<?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>IRCT20150503022068N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-25</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Comparison of the effect of online and face-to-face cognitive exercises in people with non-specific chronic low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of online and face-to-face cognitive exercises in people with non-specific chronic low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56532</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to 1 of 3 treatments, the samples will be determined in a simple random method using a random number table of Software Allocation Random software. Randomization and allocation sequence for concealment will be done by the person not involved in the research. The ratio of sample allocation will be 1: 1 and will be divided into 2 experimental groups and 1 control group, Blinding description: in this study, the outcome assessor will be blinded of the process of randomization and division of individuals into two experimental groups and control group. Another researcher(blinded to the baseline assessment) will proceed with training according to the group assignment. A blinded outcome assessor who does not know the hypothesis and study methods, measures outcome at baseline and12 weeks post intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 3  online sessions of pain neuroscience education, followed by 15 online sessions of education and exercises of motor control _cognition. The intervention will be done in three phases. The first phase is pain education. Each education session lasts 3 sessions of 30 to 60 minutes for each patient and will be online. In pain education sessions, information about the nature of pain will be targeted to reduce fear avoidance and avoidance beliefs and behaviors, thereby promoting self-efficacy. Also, the training is done using different teaching aids such as pictures and expressing metaphors and examples. The second phase of cognition-targeted motor control training with the aim of recognizing the movements in this stage is designed for different people in the same way. Exercises with at least 10 repetitions and 10 seconds of contraction will be done at home for 2 sets. The third phase is cognition-targeted dynamic and functional exercises with the aim of recognizing. Becomes. The progress of the exercises goes to the exercises in which the patient feels fear in performing those movements. In this stage, the exercises are designed for each person separately because the feeling of pain is different in each patient and in each activity, and the training of the exercises in this stage will be online. Remind the therapist during all three stages, if necessary, to teach neuroscience. Challenges and reassures patients that the exercise provided is safe. In this group, interventions are done with Skype or Whats App (depending on availability). Intervention 2: Intervention group: 3 face to face sessions of pain neuroscience education, followed by 15 face to face sessions of education and exercises of motor control _cognition. The intervention will be done in three phases. The first phase is pain education. Each education session lasts 3 sessions of 30 to 60 minutes for each patient and will be online. In pain education sessions, information about the nature of pain will be targeted to reduce fear avoidance and avoidance beliefs and behaviors, thereby promoting self-efficacy. Also, the training is done using different teaching aids such as pictures and expressing metaphors and examples. The second phase of cognition-targeted motor control training with the aim of recognizing the movements in this stage is designed for different people in the same way. Exercises with at least 10 repetitions and 10 seconds of contraction will be done at home for 2 sets. The third phase is cognition-targeted dynamic and functional exercises with the aim of recognizing. Becomes. The progress of the exercises goes to the exercises in which the patient feels fear in performing those movements. In this stage, the exercises are designed for each person separately because the feeling of pain is different in each patient and in each activity, and the training of the exercises in this stage will be face to face. Remind the therapist during all three stages, if necessary, to teach neuroscience. Challenges and reassures patients that the exercise provided is safe. Intervention 3: Control group: 3 sessions education for back and lumbar care and 15 sessions of common exercises for low back pain. Each education session will last 3 sessions of 30 to 60 minutes. The learning objectives of this training include: Acquiring biomedical knowledge focused on back pain. And 15 sessions of common low back pain exercises will last 30 to 40 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Only part of the data, such as dependent variables, The average of all samples, can be shared in scientific articles.

When:
Access period starts 3 months after the results are published

To whom:
Personal information is confidential and General outcomes in paper form Available to everyone.

Conditions:
General outcomes in paper form Available to everyone.

