<?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>IRCT20260707070092N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of Mesotherapy and Dry Needling on pain reduction and functional improvement in patients with Tennis Elbow</public_title>
      <acronym>MEDTEN Trial</acronym>
      <scientific_title>Comparison of the efficacy of Mesotherapy and Dry Needling in pain reduction and functional improvement in patients with Lateral Epicondylitis (Tennis Elbow): A Randomized clinical trial conducted at the physical medicine and rehabilitation clinics of Isfahan university of medical sciences.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91525</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to treatment groups using a fixed-block randomization method. Each block will consist of four patients, with assignment to the two treatment groups occurring at a 1:1 ratio. The randomization sequence will be generated using the Clinical Trial Randomization Tool provided by the National Cancer Institute (NCI). The randomization list will be kept confidential, and treatment group assignments will be made based on the order of patient enrollment in the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Lateral epicondylitis(Tennis elbow).</hc_freetext>
      <i_freetext>Intervention 1: The study involves 58 patients randomly assigned to either the mesotherapy group or the dry needling group.                                               In the mesotherapy intervention group, 1 cc of Piroxicam (20 mg/1 ml; Caspian Tamin Pharmaceutical Company) is administered subcutaneously using a 27-gauge needle at a 45-degree angle; a volume of 0.5 cc is injected into each of two tender points—to reduce inflammation and alleviate pain—twice weekly for a period of three weeks. Intervention 2: Second Intervention Group (Dry Needling Group): Patients in this group receive dry needling twice weekly combined with exercise therapy. The dry needling procedure involves using a 0.25 × 0.25 mm needle at the point of maximal tenderness over the lateral epicondyle; the "Hong fast-in-fast-out" technique is applied, consisting of 20 rapid insertions and withdrawals at the designated site over a 20-second period. Additionally, the Chou technique—involving simultaneous rotation during needle insertion and withdrawal—is employed to facilitate needle movement.</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 Due to the need to address ethical considerations and maintain the confidentiality of participants' data, the final decision regarding the release of the data file will be made upon completion of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Abasirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 305, Kasra Building No. 7, C2 Neighborhood, Motahari Blvd, Fooladshahr, Isfahan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8491421142</zip>
        <telephone>N/A</telephone>
        <email>fe.abasirad7374@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razieh Maghroori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital, Isfahan University of Medical Sciences, Sofeh Blvd., Isfahan , Iran</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3620 2020</telephone>
        <email>Ramaghroori@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18–70 years
pain at the lateral epicondyle for at least one month
Pain during at least one of the following tests: Maudsley’s test, Cozen ’s test (resisted extension of the middle finger), or Mill’s test.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cervical radiculopathy
Neuropathy
Arthritis or a history of arthritis in the upper extremity
Pregnancy
History of forearm or elbow surgery
Acute elbow trauma
Autoimmune disease
Local or systemic upper-extremity infection
Fibromyalgia syndrome
Cubital tunnel syndrome
Carpal tunnel syndrome
Ipsilateral medial epicondylitis
Old fracture in the affected arm
Elbow deformity
Presence of coagulation disorders
General contraindications for mesotherapy (exclusion criteria to be considered for patients undergoing the procedure): bleeding disorders; active infections in the treatment area (such as open wounds, skin infections, or severe acne); autoimmune diseases (e.g., lupus or rheumatoid arthritis); use of blood-thinning medications; and chronic skin conditions (such as psoriasis, eczema, or rosacea).</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>The study involves 58 patients randomly assigned to either the mesotherapy group or the dry needling group.                                               In the mesotherapy intervention group, 1 cc of Piroxicam (20 mg/1 ml; Caspian Tamin Pharmaceutical Company) is administered subcutaneously using a 27-gauge needle at a 45-degree angle; a volume of 0.5 cc is injected into each of two tender points—to reduce inflammation and alleviate pain—twice weekly for a period of three weeks.</i_keyword>
      <i_keyword>Second Intervention Group (Dry Needling Group): Patients in this group receive dry needling twice weekly combined with exercise therapy. The dry needling procedure involves using a 0.25 × 0.25 mm needle at the point of maximal tenderness over the lateral epicondyle; the "Hong fast-in-fast-out" technique is applied, consisting of 20 rapid insertions and withdrawals at the designated site over a 20-second period. Additionally, the Chou technique—involving simultaneous rotation during needle insertion and withdrawal—is employed to facilitate needle movement.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of pain associated with lateral epicondylitis (tennis elbow) in the study participants. Timepoint: Before the start of the study, Immediately after completion of the study,8 weeks after completion of the study. Method of measurement: Pain severity will be assessed using the Visual Analog Scale (VAS).</prim_outcome>
      <prim_outcome>Functional status and limitations in performing activities related to the upper extremity in patients with lateral epicondylitis(tennis elbow). Timepoint: Before the start of the study, Immediately after completion of the study,8 weeks after completion of the study. Method of measurement: Patient-Rated Tennis Elbow Evaluation (PRTEE).</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-06-20</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences.</contact_name>
        <contact_address>No.305,Kasra Building 7, C2 Neighborhood, Motahari Bolevard, Fooladshahr, Isfahan Fooladshahr Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
