<?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>IRCT20210816052201N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-11</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effect of Instrument Assisted Soft Tissue Mobilization Ergon Technique on Pain, Strength and Range of Motion in Plantar Fasciitis Patients: A Randomized Controlled Trial.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Instrument Assisted Soft Tissue Mobilization Ergon Technique on Pain, Strength and Range of Motion in Plantar Fasciitis Patients: A Randomized Controlled Trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58728</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated in two treatment groups by computer generated table number. After randomization, opaque sealed envelope will be offered to the patients. Once a patient has consented to enter a trial, an envelope is opened by clinician and treatment will be provided according  to the group mention on the envelope.
Group A will be treated with routine physiotherapy program 
Group B will be treated with routine physiotherapy program combined with Ergon technique , Blinding description: The assessor will be blinded by hiding the identity of patients. The patients will be trained not to give any hint about their allocation and their treatment groups. Blinding will be assessed by asking the assessor(force choice) to tell about patient group and a significant test will be used to see if there is a substantial chance that the assessor know about patient group identity for this p-value less than .05 will be used as significant value.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Planter Fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: will receive instrument assisted soft tissue mobilization technique for fifteen minutes  using ergon tools and conventional treatment including cryotherapy (10 minutes), ultrasound therapy (10 minutes) and Planter fascia stretching exercises (10 minutes), total time  (45minutes/session). The Ergon with Conventional Therapy group will treated with 3 sessions per week. Intervention 2: Control group: will receive conventional treatment including cryotherapy (10 minutes), ultrasound therapy (10 minutes) and Planter fascia stretching exercises (10 minutes), total time  (30minutes/session).The conventional group will also treated with 3 session per week.</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:
Effect of Instrument Assisted Soft Tissue Mobilization Ergon Technique on Pain, Strength and Range of Motion in Plantar Fasciitis Patients: A Randomized Controlled Trial.

When:
After publication of article the data will be available

To whom:
The data will be available to all kinds of Academic researchers

Conditions:
A request can be processed by the study sponsor or by a delegate of the sponsor (e.g., an academic institution).

Where to obtain:
Applicant must contact cores ponder of a research through email address

How to obtain:
Applicant must contact cores ponder of a research through email address

Comments:
I am very thankful to Iranian trial registry team for making steps brief and to the point for registration</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asim Arif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35183083</telephone>
        <email>asim.arif@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore, Lahore Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Asim Arif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35183083</telephone>
        <email>asim.arif@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore, Lahore Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed patients of plantar fasciitis
Connective tissue disorders (Osteoarthritis, Rheumatoid arthritis, Osteoporosis, Fibromyalgia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of previous surgical treatment or cancer of the heel
Foot and/or ankle fracture
Congenital deformity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M72.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Plantar fascial fibromatosis</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: will receive instrument assisted soft tissue mobilization technique for fifteen minutes  using ergon tools and conventional treatment including cryotherapy (10 minutes), ultrasound therapy (10 minutes) and Planter fascia stretching exercises (10 minutes), total time  (45minutes/session). The Ergon with Conventional Therapy group will treated with 3 sessions per week.</i_keyword>
      <i_keyword>Control group: will receive conventional treatment including cryotherapy (10 minutes), ultrasound therapy (10 minutes) and Planter fascia stretching exercises (10 minutes), total time  (30minutes/session).The conventional group will also treated with 3 session per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary outcome variables are pain, range of motion and strength. Timepoint: Patients will be recruited from Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore and Citi hospital Lahore. They will be assessed on selection criteria and eligible participants will be randomly allocated into two groups, using sealed enveloped method. Patients will be treated three times a week for total 5 weeks.  After allocation in groups, participants will be assessed at baseline. Afterwards data will be collected at 1st-week intervals then 3rd week until the conclusion of 5th-week of interventions. All assessments will be performed by the same assessor at all stages of data collection for all patients. Method of measurement: Visual Analogue Scale (VAS):It is used in clinical research to measure the intensity or frequency of Pain. Universal Goniometer: An instrument which measures the available range of motion (ROM) at a joint. Strength: Manual Muscle Testing is the most commonly used method for documenting impairments in muscle strength.</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>The University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-25</approval_date>
        <contact_name>Ethics committee of University of Lahore(Institutional Review Board)</contact_name>
        <contact_address>The University of Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
