<?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>IRCT20200818048446N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-11</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lumbopelvic manipulation on patellofemoral pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of lumbopelvic manipulation on Electromyography parameters of gluteus medius and vastus medialis in patients with patellofemoral pain syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51002</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants are randomly divided into two groups by block randomization method with a fixed size of each block of 4.In this way, the list of random shifts of 4 letters A and B, which represent groups one and two, is generated with Random Allocation software and is the criterion for assigning individuals in groups. For example, if ABBA permutation is generated in the first block, it indicates that the first person is in group A, the second and third person in group B, and the fourth person in group A, Blinding description: This study is a double-blind study, In the way that evaluation and treatment are done by two different people And the evaluator is not aware of the type of grouping. Statistical analysis is also performed by a third person who do not know the grouping and treatment process.
Patient blindness: Patients are told that manual therapy is to be performed on the lumbar, pelvic, and lower extremities, But they do not know the exact location and how. Patients are also not informed in which group they are.  In the placebo(control) group, the patient is placed on a supine position and the therapist stands on the opposite side of the involved knee, The patient then locks the fingers behind her/his head and then passively moved to the side bend position by the therapist and rotated to the healthy position , and is in this position for five seconds. In the treatment group, the same steps are followed, with the difference that in the last stage, the thrust (High-speed movement of the therapist hand on the patient's ASIS) is applied. Patients are given time to participate in the project in such a way  that they will not have any contact to share experiences.</study_design>
      <phase>N/A</phase>
      <hc_freetext>patellofemoral pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: one session lumbopelvic manipulation:                      The patient was positioned supine while interlocking the fingers behind the head and the elbows are in contact with each other in the front.The patient's torso is in a neutral position and the therapist is on the patient's healthy side,then the  patient was passively side-bent towards and rotated away from the painful knee.Stabilizer hand, Fix the patient's arms on the bed and The moving hand fix on the anterior superior iliac spine where the knee is involved. After getting loose, it applies a sudden thrust in the posterior-external-inferior direction. This technique is given in one session and then evaluated immediately and information is recorded. Intervention 2: Control group: one session sham manipulation: The patient is placed in the position of true lumboplevic manipulation for 5 seconds, But the technique is not applied. After giving the position of the technique, the information is recorded.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahere Zafarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganj Afrooz St</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>t.zafarian@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khodabakhsh Javanshir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganj Afrooz St</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47176-47745</zip>
        <telephone>+98 11 3219 9592</telephone>
        <email>kjavanshir@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients if they are aged less than 40 years
unilateral anterior knee pain or a pain on palpation of patellar facets provoked by at least two of these activities:ascending/descending stairs, squatting, prolonged sitting, jumping, kneeling and Isometric quadriceps contraction
positive sign in  patellar apprehension test and/or eccentric step down test and/or vastus medialis coordination test
a pain level of at least 3 points and maximum 8 points on the numerical pain rating scale(NPRS) during resisted knee extension
knee disability level between 45 and 70 based on the Kujala patellofemoral questionnaire (KPQ)
Have at least 3 of the 5 criteria to predict treatment success, including the following: The difference in the active range of motion of the internal rotation of the hip between the two limbs is more than 14 degrees- Dorsiflex active range of motion of the foot is more than 16 degrees- No stiffnes after sitting for more than 20 minutes- Navicular drop- Squatting is most painful activity</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>a history of knee or spine surgery
dislocation or fracturein pelvic
meniscal lesion
patellar subluxation/dislocation
evidenceof tendinopathy or ligamentous pathologies
neurologic disorders
patients who had previously received physiotherapy treatment orused analgesic drugs within 72 h prior to the experiment
osteoporosis with documented compression fracture
severe lumbosacral nerveroot compression signs
pregnancy
systemic disease or connective tissue disorders
Lumbar disc rupture: extrusion, sequestration
Serious spinal lesions include rheumatoid arthritis, tumors, vascular lesions of the spine, etc.
spondylolisthesis and Specified lumbar instabilities</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: one session lumbopelvic manipulation:                      The patient was positioned supine while interlocking the fingers behind the head and the elbows are in contact with each other in the front.The patient's torso is in a neutral position and the therapist is on the patient's healthy side,then the  patient was passively side-bent towards and rotated away from the painful knee.Stabilizer hand, Fix the patient's arms on the bed and The moving hand fix on the anterior superior iliac spine where the knee is involved. After getting loose, it applies a sudden thrust in the posterior-external-inferior direction. This technique is given in one session and then evaluated immediately and information is recorded.</i_keyword>
      <i_keyword>Control group: one session sham manipulation: The patient is placed in the position of true lumboplevic manipulation for 5 seconds, But the technique is not applied. After giving the position of the technique, the information is recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Onset of electromyography activity of vastus medialis muscle. Timepoint: Before and immediately after the intervention. Method of measurement: Surface electromyography device.</prim_outcome>
      <prim_outcome>Onset of electromyography activity of Gluteus medius muscle. Timepoint: Before and immediately after the intervention. Method of measurement: Surface electromyography device.</prim_outcome>
      <prim_outcome>Amplitude of electromyography activity of vastus medialis muscle. Timepoint: Before and immediately after the intervention. Method of measurement: Surface electromyography device.</prim_outcome>
      <prim_outcome>Amplitude of electromyography activity of Gluteus medius muscle. Timepoint: Before and immediately after the intervention. Method of measurement: Surface electromyography device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Intensity. Timepoint: Before, immediately after and one week after the intervention. Method of measurement: Numeric Pain Rating Scale.</sec_outcome>
      <sec_outcome>Physical function. Timepoint: Before and immediately after the intervention. Method of measurement: step down test.</sec_outcome>
      <sec_outcome>Knee joint functional level. Timepoint: Before, immediately and one week after the intervention. Method of measurement: Using kujala questionnaire.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-16</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganj Afrooz St Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
