<?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>IRCT20190303042891N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-01</date_registration>
      <primary_sponsor>Research assistance of Kashan university of medical sciences</primary_sponsor>
      <public_title>: The Effect of Uriculotherapy on Pain, Sleep Quality, and Functional Disability in Elderly People with Chronic Low Back Pain</public_title>
      <acronym></acronym>
      <scientific_title>: The Effect of Uriculotherapy on Pain, Sleep Quality, and Functional Disability in Elderly People with Chronic Low Back Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocks randomization in the form of blocks 4, 6 and 8 will be assigned to each of the two intervention and comparison groups. Using the Sealed Envelope Ltd. software. 2017 available through the site www.sealedenvelope.com  blocks 4, 4 blocks 8 and 5 blocks 6, a total of 11 blocks were defined, which will be allocated to the groups according to the order specified by the tool.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain in the elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group Uriculotherapy will be done at the time of pain, three times a day and five days a week during 4 weeks. In this group, the Vacheria seeds (with brand name Dong Bang made by Korea) are pasted by the researcher on the points of Shenman, Sympathetic, Subcortex and Lumbar. Participants will be taught by the researcher that seeds would be pressed with index and thumb finger for three minutes each time. Intervention 2: Control group: In the Control group, Uriculotherapy will be done at the time of pain, three times a day and five days a week during 4 weeks too. In this group, the Vacheria seeds (with brand name Dong Bang made by Korea) are pasted by the researcher on the points of the stomach; kidney, mouth and duodenum that have been proven these points are not related to pain. Participants will be taught by the researcher that seeds would be pressed with index and thumb finger for three minutes each time.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tagharrobi Zahra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe ravandi Boulevard</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>tagharrobi_z@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tagharribi Zahra</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotbe ravandi Boulevard</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>tagharrobi_z@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60 and above
Having a back pain for at least 3 months
3) willingness to participate in the study
Gain score more than 5/25 of the COST tool
Iranian citizenship
Get a 4 up score from the VAS tool
Get a 5 up score from Pittsburgh Sleep Quality Tool
Acquire the maximum 25-point rating of Oswestry functional disability tool
Ability to communicate in Farsi
Health in the Auricle</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lower back pain for some reason like a back injury
Acute low back pain
Those who get information from them are difficult
Known mental illness based on the contents of the electronic health record
Known mental retardation based on the contents of the electronic health record
Autoimmune and malignant diseases is confirmed by a specialist
Congenital anomalies (with the exception of mild lordosis and scoliosis), fracture or infection in the spine, confirmed by a specialist physician
Use of acupuncture or needles during the last three months
Surgery in the spine
History of bump in the back during the past month
drug and alcohol addiction
Do sports in a professional manner</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: In the intervention group Uriculotherapy will be done at the time of pain, three times a day and five days a week during 4 weeks. In this group, the Vacheria seeds (with brand name Dong Bang made by Korea) are pasted by the researcher on the points of Shenman, Sympathetic, Subcortex and Lumbar. Participants will be taught by the researcher that seeds would be pressed with index and thumb finger for three minutes each time.</i_keyword>
      <i_keyword>Control group: In the Control group, Uriculotherapy will be done at the time of pain, three times a day and five days a week during 4 weeks too. In this group, the Vacheria seeds (with brand name Dong Bang made by Korea) are pasted by the researcher on the points of the stomach; kidney, mouth and duodenum that have been proven these points are not related to pain. Participants will be taught by the researcher that seeds would be pressed with index and thumb finger for three minutes each time.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chronic low back pain. Timepoint: Measured at the beginning of the study, during the intervention (end of each week), the end of the intervention, and 4 weeks after the end of the intervention. Method of measurement: The short form of the McGill Pain questionnaire and the Visual analogue tool for pain assessment.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: Measured at the beginning of the study and after the end of the intervention and 4 weeks after the end of the intervention. Method of measurement: Pittsburgh sleep quality questionnaire.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Measured at the beginning of the study and after the end of the intervention and 4 weeks after the end of the intervention. Method of measurement: Functional disability questionnaire Oswestry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Allergy to Vacheria glue. Timepoint: Daily. Method of measurement: See red, inflammation, or feeling itching in the ear by elderly.</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>Research assistance of Kashan university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-07</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ghotbe ravandi Boulevard Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