Where to obtain:
Gelareh Alamouti Phone: 09107161695 Email: gelarehalamooti@gmail.com

How to obtain:
3 months after the publication of the results, the applicant can have the data by sending an email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gelareh Alamouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street ,Keshvari Sport complex Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>439815875</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>gelarehalamooti@gmail.com</email>
        <affiliation>Kharazmy University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gelareh Alamouti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street ,Keshvari Sport complex Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>439815875</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>gelarehalamooti@gmail.com</email>
        <affiliation>Center for Human Movement Sciences Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least time for low back pain is 12 weeks and 3 days a week. Pain should be determined at the discretion of a physician and also using the Quebec questionnaire.
People are in the medium risk group according to the Start Back tool
Score 14% or more on the Oswestry Disability Index
Has a pain intensity equal to or greater than 4 on a numerical rating scale
The pain is between the last rib and the gluteal
Have not taken any new medication or people who do not need medication during the 6 weeks before and while studying
Body mass index less than or equal to 30
Women and men 25 to 55 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant women
People with a history of lumbar tumors
People with inflammatory disease of the spine that is mentioned in their medical history or has been diagnosed by a doctor
Participate in exercise therapy courses for the treatment of low back pain in the past year
Having any fractures and surgery in the lumbar and dorsal spine</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 3  online sessions of pain neuroscience education, followed by 15 online sessions of education and exercises of motor control _cognition. The intervention will be done in three phases. The first phase is pain education. Each education session lasts 3 sessions of 30 to 60 minutes for each patient and will be online. In pain education sessions, information about the nature of pain will be targeted to reduce fear avoidance and avoidance beliefs and behaviors, thereby promoting self-efficacy. Also, the training is done using different teaching aids such as pictures and expressing metaphors and examples. The second phase of cognition-targeted motor control training with the aim of recognizing the movements in this stage is designed for different people in the same way. Exercises with at least 10 repetitions and 10 seconds of contraction will be done at home for 2 sets. The third phase is cognition-targeted dynamic and functional exercises with the aim of recognizing. Becomes. The progress of the exercises goes to the exercises in which the patient feels fear in performing those movements. In this stage, the exercises are designed for each person separately because the feeling of pain is different in each patient and in each activity, and the training of the exercises in this stage will be online. Remind the therapist during all three stages, if necessary, to teach neuroscience. Challenges and reassures patients that the exercise provided is safe. In this group, interventions are done with Skype or Whats App (depending on availability).</i_keyword>
      <i_keyword>Intervention group: 3 face to face sessions of pain neuroscience education, followed by 15 face to face sessions of education and exercises of motor control _cognition. The intervention will be done in three phases. The first phase is pain education. Each education session lasts 3 sessions of 30 to 60 minutes for each patient and will be online. In pain education sessions, information about the nature of pain will be targeted to reduce fear avoidance and avoidance beliefs and behaviors, thereby promoting self-efficacy. Also, the training is done using different teaching aids such as pictures and expressing metaphors and examples. The second phase of cognition-targeted motor control training with the aim of recognizing the movements in this stage is designed for different people in the same way. Exercises with at least 10 repetitions and 10 seconds of contraction will be done at home for 2 sets. The third phase is cognition-targeted dynamic and functional exercises with the aim of recognizing. Becomes. The progress of the exercises goes to the exercises in which the patient feels fear in performing those movements. In this stage, the exercises are designed for each person separately because the feeling of pain is different in each patient and in each activity, and the training of the exercises in this stage will be face to face. Remind the therapist during all three stages, if necessary, to teach neuroscience. Challenges and reassures patients that the exercise provided is safe.</i_keyword>
      <i_keyword>Control group: 3 sessions education for back and lumbar care and 15 sessions of common exercises for low back pain. Each education session will last 3 sessions of 30 to 60 minutes. The learning objectives of this training include: Acquiring biomedical knowledge focused on back pain. And 15 sessions of common low back pain exercises will last 30 to 40 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before and after the intervention. Method of measurement: Numerical pain rating scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before and after the intervention. Method of measurement: Oswestry Disability Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: Before and after the intervention. Method of measurement: McGill tests and Luomajoki motor control tests.</sec_outcome>
      <sec_outcome>Psychological factors. Timepoint: Before and after the intervention. Method of measurement: Tampa scale- Dass21 questioner- Fear Avoidance Belief Questionnaire- Self-Efficacy Questionnaire- Pain Catastrophizing Scale.</sec_outcome>
      <sec_outcome>Health status. Timepoint: Before and after the intervention. Method of measurement: Asking questions.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-23</approval_date>
        <contact_name>Ethics Committee of Sports Science Research Institute</contact_name>
        <contact_address>Motahhari St. - Mir Emad St. - Fifth Alley Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
