<?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>IRCT201502064231N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-02-21</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of individualized core stability exercises on management of subacute and chronic low back pain with radiculopathy.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of individualized core stability exercises on management of subacute and chronic low back pain with radiculopathy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4493</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diseases of the musculoskeletal system and connective tissue.</hc_freetext>
      <i_freetext>Eight weeks of core stability exercises (modified based on patient's symptoms): 1) Lie on back, Tighten abdominal muscles , press back down into floor - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 2) Begin on knees and hands, Tighten abdominal muscles- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 3) Walk with tightening abdominal muscles-30 minutes per day 4) Do your daily works with tightening abdominal muscles 5) Lie on back, Lift your buttocks off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 6) Begin on knees and hands, Extend your leg while lifting the opposite arm- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 7) Lie on your side, Raise your thighs and hips off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 8) Lie on back, Move your elbow to opposite knee. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 9) Lie on back, Raise your leg and ipsilateral arm off floor- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 10) Lie face down, raising your arms and legs off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 11) Lie on back, bent your legs, Rotate your legs from side to side. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 12) Begin standing, Raise one knee up. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 13) Begin standing, do lunge. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 14) Begin standing, do lunge, Raise one knee up. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds In addition, there are similar exercises on the sport ball - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ramin Kordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8863 0227</telephone>
        <email>ramin_kordi@tums.ac.ir</email>
        <affiliation>Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Pardis Noormohammadpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7- Opposite Shariati Hospital Clinic- After the overpass Nasr- Crossing Jalal Al Ahmad- Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8863 0227</telephone>
        <email>normohamadpour@tums.ac.ir</email>
        <affiliation>Sport Medicine Research Center, Tehran University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patient should be between 18 to 65 years old; Having a radicular low back pain for more than six weeks with a related annular tear or protrusion in the MRI; Having a continus or intermittent radicular pain or parestesia in lower limbs which is related to the affected disc levels.&#13;
&#13;
Exclusion criteria: Having absolute or relative indications for surgery such as cauda equina syndrome, paraparesis/paraplegia, and severe paresis or pain which has not improved over conservative treatments;  Not complying with the rehabilitation program and continuing the study; Getting pregnant during the study; History of systemic disease affecting the musculoskeletal functions, musculoskeletal deformity or abnormality with possible influence on the thickness of lateral abdominal muscles or paravertebral muscles (such as muscular dystrophy, abdominal hernia, and scleroderma); History of lumber surgery; History of lumber malignancy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lumbago with sciatica</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Eight weeks of core stability exercises (modified based on patient's symptoms): 1) Lie on back, Tighten abdominal muscles , press back down into floor - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 2) Begin on knees and hands, Tighten abdominal muscles- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 3) Walk with tightening abdominal muscles-30 minutes per day 4) Do your daily works with tightening abdominal muscles 5) Lie on back, Lift your buttocks off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 6) Begin on knees and hands, Extend your leg while lifting the opposite arm- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 7) Lie on your side, Raise your thighs and hips off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 8) Lie on back, Move your elbow to opposite knee. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 9) Lie on back, Raise your leg and ipsilateral arm off floor- 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 10) Lie face down, raising your arms and legs off floor. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 11) Lie on back, bent your legs, Rotate your legs from side to side. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 12) Begin standing, Raise one knee up. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 13) Begin standing, do lunge. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds 14) Begin standing, do lunge, Raise one knee up. - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds In addition, there are similar exercises on the sport ball - 1 sets of 10 Repetition, twice a day, hold all repetition for 15 Seconds</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain and radicular Pain. Timepoint: Before the intervention, 8 weeks after intervention. Method of measurement: VAS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: Before the intervention, 8 weeks after. Method of measurement: Iranian version of Roland and Morris Disability Questionnaire.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before the intervention, 8 weeks after. Method of measurement: Iranian version of WHOQOL: BREF questionnaire.</sec_outcome>
      <sec_outcome>Fear avoidance beliefs. Timepoint: Before the intervention, 8 weeks after. Method of measurement: Iranian version of fear avoidance beliefs questionnaire.</sec_outcome>
      <sec_outcome>Lateral Abdominal muscles thicknesses(transverse abdominis, internal oblique, and external oblique thickness). Timepoint: Before the intervention, 4 week after &amp; 8 week after. Method of measurement: ultrasound.</sec_outcome>
      <sec_outcome>Paravertebral muscles thicknesses. Timepoint: Before the intervention, 4 week after &amp; 8 week after. Method of measurement: ultrasound.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-10</approval_date>
        <contact_name>Tehran University of Medical Sciences and Health Services - Ethics committee</contact_name>
        <contact_address>Faculty of Medicine, Tehran University of Medical Sciences, Keshavarz Blvd., Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
