<?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>IRCT201205127274N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-05-30</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Guilan University of Medical Sciences</primary_sponsor>
      <public_title>A comparison between corticosteroid injection versus local anaesthetic in treatment of elbow tendinitis</public_title>
      <acronym></acronym>
      <scientific_title>A comparison between corticosteroid injection versus local anaesthetic in treatment of lateral epicondylitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7716</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral epicondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Group 2: Corticosteroid (Methyl-prednisolon acetate 1 ml) injection single dose into the painful zone. Intervention 2: Group 1: injection of a local anesthesia (procaine 2% 1 ml).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>http://www.ncbi.nlm.nih.gov/pubmed/23494116</results_url_link>
      <results_summary>Abstract&lt;br /&gt;&#13;
Introduction: This study seeks to compare two treatment methods of lateral epicondylitis: corticosteroid injection (CSI) and a local anesthetic injection (LAI).&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Materials and methods: In this single-blinded randomized clinical trial, 138 patients with the diagnosis of lateral epicondylitis were assigned either into CSI group receiving methylprednisolone 1 ml (49 patients) or LAI group (51 patients) receiving procaine 1 ml 2 % in a single dose at the maximal point tenderness site. The primary outcome&lt;br /&gt;&#13;
measure was elbow disability using Quick DASH, and secondary outcome measures were pain intensity using Visual Analogue Scale (VAS) and recurrence rate at pre-treatment visit and at 3-, 6- and 12-week post-treatment visits.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Results: There were no signiﬁcant differences between the patients in both groups for demographic factors including age, gender, dominant hand, involved hand, and work pressure. Before treatment, the patients in both groups were suffering from the same rates of elbow disability and pain as measured by Quick DASH and VAS, respectively,&lt;br /&gt;&#13;
(p[0.05). In general, the recovery rate (comparison between pretreatment visit and last post-treatment visit) was signiﬁcantly more effective and higher in CSI than LAI. CSI was dramatically more effective at 3-week visit, but less and less effective at 6- and 12-week visits. At 12-week visit the recurrence rate was 34.7 % (17 patients) in CSI group.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Conclusion: For lateral epicondylitis, CSI has the best short-term treatment results yet the highest recurrent rates.The combination of CSI with other treatment option or with a change in injection technique from single injection to peppering injection may be promising.&lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Keywords Tennis elbow   Lateral epicondylitis   Intra-lesional injection   Corticosteroids   Local anesthetic, Visual analogue scale   Treatment outcome      </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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohsen Mardani Kivi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orthopedic Department, Poursina Hospital, Parastar Avenue.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 1321 1470</telephone>
        <email>dr_mohsen_mardani@yahoo.com</email>
        <affiliation>Guilan University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Mardani Kivi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orthopedic Department, Poursina Hospital, Parastar avenue.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 1321 1470</telephone>
        <email>dr_mohsen_mardani@yahoo.com</email>
        <affiliation>Guilan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:chronic pain in lateral zone of elbow; definite tenderness in lateral  epicondylitis; age more than 15 years and VAS score more than 6. Exclusion criteria: radicular pain to the upper limbs; established Carpal Tunnel Syndrome and past history of tennis elbow treatment.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Group 2: Corticosteroid (Methyl-prednisolon acetate 1 ml) injection single dose into the painful zone</i_keyword>
      <i_keyword>Group 1: injection of a local anesthesia (procaine 2% 1 ml)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability of elbow score. Timepoint: At baseline, and 3, 6, 12 weeks after treatment. Method of measurement: The Disabilities of the Arm, Shoulder and Hand Score(QuickDash).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain severity. Timepoint: At baseline, and 3, 6, 12 weeks after treatment. Method of measurement: Value-added service (VAS) score.</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>Vice Chancellor for Research, Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-04-17</approval_date>
        <contact_name>Guilan University of Medical Science</contact_name>
        <contact_address>Vice Chancellor for Research, Guilan University of Medical Sciences, Namjou Avenue Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
