<?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>IRCT20240325061364N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-21</date_registration>
      <primary_sponsor>The University of Kharazmi</primary_sponsor>
      <public_title>Effect of self-compassion exercises combined with motor control exercises on chronic non-specific low back pain.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of motor control exercises combined with self-compassion based on mindfulness training on pain, disability, psychological factors and lumbopelvic kinematic during lifting in patients with chronic nonspecific low back pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82637</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Following the baseline examination, by using the method on the website http://randomizer.org/ (Social Psychology Network, Connecticut, USA), participants are randomly assigned into the two experimental groups (motor control_ self-compassion and motor control) and control group. This site uses the random. Math method in the programming language, JavaScript is used as the main method for generating random numbers. The allocation concealment is done using a computer-generated block randomization table, where the number 1 will be defined for the motor control training group with self-compassion training, the number 2 for the motor control training group, and the number 3 for the control group. Then the random number sequence will be placed in opaque and sealed envelopes. Also, the treatment will be continued by the researcher according to the group assignment. Finally, the results will be evaluated before the interventions and eight weeks after the interventions, Blinding description: In this study, the patients was blind to the process of randomization and assignment of individuals into experimental and control groups. During the intervention, participants will only be familiar with the members of their own therapy group. Each group will receive the treatment at different times to prevent contact between participants from the two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>non specific chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group will engage in 24 sessions of motor control exercises over 8 weeks, with each session lasting 30 minutes, supervised by two movement science specialists. This protocol is designed to facilitate patient rehabilitation by improving spinal and pelvic girdle control and coordination through motor learning principles such as segmentation and simplification. The first phase of treatment involves assessing posture, movement patterns, and muscle activation patterns based on symptoms (reduced activation of deep lumbopelvic muscles) to design personalized exercises tailored to each individual’s needs. If therapeutic goals are achieved in the first phase, the second phase will incorporate more functional activities aimed at improving coordination in both static and dynamic conditions. As movement improves, the duration and number of repetitions will be gradually increased. Intervention 2: Intervention Group: Participants in this group will engage in 8 sessions of Mindfulness-Based Self-Compassion training over 8 weeks, facilitated by two clinical psychologists. Each session of the Mindfulness-Based Self-Compassion protocol focuses on a specific topic. The first session introduces and provides a general overview of self-compassion. The second session offers foundational information about mindfulness. In the third week, the application of self-compassion in various life aspects, including chronic pain, will be discussed. Week four helps participants develop a compassionate inner voice in various situations. The fifth week emphasizes living according to core values. In week six, coping skills for dealing with difficult emotions will be taught. Week seven focuses on managing and facing challenging interpersonal relationships. In the final session, the discussion will revolve around how to connect with one’s positive aspects and life, accompanied by gratitude. Between the fourth and fifth sessions, a half-day session lasting 4 hours will be held, involving various types of meditation, restorative yoga, and mindful eating in complete silence. The self-compassion approach, which includes self-kindness during moments of pain and suffering, leads to improvements in pain-related functioning, disability, and increased brain awareness, altering the pain processing mechanism. It also enhances psychological variables (reducing stress, anxiety, pain catastrophizing, increasing self-efficacy, life satisfaction, and sleep quality) in patients with chronic low back pain. Intervention 3: Control group: It does not receive any intervention and is evaluated to compare the changes made in the other two groups.</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 Data collection has not yet been completed.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir LetafatKar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Mirdamad Street, Hesari Street, Keshvari Sports Complex, Kharazmi University Movement Sciences Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>letafatkaramir@yahoo.com</email>
        <affiliation>The University of Kharazmi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir LetafatKar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Mirdamad Street, Hesari Street, Keshvari Sports Complex, Kharazmi University Movement Sciences Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1571914911</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>letafatkaramir@yahoo.com</email>
        <affiliation>The University of  Kharazmi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Persian-native (female and male)
