<?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>IRCT20220408054449N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-28</date_registration>
      <primary_sponsor>Muhammad institute of medical and aied sciences,multan,pakistan</primary_sponsor>
      <public_title>Effects of diclofenac potassium spray and isometric exercises</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the therapeutic potential of isometric exercises with and without diclofenac potassium spray in plantar-fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62815</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: participants pain  will be assessed by using the NPRS, Randomization description: Allocation concealment occurs and patients will be recruited by using a simple randomization method by using a lottery method. The lottery method is carried out through sealed envelopes. Each participant randomly chooses the sealed envelopes and opens these sealed envelopes, Blinding description: In a double-blinded study, participants and investigators will be blinded. participants will be unaware of the type of treatment that will receive and the investigator will be unaware of the type of treatment on which group which intervention will be given and for what purpose that will be evaluated after treatment. subjects will choose between two samples. both of the samples are in the same packing. In one sample,  isometric exercises with diclofenac potassium spray. In another sample,  liquid spray as a conventional treatment for the satisfaction of patients with isometric exercises will be given. subjects and investigators will be completely unaware of the effects of both interventions.</study_design>
      <phase>2-3</phase>
      <hc_freetext>plantar fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group ( group-A): Group-A group was treated with isometric exercises and four pumps of diclofenac potassium spray with phonophoresis were also given, we used 4 pumps of diclofenac potassium spray with phonophoresis and performed isometric exercises prior to phonophoresis with a frequency of 0.8MHz, an intensity of 1.5W/CM, and a mode of pulsatile (2:1) The regimen was done for a 4 week period, 3 times per week, and each session lasted for about 5-7 mins. Intervention 2: Control group (group-B):  isometric exercises. The regimen was done for a 4 week period, 3 times per week, and each session lasted for about 5-7 mins.</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 undecided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Humera Tahir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bosan road Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 302 9132647</telephone>
        <email>komalbukhari608@gmai.com</email>
        <affiliation>Muhammad institute of medical and allied sciences,Multan,pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Humera Tahir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bosan road Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 302 9132647</telephone>
        <email>komalbukhari608@gmail.com</email>
        <affiliation>Muhammad institute of medical and allied sciences,multan,pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 25 to 55 years
Patients with heel pain &gt;3 months
Both genders
Heel pain</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Vascular neoplasia
Fibromyalgia
Rheumatoid arthritis
Radiculopathy
Neuropathy
Fractures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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 ( group-A): Group-A group was treated with isometric exercises and four pumps of diclofenac potassium spray with phonophoresis were also given, we used 4 pumps of diclofenac potassium spray with phonophoresis and performed isometric exercises prior to phonophoresis with a frequency of 0.8MHz, an intensity of 1.5W/CM, and a mode of pulsatile (2:1) The regimen was done for a 4 week period, 3 times per week, and each session lasted for about 5-7 mins.</i_keyword>
      <i_keyword>Control group (group-B):  isometric exercises. The regimen was done for a 4 week period, 3 times per week, and each session lasted for about 5-7 mins.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decreased pain. Timepoint: after 3rd week. Method of measurement: NPRS 11 point numeric scale ranges from 0 representing one pain extreme(no pain)to 10 representing the other pain extreme severity.</prim_outcome>
      <prim_outcome>Increased functional activity. Timepoint: After 3rd week. Method of measurement: 11  point numeric scale ranges from 0 representing one pain extreme(no pain)to 10 representing the other pain extreme severity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>ROMs improvement. Timepoint: After 3rd week. Method of measurement: 11  point numeric scale ranges from 0 representing one pain extreme(no pain)to 10 representing the other pain extreme severity.</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>Muhammad institute of medical and aied sciences,multan,pakistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-18</approval_date>
        <contact_name>the Muhammad Institute of Medical and Allied Sciences' ethics committee in Multan, Pakistan</contact_name>
        <contact_address>Bosan road Multan Multan punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
