<?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>IRCT2016112931166N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-30</date_registration>
      <primary_sponsor>Yasuj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology massage and stretching exercises in patients with rheumatoid arthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of foot reflexology massage and stretching exercises on pain and fatigue of patients with rheumatoid arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24573</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Rheumatoid arthritis.</hc_freetext>
      <i_freetext>Intervention 1: For trial group (1), reflexology of metatarsus would be performed in 3 levels including: preparation (5 minutes), warm up (10 minutes) and reflexology of metatarsus techniques (15 minutes) which last for a month, 3 30-minute sessions a week. The reflexive point starts from the end of the first knuckle of the finger and it ends in the sole. Preparation and warm up include warming up the feet by hands by determined movements, holding the foot from back and front by two hands and forming bending backwards movements, bending the metatarsus, rotation toward outside and movements in the sole. For stimulating reflexive points, massage would be performed using the fingers moving back and forth and by exerting a pressure about 0/5 centimeters. Intervention 2: The patients of the trial would only receive the routine treatment for a month and no intervention would happen during this period. Before proceeding to any intervention, the excessiveness of pain and fatigue would be assessed in every 3 groups utilizing visual-criterion scale and MFI-20 fatigue multi-dimensional questionnaire. Intervention 3: In trial group (2), stretching exercises would be used for intervention. Stretching exercises include 10 minutes of warm up, 15 minutes stretching and 5 minutes cooling down. Stretching exercises include 33 movements and have been chosen according to Bob Anderson stretching exercises in a way that no particular physical preparation is needed other than a simple warm up.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahla Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zeinab School of Nursing and Midwifery, Adjacent to the  Imam Sajjad haspital</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74133234115</telephone>
        <email>Shahlaiss@yahoo.com</email>
        <affiliation>Yasuj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahla Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj, Zeinab School of Nursing and Midwifery, Adjacent to the  Imam Sajjad hospital</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74133234115</telephone>
        <email>shahlaiss@yahoo.com</email>
        <affiliation>Yasuj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for entering trials include: patient's tendency for participating in the trial; being older than 18; definite diagnosis of rheumatoid arthritis by the specialist; at least a year must have passed from the diagnosis; owning pain degree of (4-7) and above average based on MFI-20 questionnaire; pain measurement and total fatigue degree 50 and above 50 based on numerical scale; lack of known psychological problems including depression; not being under medication with psychochemical drugs prior to the disease; not being afflicted by other chronic and hazardous diseases; not being afflicted by dermatological disease in feet and sensual disorders in feet; lack of experience of reflexology of metatarsus; lack of wound; fracture and dermatological and movement disorders in feet; passage of at least 4 hours from taking pain killers; not being addicted to drugs; lack of cardiovascular diseases in lower limbs; lack of experience in participating at any regular exercise program in the last six months and being allowed to participate at exercise programs with the specialist's confirmation.&#13;
&#13;
Criteria for existing from the trial include: lack of tendency to continue the cooperation after the trial starts; alteration in any requirements of entering the trial; not being able to perform exercise program due to any reason; taking a new medication during the trial; being absent 4 cessions of the 12 cessions of the trial.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M06.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For trial group (1), reflexology of metatarsus would be performed in 3 levels including: preparation (5 minutes), warm up (10 minutes) and reflexology of metatarsus techniques (15 minutes) which last for a month, 3 30-minute sessions a week. The reflexive point starts from the end of the first knuckle of the finger and it ends in the sole. Preparation and warm up include warming up the feet by hands by determined movements, holding the foot from back and front by two hands and forming bending backwards movements, bending the metatarsus, rotation toward outside and movements in the sole. For stimulating reflexive points, massage would be performed using the fingers moving back and forth and by exerting a pressure about 0/5 centimeters.</i_keyword>
      <i_keyword>The patients of the trial would only receive the routine treatment for a month and no intervention would happen during this period. Before proceeding to any intervention, the excessiveness of pain and fatigue would be assessed in every 3 groups utilizing visual-criterion scale and MFI-20 fatigue multi-dimensional questionnaire.</i_keyword>
      <i_keyword>In trial group (2), stretching exercises would be used for intervention. Stretching exercises include 10 minutes of warm up, 15 minutes stretching and 5 minutes cooling down. Stretching exercises include 33 movements and have been chosen according to Bob Anderson stretching exercises in a way that no particular physical preparation is needed other than a simple warm up.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Once the first day of the intervention and before intervention And again on the last day and within 10 minutes after intervention. Method of measurement: Numerical Pain Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fatigue. Timepoint: Once the first day of the intervention and before intervention  And again on the last day and within 10 minutes after intervention. Method of measurement: Multidimensional Fatigue Inventory.</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>Yasuj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-29</approval_date>
        <contact_name>Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj, Motahari Boulevard, Yasuj University of Medical Sciences Yasuj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
