<?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>IRCT20190715044217N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-04</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of trigger points dry needling and shockwave therapy on pain, function and quality of life in patients with chronic plantar fasciitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of trigger points Dry needling and Shockwave therapy on pain, function and quality of life in patients with chronic plantar fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40833</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly allocated blocks and hiding in a non-transparent envelope sealed into two groups, Blinding description: In this study, the evaluator and analyst are blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plantar fasciitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, 3 sessions of shockwave therapy will apply for three weeks and once a week. Intervention 2: Intervention group: In this group, individuals will receive dry needling for 3 weeks and once a week at painful trigger points of cuff muscles. These muscles include Soleus, Quadratus plantae, Flexor digitorum brevis, Flexor hallusic longus, Gastrocnemius and Abductor hallucis.</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 results will be published as an article in the research international journals

When:
In the next one to two years

To whom:
Only people who ask the information from the main investigator

Conditions:
With the permission through a written or an oral request

Where to obtain:
School of Rehabilitation Sciences, Shiraz University of Medical Sciences, 1st Abiverdi, Chamran Blv., Miss Tahere salehi, Phone number: 0098 71 36271551

How to obtain:
With a written request, they can access the library of Shiraz University of Medical Sciences, School of Rehabilitation Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ebrahimi samaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Abiverdi 1 St., Chamran Blvd., Shiraz, Iran</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1733-71345</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>EbrahimiS@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ebrahimi samaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71345-1733</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>EbrahimiS@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Resistance to treatment in the last 6 months
Point pain on the inside of the calcaneus and origin of plantar fasciitis
Having a minimum score of numerical scale of pain 4 in the first step
Having or not having  heel spur
Adoption interrupted of analgesics, anti-inflammatory and non-steroidal drugs and topical or oral analgesics for at least 14 days before the initial assessment and during the study
Having trigger points in the initial assessment of cuff muscles
Ability to walk 50 meters without assistance</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dry needle contraindications include: Needle phobia, People with a history of needle or injection abnormal reactions, Emergency situations, Anticoagulant drugs, Lymphedema, Vascular Diseases, Diabetes, Pregnancy, Epilepsy, and Metal Sensitivity latex
Secondary heel pain leads to more serious problems such as fractures, cancer and infection
History of coagulation disorders or taking anticoagulants except acetylsalicylic acid to a dose of 325 mg / day
Dermatological Disease in place of dry needle
Previous experience in using dry needles or acupuncture
connective tissue disease
A history of chronic diseases such as RA, PSORIATIC, SCIATIC
History of Plantar Fascia Surgery or Injection 3 months ago
Systemic or topical neurological disorders
Spinal deformities
Lower limb bone disorders such as gout and Paget's</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: In this group, 3 sessions of shockwave therapy will apply for three weeks and once a week</i_keyword>
      <i_keyword>Intervention group: In this group, individuals will receive dry needling for 3 weeks and once a week at painful trigger points of cuff muscles. These muscles include Soleus, Quadratus plantae, Flexor digitorum brevis, Flexor hallusic longus, Gastrocnemius and Abductor hallucis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention, one week and five weeks after the intervention. Method of measurement: Numeric rate scale.</prim_outcome>
      <prim_outcome>Function. Timepoint: Before the intervention, one week and five weeks after the intervention. Method of measurement: FAAM questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention, one week and five weeks after the intervention. Method of measurement: Short form 12 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-13</approval_date>
        <contact_name>Research Ethics Committee of Shiraz School of Rehabilitation Sciences</contact_name>
        <contact_address>School of Rehabilitation Sciences - Abiverdi 1 St. - Chamran Blvd. - Shiraz - Iran shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
