<?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>IRCT20210930052641N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-20</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of peri-articular injection of dextrose and corticosteroid with  dextrose  alone on pain relief in patients with knee osteoarthritis.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of peri-articular injection of dextrose and corticosteroid with  dextrose  alone on pain relief in patients with knee osteoarthritis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60035</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: none, Randomization description: The sample will be randomly divided into 2 groups so that the patients with the condition are assigned as a double block (AB) by the researcher based on the random allocation table. Then a package containing 40 cards with one of the letters A and B (20 each), It is considered to randomly select a card from the package and enter one of the groups according to the Latin letter. Sampling is done in parallel in 2 groups until the number of samples is completed.
It is then randomly divided into two groups receiving 20% ​​dextrose alone and 20% dextrose with corticosteroid, Blinding description: In this study, patients are aware of receiving the drug to each of the intervention and control groups, but do not know to which intervention and control group they were randomly assigned.</study_design>
      <phase>3</phase>
      <hc_freetext>Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group (group receiving 20% dextrose alone), both legs will be injected into the periarticular area. Dextrose 0.5 cc Dextrose 20% in combination with 0.5 cc lidocaine 2% injection will be performed in the periarticular area. Intervention 2: In the control group (group receiving 20% dextrose with corticosteroids), a single dose of 40 mg methylprednisolone acetate (0.5 cc) in combination with 0.5 cc of 2% lidocaine with 0.5 cc of 20% dextrose in combination with 0.5 CC lidocaine 2% injection is performed in the periarticular area and patients will be followed up for up to three months.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shirin Nourbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Internal Medicine, School of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616813131</zip>
        <telephone>+98 87 3328 6112</telephone>
        <email>shrn.nourbakhsh@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirin Nourbakhsh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Internal Medicine, School of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616813131</zip>
        <telephone>+98 87 3328 6112</telephone>
        <email>shrn.nourbakhsh@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Existence of at least three of the six ACR criteria: 1. Age over 50 years, 2. Morning stiffness less than 30 minutes, 3. Cryptation sensation in active knee movements, 4. Bone sensitivity, 5. Bone enlargement, 6. Absence of warmness at the touch of the joint
Evidence for osteoarthritis on knees radiography
Grade 2 or 3 osteoarthritis based on the Kellgren-Lawrence index</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous therapeutic injection with dextrose
Use of braces or NSAIDs or daily use of opioids during the study
Pregnancy, Lactation
Contraindication to corticosteroid injection
History of metabolic bone disease, coagulation disorders
Injection of steroid drugs in the last 2 months
History of joint fracture
History of inflammatory joint disease, post-infection arthritis, joint dysplasia, congenital anomalies, crystallopathy, post-traumatic arthritis, malignancy, vascular necrosis
Obesity BMI&gt;30
Knee infection in the last three months or knee inflammation
Candidate patients for knee surgery
Diabetes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M19.91</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primary osteoarthritis, unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group (group receiving 20% dextrose alone), both legs will be injected into the periarticular area. Dextrose 0.5 cc Dextrose 20% in combination with 0.5 cc lidocaine 2% injection will be performed in the periarticular area.</i_keyword>
      <i_keyword>In the control group (group receiving 20% dextrose with corticosteroids), a single dose of 40 mg methylprednisolone acetate (0.5 cc) in combination with 0.5 cc of 2% lidocaine with 0.5 cc of 20% dextrose in combination with 0.5 CC lidocaine 2% injection is performed in the periarticular area and patients will be followed up for up to three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention , 1 month after one intervention and 3 months after one intervention. Method of measurement: using questionnaire (Western Ontario &amp; McMaster Universities Osteoarthritis Index ).</prim_outcome>
      <prim_outcome>Knee fatigue. Timepoint: Before intervention , 1 month after one intervention and 3 months after one intervention. Method of measurement: using questionnaire (Western Ontario &amp; McMaster Universities Osteoarthritis Index ).</prim_outcome>
      <prim_outcome>Physical function. Timepoint: Before intervention , 1 month after one intervention and 3 months after one intervention. Method of measurement: using questionnaire (Western Ontario &amp; McMaster Universities Osteoarthritis Index ).</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-17</approval_date>
        <contact_name>Ethics Committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Department of Internal Medicine, School of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
