<?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>IRCT20201130049545N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of kinesio tape and low dye tape on pain and function in patients with plantar fasciitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of kinesio tape and low dye tape on pain and function in patients with plantar fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52667</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Other design features: Before entering the study, the research conditions will be explained to all patients and the people who filled out the informed consent will enter the project.For all patients, the relevant checklist will be filled in first including demographic information (age, sex, height, weight, body mass profile, level of physical activity, occupation, education, time of onset of pain) and plantar fasciitis risk factors. Comprehensive physical and neurological evaluations will be performed for all patients to rule out other clinical causes of foot and heel pain. All patients will also be asked about their medical history, previous medical history, and underlying medical conditions, and their findings will be carefully recorded.Then the amount of morning pain and daily pain will be marked separately by VAS criteria.Patients will determine their pain intensity based on the VAS as a degree from the 10 cm line. The patient should have at least 40 mm of pain.The American Orthopedic Foot and Ankle Scale (AOFAS) will also be used to assess performance.For pre-tape people, the pain scale is based on the VAS questionnaire and the American Foot and Ankle Association Scale (AOFAS), a clinical assessment system that measures pain and patient performance based on patient and physician perceptions, regardless of radiographic results. Will be taken.An hour later, the pain will be measured again on the above scales. 72 hours later, patients will return for taping, and before that, the above scales will be re-examined for pain, Randomization description: Patients will be divided into two groups using the Permuted Block Randomization method. The website https://www.sealedenvelope.com will be used to create a random sequence in the block randomization approach. Also, to hide the allocation concealment, a random sequence is provided to a specific person. The researcher then contacts the person based on the order in which the participants enter the study and asks about the random assignment of the participant to a specific group. For each intervention, a number (code) is defined and inserted on the envelope according to the random sequence created, Blinding description: Before entering the study, the research conditions will be explained to all patients and the people who filled out the informed consent will enter the project.
In this study, patients will be divided into two groups using a table of random numbers.
Patients will not be informed about the type of tape used and the study is one-sided blind, but other people, including Hori and the researcher of the project, are fully aware of the type of patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plantar fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Kase technique will be used in the kinesio tape group. The type used for patients will be 2-inch tape. This brigade has been approved by Dr. Kase, the creator of this technique. Two tapes of the Kinesio tape will be measured and cut. A strip from the base of the calcaneus to the metatarsals will be measured and divided into 4 to 6 strips at the end of the tip. Another strip will be measured from the outer side of the foot above the cuboid, below the plantar surface of the foot and in the antromedial direction of the distal third of the tibia. This strip will be cut I-shped with rounded corners. While the foot is in the dorsiflexion position, the tip is glued to the bottom of the heel without any stretching. The last 4 strips of the first strip will be glued to the beginning of the plantar surface with 15 to 25% tension on the beginning of the metatarsals. The second band of the Kinesio tape is I-shped on the lateral surface of the foot without any stretching and then while the foot is in the dorsiflexion position, the tape will be attached obliquely to the arch of the sole of the foot with 25% tension. The rest of the tip will be applied on the medial surface of the wrist with 15 to 25% tension. The patient will be asked to refrain from getting water on the body while it is on the body, and to be careful not to detach it from the skin while wearing the garment. In the next session, the brigade will be removed from the skin by the therapist and the subject will be carefully examined for possible skin allergies. Intervention 2: Control group: In the low-dye group, this 1.5-inch tape is with the best quality straps that are of the best quality and are used by athletes around the world. Working with a zinc oxide cloth adhesive is one inch wide and is done in five steps. The starting point is the outer edge of the foot just below the little toe. The glue starts from this place and goes down to the outer edge of the foot and passes behind the heel and returns to the first place under the sole of the foot. The glue should not wrinkle on the skin, otherwise it will cause blistering. The same is done for the inside of the foot and starts from the inside of the foot just below the big toe and goes from the inside of the foot to the back of the heel and returns to its first place through the sole of the foot. Then with a series of glue We cover the transverse holes in the sole of the foot with the previous adhesives.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After completing the study

