<?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>IRCT20231103059934N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-12</date_registration>
      <primary_sponsor>Riphah International University, Lahore</primary_sponsor>
      <public_title>Effects of Periosteal pecking and shock absorbing insoles in Medial Tibial Stress syndrome in Atletes</public_title>
      <acronym>MTSS</acronym>
      <scientific_title>Effects of  Shock Absorbing Insoles with and without Periosteal Pecking on Pain and Functional Mobility in Athletes with Medial Tibial Stress Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73531</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study will be a Randomized Controlled Trial, Randomization description: Sealed Envelop.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Medial Tibial Stress syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group  1 :  18 participants will be randomly allocated to Group A. Participants will be given shock absorbing insoles and Kinesthetic awareness exercises will be used as baseline treatment and will be given to all participants irrespective of their group allocation. In addition Group A participants will receive periosteal pecking i.e. using dry needling technique, in which dry needle of 30mm will be inserted at tendon osseous (T-O)  junction and when it comes into contact with periosteum of  tibia at distal posteromedial border, needle will be removed after 20 taps , it will  promote growth and repair by stimulating inflammatory activity. Pre and  post measures for NPRS, HOP Test and FMS will be taken. 3 follow ups for this session will be done on 0, and 6th week respectively. Intervention 2: Control Group:  18 Participants  after allocation to Group B will be given shock absorbing insoles of a standard height of 1.5 cm  for a period of 6 weeks and pre and post reading of measuring tools NPRS, HOP Test and FMS will be taken on 0, and 6th week respectively. Kinesthetic awareness exercises will be used as baseline treatment and will be given to all participants irrespective of their group allocation.</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 haven't decided  yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Laila Niaz Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University, Gulberg III Campus, Lahore 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore,</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54660</zip>
        <telephone>+9234510055934</telephone>
        <email>lailaniaz321@gmail.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Laila Niaz Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah International University, Gulberg III Campus, Lahore 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore,</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54660</zip>
        <telephone>+92 345 1055934</telephone>
        <email>lailaniaz321@gmail.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pain along the posteromedial border of tibia that triggers with activity and relieves with rest
Tenderness at Tendo Achilles
Positive single leg Hop test
Positive 6 meters timed run Test
local Tenderness &lt; 5cm at distal postero medial border of tibia
Pain on resisted plantar flexion</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Compartment syndrome
Popliteal artery entrapment
Bilateral lower limb injuries
Lumbar radiculopathy
Athletes with Tibial  stress fracture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M70.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Tibialis Posterior tendon overuse injury</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group  1 :  18 participants will be randomly allocated to Group A. Participants will be given shock absorbing insoles and Kinesthetic awareness exercises will be used as baseline treatment and will be given to all participants irrespective of their group allocation. In addition Group A participants will receive periosteal pecking i.e. using dry needling technique, in which dry needle of 30mm will be inserted at tendon osseous (T-O)  junction and when it comes into contact with periosteum of  tibia at distal posteromedial border, needle will be removed after 20 taps , it will  promote growth and repair by stimulating inflammatory activity. Pre and  post measures for NPRS, HOP Test and FMS will be taken. 3 follow ups for this session will be done on 0, and 6th week respectively.</i_keyword>
      <i_keyword>Control Group:  18 Participants  after allocation to Group B will be given shock absorbing insoles of a standard height of 1.5 cm  for a period of 6 weeks and pre and post reading of measuring tools NPRS, HOP Test and FMS will be taken on 0, and 6th week respectively. Kinesthetic awareness exercises will be used as baseline treatment and will be given to all participants irrespective of their group allocation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional movement screening scale. Timepoint: Before intervention and 6th week after intervention. Method of measurement: Functional Movement Screening Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Reduction. Timepoint: Before intervention and 6th week after intervention. Method of measurement: Numerical Pain 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>Riphah International University, Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-03</approval_date>
        <contact_name>Research &amp; Ethics Committee</contact_name>
        <contact_address>Riphah International University, Gullberg Campus, Lahore, Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
