<?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>IRCT20221030056342N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-28</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of dry needling and functional joint mobilization with functional joint mobilization only on pain, disability and quality of life in patients with patellofemoral pain syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of dry needling and functional joint mobilization with functional joint mobilization only on pain, disability and quality of life in patients with patellofemoral pain syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66592</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization will be done using random block method. Using the Sealedenvelope.com website, a sequence of 28 letters consisting of letters a and b will be placed in opaque, sealed envelopes, respectively. When the patients visit, the envelopes are taken from the collection of envelopes and according to the order determined by the number on the back of the envelopes, the sample allocator (department secretary) after obtaining informed consent, opens the envelope and assigns the patient to the relevant group. The secretary of the department is also unaware of how to code, Blinding description: The allocator is the secretary of the physiotherapy department and does not know how to code. Also, the evaluator and statistical analyst are not aware of the way of grouping.
Allocation Concealment method: closed, opaque, and sealed envelopes and numbered in order.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patella Femoral Pain Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: At first, they receive conventional physiotherapy. Exercises are applied in 3 sets with 10 repetitions. The cold pack is applied for 15 minutes after the sessions. Physiotherapy takes place for 12 sessions and 3 times a week. Patients will be taught knee and thigh strengthening exercises at home and exercise brochures will be provided to them. In addition to these, neuromuscular electrical stimulation is used for patients, in which the patient contracts his quadriceps muscle simultaneously with the electrical current. Two surface adhesive electrodes are attached to the movement points of the quadriceps: on the vestus medialis and the vestus lateralis. During the application of neuromuscular electrical stimulation, the patient performs two types of movements: 1. Isometric quadriceps strengthening (30 isometric exercises) 2. Then Terminal knee extension from zero to 30 degrees (30 isotonic exercises). Intervention 2: Intervention group: Functional mobilization is the second intervention, which includes movement of the patella and movement of internal rotation of the tibia in relation to the femur, first in a less functional and non-weight bearing state, then in a weight bearing state, while bending and straightening the knee, standing, squatting, and on the stairs. Intervention 3: Intervention group: The third intervention is the use of dry needling for the quadriceps muscles in the trigger pain points that are detected by the physiotherapist during the manual examination. Intervention 4: Control group: At first, they receive conventional physiotherapy. Exercises are applied in 3 sets with 10 repetitions. The cold pack is applied for 15 minutes after the sessions. Physiotherapy takes place for 12 sessions and 3 times a week. Patients will be taught knee and thigh strengthening exercises at home and exercise brochures will be provided to them. In addition to these, neuromuscular electrical stimulation is used for patients, in which the patient contracts his quadriceps muscle simultaneously with the electrical current. Two surface adhesive electrodes are attached to the movement points of the quadriceps: on the vestus medialis and the vestus lateralis. During the application of neuromuscular electrical stimulation, the patient performs two types of movements: 1. Isometric quadriceps strengthening (30 isometric exercises) 2. Then Terminal knee extension from zero to 30 degrees (30 isotonic exercises). Intervention 5: Control group: Functional mobilization is the second intervention, which includes movement of the patella and movement of internal rotation of the tibia in relation to the femur, first in a less functional and non-weight bearing state, then in a weight bearing state, while bending and straightening the knee, standing, squatting, and on the stairs.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohre Khorshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3869 8719</telephone>
        <email>Zohreh.khorshidi7@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Khorshidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3869 8719</telephone>
        <email>Zohreh.khorshidi7@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of participants is between 18 and 40 years.
The diagnosis of this syndrome is based on the pain behind the Patella or around the patella.
Presence of at least one active trigger point.
Have at least a score of 3 on the VAS pain scale.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of knee surgery                                                                                                                                 P
Patellar tendinopathy or osteoarthritis, any systemic disease
Symptoms of pressure on the lumbosacral nerve root
If the participants had acupuncture, injection or dry needling treatment of the quadriceps or knee muscles in the last 6 months.
knee sports injury such as meniscus tear or cruciate ligament injury
If the participants use anticoagulant drugs, or have blood disorders or are pregnant.
