<?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>IRCT20210409050913N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-17</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>ultrasound guided dry needling for jumper's knee</public_title>
      <acronym></acronym>
      <scientific_title>OUTCOME COMPARISON OF ULTRASOUND GUIDED DRY NEEDLING IN ADDITION TO CONVENTIONAL PHYSICAL THERAPY FOR TREATMENT OF PATIENTS WITH JUMPER’S KNEE</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55607</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Parallel groups, single blinded, single setting, Randomization description: The patients having diagnosed Jumper’s knee will be recruited in the study by convenient sampling, and the patients who fulfill the inclusion and exclusion criteria will be selected, with similar baseline characteristics. The consent will be taken from the subjects to participate in the study.It will be a single blinded trial in which the assessor will be kept blind.The subjects will be randomly assigned to one of two groups by using a table of random numbers generated the randomization sequence, using a restricted randomization scheme to assure equal numbers in each group. Random allocation to all groups will be ensured, from all study personnel and participants by entry of data into computer randomization program immediately.Group assignments will be sealed in opaque envelopes and opened sequentially by the investigators, Blinding description: It will be a single blinded trial in which the assessor will be kept blind.Assessor will be senior physiotherapist who will take measurements after giving consent to participate in the study. He will be blind, not confirmed about the group of intervention.</study_design>
      <phase>2</phase>
      <hc_freetext>Jumper's knee.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Ultrasound guided dry needling in addition to routine physical therapy. each session of ultrasound guided dry needling  will consist of three needle insertions lasting 3 seconds each and the number of times the needle will pass through the tendon will range from 15 to 30 passes, depending on the size of the tendon abnormality. Routine physiotherapy treatment will be administered to the patients which includes these: •An exercise program will consist of stretching and strengthening exercises of quadricep &amp; hamstring: mini-squats, seated knee extensions, lunges, and lateral steps. Each exercise will be conducted in 3 sets of 15 repetitions. Each repetition will begin with the concentric phase, followed by the eccentric phase of the exercise. • Physiotherapy modalities will include 10 minutes of Heat Therapy by moist hot pack, phonophoresis (pulsed ultrasound) and transverse friction massage.•The use of knee strap &amp; activity modification. Intervention 2: Control group: It will be given same routine physical therapy treatment methods given generally to treat such patients for same time.</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:
all collected IPD for all outcome measures

When:
starting in November 2021 6 months after publication

To whom:
persons in academic institutes and researchers

Conditions:
it could be used on permission from investigator

Where to obtain:
through email to investigator faiza.sharif@uipt.uol.edu.pk

How to obtain:
through email to investigator faiza.sharif@uipt.uol.edu.pk and call 0092321  4600797

Comments:
data can be provided on request</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faiza Sharif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-km defence road, off bhoptian chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35322501</telephone>
        <email>faiza.sharif@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faiza Sharif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-km defence road, off bhoptian chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35322501</telephone>
        <email>faiza.sharif@uipt.uol.edu.pk</email>
        <affiliation>The university of lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Athletes with medical diagnosis of patellar tendinopathy and anterior knee pain located on the inferior pole of the patella for over 1 month. The intensity of pain of 3.0 or greater on a 0-to-10 visual analog scale while walking up and down stairs and high pain intensity in single leg decline squat test. Palpation tenderness of the superior insertion of the patellar tendon.
Athletes of either genders Age ranges between 18 to 45 years.
A score below 80 on the Victorian Institute of Sports Assessment for PT (VISA-P) questionnaire.
Pain provocation on Single leg decline squat test as a score &gt;0 on the NRS.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Knee surgery within the previous 6 months.
Chronic knee joint diseases.
Corticosteroid injection in the patellar tendon within the last 1 month.
Contraindications for needling such as allergies/sensitivities, diseases/conditions, implants, areas of acute inflammation, acute systemic infections, on blood thinner or anticoagulants, with known history of bleeding disorders.
Presence of multiple focal areas of calcification within the proximal tendon or radiographic fractures around the knee.
Use of analgesics for last 48 hours.
Any other concomitant treatment for jumper’s knee.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M76.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellar tendinitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Ultrasound guided dry needling in addition to routine physical therapy. each session of ultrasound guided dry needling  will consist of three needle insertions lasting 3 seconds each and the number of times the needle will pass through the tendon will range from 15 to 30 passes, depending on the size of the tendon abnormality. Routine physiotherapy treatment will be administered to the patients which includes these: •An exercise program will consist of stretching and strengthening exercises of quadricep &amp; hamstring: mini-squats, seated knee extensions, lunges, and lateral steps. Each exercise will be conducted in 3 sets of 15 repetitions. Each repetition will begin with the concentric phase, followed by the eccentric phase of the exercise. • Physiotherapy modalities will include 10 minutes of Heat Therapy by moist hot pack, phonophoresis (pulsed ultrasound) and transverse friction massage.•The use of knee strap &amp; activity modification</i_keyword>
      <i_keyword>Control group: It will be given same routine physical therapy treatment methods given generally to treat such patients for same time</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: baseline, 1st, 2nd, and 4th week after the intervention. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional disability. Timepoint: baseline, 1st, 2nd and 4th week after the intervention. Method of measurement: VISA-P Score, KOOS Score, Lysholm score.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-11</approval_date>
        <contact_name>Institutional Review Board Committee</contact_name>
        <contact_address>1-km defence road, off bhoptian chowk, Lahore Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
