<?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>IRCT20151123025202N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-16</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the therapeutic effect of laser and extracorporeal shock waves in plantar fasciitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the efficacy of Extracorporeal shockwave therapy and high-level laser therapy in patients with plantar fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57458</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 patients with inclusion will be selected by convenience sampling. The samples will be randomly coded with computer software in two groups E and L and the relevant codes will be entered in the raw checklists. Upon patient referral, one of the checklists will be randomly assigned to each patient. If the selected code is E, the patient will be in the ESWT treatment group and if it is L, he/she will be in the laser treatment group, Blinding description: The evaluator of intervention outcome will be blinded to the patients' group.</study_design>
      <phase>3</phase>
      <hc_freetext>plantar fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A will be allocated to ESWT by a physical therapist for 3 consecutive weeks and one session per week. ESWT will be performed while the patient is lying on a quiet bed at the point where the greatest intensity of tenderness is found. Device settings: frequency 4 Hz, pulse 1500, energy 0.15 mj / mm2. will be done. Intervention 2: Control group: Patients in group B will receive powerful laser therapy. In this group, gallium aluminum arsenide diode laser (model K-laser-cube 4) with a wavelength of 1064 nm, output power of 8 watts, and an average energy intensity of 6-10 joules per square centimeter will be used. The laser wave is of continuous type and will be applied by scanning method. The total duration of treatment in each session will be 5-7 minutes. All patients will be treated for 3 consecutive weeks (6 sessions).</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3838 0097</telephone>
        <email>a.moradi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>محمدرضا نیکو</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat Hospital, Shahid Beheshti Blv, Hamedan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6514845411</zip>
        <telephone>+98 81 3264 0030</telephone>
        <email>mohammadrezanikoo@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of plantar fasciitis according to clinical criteria and para -clinical imaging by a specialist physician
The duration of diagnosis is at least 3 months
Age 65-18 years
Minimum pain intensity &gt; 3 according to VAS scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbidity other ankle and heel diseases such as tarsal tunnel syndrome, osteomyelitis, malignancy
History of recent ankle or heel surgery or trauma
Vascular diseases
Treatment corticosteroid  past 4 months
NSAID treatment</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A will be allocated to ESWT by a physical therapist for 3 consecutive weeks and one session per week. ESWT will be performed while the patient is lying on a quiet bed at the point where the greatest intensity of tenderness is found. Device settings: frequency 4 Hz, pulse 1500, energy 0.15 mj / mm2. will be done</i_keyword>
      <i_keyword>Control group: Patients in group B will receive powerful laser therapy. In this group, gallium aluminum arsenide diode laser (model K-laser-cube 4) with a wavelength of 1064 nm, output power of 8 watts, and an average energy intensity of 6-10 joules per square centimeter will be used. The laser wave is of continuous type and will be applied by scanning method. The total duration of treatment in each session will be 5-7 minutes. All patients will be treated for 3 consecutive weeks (6 sessions).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plantar fascia thickness. Timepoint: 3, 6 and 12 weeks after treatment. Method of measurement: Ultrasound examination of the heel in prone position.</prim_outcome>
      <prim_outcome>Severity of plantar pain. Timepoint: 3, 6 and 12 weeks after treatment. Method of measurement: with Visual Analogue Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Life Quality. Timepoint: Before, 3. 6 and 12 weeks after intervention. Method of measurement: SF-12 Questionnaire.</sec_outcome>
      <sec_outcome>Treatment Complications. Timepoint: 3, 6 and 12 weeks after the intervention. Method of measurement: Examination and observation.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-16</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Science</contact_name>
        <contact_address>ُShahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