Any structural problem of the lower limb (such as arthritis or the presence of a prosthesis)
Any peripheral or central neurological damage or chronic disease such as diabetes
Any                                                                                                                                                                                                                                                                                                      Fear of needles
resence of bilateral patellofemoral pain syndrome.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2X</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>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: At first, they receive conventional physiotherapy. Exercises are applied in 3 sets with 10 repetitions. The cold pack is applied for 15 minutes after the sessions. Physiotherapy takes place for 12 sessions and 3 times a week. Patients will be taught knee and thigh strengthening exercises at home and exercise brochures will be provided to them. In addition to these, neuromuscular electrical stimulation is used for patients, in which the patient contracts his quadriceps muscle simultaneously with the electrical current. Two surface adhesive electrodes are attached to the movement points of the quadriceps: on the vestus medialis and the vestus lateralis. During the application of neuromuscular electrical stimulation, the patient performs two types of movements: 1. Isometric quadriceps strengthening (30 isometric exercises) 2. Then Terminal knee extension from zero to 30 degrees (30 isotonic exercises).</i_keyword>
      <i_keyword>Intervention group: Functional mobilization is the second intervention, which includes movement of the patella and movement of internal rotation of the tibia in relation to the femur, first in a less functional and non-weight bearing state, then in a weight bearing state, while bending and straightening the knee, standing, squatting, and on the stairs.</i_keyword>
      <i_keyword>Intervention group: The third intervention is the use of dry needling for the quadriceps muscles in the trigger pain points that are detected by the physiotherapist during the manual examination.</i_keyword>
      <i_keyword>Control group: At first, they receive conventional physiotherapy. Exercises are applied in 3 sets with 10 repetitions. The cold pack is applied for 15 minutes after the sessions. Physiotherapy takes place for 12 sessions and 3 times a week. Patients will be taught knee and thigh strengthening exercises at home and exercise brochures will be provided to them. In addition to these, neuromuscular electrical stimulation is used for patients, in which the patient contracts his quadriceps muscle simultaneously with the electrical current. Two surface adhesive electrodes are attached to the movement points of the quadriceps: on the vestus medialis and the vestus lateralis. During the application of neuromuscular electrical stimulation, the patient performs two types of movements: 1. Isometric quadriceps strengthening (30 isometric exercises) 2. Then Terminal knee extension from zero to 30 degrees (30 isotonic exercises).</i_keyword>
      <i_keyword>Control group: Functional mobilization is the second intervention, which includes movement of the patella and movement of internal rotation of the tibia in relation to the femur, first in a less functional and non-weight bearing state, then in a weight bearing state, while bending and straightening the knee, standing, squatting, and on the stairs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Visual Analogue scale. Method of measurement: In this scale, there is a horizontal line of 10 cm. The left end of this line corresponds to the absence of pain and the other end corresponds to the most intense pain that a person experiences. The distance between the two ends is calculated in centimeters and is calculated as the pain intensity.</prim_outcome>
      <prim_outcome>Performance. Timepoint: Persian version of Kujala questionnaire. Method of measurement: It is used to assess the functional activity of the knee during movements that potentially stress the knee joint. This questionnaire contains 13 items that are completed by the participant. The scoring range of this questionnaire is from zero to one hundred. Higher scores indicate lower levels of disability, and zero means the most severe disability. The Persian version of this questionnaire has been localized and validated for patients with patellofemoral pain syndrome.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before and after of treatment. Method of measurement: Persian questionnaire SF36.</sec_outcome>
      <sec_outcome>The effectiveness of treatment. Timepoint: Before and after of treatment. Method of measurement: Global Rating Scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-30</approval_date>
        <contact_name>Research Ethics Committees of School of Paramedical Sciences and Health School</contact_name>
        <contact_address>Khorasan Razavi, Mashhad, Shaheed Fakuri Blvd, between Shahidjovan and Al Shahidi Square, Danesh and Salamat Shahrek Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
