<?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>IRCT20220421054600N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-04</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Whole body electrical muscle stimulation in patellofemoral pain syndrome</public_title>
      <acronym>PFPS</acronym>
      <scientific_title>Evaluation of the  effect of whole body electrical muscle stimulation  and common strengthening exercises on pain and  improvement of function  in women with patellofemoral pain syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63131</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: People with patellofemoral pain syndrome are randomly divided into two groups include: strengthening exercises and strengthening exercises with electrical stimulation of the whole body by tossing coins, Blinding description: Three specialist are involved in the study process. The first specialist is in charge of the evaluation, the second specialist is in charge of therapeutic interventions, and the third specialist is in charge of analyzing the results. In this study, the specialist who evaluations patient is blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Exercise therapy with whole body electrical stimulation .The treatment protocol in this group includes the knee and hip muscles strengthening : quadriceps isometric contraction, abductor and external-internal rotator muscles, single leg raising in all plane, weigth training , elastic band training in all plane, lower extermity balance training( static and movable surface with tilt board)  (three times per week) and whole body electrical stimulation (1.5 sessions per week : 1 session per week and in the next week  2 session per week ). This protocol is performed for seven weeks .frequency of current is 50 hz, puls duration 350 micoro sescend and treatment time-15 min. Intervention 2: Control group: In this group, common strengthening exercises of knee and hip muscles are performed for 7 weeks and with a frequency of three times a week.</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 the raw data of all participant will not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda Oraki far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, University of Medical Sciences, Golestan Blvd  ,Ahvaz Town</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33133 -61357</zip>
        <telephone>+98 61 3335 3600</telephone>
        <email>nedaoraki@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Oraki far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, University of Medical Sciences, Golestan Blvd  ,Ahvaz Town</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33133 -61357</zip>
        <telephone>+98 61 3335 3600</telephone>
        <email>nedaoraki@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Young women with a gradual onset of anterior knee pain without a history of trauma for at least 6 months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any intra-articular symptoms such as ligament and meniscal injury.
Existence of pain and tenderness in the patellar tendon, the internal hamstring tendon , ilio tibial band.
Osgood Schlatter or Sinding Larsen-Johansson syndrome.
Referral pain of hip and lumbar.
History of patellar dislocation.
History of previous surgery on the patellofemoral  joint.
Existence of signs of degeneration in radiographic finding.
Taking corticosteroids and anti-inflammatory drugs.
Having a pacemaker, implant .
Pregnancy.
Epilepsy.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellofemoral disorders</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 whole body electrical stimulation .The treatment protocol in this group includes the knee and hip muscles strengthening : quadriceps isometric contraction, abductor and external-internal rotator muscles, single leg raising in all plane, weigth training , elastic band training in all plane, lower extermity balance training( static and movable surface with tilt board)  (three times per week) and whole body electrical stimulation (1.5 sessions per week : 1 session per week and in the next week  2 session per week ). This protocol is performed for seven weeks .frequency of current is 50 hz, puls duration 350 micoro sescend and treatment time-15 min</i_keyword>
      <i_keyword>Control group: In this group, common strengthening exercises of knee and hip muscles are performed for 7 weeks and with a frequency of three times a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in the visual analogue scale. Timepoint: Measurement of pain at the beginning of the study, seven weeks and three months after starting interventions. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Function(strength). Timepoint: Measurement of function (strength ) at the beginning of the study, seven weeks and three months after starting interventions. Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>Function (Step down test). Timepoint: Measurement of function (step down  test ) at the beginning of the study, seven weeks and three months after starting interventions. Method of measurement: The number of repetitions.</prim_outcome>
      <prim_outcome>Function(muscle endurance). Timepoint: Measurement of function (muscle endurance) at the beginning of the study, seven weeks and three months after starting interventions. Method of measurement: time.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-08</approval_date>
        <contact_name>Ethics Committee of Ahvaz Rehabilitation School</contact_name>
        <contact_address>Blv Golestan,Ahvaz Town Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
