<?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>IRCT20210111050005N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-01</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Effectiveness of Graston technique treatment on chronic plantar Fasciitis</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Graston technique treatment on Pain, and Foot General Health of chronic Plantar Fasciitis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53637</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: Objective 1= To assess the effectiveness of Graston technique with taping on the treatment of chronic plantar heel pain in chronic plantar fasciitis patients, Objective 2= To assess the effectiveness of Graston technique with taping on foot function and foot health related quality of life of chronic plantar fasciitis patients, Randomization description: Each patient of heel pain coming to the recruitment center will be screened. I will make a list of 30 patients according to the sequence as they are coming I will be give them numbers 1 to 30 i.e. the first patient enrolled will be given number 1 and last patient  enrolled will be given number 30. Every odd will be allocated into treatment group and every even number will be allocated into control group, Blinding description: I will give each participant a number, e.g 1 to 30, on the basis of these numbers i will make two groups, one will be treatment group in which all even numbers will be allocated, and one will control group in which all odd numbers will be allocated. In this way this way i could not know which participant will be in which group and participant will also not know who will be entered in which group.</study_design>
      <phase>2</phase>
      <hc_freetext>Plantar fasciitis. Overloading and repetitive micro trauma results plantar fasciitis This is a health condition not a disease..</hc_freetext>
      <i_freetext>Intervention 1: It will receive baseline treatment (Therapeutic ultrasound, stretching exercises of calf and plantar fascia, taping ) and Graston technique by Graston tool. treatment will be of 2 sessions per week ( every 3rd day) for 4 weeks. Ultrasaound protocol= Therapeutic ultrasound was given to the patients for 5 minutes(continuous mode, intensity of 1 W/cm2 with frequency of 1 MHz for five minutes in prone lying (Sankhe, et al., 2016). Stretching exercises of calf and plantar fascia= Stretching exercises of plantar fascia muscle and calf muscles, performed 10 stretches holding each for 10 seconds (DiGiovanni et al., 2006, Garret and Neibert, 2019). Taping mechod= low dye taping with calcaneal sling technique will be used. leukotape (type of tape) will be used for this purpose. taping will be apllied on every 3rd day of week, after application patient will will be guided to remove tape after 24 hours (Hyland et al., 2006, Weon, Kim and Jung, 2015). Graston technique= First of all Graston technique lubricant will be applied on plantar surface of foot. For 8 minutes sweeping strokes will applied start from meta-tarsals to calcaneus then from calcaneus to meta-tarsal. For this purpose  Graston tool to mobilize the soft tissue will be used. The area where high restriction of the soft tissue will present, aggressive Graston treatment with increase force and shorter strokes on that area will applied. Patients will be monitored if there is an increase in pain or discomfort during whole treatment (Jones et al., 2010). Intervention 2: It will receive only baseline treatment (Therapeutic ultrasound, stretching exercises of calf and plantar fascia, taping ). treatment will be of 2 sessions per week ( every 3rd day) for 4 weeks. Ultrasaound protocol= Therapeutic ultrasound was given to the patients for 5 minutes(continuous mode, intensity of 1 W/cm2 with frequency of 1 MHz for five minutes in prone lying (Sankhe, et al., 2016). Stretching exercises of calf and plantar fascia= Stretching exercises of plantar fascia muscle and calf muscles, performed 10 stretches holding each for 10 seconds (DiGiovanni et al., 2006, Garret and Neibert, 2019). Taping mechod= low dye taping with calcaneal sling technique will be used. leukotape (type of tape) will be used for this purpose. taping will be apllied on every 3rd day of week, after application patient will will be guided to remove tape after 24 hours (Hyland et al., 2006, Weon, Kim and Jung, 2015).</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Data is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Noreen kiran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>P176, Namat colony no 2, street no 6, near khuram chock, jaranwala road Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>011925212044</telephone>
