<?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>IRCT20231119060113N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-09</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effects of Multimodal intervention on Pain, Range of motion and Trunk Endurance in patients with Hamstring Strain Injury</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Multimodal intervention on Pain, Range of motion and Trunk Endurance in patients with Hamstring Strain Injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73879</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: Trunk flexor musculature, Lateral and posterior trunk musculature used for trunk stability, Randomization description: Lottery method of randomization will use and done by one of the research team members who will be blinded and not involve in patient recruitment or assessment or data analysis. Allocation assignments will be kept in opaque and sealed envelope and will be unsealed by researcher after baseline assessment.
Participants are randomly allocated into two groups through drawing a number, Blinding description: The study is single blinded and the participants did not know while they are receiving experimental or conventional treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Hamstring Strain Injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants will receive tens and ultrasound therapies after that strengthening exercises will be applied. For 6th weeks, All participants received a total of 18 treatment sessions over a six week period which consisted of 3 treatment sessions per week. Intervention 2: Control group: This group will receive conventional physical therapy. Participants will receive regular physiotherapy interventions which includes 10 minutes of hot pack followed by TENS which continues till 6th week. After applying modalities patients will receive manual therapy sessions of stretching as well as strengthening exercises of hamstring muscles.</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:
Demographic data and data related to final outcome will be shared by maintaining the confidentially.

When:
Data will be available from 15 June 2024 to 15 Dec 2024 after 6 month of publication

To whom:
Hiba Saeed, University of Lahore

Conditions:
For research purpose

Where to obtain:
To the corresponding author of the study, Hiba Saeed and can contact on +923097158785, hibasaeed992@gmail.com

How to obtain:
Open access and there is the  traditional public data release where anyone can get access to the data with no registration

Comments:
I want randomized controlled trials registration</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hiba Saeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 309 7158785</telephone>
        <email>drhibasaeed21@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hiba Saeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 309 7158785</telephone>
        <email>drhibasaeed21@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 30 years.
Both genders.
Previous hamstring strain in last year.
Athletes diagnosed with hamstring strain injury.
Grade I and II patients with hamstring strain injury will be included.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Muscular pain or illness in other than hamstring muscles.
Lumbopelvic or lower limb surgery.
History of fracture due to hamstring strain injury.
History of Lower limb fracture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified soft tissue disorders</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: Participants will receive tens and ultrasound therapies after that strengthening exercises will be applied. For 6th weeks, All participants received a total of 18 treatment sessions over a six week period which consisted of 3 treatment sessions per week.</i_keyword>
      <i_keyword>Control group: This group will receive conventional physical therapy. Participants will receive regular physiotherapy interventions which includes 10 minutes of hot pack followed by TENS which continues till 6th week. After applying modalities patients will receive manual therapy sessions of stretching as well as strengthening exercises of hamstring muscles.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain will be measured by visual analogue scale. Timepoint: Before intervention, During intervention (3rd week) and after intervention(6th week). Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: Before intervention, During intervention (3rd week) and after intervention(6th week). Method of measurement: Range of motion will be measured by Goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Trunk Endurance. Timepoint: Before and 6th week after intervention. Method of measurement: Trunk endurance will be measured by Trunk flexor musculature, Lateral trunk musculature and Posterior trunk musculature.</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>2023-10-16</approval_date>
        <contact_name>Research Ethics Committee</contact_name>
        <contact_address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
