<?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>IRCT20221201056676N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-16</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Study of the effects of dry needling on fatigue</public_title>
      <acronym></acronym>
      <scientific_title>Study of the neurophysiologic effects of dry needling on quadriceps muscle fatigue of amateur  healthy men athletes immediately and one hour after dry needling</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67185</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization with sealed envelops:
every participants are given a personal information form. there are written A and B on these forms to determine the intervention and placebo groups. these forms are given to participants randomly. if someone get the A form, he would be in the intervention group and if he get the B form, he would be in the placebo group, Blinding description: to blinding, tests and measurements are done by the assessor, who is unaware of the groups of people. on the other hand intervention is done by another person.
Also, for intervention, people in the placebo group are set on the same position as the intervention group and they get the sham needles (plastic needles on the tube) on the same points as the intervention group. these needles are put on the skin and are pushed on it, but they do not enter into body.</study_design>
      <phase>N/A</phase>
      <hc_freetext>fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: An expert physical therapist qualified in DN performs the needling procedure of the Quadriceps Femoris of the dominant lower extremity. While the subject is in supine with the leg in an extended neutral position, points on the Vastus Medialis (VM), Vastus Lateralis (VL), and the Rectus Femoris (RF) muscles are randomly needled using stainless steel needles with a diameter of 0.3 mm and a length of 50 mm  each for one minute using a fast in-fast out technique. The VM point is located at about 25% of the distance of a line from the medial superior border of the patella to the Anterior Superior Iliac Spine (ASIS); the VL point is located at the mid-thigh along a line from the lateral superior border of the patella to the apex of greater trochanter; the RF point is located at the mid-thigh along a line from the superior border of patella to the ASIS. Intervention 2: Control group: Cases in this group are positioned as same as the intervention group. Sham needles, plastic needles in tubes, are applied to the same points. These needles are put on the skin and are pushed, but they do not insert into it.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The raw data of research and its analysis will be available to the researcher if they request it.

When:
After the publication of articles resulting from the research.

To whom:
Researchers working in academic institutions.

Conditions:
The data are only available to other researchers to study and evaluate treatment outcomes.

Where to obtain:
Department of physiotherapy, School of Rehabilitation, Enghelab street; Professor Soofia Naghdi
Email address: naghdi@sina.tums.ac.ir

How to obtain:
By sending an official Email to the corresponding author: professor Soofia Naghdi (naghdi@sina.tums.ac.ir) and requesting the data, the researcher will be answered as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Melika Rostamkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Hoseini Alley, 21Metrijey Street, Ostadmoein Square, Azadi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1341767177</zip>
        <telephone>+98 21 6619 6145</telephone>
        <email>melikarostamkhani137@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Melika Rostamkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.5, Hoseini Street, 21Metrijey Street, Ostadmoein Square, Azadi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1341767177</zip>
        <telephone>+98 21 6619 6145</telephone>
        <email>melikarostamkhani137@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>no history of lower extremity injury
no vestibular disorders
no cardio-vascular-pulmunary diseases
no neuromusculoskeletal diseases
age of 18-40 years
minimum exercise of 1-hour, 3 sessions per week (at least 2 months)
no pain in lower extremity in at least recent 2 months
no Trypanophobia (needle phobia)
no needle contradictions
no history of dry needle experience</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>lack of consent
have pain during the study
inability to continue the test
have strenuous physical activity 48 hours before the test
being a physical therapy student</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: An expert physical therapist qualified in DN performs the needling procedure of the Quadriceps Femoris of the dominant lower extremity. While the subject is in supine with the leg in an extended neutral position, points on the Vastus Medialis (VM), Vastus Lateralis (VL), and the Rectus Femoris (RF) muscles are randomly needled using stainless steel needles with a diameter of 0.3 mm and a length of 50 mm  each for one minute using a fast in-fast out technique. The VM point is located at about 25% of the distance of a line from the medial superior border of the patella to the Anterior Superior Iliac Spine (ASIS); the VL point is located at the mid-thigh along a line from the lateral superior border of the patella to the apex of greater trochanter; the RF point is located at the mid-thigh along a line from the superior border of patella to the ASIS</i_keyword>
      <i_keyword>Control group: Cases in this group are positioned as same as the intervention group. Sham needles, plastic needles in tubes, are applied to the same points. These needles are put on the skin and are pushed, but they do not insert into it.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximum isometric torque of quadriceps. Timepoint: measuring maximum isometric torque of quadriceps at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention. Method of measurement: handheld dynamometer.</prim_outcome>
      <prim_outcome>Function. Timepoint: measuring function at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention. Method of measurement: single leg hop test.</prim_outcome>
      <prim_outcome>H/M ratio. Timepoint: measuring H/M ratio at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention. Method of measurement: electromyography (EMG).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance. Timepoint: measuring balance at the beginning of the study, after fatigue protocol, after intervention, and one hour after intervention. Method of measurement: single leg stance test.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-28</approval_date>
        <contact_name>Ethics committee of Nursing and Midwifery department and Rehabilitation department of Tehran Univers</contact_name>
        <contact_address>No. 20, West First Golzar Ave., Majdi Blvd., Artesh Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
