<?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>IRCT20211006052686N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-05</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of myofascial chain release in patients with chronic plantar fasciitis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of myofascial chain release on clinical symptoms, gastrocnemius muscle stiffness and plantar fascia thickness and stiffness in patients with chronic plantar fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple random sampling by sealed envelope - The control group is written in one envelope and the intervention group is written in the other envelope. The patient chooses one of them without knowing the contents of the envelope, Blinding description: The patient receives the type of intervention in sealed envelopes.
The data analyser and the safety committee are unaware of the type of intervention group.</study_design>
      <phase>3</phase>
      <hc_freetext>Plantar Fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: myofascial chain release in hamstring and gastrocnemius muscle and plantar fascia. Intervention 2: Control group: myofascial release in gastrocnemius mucsle.</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 data can be shared

When:
6 months after publication of the results

To whom:
Academic Researchers

Conditions:
In order to use the results of this research to design future studies

Where to obtain:
The applicant can send email with these addresses: mohsenipour.sm@iums.ac.ir or mohsenipour@hotmail.com.

How to obtain:
The application will be submitted to the physiotherapy department of the Rehabilitation Faculty and will be sent to the applicant after the approval of the supervisor and the department manager.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed mehdi Mohsenipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th Floor, No 32, Phase 6, Tehran University Town, Lashgari Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1389938311</zip>
        <telephone>+98 21 4490 1637</telephone>
        <email>mohsenipour.sm@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed mehdi Mohsenipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th Floor, No 32, Phase 6, Tehran University Town, Lashgari Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1389938311</zip>
        <telephone>+98 21 4490 1637</telephone>
        <email>mohsenipour.sm@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>pain over the origin of plantar fascia near medial tubercle of calcaneus bone
first steps pain in the morning or after prolonged rest
More than 3 months have passed since the onset of pain
35 to 60 years
the degree pf pain is between 3-7 on the VAS scale</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of orthopedic surgery in the lower extremities
Having diabetes and other underlying diseases affecting connective tissue
Perform injection, shock wave therapy and physiotherapy in the last 3 months
Contraindications for the treatment of myofascial release
Unwillingness to continue treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M72. 2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>A superficial fibromatosis arising from soft tissue of the plantar regions. It is characterized by the presence of spindle-shaped fibroblasts, hypercellularity, and an infiltrative growth pattern.An inflammation of the plantar fascia, the tissue along the</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: myofascial chain release in hamstring and gastrocnemius muscle and plantar fascia</i_keyword>
      <i_keyword>Control group: myofascial release in gastrocnemius mucsle</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Young's modulus of plantar fascia. Timepoint: before intervention - 2 or 3 days after intervention. Method of measurement: compressive sonoelastography.</prim_outcome>
      <prim_outcome>Young's modulus of medial gastrocnemius. Timepoint: before intervention - 2 or 3 days after intervention. Method of measurement: compressive sonoelastography.</prim_outcome>
      <prim_outcome>Young's modulus of lateral gastrocnemius. Timepoint: before intervention - 2 or 3 days after intervention. Method of measurement: compressive sonoelastography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Plantar fascia thickness. Timepoint: before intervention - 2 or 3 days after intervention. Method of measurement: sonography.</sec_outcome>
      <sec_outcome>Pain intensity. Timepoint: before intervention - 2 or 3 days after intervention. Method of measurement: numeric pain rating scale.</sec_outcome>
      <sec_outcome>Functional assessment. Timepoint: before intervention - 2 or 3 days after intervention. Method of measurement: FAAM Questionare.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-06</approval_date>
        <contact_name>Research Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Rehabilitation Faculty of Iran University of Medical Sciences, Madadkaran Ave, Shahnazari St, Madar Sq, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
