<?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>IRCT20190909044734N3</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 effect of adding dry needling in calf muscles to stretching exercise in improving pain and function in patients with chronic patellofemoral pain</public_title>
      <acronym></acronym>
      <scientific_title>Added value of calf muscles dry needling to stretching exercise in improving knee pain and function in patients with chronic patellofemoral pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64460</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, 36 numbers are considered for each case and the software defines 9 blocks of 4, from 4 to 2 people in the stretching group and 2 people in the stretching group with dry needling. They are dried and thus 36 people are completed, Blinding description: The person who will evaluate the patients and analyze the data is completely unaware of the details of the patient grouping and the treatments performed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic patellofemoral pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group : Stretching exercise with dry needling group: People with patellofemoral pain who in addition to stretching exercises of the gastrocnemius, soleus and peroneal muscles according to the routine of the control group, receive 4 sessions of dry needling twice a week for two weeks in the trigger points of gastrocnemius, soleus and peroneal muscles. Intervention 2: Control group: Stretching Exercise Group: People with patellofemoral pain who receive only gastrocnemius, soleus and peroneal muscle stretching exercises.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty , Abiverdi 1 street , Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>leabbasi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, Abiverdi St 1, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>leabbasi@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 18 to 45 years old with unilateral patellofemoral pain
Complaints of anterior knee pain in at least 2 daily activities include: prolonged sitting, going up and down stairs, squatting, kneeling, jumping, and running.
Report of pain when touching the internal and external patellar procedures and positive Clark test in knee extension and sitting position.
Gradual onset of symptoms with no history of trauma or injury for at least the past 3 months.
Kujala score level 80-50 with moderate disability.
Have an average pain level of 4-7 on a numerical pain scale over the past week.
Have at least one active or latent trigger point in each group of gastrosoleus muscles and peroneal muscles of the affected side, which is felt as a taut, sensitive and painful bundle.
People with BMI=18.5-25</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Injury of knee joint such as rupture of the meniscus or ligaments and tendons of the knee, osteoarthritis of the knee joint, dislocation of the patella
Ankle injuries such as rupture of ligaments and tendons, ankle osteoarthritis, dislocation of ankle
Ankle sprain in the last 6 months
History of surgery and trauma to the entire lower extremity in the last 6 months
Neurological disorders of the lower extremities and neuropathic pain
Athletes who engage in certain sports activities at least two hours a day and three times a week
People who have received physiotherapy and dry needling for patellofemoral pain in the last 6 months
Contraindications to the use of dry needling: - The presence of metabolic diseases such as diabetes, rheumatic diseases - Local or systemic infections - Local ulcers on the skin - Pregnancy - Respiratory and cardiovascular problems (peripheral vascular disease, cancer, hepatitis, AIDS and any Malignancy - Taking immunosuppressive drugs - Any fear and reluctance to needle (needle phobia) - Epilepsy and mental health problems - Bleeding disorders and taking anticoagulants</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 : Stretching exercise with dry needling group: People with patellofemoral pain who in addition to stretching exercises of the gastrocnemius, soleus and peroneal muscles according to the routine of the control group, receive 4 sessions of dry needling twice a week for two weeks in the trigger points of gastrocnemius, soleus and peroneal muscles.</i_keyword>
      <i_keyword>Control group: Stretching Exercise Group: People with patellofemoral pain who receive only gastrocnemius, soleus and peroneal muscle stretching exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention, after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up. Method of measurement: NPRS.</prim_outcome>
      <prim_outcome>Pain pressure threshold. Timepoint: Before the intervention, after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up. Method of measurement: Pressure algometer device.</prim_outcome>
      <prim_outcome>Function. Timepoint: Before the intervention, immediately after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up. Method of measurement: Kujala questionnaire.</prim_outcome>
      <prim_outcome>ROM of dorsiflexion and inversion. Timepoint: Before the intervention, immediately after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Functional tests. Timepoint: Before the intervention, immediately after the end of the treatment (at the end of the second week) and two weeks after the end of the treatment as a follow-up. Method of measurement: Step down and anteromedial lunge tests.</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>2022-06-15</approval_date>
        <contact_name>Ethics Committee in Research, Shiraz Faculty of Rehabilitation Sciences</contact_name>
        <contact_address>Abiverdi Street 1, Chamran Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
