<?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>IRCT20211221053475N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-10</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on pain intensity and sleep quality in patients with knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on the severity of pain and sleep quality in patients with osteoarthritis of the knee.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60805</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: All sample subjects are divided into three equal groups by simple randomized methods. first 126 cards (equal to the number of sample volumes) will be prepared. Then, one of the letters A, B or C will be written on each card (42cards A, 42 cards B and 42cards C).These cards will be placed inside a box. so, no one will be able to see the cards inside the box.After shuffling the cards by the researcher, patients are asked to randomly remove a card from the box (selected cards will not be returned to the box after selection).Thus, Participants are divided into three groups of 42members A, B and C.In this way, three cards are prepared and one of the numbers one, 2 and 3 will be written on each card.Numbers 1, 2 and 3 will belong to intervention, placebo and control, respectively.These cards will be placed in a box and after shuffling, the researcher will randomly select a card for each group (the selected cards will not be returned to the box after selection), Blinding description: In this study, the assistant researcher will complete the questionnaires to prevent bias in the results. Thus, the assistant researcher will be unaware of the groupings and the type of interventions performed in each group and by each Patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Osteoarthritis of knee.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: To perform the intervention, the researcher is trained under the supervision of a traditional medicine specialist.After obtaining a certificate and approval from a traditional medicine specialist, the intervention is performed.In this way, in the intervention group, the researcher first teaches the location of the points that are used for pain.In the present study, the points that will be used to reduce pain include ST34 / ST36 / SP 9 / SP 10 / GB 34. Then, the researcher teaches how to perform acupressure on specific points in person and practice and present educational pamphlets to patients in groups of 10 people.Patients are asked to intervene on the trained points every day for a month.Evaluation will be done on the day of the study and 4 weeks after the start and 8 weeks after the start of the study. Intervention 2: Facade therapy group: The trainings of intervention group 1 are also given to this group, with the difference that the points related to acupressure are taught on false points. Intervention 3: Control group:This group does not receive any acupressure treatment.</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 There is not more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Shourabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Noor St., Noor 13, No. 151, Second Floor</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319636333</zip>
        <telephone>+98 51 4262 7901</telephone>
        <email>1376eli@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aboulfazl Vagharseyedin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghaffari St., Birjand University of Medical Sciences, School of Nursing and Midwifery</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 56 3238 1407</telephone>
        <email>Waghars@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Grade 2 and 3 osteoarthritis of the knee according to the scale (Kellegren-Lawrence) K-L.
Not take being NSAIDs more than three times a week (maximum 1500 mg naproxen per week).
Patient willingness and satisfaction to participate in research.
Not being addicted to drugs.
Lack of physical disability and lack of psycho-cognitive dysfunction.
Lack of inflammation, infection or sensory disturbance or neuropathy at the site of acupressure.
Not doing acupressure in the last six months, Not being history of joint surgery and steroid injections last month.
BMI less than 35.
Not being pregnant.
Not being take anticoagulants and Lack of history of coagulation disorders
Take more than 5score Petersburg quality sleep questionnaire
Not being Mental Illness.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Grade 1 osteoarthritis of the knee according to the scale (Kellegren-Lawrence) K-L.
BMI more than 35</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: To perform the intervention, the researcher is trained under the supervision of a traditional medicine specialist.After obtaining a certificate and approval from a traditional medicine specialist, the intervention is performed.In this way, in the intervention group, the researcher first teaches the location of the points that are used for pain.In the present study, the points that will be used to reduce pain include ST34 / ST36 / SP 9 / SP 10 / GB 34. Then, the researcher teaches how to perform acupressure on specific points in person and practice and present educational pamphlets to patients in groups of 10 people.Patients are asked to intervene on the trained points every day for a month.Evaluation will be done on the day of the study and 4 weeks after the start and 8 weeks after the start of the study.</i_keyword>
      <i_keyword>Facade therapy group: The trainings of intervention group 1 are also given to this group, with the difference that the points related to acupressure are taught on false points.</i_keyword>
      <i_keyword>Control group:This group does not receive any acupressure treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity in patients with osteoarthritis of the knee. Timepoint: At the beginning of the study, 4 weeks after starting the study, 8 weeks after starting the study. Method of measurement: Womak Questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality in patients with knee osteoarthritis. Timepoint: At the beginning of the study, 4 weeks after starting the study, 8 weeks after starting the study. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fatigue. Timepoint: At the beginning of the study, 4 weeks after starting the study, 8 weeks after starting the study. Method of measurement: FSS Fatigue Intensity 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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-10</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Ghaffari St., Birjand University of Medical Sciences, Vice Chancellor for Research and Technology birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