        <email>Noreen.kian@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Noreen Kiran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Muslim town 3, street number 09, Sargodha road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 5212044</telephone>
        <email>Noreen.kiran@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients diagnosed with chronic plantar fasciitis
Patients having pain started before more than 6 weeks and less than 6 months
Both male and female of age 20 to 45 years were included
Patients having pain on first steps of walking out of bed in the morning or after prolonged standing, or sitting
Patients having pain located at the anterio- medial surface of heel or mid-foot and presence of an everted calcaneus greater than or equal to 2</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients having previous history of severe vascular disease, cancer, rheumatoid arthritis, or osteoporosis, neurological disorders related to lower limb of affected side, pathological calcaneal spur
Patients having Ankle and foot soft tissue masses/bursitis, tendon pathology or scar, heel fat pad atrophy/hypertrophy
Patients having Ankle and foot fracture or surgery before 6 months and stress fracture before 8 months
Patients having pain or foot related complications after fracture or surgery
Patients having fascia release surgery done within 3 months back
Patients having Diabetics and altered skin sensation or foot dermal conditions
Who are already taking physical therapy treatment or corticosteroid injections and who were not willing to quit such treatment during 30 days of participation
Pregnant female
Who refuse to participate in the study</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>It will receive baseline treatment (Therapeutic ultrasound, stretching exercises of calf and plantar fascia, taping ) and Graston technique by Graston tool. treatment will be of 2 sessions per week ( every 3rd day) for 4 weeks. Ultrasaound protocol= Therapeutic ultrasound was given to the patients for 5 minutes(continuous mode, intensity of 1 W/cm2 with frequency of 1 MHz for five minutes in prone lying (Sankhe, et al., 2016). Stretching exercises of calf and plantar fascia= Stretching exercises of plantar fascia muscle and calf muscles, performed 10 stretches holding each for 10 seconds (DiGiovanni et al., 2006, Garret and Neibert, 2019). Taping mechod= low dye taping with calcaneal sling technique will be used. leukotape (type of tape) will be used for this purpose. taping will be apllied on every 3rd day of week, after application patient will will be guided to remove tape after 24 hours (Hyland et al., 2006, Weon, Kim and Jung, 2015). Graston technique= First of all Graston technique lubricant will be applied on plantar surface of foot. For 8 minutes sweeping strokes will applied start from meta-tarsals to calcaneus then from calcaneus to meta-tarsal. For this purpose  Graston tool to mobilize the soft tissue will be used. The area where high restriction of the soft tissue will present, aggressive Graston treatment with increase force and shorter strokes on that area will applied. Patients will be monitored if there is an increase in pain or discomfort during whole treatment (Jones et al., 2010).</i_keyword>
      <i_keyword>It will receive only baseline treatment (Therapeutic ultrasound, stretching exercises of calf and plantar fascia, taping ). treatment will be of 2 sessions per week ( every 3rd day) for 4 weeks. Ultrasaound protocol= Therapeutic ultrasound was given to the patients for 5 minutes(continuous mode, intensity of 1 W/cm2 with frequency of 1 MHz for five minutes in prone lying (Sankhe, et al., 2016). Stretching exercises of calf and plantar fascia= Stretching exercises of plantar fascia muscle and calf muscles, performed 10 stretches holding each for 10 seconds (DiGiovanni et al., 2006, Garret and Neibert, 2019). Taping mechod= low dye taping with calcaneal sling technique will be used. leukotape (type of tape) will be used for this purpose. taping will be apllied on every 3rd day of week, after application patient will will be guided to remove tape after 24 hours (Hyland et al., 2006, Weon, Kim and Jung, 2015)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention, and 2, 4 weeks after intervention. Method of measurement: by using plantar fasciitis pain scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>General foot health status. Timepoint: before intervention and 2, 4 weeks after intervention. Method of measurement: by The Foot Health Status Questionnaire.</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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-08-03</approval_date>
        <contact_name>Ethical committee of The University of Fiasalabad</contact_name>
        <contact_address>Medina University near kea motors showroom, Sargodha road Faisalabad Faisalabad punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
