<?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>IRCT20181210041911N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-07</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of kinesio tape  on low back pain and performance dysfunction in pregnant women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of kinesio tape on low back pain and performance dysfunction in pregnant women presenting to comprehensive health centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35827</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization by tossing a coin (to determine the first group), Blinding description: Participants and outcome evaluators are blinded to sample ellocation of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low back pain and Performance disability of the second and third trimester of pregnancy.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: Kinesio adhesive tape, 5-meter roll and 5 cm wide (made in Korea). two strips of 20 centimeters with a width of 5 centimeters are placed with medium stretching from the bottom of the pain area upwards on the sides of the spine,another with 70% stretching is attached transversally to the sacroiliac joint.To reduce the pressure of the lumbar vertebrae and support the abdominal muscles, a tape is also inserted on the stomach without stretching.The tapes are removed on day 5 by the participant. Intervention 2: the control group: Leukoplast tape, 5 m long and 5 cm wide (made in China).  Two 20 cm tape strips with a width of 5 cm are placed from the bottom of the pain area upward on the sides of the spine.Another tape is transversely attached to the sacroiliac joint to reduce the pressure of the lumbar vertebrae and support the abdominal muscles. A tape is also inserted on the abdomen. The tapes are removed on day 5 by the participant.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh alishahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Ave, Motahhari Blvd Faculty of Nursing, Midwifery,</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34 3425 5900</telephone>
        <email>www.alishahitayebeh@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyedeh Maryam Lotfipour Rafsanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing Ave, Motahhari Blvd Faculty of Nursing  Midwifery</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 343434255900</telephone>
        <email>www.maryam_lotfipur@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Written informed consent
Age:18-40 years old
Being pregnant in the  second or third trimester (gestational age of 18-32 week)
Mild to moderate low back pain (Visual analogue scale 1-7)
No known or suspected orthopedic or rheumatologic disorders including scoliosis, spine injuries,rheumatoid arthritis
No known intervertebral discopathy
No skin lesion in the lumbosacral area
No vertebral anomaly
NO skin allergy
Singleton pregnancy
NO history of low back pain prior to pregnancy
No addiction
No NSAID consumption
No history of other non-medical treatments</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Allergy to kinesio tape
kinesio tape coming off before the fifth day
Any uncontrolled medical condition
Severe low back pain (Visual analogue scale 7-10)
Unwillingness to continue the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O26.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified pregnancy related conditions</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>The intervention group: Kinesio adhesive tape, 5-meter roll and 5 cm wide (made in Korea). two strips of 20 centimeters with a width of 5 centimeters are placed with medium stretching from the bottom of the pain area upwards on the sides of the spine,another with 70% stretching is attached transversally to the sacroiliac joint.To reduce the pressure of the lumbar vertebrae and support the abdominal muscles, a tape is also inserted on the stomach without stretching.The tapes are removed on day 5 by the participant.</i_keyword>
      <i_keyword>the control group: Leukoplast tape, 5 m long and 5 cm wide (made in China).  Two 20 cm tape strips with a width of 5 cm are placed from the bottom of the pain area upward on the sides of the spine.Another tape is transversely attached to the sacroiliac joint to reduce the pressure of the lumbar vertebrae and support the abdominal muscles. A tape is also inserted on the abdomen. The tapes are removed on day 5 by the participant.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Low back pain score with visual analogue scale(vas). Timepoint: Measurement of low back pain before intervention and 1،2،7 and 14 days after intervention. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional disability score with Roland morris disability questionnaire. Timepoint: Measurement of disability before intervention and 7،14 days after intervention. Method of measurement: Roland morris disability 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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-18</approval_date>
        <contact_name>Ethics committee of rafsanjan university of medical sciences</contact_name>
        <contact_address>Rafsanjan-Imam Ali Blvd. - Central Organization Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
