<?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>IRCT20250224064842N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-30</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Determining the effect of dry needling combination  with counterforce brace on lateral epicondylitis</public_title>
      <acronym></acronym>
      <scientific_title>Determining the effect of dry needling combination  with counterforce brace on pain, grip strength, and upper limb function in individuals with lateral epicondylitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82137</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Three envelopes with the names of the groups written inside and sealed, and we ask the patient to choose one envelope, Blinding description: The person who measures and evaluates variables in patients does not know the type of patient intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral epicondylitis (Tennis elbow).</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Control group: treatment in group 1 (routine physiotherapy) is performed in a way that includes stretching exercises of the wrist extensor muscles for 30 seconds with 5 repetitions and ultrasound with an intensity of 1.5 for 3 minutes in the painful area and deep friction massage for 5 minutes. Intervention 2: Second intervention group: Treatment in group 2 (routine physiotherapy and dry needling) immediately after the routine physiotherapy, the patient is placed in an open arch position, the elbow is slightly bent, the forearm is in a normal position and a pillow is placed under the hand. After cleaning the skin, 5 dry needles 0.25 x 25 mm (needle size varies depending on the size of the muscle) will be inserted in the external epicondyle area and in the trigger points of the extensor carpi radialis brevis tendon .We find the extensor carpi radialis brevis tendon by resisting raising the third finger. Then rotate the needle 3 to 4 times and it will remain in place for 10 minutes and will be pulled out. To perform dry needling twice in the first and second weeks (three days between each session) and once in the third week, dry needling is repeated and routine physiotherapy will be performed immediately after applying dry needling. Intervention 3: Third intervention group: In group 3 (dry needling, routine physiotherapy, and brace), it is done in such a way that the brace is used immediately after dry needling and routine physiotherapy. The prefabricated Counterforce brace is closed 5 cm below the origin of the wrist extensor tendon according to the size of the patient. To make sure, under the supervision of an orthotist, patients bend and straighten their elbow so that the brace does not interfere with their range of motion and does not slip.</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 Data collection has not been done yet, if all patients are satisfied, there is a plan to release it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razieh jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Damavand Street, Imam Hossein Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>+98 21 7787 9719</telephone>
        <email>razieh.jafari401@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>razieh jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, in front of Bo Ali Hospital, Damavand Street, Imam Hossein Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1616913111</zip>
        <telephone>2057 7754 21 98+</telephone>
        <email>razieh.jafari401@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People whose dominant hand is involved
No contraindications for using dry needles
Pain on palpation of the external epicondyle of the humerus in the dominant hand
Cozen's test is positive
They have not responded to conservative treatment in the past 6 months
No history of corticosteroid injections in the past 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Control group: treatment in group 1 (routine physiotherapy) is performed in a way that includes stretching exercises of the wrist extensor muscles for 30 seconds with 5 repetitions and ultrasound with an intensity of 1.5 for 3 minutes in the painful area and deep friction massage for 5 minutes.</i_keyword>
      <i_keyword>Second intervention group: Treatment in group 2 (routine physiotherapy and dry needling) immediately after the routine physiotherapy, the patient is placed in an open arch position, the elbow is slightly bent, the forearm is in a normal position and a pillow is placed under the hand. After cleaning the skin, 5 dry needles 0.25 x 25 mm (needle size varies depending on the size of the muscle) will be inserted in the external epicondyle area and in the trigger points of the extensor carpi radialis brevis tendon .We find the extensor carpi radialis brevis tendon by resisting raising the third finger. Then rotate the needle 3 to 4 times and it will remain in place for 10 minutes and will be pulled out. To perform dry needling twice in the first and second weeks (three days between each session) and once in the third week, dry needling is repeated and routine physiotherapy will be performed immediately after applying dry needling.</i_keyword>
      <i_keyword>Third intervention group: In group 3 (dry needling, routine physiotherapy, and brace), it is done in such a way that the brace is used immediately after dry needling and routine physiotherapy. The prefabricated Counterforce brace is closed 5 cm below the origin of the wrist extensor tendon according to the size of the patient. To make sure, under the supervision of an orthotist, patients bend and straighten their elbow so that the brace does not interfere with their range of motion and does not slip.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention and after the intervention and one month later. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Grip strength. Timepoint: Before the intervention and after the intervention and one month later. Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>Upper limb function. Timepoint: Before the intervention and after the intervention and one month later. Method of measurement: Quick Dash questionnaire.</prim_outcome>
      <prim_outcome>Pressure pain threshold. Timepoint: Before the intervention and after the intervention and one month later. Method of measurement: Algometer.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention and after the intervention and one month later. Method of measurement: 36-question quality of life questionnaire (SF-36).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of disability. Timepoint: Before the intervention and after the intervention and one month later. Method of measurement: Patient-Rated Tennis Elbow Evaluation Questionnaire.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-09</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Arabi St, Daneshjoo Blvd ,Valenjak, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
