<?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>IRCT20180728040618N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-01</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of eccentric exercises on pain and function in patients with chronic lateral epicondylitis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eccentric exercises on maximum grip strength, function, pain and thickness of common extensor tendon in patients with chronic lateral epicondylitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62591</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are randomly assigned to one of the two groups of usual passive physiotherapy and progressive eccentric strengthening exercises equally by the restricted randomization and law of random allocation (drawing a card from the number of cards equal to the sample size and entering a group of two groups), Blinding description: After placing the patients in the desired group, they are asked not to provide their grouping information to the examiner. All evaluations will be performed by a physical therapist. This person does not know about the grouping of patients with external epicondylitis of the elbow. In other words, during the initial and final evaluation of the patients, the examiner is not able to distinguish what type of treatment each patient received. Therapeutic interventions will be applied by another physiotherapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic lateral epicondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: People receive stretching of the wrist extensor muscles, ultrasound, friction massage, and analgesic TENS during physiotherapy treatment. Stretching exercises for both groups are performed 2 times a day with 3 repetitions and 30 seconds rest between each repetition, in such a way that the person is standing and his shoulder is at a 90-degree flexion angle and his elbow is at a 0-degree flexion angle and his palm is It is towards the ground and with the healthy hand, he takes his wrist to flexion and ulnar deviation and maintains the tension for 30 seconds. In this study, ultrasound with a frequency of 1 Mhz and an intensity of 1-1.5 W/Cm2 is used. The circumference of the applicator head is four square centimeters, which is applied to the junction of the tendon of the extensor carpi radialis brevis muscle for 5 minutes. The modern pain-relieving TENS device is used with high frequency (110Hz) and intermittently in time intervals of 200 μs and with an intensity that is strong for the patient and at the same time tolerable. Ice massage for the people of both groups is performed 3 times a day using an ice pack in the painful area of the external epicondyle in a circle for 5-10 minutes until this area becomes numb. Intervention 2: Intervention group: The treatment group performed progressive eccentric strengthening exercises while sitting in a straight position, while their elbows and wrists are in maximum extension and forearms are in pronation and supported by a surface, and the palms are facing the ground so that the wrists are used for performing movements. It hangs freely. The patient is asked to slowly bend the wrist for 30 counts and use the opposite hand to return it to the original position. This exercise is performed 3 times a day with 10 repetitions and at least 1-minute rest between each time. Before and after performing these exercises, wrist extensor muscles are stretched and finally, ice massage is performed on the external epicondyle of the humerus. Eccentric exercises are started at a low speed with or with weights according to the individual's condition, and the individual is told to continue the exercise if he has mild pain (pain less than 4 on the linear scale of pain), but if it worsens and becomes unbearable If pain occurs, stop the exercise. When the person will be able to do the exercise without any pain and discomfort, the exercise is done at a medium speed and with the same load, and again when the person does not feel pain and discomfort at this level, the exercise is done quickly. When the person is able to perform high-speed training without feeling pain and discomfort, the training load will be increased by using free weights based on the ten-repetition maximum of the patients. And during treatment, progress continues in this way. Eccentric exercises are taught to the patient in the first session of treatment, and corrections and improvements are made during weekly appointments for people to receive TENS and ultrasound treatment.</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:
Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary

When:
Starting 6 months after publication

To whom:
The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders

Conditions:
The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of lateral epicondylitis  treatment and effects of eccentric exercises.

Where to obtain:
Applicants can contact the researcher of this study Sahar Torkaman by email. Email address: shr_torkaman@yahoo.com

