<?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>IRCT20220628055300N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-27</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of exercise therapy plus Quadriceps , Gluteus Medius and Quadratus Lumborum self-myofascial-release in patellofemoral pain through telerehabilitation</public_title>
      <acronym></acronym>
      <scientific_title>The effects of exercise therapy plus Quadriceps , Gluteus Medius and Quadratus Lumborum  self-myofascial-release on pain , function and balance in patients with patellofemoral pain through telerehabilitation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64540</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using of randomization software,60 numbers are dedicated to each case and the program defines 15  blocks of 4, 2 of which are allocated to exercise therapy plus Quadriceps , Gluteus Medius and Quadratus Lumborum  self-myofascial-release through telerehabilitation group and the other 2 people are placed in exercise therapy through telerehabilitation group, Blinding description: The person who evaluates the patients is completely unaware of grouping patients and their allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: exercise therapy with Quadriceps, Gluteus Medius, Quadratus Lumborum self-myofascial release through telerehabilitation in patients with patellofemoral pain. On assessment day, they are given pamphlet including exercises and pictures related to them and advice about changing their poor habits such as avoiding sitting for a long time and sitting on a short chair then they will be received videos including exercise program and self-myofascial release every week for four weeks also video calls are made to them every week to ensure the correct way of doing the exercises .These people are asked to do exercises 3 times a week and before starting, use a cold pack on their knees for 20 minutes. Also, these people do self-myofascial release techniques on 2 of the 3 days. Intervention 2: Control group: exercise therapy through telerehabilitation in patients with patellofemoral pain. Pamphlet, exercise therapy program, exercises frequency, exercises video and video call for this group is the same as intervention group. They just do not perform self-myofascial release techniques.</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>Sara Abolahrari-Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Abiverdi 1 St., Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۷۳۳-۷۱۳۴۵</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>SAhrari@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Abolahrari-Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Abiverdi 1 St., Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1733</zip>
        <telephone>+98 71 3627 1552</telephone>
        <email>SAhrari@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People between the ages of 18 and 45 (both sexes).
The onset of pain is more than 1 month which is aggravated by at least two of these activities prolonged sitting, squatting , kneeling ,running ,upstairs and downstairs ,jumping and landing also pain is at least 30 from 100 on visual analogue scale during activities.
Unilateral anterior knee pain, prepatellar or retro patellar pain that person reports at least 30 from 100 on pain visual analogue scale in the last week. If the pain is bilateral, the side with more pain is considered.
Positive Clarke's sign
KUJALA questionnaire score is less than 85
The presence of trigger points in Gluteus Medius muscle of the affected side, Quadratus Lumborum on the opposite side and at least one part of the Quadriceps muscle.
People have ability to use the Internet and virtual communication.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of back, hip, ankle or other anatomical knee structures injury in previous 6 months
History of lower limb trauma in recent 6 months
History of knee surgery
History of lower limb surgery
Meniscus or knee ligaments injury
Patellar tendinopathy
History of patellar dislocation
History of knee intra-articular injection in last 3 months
Systemic or local infections
Referral pain from lumbar region
Writing and speaking inability
Systemic diseases such as Rheumatoid Arthritis and other inflammatory joint diseases
Neurological disease such as Multiple Sclerosis, history of stroke and any other nervous system problem
Person has received physiotherapy due to his problem since 6 months ago.
Sever lower limb deformity
People who are suffering from cancer or history of chemotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.56</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in knee</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: exercise therapy with Quadriceps, Gluteus Medius, Quadratus Lumborum self-myofascial release through telerehabilitation in patients with patellofemoral pain. On assessment day, they are given pamphlet including exercises and pictures related to them and advice about changing their poor habits such as avoiding sitting for a long time and sitting on a short chair then they will be received videos including exercise program and self-myofascial release every week for four weeks also video calls are made to them every week to ensure the correct way of doing the exercises .These people are asked to do exercises 3 times a week and before starting, use a cold pack on their knees for 20 minutes. Also, these people do self-myofascial release techniques on 2 of the 3 days.</i_keyword>
      <i_keyword>Control group: exercise therapy through telerehabilitation in patients with patellofemoral pain. Pamphlet, exercise therapy program, exercises frequency, exercises video and video call for this group is the same as intervention group. They just do not perform self-myofascial release techniques.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, immediately after the last treatment session and two weeks after the end of the treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pressure pain Threshold. Timepoint: Before treatment and immediately after the last treatment session. Method of measurement: Algometer.</prim_outcome>
      <prim_outcome>Function. Timepoint: Before treatment, immediately after the last treatment session and two weeks after the end of the treatment. Method of measurement: KUJALA questionnaire.</prim_outcome>
      <prim_outcome>Lower extremity function. Timepoint: Before treatment, immediately after the last treatment session and two weeks after the end of the treatment. Method of measurement: Lower Extremity Functional Scale.</prim_outcome>
      <prim_outcome>Balance. Timepoint: Before treatment, immediately after the last treatment session and two weeks after the end of the treatment. Method of measurement: Modified Star Excursion Balance Test.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-03</approval_date>
        <contact_name>Ethics committee in Research, Shiraz Faculty of Rehabilitation Sciences</contact_name>
        <contact_address>Abiverdi1 Street, Chamran Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
