Baluchestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with non-specific chronic back pain
Being at the age of 48 - 58 years 
Hamstring contracture</inclusion_criteria>
      <agemin>48 years</agemin>
      <agemax>58 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receiving treatment related to non-specific chronic back pain in the last month
Back pain caused by a fracture or protrusion of a lumbar disc
Diseases that affect the research process
Cardiovascular diseases or diabetes
Cancer
Osteoporosis
Surgery in the lower limbs, abdomen or chest and spine
Back pain caused by trauma
Accompanying structural changes in the tissues of the back or hamstring muscles</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: core stability exercises and hamstring stretching exercises to increase the flexibility of this muscle. Exercises will be performed three times a week for 8 weeks</i_keyword>
      <i_keyword>Control group: core stability exercises ,three times a week for 8 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain level. Timepoint: Before the start of the intervention, one day after the end of the intervention. Method of measurement: Visual Analogue Pain Scale,.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before the start of the intervention, one day after the end of the intervention. Method of measurement: sorensen test,.</prim_outcome>
      <prim_outcome>Sense of situation. Timepoint: Before the start of the intervention, one day after the end of the intervention. Method of measurement: repositioning error.</prim_outcome>
      <prim_outcome>Fear of movement. Timepoint: Before the start of the intervention, one day after the end of the intervention. Method of measurement: Five times sit to stand test.</prim_outcome>
      <prim_outcome>Performance. Timepoint: Before the start of the intervention, one day after the end of the intervention. Method of measurement: Roland‐Morris Disability Questionnaire, oswestry disability index ،.</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>Sistan and Baluchestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-09</approval_date>
        <contact_name>Ethics Committee in Research of Sistan and Baluchistan University</contact_name>
        <contact_address>Dasneshgah blvd. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
