<?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>IRCT20200515047451N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-04</date_registration>
      <primary_sponsor>Faiza Altaf</primary_sponsor>
      <public_title>Effects of myofascial release with and without emmett technique in iliotibial band syndrome</public_title>
      <acronym>NIL</acronym>
      <scientific_title>Effects of myofascial release with and without emmett technique in iliotibial band syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48773</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Non-probability convenient sampling technique will be used to recruit the individuals for the study and then randomization will be done by lottery method to divide the individuals into 2 treatment groups. Sealed envelops will be used for allocation concealment, Randomization description: Randomization was done through lottery method and than participant's were allocated in two groups through concealed allocation.</study_design>
      <phase>4</phase>
      <hc_freetext>Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. This overuse injury often causes weakness of hip abductor muscles and decreased range of motion of hip adductors..</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group A after a 20 minutes of hot pack will receive Manual myofascial release to iliotibial band by having the subject to lie in the side lying position on the unaffected side. The upper leg to be tested was rested on the table with hip and knee flexion. Then the therapist applied a few kilograms of force weight along the iliotibial band course proximally to distally. The therapist will repeat this for 6 minutes. Intervention 2: Intervention group B after a 20 minutes of hot pack B will receive manual myofascial release and the Emmett intervention with the subject sitting upright on a 45cm wooden chair; light, constant pressure via the middle finger (at a perpendicular angle to the skin) will be applied at both points, three times for 10-20s with 5-10s breaks between. A light sweeping action over the sensory area that will treated will be performed once, using the back of the fingers. The rationale for this is that the light brushing action “disperses the sensory awareness to move without being too heavy or specific enough to create muscular response.” The sequence performed on one side will then repeated on the opposite leg. In Ross Emmett’s teachings of the technique he insists on treatment of both sides when focusing on the lower body (for balance). Once both sides will be completed, the subject will be instructed to walk around the room for a minute.</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 decision and information decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faiza Altaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar e Millat road, Quaid e Azam real estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>46770</zip>
        <telephone>NIL</telephone>
        <email>faiza.altaf@umt.edu.pk</email>
        <affiliation>Riphah College of Rehabilitation Sciences (RCRS)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faiza Altaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madar e Millat road, Quaid e Azam real estate</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>46770</zip>
        <telephone>NIL</telephone>
        <email>faiza.altaf@umt.edu.pk</email>
        <affiliation>Riphah College of Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Positive Ober’s Test
Both males and females
Age 25 to 45 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>TFL (Tensor Fascia Lata) tightness
Any pathological and traumatic conditions, Fractures and Dislocation
Already received few sessions of Manual Therapy treatment
Taking corticosteroids, analgesic or anti-inflammatory drugs.
Treatment of lower limb myofascial pain or trigger points at the time of the study
Current or previous symptoms of pathology reported in the lower limbs or pelvis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Iliotibial band syndrome, unspecified leg</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 A after a 20 minutes of hot pack will receive Manual myofascial release to iliotibial band by having the subject to lie in the side lying position on the unaffected side. The upper leg to be tested was rested on the table with hip and knee flexion. Then the therapist applied a few kilograms of force weight along the iliotibial band course proximally to distally. The therapist will repeat this for 6 minutes.</i_keyword>
      <i_keyword>Intervention group B after a 20 minutes of hot pack B will receive manual myofascial release and the Emmett intervention with the subject sitting upright on a 45cm wooden chair; light, constant pressure via the middle finger (at a perpendicular angle to the skin) will be applied at both points, three times for 10-20s with 5-10s breaks between. A light sweeping action over the sensory area that will treated will be performed once, using the back of the fingers. The rationale for this is that the light brushing action “disperses the sensory awareness to move without being too heavy or specific enough to create muscular response.” The sequence performed on one side will then repeated on the opposite leg. In Ross Emmett’s teachings of the technique he insists on treatment of both sides when focusing on the lower body (for balance). Once both sides will be completed, the subject will be instructed to walk around the room for a minute.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and 1,2,6 weeks after intervention. Method of measurement: Numeric Pain Rating scale (NPRS).</prim_outcome>
      <prim_outcome>Range of motion(ROM) of adductors of hip. Timepoint: Before intervention and 1,2,6 weeks after intervention. Method of measurement: Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Power of lower limbs. Timepoint: Before intervention and 1,2,6 weeks after intervention. Method of measurement: Vertical jump 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>Faiza Altaf</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-01</approval_date>
        <contact_name>Riphah College of Rehabilitation Sciences (RCRS) Research Ethical Committee (REC)</contact_name>
        <contact_address>Madar e Millat road, Quaid e Azam real Estate Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
