<?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>IRCT20200211046456N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-16</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effect of core stability exercise in treatment of iliotibial band syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effects of routine physical therapy with and without core stability in improving pain, functional mobility and quality of life in patients with iliotibial band syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45731</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study was designed to be a parallel group randomized controlled trial. Random numbers were generated, without stratification, from 1-40 using an online random numbers generator in two sets by an independent statistician. Set 1 was assigned routine physical therapy and set 2 was assigned core stability exercises and routine physical therapy. Opaque, sealed envelope method was used to randomly assign patients (in a 1:1 ration) into both groups and unsealed by a researcher after baseline testing. Outcome assessors were unaware of group assignment, Blinding description: After randomisation, patients were told about their treatment regime by their therapist, keeping blind about the other group treatment. Patients were only informed about treatment programme similarities in both groups (soft tissue, cryotherapy, stretching and strengthening exercises). Both treatment programmes were tailored to the patient’s abilities to make sure all eligible patients could complete the trial. Outcome assessors and data analyzers were masked to group allocation. Patients were told not to talk about the treatment protocol they were given during the trial with the outcome assessors and could contact their therapist in case of any problems during trial participation. Besides, if two or more study participants were in the clinic at the same time, they were assigned to different treatment areas without any opportunity to observe each other or their treatment times were rearranged to prevent unintended crossover.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Iliotibial Band Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group include combination of routine physical therapy and core stability exercises as part of treatment. Core stability exercise includes: 1- Transversus abdominus (perform 30 reps with 8s hold) Bracing with heel slides, Abdominal bracing, bridging, standing, standing row, walking, leg lifts. 2- Paraspinals/multifidi (perform 30 reps with 8s hold). Quadruped legs lifts and arm lifts with bracing, Quadruped alternate legs and arms lifts with bracing. 3- Quadratus lumborum and obliques ((perform 30 reps with 8s hold). Side plank with knees flexed and extended. 4- Trunk curl. (Conventional) Routine physical therapy protocol include 1- specific stretching exercises focused on the ITB, tensor fascia latae, and gluteus medius.  2- soft tissue and medial patella mobilizations. 3-	active release soft-tissue mobilization techniques.  4- foam roller as a myofascial release tool. 5- strengthening exercises for ITBS.  6- cryotherapy.  7- phonophoresis.  8- immobilization. Total treatment duration was 40 mins per session, 3 days a week (on alternate basis) for 6 weeks. Intervention 2: Control group: In this group participant only received (Conventional) Routine physical therapy protocol include 1- specific stretching exercises focused on the ITB, tensor fascia latae, and gluteus medius.  2- soft tissue and medial patella mobilizations. 3- active release soft-tissue mobilization techniques.  4- foam roller as a myofascial release tool. 5- strengthening exercises for ITBS.  6- cryotherapy.  7- phonophoresis.  8- immobilization. Total treatment duration was 40 mins per session, 3 days a week (on alternate basis) for 6 weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rabia Saeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No.12, Street 3, Chung, Multan Road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 32300865</telephone>
        <email>rabiasaeed534@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rabia Saeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No.12, Street 3, Chung, Multan Road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 32300865</telephone>
        <email>rabiasaeed534@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age between 18-50 years in both the gender
Presence of local tenderness over the lateral epicondyle
Subjects with Positive Noble compression test
Subjects with Positive modified ober’s test</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic illness
Peripheral nerve involvement in lower extremity
Any type of Arthritis of lower limb
Tumor
History of previous knee trauma and surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iliotibial band syndrome</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 include combination of routine physical therapy and core stability exercises as part of treatment. Core stability exercise includes: 1- Transversus abdominus (perform 30 reps with 8s hold) Bracing with heel slides, Abdominal bracing, bridging, standing, standing row, walking, leg lifts. 2- Paraspinals/multifidi (perform 30 reps with 8s hold). Quadruped legs lifts and arm lifts with bracing, Quadruped alternate legs and arms lifts with bracing. 3- Quadratus lumborum and obliques ((perform 30 reps with 8s hold). Side plank with knees flexed and extended. 4- Trunk curl. (Conventional) Routine physical therapy protocol include 1- specific stretching exercises focused on the ITB, tensor fascia latae, and gluteus medius.  2- soft tissue and medial patella mobilizations. 3-	active release soft-tissue mobilization techniques.  4- foam roller as a myofascial release tool. 5- strengthening exercises for ITBS.  6- cryotherapy.  7- phonophoresis.  8- immobilization. Total treatment duration was 40 mins per session, 3 days a week (on alternate basis) for 6 weeks.</i_keyword>
      <i_keyword>Control group: In this group participant only received (Conventional) Routine physical therapy protocol include 1- specific stretching exercises focused on the ITB, tensor fascia latae, and gluteus medius.  2- soft tissue and medial patella mobilizations. 3- active release soft-tissue mobilization techniques.  4- foam roller as a myofascial release tool. 5- strengthening exercises for ITBS.  6- cryotherapy.  7- phonophoresis.  8- immobilization. Total treatment duration was 40 mins per session, 3 days a week (on alternate basis) for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: At baseline (before intervention), 3 weeks of treatment and at end of treatment (6 weeks). Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Functional Mobility. Timepoint: At baseline (before intervention), 3 weeks of treatment and at end of treatment (6 weeks). Method of measurement: Lower Extremity Functional Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: At baseline (before intervention) and at end of treatment (6 weeks). Method of measurement: Short Form (36) Health Survey.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-31</approval_date>
        <contact_name>Institutional Review Board of University of Lahore</contact_name>
        <contact_address>1-KM Defence Road, Off Bhobatian Chowk, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