How to obtain:
Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Holakoo Mohsenifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>mohsenifarpt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Holakoo Mohsenifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd,</address>
        <city>Tehran,</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 912 380 7685</telephone>
        <email>mohsenifarpt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with chronic lateral epicondylitis(more than 3 months)
Moderate pain based on the VAS scale (between 3-7) in the external epicondyle of the humerus, which increases with active wrist extension and decreases with rest
Positive Mills test
Positive Cozen test
Positive Maudslesy
Existence of tenderness at the tenoperiosteal site or at the junction of the common extensor tendon to the external epicondyle of the humerus
The average age is 55-35 years referred by a doctor</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pain in the lateral epicondyle of the humerus due to involvement of the neck, shoulders and thorax
Acute lateral epicondylitis
Pain in the lateral epicondyle of the humerus following a trauma to the elbow
Radial tunnel syndrome and pain in the posterior interosseous nerve pathway
Inflammation of the elbow joint
Damage to the internal and external ligaments of the elbow joint
Sensory disturbance in the involved limb
Patients with bilateral symptoms or other specific problems in the upper extremities
Neck problems
Any surgical treatment, medication, topical injection and physiotherapy during the last 3 months
Pregnancy
Infection in the elbow joint
Malignancy
Hemophilia
Dissatisfaction of participants in the study
Patients with mental disorders or inability to communicate
Patients who refuse to exercise</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: People receive stretching of the wrist extensor muscles, ultrasound, friction massage, and analgesic TENS during physiotherapy treatment. Stretching exercises for both groups are performed 2 times a day with 3 repetitions and 30 seconds rest between each repetition, in such a way that the person is standing and his shoulder is at a 90-degree flexion angle and his elbow is at a 0-degree flexion angle and his palm is It is towards the ground and with the healthy hand, he takes his wrist to flexion and ulnar deviation and maintains the tension for 30 seconds. In this study, ultrasound with a frequency of 1 Mhz and an intensity of 1-1.5 W/Cm2 is used. The circumference of the applicator head is four square centimeters, which is applied to the junction of the tendon of the extensor carpi radialis brevis muscle for 5 minutes. The modern pain-relieving TENS device is used with high frequency (110Hz) and intermittently in time intervals of 200 μs and with an intensity that is strong for the patient and at the same time tolerable. Ice massage for the people of both groups is performed 3 times a day using an ice pack in the painful area of the external epicondyle in a circle for 5-10 minutes until this area becomes numb.</i_keyword>
      <i_keyword>Intervention group: The treatment group performed progressive eccentric strengthening exercises while sitting in a straight position, while their elbows and wrists are in maximum extension and forearms are in pronation and supported by a surface, and the palms are facing the ground so that the wrists are used for performing movements. It hangs freely. The patient is asked to slowly bend the wrist for 30 counts and use the opposite hand to return it to the original position. This exercise is performed 3 times a day with 10 repetitions and at least 1-minute rest between each time. Before and after performing these exercises, wrist extensor muscles are stretched and finally, ice massage is performed on the external epicondyle of the humerus. Eccentric exercises are started at a low speed with or with weights according to the individual's condition, and the individual is told to continue the exercise if he has mild pain (pain less than 4 on the linear scale of pain), but if it worsens and becomes unbearable If pain occurs, stop the exercise. When the person will be able to do the exercise without any pain and discomfort, the exercise is done at a medium speed and with the same load, and again when the person does not feel pain and discomfort at this level, the exercise is done quickly. When the person is able to perform high-speed training without feeling pain and discomfort, the training load will be increased by using free weights based on the ten-repetition maximum of the patients. And during treatment, progress continues in this way. Eccentric exercises are taught to the patient in the first session of treatment, and corrections and improvements are made during weekly appointments for people to receive TENS and ultrasound treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tendon thickness. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Ultrasonographic imaging.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Visual analog scale.</prim_outcome>
      <prim_outcome>Maximum hand- grip strength. Timepoint: Before the intervention and after the last treatment session. Method of measurement: Digital hand held dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Function. Timepoint: Before the intervention and after the last treatment session. Method of measurement: The PREE questionnaire is used to measure performance. This questionnaire has 20 questions that examine two areas of pain and disability. The first field examines the degree of elbow pain in 5 questions. The maximum total score of this field is 50 (for each question, 0 pain-free state, and 10 maximum imaginable pain). The second field is related to disability, which measures a person's functional capacity during special activities (11 items) and usual activities (4 items). The maximum score of this domain is 50 (for each question, 0 is no limit, and 10 is the maximum difficulty to perform the activity). The final score of this questionnaire ranges from zero (the best score) to 100 (the worst 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-26</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
