<?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>IRCT20180107038257N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of dry needling and exercise therapy vs. exercise therapy alone on foot function in patients with heel pain</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of dry needling and exercise therapy vs. exercise therapy alone on pain, foot function, quality of life, thickness and echogenicity  of  the plantar fascia in patients with plantar fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30818</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: randomized block design, block size:4, ratio 1:1
Randomization tool: software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>plantar fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive  the exercise therapy and the dry needling for six weeks. The exercise therapy consist of the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor  and stretching on the static wooden wedge. The patients do  the stretching exercise two times per day; any time fifteen repetitions; each taking 30 seconds; during six weeks. Dry needling is done according to the modified-delphi protocol.    According to the protocol, the muscles that are primarily responsible for the pain including: the soleus; the quadratus plantae; the flexor digitorum brevis and the abductor hallucis.  The intervention group will receive  the dry needling once a week; during six weeks. Intervention 2: Control group: The control group will receive the exercise therapy  for six weeks. The exercise therapy consist of  the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor and stretching on the static wooden wedge . The patients do the stretching exercise two times per day; any time fifteen repetitions; each taking 30 seconds; during six weeks.</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:
The original data is shared in thesis format.

When:
After defense of thesis, the original data is shared in thesis format.

To whom:
Academic researchers, physiotherapists

Conditions:
In order to use clinical results, the original data is shared in thesis format.

Where to obtain:
Library of the faculty of rehabilitation of Tehran University of Medical Sciences

How to obtain:
Referral to library of the faculty of rehabilitation of Tehran University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saman Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of rehabilitation of Tehran University of Medical Science; Piche Shemiran; Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>salehis@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azade Shadmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of rehabilitation of Tehran University of Medical Science; Piche Shemiran; Enghelab street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148956111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>shadmehr@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>individuals with plantar fasciitis
age between 20-45 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of direct trauma to the heel
The presence of systemic inflammatory disorders
Low back pain caused by disc herniation
The presence of Tarsal tunnel syndrome(TTS)
History of fracture in foot and ankle
Use aid of support for walking
The presence of contraindication for dryneedling
Women who are pregnant
Treatment for plantar heel pain in the previous 4 weeks
Unwillingness to participate in the study</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>Intervention group: The intervention group will receive  the exercise therapy and the dry needling for six weeks. The exercise therapy consist of the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor  and stretching on the static wooden wedge. The patients do  the stretching exercise two times per day; any time fifteen repetitions; each taking 30 seconds; during six weeks. Dry needling is done according to the modified-delphi protocol.    According to the protocol, the muscles that are primarily responsible for the pain including: the soleus; the quadratus plantae; the flexor digitorum brevis and the abductor hallucis.  The intervention group will receive  the dry needling once a week; during six weeks.</i_keyword>
      <i_keyword>Control group: The control group will receive the exercise therapy  for six weeks. The exercise therapy consist of  the stretching exercise of the plantar fascia; the soleus muscle; the gastrocnemius muscle and the big-toe flexor and stretching on the static wooden wedge . The patients do the stretching exercise two times per day; any time fifteen repetitions; each taking 30 seconds; during six weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up. Method of measurement: Short-form36(SF-36) questionnaire.</prim_outcome>
      <prim_outcome>Foot function. Timepoint: At the baseline, after three weeks of intervention, after six weeks of intervention, and after a two-week follow-up. Method of measurement: Foot and Ankle Ability Measure questionnaire (FAAM) and Foot and ankle outcome score (FAOS).</prim_outcome>
      <prim_outcome>Thickness of the plantar fascia. Timepoint: At the baseline, after six weeks of intervention. Method of measurement: Ultrasonography.</prim_outcome>
      <prim_outcome>Echogenicity  of  the plantar fascia. Timepoint: At the baseline, after six weeks of intervention. Method of measurement: Ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Foot range of motion. Timepoint: At the baseline, after three weeks of intervention, after six weeks of intervention and after a two-week follow up period. Method of measurement: Goniometer.</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>2018-05-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Science</contact_name>
        <contact_address>Department of research and technology of Tehran University of Medical Sciences; Keshavarz Blvd; Ghods St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
