<?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>IRCT20230712058753N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-01</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effect of magnet therapy on foot pain and function in people with plantar inflammation</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of pulsed electromagnetic field on pain and function index in people with plantar fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71281</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, two non-surgical treatment methods are compared for people with plantar fasciitis.After starting the study, the patients referred by the orthopedic doctor, who refer to the physiotherapy center during the study period, are divided into two groups of 20 people by a random block method and using a table of random numbers by someone other than the therapist and the evaluator.It is worth mentioning that in this study we will have ten blocks of four, so that two people from the intervention group and two people from the control group will be randomly placed in each block of four, Randomization description: Patients are divided into two groups of 20 people in a random block manner using a table of random numbers by a person other than the therapist and evaluator.In this study, there are ten blocks of four, two people from the intervention group and two people from the control group will be randomly placed in each block of four, Blinding description: In order to create double blinding, it will be so that the patients as well as the evaluator and statistical analyst do not know how to group people, and someone other than the therapist evaluates the patients.
In other words, the patients are in progress, and we have two treatment groups in this study, but they are unaware of which group they belong to, because in both groups, a magnet device is used, with the difference that in the control group, the device will not have an output and only the therapist is aware of it; Actually, because the device does not generate heat, the patient does not feel any special symptoms when the device is on and the current is established. Therefore, in this study, the patients and the evaluator (a person other than the therapist) are blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plantar fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: People only receive 10 sessions of common physiotherapy treatment. Each session includes 5 minutes of pulse ultrasound therapy (with 50% duty cycle, 1MHz frequency and 1.2W/cm2 intensity) and 20 minutes of TENS analgesic modality along (with 8Hz frequency, 300µs pulse width and motor intensity) with stretching exercises for the cuff muscles and plantar fascia and strengthening exercises for the anterior tibialis muscle. Intervention 2: Intervention group: In addition to receiving 10 sessions of common physiotherapy, people also receive 10 sessions of the electromagnetic field treatment program (with square wave shape and 30% duty cycle and 7.5Hz frequency and 100mT intensity) for 10 minutes.</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 According to the obtained results, a decision will be made in this regard.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Navid Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy group; Faculty of Rehabilitation Sciences; Isfahan University of Medical Sciences; Hezarjarib Street;</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 5049</telephone>
        <email>n_taheri@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Navid Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy group; Faculty of Rehabilitation Sciences; Isfahan University of Medical Sciences; Hezarjarib Street;</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 5049</telephone>
        <email>n_taheri@rehab.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People aged between 20 up to 68 years
Pain in the heel or sole of the foot for more than three months
The presence of pain in the heel or the sole of the foot with a score of 5 or more according to the VAS scale in the morning and at the end of the day
Painful palpation with local pressure at the origin of the plantar fascia on the medial tubercle of the heel</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>68 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of any injury, tear and previous local trauma in the heel and sole of the foot
History of foot surgery in the past
Local steroid injection in the last 3 months
The presence of severe and congenital abnormalities in the knee or ankle (such as severe knee braces, etc.)
Having diabetes, tumor, peripheral neuropathy with any cause, systemic inflammatory disease
The presence of a pacemaker or metal implant
The presence of other musculoskeletal disorders with any cause that causes clinical manifestations in the lower limbs or spine
Pregnancy
People with a body mass index greater than 30</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: People only receive 10 sessions of common physiotherapy treatment. Each session includes 5 minutes of pulse ultrasound therapy (with 50% duty cycle, 1MHz frequency and 1.2W/cm2 intensity) and 20 minutes of TENS analgesic modality along (with 8Hz frequency, 300µs pulse width and motor intensity) with stretching exercises for the cuff muscles and plantar fascia and strengthening exercises for the anterior tibialis muscle.</i_keyword>
      <i_keyword>Intervention group: In addition to receiving 10 sessions of common physiotherapy, people also receive 10 sessions of the electromagnetic field treatment program (with square wave shape and 30% duty cycle and 7.5Hz frequency and 100mT intensity) for 10 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain: It is a dependent variable that is usually measured by a score, and it is a score that a person should give to the level of pain from zero to ten. In fact, a score of zero equals no pain and a score of ten equals severe unbearable pain. Timepoint: Before starting the intervention; immediately after the last treatment session; Four weeks after completion of treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Foot Function Index: It is a questionnaire that is used in patients with foot problems, it has 23 items that are placed in three subgroups, and it examines the intensity of pain, disability and limitations of people. People should give each question a score between 0-10. Timepoint: Before starting the intervention; immediately after the last treatment session; Four weeks after completion of treatment. Method of measurement: Foot Function Index 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>2023-05-24</approval_date>
        <contact_name>Ethics Committee of Nursing, Rehabilitation and Management schools- Isfahan University of medical Sc</contact_name>
        <contact_address>Hezar Jerib Avenue, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
