<?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>IRCT20190610043858N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-04-20</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Methylprednisolone and Betamethasone on the treatment of lateral epicondylitis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Methylprednisolone and Betamethasone on the treatment of lateral epicondylitis in patients referred to Shafaihiaian and Rasoul Akram hospitals in Tehran in 2025;A randomized clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85148</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients are distributed into study groups based on pain intensity and age. Specifically, individuals are categorized by age into two groups: ≤ 40 years and &gt; 40 years. Regarding pain intensity, based on the VAS scale, individuals are categorized into two blocks: ≤ 7 and &gt; 7. They are then sequentially and consecutively assigned to study groups A and B. Individuals aged ≤ 40 years are classified into the above pain intensity categories (Block A and Block B), while individuals aged &gt; 40 years are classified into the same pain intensity categories (Block C and Block D). These categories are labeled with the corresponding Persian letters in the checklist, so the distribution of patients across groups is symbolically represented to maintain consistency, Blinding description: In this study, participants are unaware of the type of injectable medication being used. Additionally, a trained orthopedic resident who collects data before and after the intervention is also unaware of the type of intervention being performed.</study_design>
      <phase>2</phase>
      <hc_freetext>Lateral epicondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A- Local injection of Methylprednisolone (40 mg/mL – Iran Hormone Company) administered at the tendinoperiosteal site approximately 2 cm inferior and anterior to the lateral epicondyle, aligned with the point of maximum tenderness. Intervention 2: Intervention group: Local injection of Betamethasone (4 mg/mL – Aburaihan Company) administered at the tendinoperiosteal site approximately 2 cm inferior and anterior to the lateral epicondyle, aligned with the point of maximum tenderness.</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 Maintaining research ethics</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattar Khan, Niayesh Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 6435 1000</telephone>
        <email>amirsaberi20@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattar Khan, Niayesh Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 6435 1000</telephone>
        <email>amirsaberi20@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with lateral epicondylitis: individuals who, within one to six months prior to entering the study, meet at least two diagnostic criteria in the lateral elbow and forearm region, including tenderness over the lateral epicondyle, positive Cozen’s test: pain occurring in the lateral elbow and forearm during wrist extension against resistance, positive Moudley test: pain occurring in the lateral elbow and forearm during middle finger extension against resistance, positive Chair test: pain occurring in the lateral elbow while lifting a heavy object weighing approximately 3 to 5 kilograms.
Age range between 25 and 60 years
Pain intensity greater than or equal to 5 based on the Visual Analog Scale (VAS)
Obtaining written informed consent
No receipt of local interventions such as PRP injections for the treatment of lateral epicondylitis within one to six months prior to study entry
No use of NSAIDs, braces, or physiotherapy for the treatment of lateral epicondylitis within two weeks prior to the start of the study</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with systemic inflammatory diseases, fibromyalgia syndrome, cervical radiculopathy, or peripheral neuropathy in the upper limb
History of allergy to corticosteroids
Ipsilateral medial epicondylitis
Ipsilateral carpal tunnel syndrome
Pregnancy and breastfeeding
History of elbow fracture
Coagulation disorders or use of anticoagulant medications
Patients with psychological disorders
Presence of a cardiac pacemaker</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M77.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lateral epicondylitis</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>Intervention group: A- Local injection of Methylprednisolone (40 mg/mL – Iran Hormone Company) administered at the tendinoperiosteal site approximately 2 cm inferior and anterior to the lateral epicondyle, aligned with the point of maximum tenderness</i_keyword>
      <i_keyword>Intervention group: Local injection of Betamethasone (4 mg/mL – Aburaihan Company) administered at the tendinoperiosteal site approximately 2 cm inferior and anterior to the lateral epicondyle, aligned with the point of maximum tenderness</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: before and at 2, 6, and 12 weeks after the intervention. Method of measurement: Visual analog  scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Individual's daily function. Timepoint: before and at 2, 6, and 12 weeks after the intervention. Method of measurement: quick DASH , Patient-Rated Tennis Elbow Evaluation (PRTEE).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-13</approval_date>
        <contact_name>Ethics Committee of the Faculty of Medicine, Iran university of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
