<?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>IRCT20230806059059N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-23</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>exercise therapy in lowback pain</public_title>
      <acronym></acronym>
      <scientific_title>comparison between effects of core stabilization and Mckenzie exercises in mechanical low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71892</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: in this study we do not use any type of modalities or drugs and all participants will only do the prescribed exercises at the time of study Furthermore;all of them will be assessed via mechanical assessment form introduced by Mckenzie institute before grouping, Randomization description: participants will fill their demographic and personal data.Their pain based on VAS,range of motion based on FTF,disability based on ODI questionnaire and functional status based on unilateral single limb stance will be measured.All participants will be assessed via mechanical assesment form(mechanical diagnosis and therapy from Mckenzie institute) and then we will use a dice,even puts them in Mckenzie exercises group and odd puts them in core stability exercises group, Blinding description: all procedures except name of groups will be described to patients so that they will perform exercises according to the educations without knowing their group name.Each participants will be paired by a code to their names in a separate paper from their files so the final assessor would be blind of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mechanical low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: core stability group in this group patients after mechanical assessment with mechanical assessment form will be educated to perform abdominal drawing in,unilateral prone leg extension and bridging in two sets and each set 5 seconds holding contraction and 5 minutes rest between each set. Intervention 2: Intervention group: Mckenzie exercises in this group after assessment with mechanical assessment form patients will first do prone lying for 5 minutes,if symptoms does not get worse they will be progressed to prone on elbow position for 5 minutes.again if symptoms does net get worse they will perform extension in lying to end range and hold it for 2 seconds and 10 repetition then they will rest for 5 minutes and repeat for 10 times.</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:
All data related to pain,disability,range of motion,balance and function can be reported.Other data including demographic features can also be reported but they are not the purpose of this study

When:
start of publishing data:3 months after conclusions reported

To whom:
All of physiotherapist are allowed

Conditions:
for the data mentioned above, no other permissions are required and all of physiotherapist are allowed to use these data.

Where to obtain:
Just email of Hamidreza Nemati,Conductor of study is available
Hmdrea9898@gmail.com

How to obtain:
The detail of data asked should be emailed in one mail and after about one to two weeks the data will be send for them

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.16,Paeiz Ave,Arghavan st,Mahan Blvd</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3145944516</zip>
        <telephone>+98 26 3448 0756</telephone>
        <email>hmdreza9898@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 16,Paeiz Ave,Arghavan St,Mahan Blvd</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3145944516</zip>
        <telephone>+98 26 3448 0756</telephone>
        <email>hmdreza9898@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lowback pain with or without radiculopathy
Having a defined baseline for painful positions
Having at least pain level of 2 based on VAS
BMI lower than 30</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>history of any surgeries in Lumbar vertebrae including laminectomy or etc
History of tumor or possibility of it
History of trauma or possibility of infection or fracture
Unwillingness to continue at any stages
Urinary or fecal incontinence
Pregnancy
Hamstring shortness
brain injuries
Vestibular disorders,alcohol or drug abuse and psychotropic drugs</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: core stability group in this group patients after mechanical assessment with mechanical assessment form will be educated to perform abdominal drawing in,unilateral prone leg extension and bridging in two sets and each set 5 seconds holding contraction and 5 minutes rest between each set.</i_keyword>
      <i_keyword>Intervention group: Mckenzie exercises in this group after assessment with mechanical assessment form patients will first do prone lying for 5 minutes,if symptoms does not get worse they will be progressed to prone on elbow position for 5 minutes.again if symptoms does net get worse they will perform extension in lying to end range and hold it for 2 seconds and 10 repetition then they will rest for 5 minutes and repeat for 10 times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Flexion in standing range of motion. Timepoint: before study and after 8 sessions therapy. Method of measurement: ruler.</prim_outcome>
      <prim_outcome>Pain intensity. Timepoint: before study and after 8 sessions therapy. Method of measurement: visual analogous scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: before study and after 8 sessions of therapy. Method of measurement: oswetry disability index.</prim_outcome>
      <prim_outcome>Function and balance. Timepoint: before study and after 8 session therapy. Method of measurement: using a striated curtain with 1 meters away from patient.Test if positive if any compensatory movement or deviation occurs that does not turn back to the starting position immediately.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>2023-05-30</approval_date>
        <contact_name>ethics committe of shahid beheshti university of medical sciences</contact_name>
        <contact_address>No 16,Arghavan street,west mahan Blvd Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
