<?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>IRCT20231105059968N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The therapeutic effect of Tecar on patients with plantar fasciitis</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Tacar treatment on improving symptoms and performance of patients with plantar fasciitis and comparing it with drug treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74424</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who will enter the study phase will be randomly assigned to one of the two intervention groups. The randomization method is that 25 random numbers from 1 to 50 are created by random number generation software, which are assigned to the first intervention group, and then the remaining 25 numbers are assigned to the second group, Blinding description: data analysts are unaware of which group each patient was placed in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plantar fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Tecarotherapy (8 sessions: 2 days a week) and exercise (including stretching of calf muscles, plantar fascia, passive dorsiflexion of fingers, strengthening of intrinsic foot muscles and rolling soles, 9 times a day, including 3 times in the morning, 3 times in the afternoon, 3 times in the evening, 30 seconds each time) and (Soft medial longitudinal arch support or Silicon Heel Pad) is prescribed along with medicine (Celecoxib 200 mg, once a day for 15 days). Intervention 2: Control group: Exercise (including stretching of calf muscles, plantar fascia, passive dorsiflexion of fingers, strengthening of intrinsic foot muscles, rolling soles, 9 times a day, including 3 times in the morning, 3 times in the afternoon, 3 times at night, 30 seconds each time) along with medicine (Celecoxib 200 mg, once a day) for 15 days) and (Soft medial longitudinal arch support or Silicon Heel Pad) are prescribed. After the completion of the treatments, the pain level of the patients by VAS), the severity of the symptoms and the performance of the patients by the RM questionnaire will be measured again immediately after the end of the treatment and 2 months after the end of the treatment and with the other group and also at the beginning of the treatment under Comparison will be made.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh Maghroori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jarib Street, Isfahan University of Medical Science and health services</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>ramaghroori@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Izadi Najafabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan university of medical science, Hezarjarib Ave</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>Fatemeh.izadi68@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of plantar fasciitis (worsening of the pain in the inner part of the heel in the morning after waking up and also after a lot of activity during the day and the presence of local tenderness in the lower inner part of the calcaneus) by a physical medicine and rehabilitation specialist with a physical examination
Heel pain for at least 4 weeks
Age between 18 and 68 years
Presence of VAS greater than 3
Informed written consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>68 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of inflammatory joint disease
Achilles tendon or nerve damage
History of heel surgery or injection in the last 6 months
History of injury to the affected heel
The presence of diseases mimicking the symptoms of plantar fasciitis
Contraindications of the Tecar device (pregnancy, pacemaker, insulin pump, growth plate, cancer, open wound and skin lesions, skin sensitivity, insensitivity to heat)
Patients with intense physical activity or sports who are unable to reduce their activity level</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: Tecarotherapy (8 sessions: 2 days a week) and exercise (including stretching of calf muscles, plantar fascia, passive dorsiflexion of fingers, strengthening of intrinsic foot muscles and rolling soles, 9 times a day, including 3 times in the morning, 3 times in the afternoon, 3 times in the evening, 30 seconds each time) and (Soft medial longitudinal arch support or Silicon Heel Pad) is prescribed along with medicine (Celecoxib 200 mg, once a day for 15 days).</i_keyword>
      <i_keyword>Control group: Exercise (including stretching of calf muscles, plantar fascia, passive dorsiflexion of fingers, strengthening of intrinsic foot muscles, rolling soles, 9 times a day, including 3 times in the morning, 3 times in the afternoon, 3 times at night, 30 seconds each time) along with medicine (Celecoxib 200 mg, once a day) for 15 days) and (Soft medial longitudinal arch support or Silicon Heel Pad) are prescribed. After the completion of the treatments, the pain level of the patients by VAS), the severity of the symptoms and the performance of the patients by the RM questionnaire will be measured again immediately after the end of the treatment and 2 months after the end of the treatment and with the other group and also at the beginning of the treatment under Comparison will be made.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: The severity of symptoms and performance of patients before the treatment will be measured again immediately after the end of the treatment and 2 months after the end of the treatment. Method of measurement: Pain level of patients by Visual Analogue Scale questionnaire - intensity of symptoms and performance of patients by RM(The modified Roles and Maudsley) questionnaire.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-19</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Science</contact_name>
        <contact_address>Hezarjerib ave, Isfahan University of Medical Science isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