When:
After completing the study

To whom:
There is no limit

Conditions:
Send resume and reason for requesting data

Where to obtain:
drelhamkarimi89@gmail.com
Belongs to Elham Karimi Shervedani

How to obtain:
Send the request and use the data to the email address listed

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 10, yavary alley , East orumiye street , Jomhouri square , Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>+98 21 6691 0301</telephone>
        <email>drelhamkarimi89@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Karimi shervedani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No .10,Yavary Alley, East Orumiye street, Johouri square , Tehran Town,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1234567890</zip>
        <telephone>+98 31 3741 8590</telephone>
        <email>drelhamkarimi89@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being 20 to 75 years old
No history of ankle or heel fractures
No history of ankle surgery
No diabetes
Do not use nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to enrollment
Do not use orthoses from the time of diagnosis until enrollment
Not having any neuromuscular damage in the lower extremities that affects daily activities
Do not have any painful lesions on the foot such as bunion or cerebellum or nail growth in the tissues around the nail
No congenital defects in the lower extremities
Existence of pain in the heel for at least one month with Vas greater than or equal to 4 at the time of examination
No open sores on the soles of the feet and heels</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Positive tunnel sign
History of systemic inflammatory disease and connective tissue
History of hernia with S1 radiculopathy
History of gout
History of surgery or injection in the last 6 months
Pain in the back of the heel associated with Achilles bursitis
Dissatisfaction with enrollment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M72.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inflammation of the plantar fascia</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: Kase technique will be used in the kinesio tape group. The type used for patients will be 2-inch tape. This brigade has been approved by Dr. Kase, the creator of this technique. Two tapes of the Kinesio tape will be measured and cut. A strip from the base of the calcaneus to the metatarsals will be measured and divided into 4 to 6 strips at the end of the tip. Another strip will be measured from the outer side of the foot above the cuboid, below the plantar surface of the foot and in the antromedial direction of the distal third of the tibia. This strip will be cut I-shped with rounded corners. While the foot is in the dorsiflexion position, the tip is glued to the bottom of the heel without any stretching. The last 4 strips of the first strip will be glued to the beginning of the plantar surface with 15 to 25% tension on the beginning of the metatarsals. The second band of the Kinesio tape is I-shped on the lateral surface of the foot without any stretching and then while the foot is in the dorsiflexion position, the tape will be attached obliquely to the arch of the sole of the foot with 25% tension. The rest of the tip will be applied on the medial surface of the wrist with 15 to 25% tension. The patient will be asked to refrain from getting water on the body while it is on the body, and to be careful not to detach it from the skin while wearing the garment. In the next session, the brigade will be removed from the skin by the therapist and the subject will be carefully examined for possible skin allergies.</i_keyword>
      <i_keyword>Control group: In the low-dye group, this 1.5-inch tape is with the best quality straps that are of the best quality and are used by athletes around the world. Working with a zinc oxide cloth adhesive is one inch wide and is done in five steps. The starting point is the outer edge of the foot just below the little toe. The glue starts from this place and goes down to the outer edge of the foot and passes behind the heel and returns to the first place under the sole of the foot. The glue should not wrinkle on the skin, otherwise it will cause blistering. The same is done for the inside of the foot and starts from the inside of the foot just below the big toe and goes from the inside of the foot to the back of the heel and returns to its first place through the sole of the foot. Then with a series of glue We cover the transverse holes in the sole of the foot with the previous adhesives</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain is a quantitative  variable measured by the Visual Analogue Scale. Timepoint: The measurement of the variable at the beginning of the study is before the intervention and one hour after the intervention and 72 hours after. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ankle function is a variable measured by the AOFAS questionnaire. Timepoint: The variable is measured before the intervention and one hour after the intervention and 72 hours after. Method of measurement: The American Orthopaedic Foot &amp; Ankle Scale.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-30</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Research assistant , Ghods Street , Keshavarzi  Boulevard ,  Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
