<?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>IRCT20171111037396N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-18</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Prolotherapy in Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis without effusion</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29353</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomly allocate 60 eligible subjects to two parallel groups: Intra-articular injection as group A and Peri-articular injection as group B by the administrator of the clinician who educated to use a block randomization list. The list is made by computer as non-stratified list, with the equal block length. The patients will be not aware of being allocated in the group A or B. Also, statisticians will be kept blind about the allocation, Blinding description: Participants will be allocated by blocked randomization list to 2 groups by investigator A :Intraarticular prolotherapy and B:Periarticular prolotherapy. the patients will be not aware of being allocated in the group A or B.  In both groups the investigator will inject the prolotherapy agent.The patients will be visited by a second colleague who will be not aware of the groups during the study.outcome assessor will be not blind but statisticians will be kept blind about the allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: In the group A patient lies on bed, patient’s knee with placing a pillow under it flexes to 30 degrees then practitioner prepare the knee and injects 5 cc dextrose 25% from inferiolateral side of the knee joint by 23 gauge Syringe. Preparation of dextrose 25%( 2.5 cc lidocaine2% plus 2.5 cc dextrose 50%). Intervention 2: In the group B, 5 cc of dextrose 25% will be injected by using 25 gauge syringe around knee joint maximum in two points (lateral or medial). These points are the most painful points, except pesanserine bursitis. Preparation of dextrose 25%( 2.5 cc lidocaine2% plus 2.5 cc dextrose 50%).</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 no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dashtimakan Hadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz School of Medicine, Shiraz University of Medical Science, Zand Blvd, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134845794</zip>
        <telephone>+98 71 3233 7855</telephone>
        <email>hadidashtimakan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rooshanzamir Sharareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine and Rehabilitation, Second floor, Faghihi Hospital, Zand Blvd, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 3231 9040</telephone>
        <email>sharareh.roshanzamir@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Negative Ballottement test
Negative Fluid wave test
Age from 38 years old to 70 years old of both sex
Diagnosed as knee osteoarthritis according to clinical criteria of American College of Rheumatology
Having grade 2 and 3 based on Kellgern and Lawrence Grading Scale
Complain of pain, crepitation and knee joint stiffness that lasted at least three months before study</inclusion_criteria>
      <agemin>38 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Foot deformity
Sever genu valgum
Any infection involving the knee skin
Any intra or peri articular injection during the three last months
History of rheumatic or inflammatory disease involving the knee joints
Prior total knee arthtoplasty
Poorly controlled DM with HbA1c more than 7.5%
BMI more than 42
History of knee trauma or fracture during the three last months
History of acute lumbosacral radiculopathy or peripheral neuropathy
History of cancer
Bleeding disorders
Pregnancy
Severe genu varum</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bilateral primary osteoarthritis of knee</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 group A patient lies on bed, patient’s knee with placing a pillow under it flexes to 30 degrees then practitioner prepare the knee and injects 5 cc dextrose 25% from inferiolateral side of the knee joint by 23 gauge Syringe. Preparation of dextrose 25%( 2.5 cc lidocaine2% plus 2.5 cc dextrose 50%)</i_keyword>
      <i_keyword>In the group B, 5 cc of dextrose 25% will be injected by using 25 gauge syringe around knee joint maximum in two points (lateral or medial). These points are the most painful points, except pesanserine bursitis. Preparation of dextrose 25%( 2.5 cc lidocaine2% plus 2.5 cc dextrose 50%)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before injection, 4 and 8 weeks after injection. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
      <prim_outcome>Function. Timepoint: Befor injection and 2 and 4 weeks after injection. Method of measurement: The WOMAC consists of 24 items divided into 3 sub scales : Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing.Stiffness (2 items): after first waking and later in the day.Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-22</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences, Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
