<?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>IRCT20191015045122N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-06</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>"The comparison of the effect of flexi-bar and lumbar stability exercises in treatment of low back pain"</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of flexi-bar and lumbar stability exercises on postural control of people with nonspecific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43072</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random method: Patients were given a number according to the order of their choice; then, with the help of a draw, the patients were divided into treatment and control groups. The first number was assigned to the treatment group and the next number entered the two groups, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nonspecific low backpain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group receives 20 minutes of routine physiotherapy treatment including TENS, Hot pack, US, each session, followed by 15 minutes of bike warm-up and stretching exercises including cuff, hamstring, iliopsoas and back muscles, followed by 30 minutes Flexi-Bar exercises (Flexi-Bar of an elastic rod about 7.0 mm in diameter and 5.1 meters long with two ends fluctuating. Shaking flexi-load produces vibrational excitation at a low frequency of 5 HZ). They do it progressively. These exercises include shaking the bar on the horizontal, sagittal, and frontal plates. At the end, they do stretching exercises, such as stretching the cuff muscles, hamstring, iliopsoas, and back muscles for cool down. Intervention 2: Control group: This group receives 20 minutes of routine physiotherapy treatment including TENS, Hot pack, US, each session, followed by 15 minutes of bike warm-up and stretching exercises including cuff, hamstring, iliopsoas and back muscles, followed by 30 minutes stability exercises including abdominal drawing-in, bridging, bird-dog exercise, Supine Dead Bugs progressively, 10 to 20 repetitions of each exercise. At the end, they do stretching exercises, such as stretching the cuff muscles, hamstring, iliopsoas, and back muscles for cool down.</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>Fatemeh Amiri doomari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 11، Shahid Beheshti Ave، Azadi Square، Kerman Town</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619738890</zip>
        <telephone>+98 34 3245 6119</telephone>
        <email>fatemehamiri4727@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mohsen  Roostayi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation of Shahid Beheshti University of Medical Sciences, Damavand St, Imam Hossein Square, Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7756 1721</telephone>
        <email>mohsen42@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All persons aged 20 to 45 years with chronic low back pain who have chronic or recurrent pain for more than three months
Local pain in the lumbar spine (between l1 and gluteal fold)
Pain severity between 1 and 5 based on VAS scale
BMI 20 to 25</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of lumbar spine injection
Pregnancy
History of spine surgery
Orthopedic, neurological, vestibular or cardiovascular, respiratory disorders
Diabetic neuropathy</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: This group receives 20 minutes of routine physiotherapy treatment including TENS, Hot pack, US, each session, followed by 15 minutes of bike warm-up and stretching exercises including cuff, hamstring, iliopsoas and back muscles, followed by 30 minutes Flexi-Bar exercises (Flexi-Bar of an elastic rod about 7.0 mm in diameter and 5.1 meters long with two ends fluctuating. Shaking flexi-load produces vibrational excitation at a low frequency of 5 HZ). They do it progressively. These exercises include shaking the bar on the horizontal, sagittal, and frontal plates. At the end, they do stretching exercises, such as stretching the cuff muscles, hamstring, iliopsoas, and back muscles for cool down.</i_keyword>
      <i_keyword>Control group: This group receives 20 minutes of routine physiotherapy treatment including TENS, Hot pack, US, each session, followed by 15 minutes of bike warm-up and stretching exercises including cuff, hamstring, iliopsoas and back muscles, followed by 30 minutes stability exercises including abdominal drawing-in, bridging, bird-dog exercise, Supine Dead Bugs progressively, 10 to 20 repetitions of each exercise. At the end, they do stretching exercises, such as stretching the cuff muscles, hamstring, iliopsoas, and back muscles for cool down.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static posture control. Timepoint: Before the intervention and at the end of the intervention. Method of measurement: Bertec Force plate machine.</prim_outcome>
      <prim_outcome>Dynamic posture control. Timepoint: Before the intervention and at the end of the intervention. Method of measurement: Star Excursion Balance Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of pain. Timepoint: Before the intervention and after the intervention. Method of measurement: Visual analogue scale (VAS).</sec_outcome>
      <sec_outcome>Functional disability. Timepoint: Before the intervention and after the intervention. Method of measurement: Oswestry questionnaire.</sec_outcome>
      <sec_outcome>Isometric Tolerance of the Dorsal Muscle. Timepoint: Before the intervention and after the intervention. Method of measurement: Sorensen Test.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-23</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Third Floor, Faculty of Medicine, Next to Taleghani Hospital, Evin, Shahid Chamran Highway, Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
