<?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>IRCT20241202063917N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-22</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of eccentric and concentric exercises in the treatment of lateral epicondylitis</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of eccentric and concentric exercises in the treatment of lateral epicondylitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: The minimum total sample size was estimated to be 81 patients. Taking into account the probability of falling, a total of 90 samples are selected, which are randomly divided into three groups of 30 people using a lottery. For randomization, after coding each patient, we create a series of random numbers from 1 to 90 using kitset.ir. The first 30 numbers are assigned to group 1 (eccentric exercises), the second 30 numbers to group 2 (concentric exercises) and the third 30 numbers to group 3 (eccentric-concentric exercises), Blinding description: For blinding, the person assessing the outcomes (eg, measuring pain, function and grip strength) will be unaware of patient grouping. This is done by coding the patients and presenting the results to the evaluator without showing the assigned group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral epicondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the eccentric exercise group, eccentric wrist extensor exercises are performed with the elbow on the bed in full extension, the forearm in pronation, the wrist in a stretched position (as high as possible), and the hand hanging over the edge. From this position, patients slowly bend their wrist while counting to 30 and return to the starting position with the help of the other hand. Exercises are performed in the form of 3 sets of 15 repetitions of slow progressive wrist extensor exercises in each treatment session with a 1-minute rest interval between each set. Intervention 2: Intervention group: In the concentric exercise group, the patient is seated with the elbow fully flexed (90 degrees), the forearm pronated, and the wrist in a neutral position. From this position, the patient slowly extends the wrist to maximum extension for a count of 30, using the opposite hand to return the wrist to flexion. Exercises are performed in the form of 3 sets of 15 repetitions of slow progressive wrist extensor exercises in each treatment session with a 1-minute rest interval between each set. Intervention 3: Intervention group: In the eccentric-concentric exercise group, the elbow is in full extension on the bed, the forearm is in pronation, the wrist is extended (as high as possible), and the hand is hanging over the edge of the bed. From this position, patients slowly flex their wrist while counting to 30, then return to the starting position (stretch). Exercises are performed in the form of 3 sets of 15 repetitions of slow progressive wrist extensor exercises in each treatment session with a 1-minute rest interval between each set.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data on the study's three primary outcomes, pain, function, and grip strength, can be shared after de-identifying subjects.

When:
Access starts 6 months after results are published

To whom:
The data will be accessible to all people who want to use the data, including researchers, students, doctors, etc.

Conditions:
The data can be used for review articles provided the source is mentioned.

Where to obtain:
Applicants can send their application through the email of the authors of the article.

How to obtain:
After sending the request by the applicant, the request will be raised with other writers and if they agree, the data will be sent to the applicant. This process will take about a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Dehghan Marvast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan, Valiasr St., Mushfaq Kashani North, Sub-Division 11</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8179664368</zip>
        <telephone>+98 31 3778 9423</telephone>
        <email>alidehqa@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Dehghan marvast</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan, Valiasr St., Mushfaq Kashani North, Sub-Division 11</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8179664368</zip>
        <telephone>+98 31 3778 9423</telephone>
        <email>alidehqa@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of lateral epicondylitis by a specialist doctor
Having symptoms of lateral epicondylitis for more than 3 months
Willingness and satisfaction of patients to perform regular exercise
Age between 20 and 65 years
Absence of inability to understand the scales used in the present study
Ability to respond</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Joint crepitus, instability, deformity or loss of motion and previous history of elbow fracture
People with heavy and manual jobs (such as construction and industrial workers, heavy machinery operators, mechanics, construction painters, carpenters, etc.)
Fibromyalgia, sprain, surgery or arthritis
Neck radiculopathy
Receiving treatments other than painkillers such as local steroid injection, physiotherapy, autologous blood injection, botulinum injection, etc.</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the eccentric exercise group, eccentric wrist extensor exercises are performed with the elbow on the bed in full extension, the forearm in pronation, the wrist in a stretched position (as high as possible), and the hand hanging over the edge. From this position, patients slowly bend their wrist while counting to 30 and return to the starting position with the help of the other hand. Exercises are performed in the form of 3 sets of 15 repetitions of slow progressive wrist extensor exercises in each treatment session with a 1-minute rest interval between each set.</i_keyword>
      <i_keyword>Intervention group: In the concentric exercise group, the patient is seated with the elbow fully flexed (90 degrees), the forearm pronated, and the wrist in a neutral position. From this position, the patient slowly extends the wrist to maximum extension for a count of 30, using the opposite hand to return the wrist to flexion. Exercises are performed in the form of 3 sets of 15 repetitions of slow progressive wrist extensor exercises in each treatment session with a 1-minute rest interval between each set.</i_keyword>
      <i_keyword>Intervention group: In the eccentric-concentric exercise group, the elbow is in full extension on the bed, the forearm is in pronation, the wrist is extended (as high as possible), and the hand is hanging over the edge of the bed. From this position, patients slowly flex their wrist while counting to 30, then return to the starting position (stretch). Exercises are performed in the form of 3 sets of 15 repetitions of slow progressive wrist extensor exercises in each treatment session with a 1-minute rest interval between each set.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score in visual analog quality (VAS). Timepoint: Pain assessment at the beginning of the study (zero week), the end of treatment (fourth week) and one month after treatment (eighth week). Method of measurement: Visual analog quality (VAS).</prim_outcome>
      <prim_outcome>Upper limb function using the DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire. Timepoint: Pain assessment at the beginning of the study (zero week), the end of treatment (fourth week) and one month after treatment (eighth week). Method of measurement: DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire.</prim_outcome>
      <prim_outcome>Measuring the patient's grip strength using Jamar's grip dynamometer. Timepoint: Measurement at the beginning of the study (week zero), the end of treatment (week four) and one month after treatment (week eight). Method of measurement: Jamar grip dynamometer.</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>2024-11-02</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Faculty of Medicine, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