primary complaint backpain (more than 3 months, experienced between L1 and the gluteal fold without pathoanatomical cause) confirmed by an orthopedic specialist.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>69 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous spinal surgery and neurological signs
Specific spinal pathology
Conditions that may be uncontrolled for self-compassion meditation (psychosis, major depression or anxiety)
pregnancy</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>Treatment - Other</i_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in this group will engage in 24 sessions of motor control exercises over 8 weeks, with each session lasting 30 minutes, supervised by two movement science specialists. This protocol is designed to facilitate patient rehabilitation by improving spinal and pelvic girdle control and coordination through motor learning principles such as segmentation and simplification. The first phase of treatment involves assessing posture, movement patterns, and muscle activation patterns based on symptoms (reduced activation of deep lumbopelvic muscles) to design personalized exercises tailored to each individual’s needs. If therapeutic goals are achieved in the first phase, the second phase will incorporate more functional activities aimed at improving coordination in both static and dynamic conditions. As movement improves, the duration and number of repetitions will be gradually increased.</i_keyword>
      <i_keyword>Intervention Group: Participants in this group will engage in 8 sessions of Mindfulness-Based Self-Compassion training over 8 weeks, facilitated by two clinical psychologists. Each session of the Mindfulness-Based Self-Compassion protocol focuses on a specific topic. The first session introduces and provides a general overview of self-compassion. The second session offers foundational information about mindfulness. In the third week, the application of self-compassion in various life aspects, including chronic pain, will be discussed. Week four helps participants develop a compassionate inner voice in various situations. The fifth week emphasizes living according to core values. In week six, coping skills for dealing with difficult emotions will be taught. Week seven focuses on managing and facing challenging interpersonal relationships. In the final session, the discussion will revolve around how to connect with one’s positive aspects and life, accompanied by gratitude. Between the fourth and fifth sessions, a half-day session lasting 4 hours will be held, involving various types of meditation, restorative yoga, and mindful eating in complete silence. The self-compassion approach, which includes self-kindness during moments of pain and suffering, leads to improvements in pain-related functioning, disability, and increased brain awareness, altering the pain processing mechanism. It also enhances psychological variables (reducing stress, anxiety, pain catastrophizing, increasing self-efficacy, life satisfaction, and sleep quality) in patients with chronic low back pain.</i_keyword>
      <i_keyword>Control group: It does not receive any intervention and is evaluated to compare the changes made in the other two groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using a visual analog pain scale or pain ruler (scale 0 to 10).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using the Persian translation of the Roland Morris Disability Questionnaire.</sec_outcome>
      <sec_outcome>Fear-avoidance beliefs. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using the Persian translation of the 16-item Fear Avoidance Beliefs Questionnaire.</sec_outcome>
      <sec_outcome>Catastrophic pain. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using the Persian translation of the Catastrophizing Pain Scale.</sec_outcome>
      <sec_outcome>Fear of movement. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using the Persian translation of the Tampa Scale of Kinesiophobia.</sec_outcome>
      <sec_outcome>Range of motion of the lumbar flexion relative to the pelvis during forward bending and lifting. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using a 3D motion capture device while bending forward and lifting a load at their chosen speed for up to 5 repetitions.</sec_outcome>
      <sec_outcome>Range of motion of the lumbar flexion relative to the hip while bending forward and lifting a load. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using a 3D motion capture device while bending forward and lifting a load at their chosen speed for up to 5 repetitions.</sec_outcome>
      <sec_outcome>Range of motion of hip flexion relative to the pelvis during forward bending and lifting. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using a 3D motion capture device while bending forward and lifting a load at their chosen speed for up to 5 repetitions.</sec_outcome>
      <sec_outcome>Angular velocity of the lumbopelvic during forward bending and lifting of a load. Timepoint: 2 weeks before intervention, 2 weeks after intervention (12th week). Method of measurement: Using a 3D motion capture device while bending forward and lifting a load at their chosen speed for up to 5 repetitions.</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>No governmental fund has been received for this study, and it is conducted by researchers.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-03-03</approval_date>
        <contact_name>Sport Sciences Research Institute</contact_name>
        <contact_address>No. 3, Fifth Alley, Mir Emad St., Ostad Motahari St., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
