<?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>IRCT20261017071462N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-31</date_registration>
      <primary_sponsor>Faculty of Sports and Health Sciences, University of Tehran</primary_sponsor>
      <public_title>Comparison of the core stability exercises with internal and external focus of attention on pain, quality of life and lumbar proprioception in people with chronic nonspecific low back pain.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the core stability exercises with internal and external focus of attention on pain, quality of life and lumbar proprioception in people with chronic nonspecific low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/94149</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: I hope this message finds you well. The requested dates were somewhat ambiguous. We interpreted the participant recruitment start date as the date when announcements inviting individuals to participate in the study began, rather than the date when the exercise intervention commenced, Randomization description: Following the baseline assessment, simple individual randomization was performed. Each eligible participant was assigned a number, and the numbers were randomly drawn from a box to allocate participants to one of three groups(Lottery Method): core stability exercises without a specific attentional focus (active control), core stability exercises with an internal attentional focus, and core stability exercises with an external attentional focus. The allocation ratio was 1:1:1, Blinding description: Participants were unaware of their group allocation and the specific intervention assigned to them. The outcome assessor was also unaware of the participants’ group assignments and the type of exercises administered to each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Nonspecific Low Back Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention Group 1 (Active Control): Participants performed core stability exercises for six weeks, three sessions per week, with each session lasting 60 minutes, without any specific attentional focus (neither internal nor external). Intervention 2: Intervention group: Intervention Group 2: Participants performed core stability exercises for six weeks, three sessions per week, with each session lasting 60 minutes, with an emphasis on internal focus of attention, that is, focusing on the activity and contraction of the muscles involved during exercise. Intervention 3: Intervention group: Intervention Group 3: Participants performed core stability exercises for six weeks, three sessions per week, with each session lasting 60 minutes, with an emphasis on external focus of attention, that is, focusing on the effect or outcome of the movement during exercise.</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 For ethical reasons and to protect the confidentiality of participants’ information, individual-level data from this study will not be publicly available. Furthermore, in accordance with university regulations and policies, raw data cannot be shared. Aggregated or analyzed data may be made available to qualified researchers upon formal request and subject to the completion of the required legal procedures.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Square, 16 Azar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439813118</zip>
        <telephone>+98 21 8835 1730</telephone>
        <email>rrajabi@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab Square, 16 Azar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439813118</zip>
        <telephone>+98 21 8835 1730</telephone>
        <email>rrajabi@ut.ac.ir</email>
        <affiliation>The University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men aged 20–40 years with chronic nonspecific low back pain lasting longer than 3 months.
Pain intensity ranging from 3 to 7 on the Visual Analogue Scale (VAS).
No history of spinal surgery or specific spinal injuries, such as vertebral fractures.
No history of traumatic brain injury and no known balance disorders.
No radiating pain to the lower extremities.
No lower-extremity injuries within the past 6 months.
Absence of identifiable spinal deformities, such as scoliosis, as assessed by a spine specialist.
No participation in other therapeutic interventions or specific exercise programs during the study period.
Final approval from a spine specialist confirming eligibility to participate in core stabilization exercises.
Confirmation of informed consent by participants to participate in the study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Presence of specific low back pain, as diagnosed by a specialist physician.
Use of medications that affect pain or neuromuscular function, as assessed by a specialist physician.</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>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention Group 1 (Active Control): Participants performed core stability exercises for six weeks, three sessions per week, with each session lasting 60 minutes, without any specific attentional focus (neither internal nor external).</i_keyword>
      <i_keyword>Intervention group: Intervention Group 2: Participants performed core stability exercises for six weeks, three sessions per week, with each session lasting 60 minutes, with an emphasis on internal focus of attention, that is, focusing on the activity and contraction of the muscles involved during exercise.</i_keyword>
      <i_keyword>Intervention group: Intervention Group 3: Participants performed core stability exercises for six weeks, three sessions per week, with each session lasting 60 minutes, with an emphasis on external focus of attention, that is, focusing on the effect or outcome of the movement during exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lumbar proprioception is assessed by measuring joint repositioning error (JRE) using an isokinetic dynamometer before and after a six-week core stability exercise intervention. A reduction in joint repositioning error indicates improved lumbar proprioceptive accuracy. Timepoint: Measurement of lumbar proprioception before the start of the exercise intervention and after completion of the six-week core stability exercise program. Method of measurement: The joint repositioning error is measured using an isokinetic dynamometer by calculating the deviation of the reproduced angle from the target angle while the participant's eyes are closed. The error is reported in degrees.</prim_outcome>
      <prim_outcome>Pain intensity is measured using the Visual Analogue Scale (VAS), also known as the pain ruler, before the start of the exercise intervention and after completion of the six-week core stability exercise program. A reduction in the scale score indicates a decrease in pain intensity. Timepoint: Measurement of pain intensity before the start of the exercise intervention and after completion of the six-week core stability exercise program. Method of measurement: The Visual Analogue Scale (VAS) consists of a 10-cm line with two endpoints labeled “No pain” and “Worst pain imaginable.” The participant indicates their pain intensity by marking a point on the line. The pain score is calculated by measuring the distance from the starting point to the mark and is expressed in millimeters or centimeters.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Proprioception is assessed indirectly using the Y-Balance Test before the exercise intervention and after completion of the six-week core stability exercise program. This test serves as a non-specific method for evaluating functions related to proprioception and sensorimotor control by assessing an individual's ability to maintain dynamic balance. An improvement in the test score indicates improved dynamic balance performance. Timepoint: Dynamic balance was assessed using the Y-Balance Test before the start of the exercise intervention and after completion of the six-week core stability exercise program. Method of measurement: The participant stands on one leg and reaches as far as possible with the other leg in three directions: anterior, posteromedial, and posterolateral. The maximum reach distance in each direction is recorded and calculated according to the test protocol to assess dynamic balance performance.</sec_outcome>
      <sec_outcome>Quality of life is assessed using the 36-Item Short Form Health Survey (SF-36) before the start of the exercise intervention and after completion of the six-week core stability exercise program. The questionnaire assesses various dimensions of physical and mental health. Higher scores indicate improved health-related quality of life. Timepoint: Quality of life is assessed using the SF-36 questionnaire before the start of the exercise intervention and after completion of the six-week core stability exercise program. Method of measurement: The participant completes the SF-36 quality-of-life questionnaire. The final score is calculated according to the standard scoring guidelines and reported on a scale of 0 to 100, with higher scores indicating better health-related quality of life.</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>Faculty of Sports and Health Sciences, University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-19</approval_date>
        <contact_name>Research Ethics Committee of the Faculty of Sports and Health Sciences, University of Tehran</contact_name>
        <contact_address>North Kargar Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
