<?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>IRCT20091214002851N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-12</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of Kinesio taping, Counterforce brace and Corticosteroid injection in tennis elbow</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of Kinesio taping, Counterforce brace and Corticosteroid injection on common extensor  tendon thickness and pain intensity in patients with tennis elbow.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64561</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Comparing the effects of Kinesio taping, Counterforce brace and Corticosteroid injection on common extensor  tendon thickness and pain intensity in patients with tennis elbow, Randomization description: Randomization will be done by Permuted block randomization method. The size of each block is considered to be 6. There are equal numbers of each group in each block. In addition, the order of placement of three treatments in each block is random and determined by a statistician. The letters A, B, and P are written in the letter envelopes, and the patients randomly pick an envelope, and based on that, their treatment group is determined. Patients who remove letter A envelope are placed in the Counterforce brace treatment group, patients who remove letter B envelope are placed in the Kinesiotape treatment group, and patients who remove envelope P are placed in the Corticosteroid injection group. A random code is written on each envelope, and when people enter the study, an envelope (in the above order) is assigned to them. The code on the envelope will be written on the patient's file (checklist), Blinding description: In this study, which will be conducted as a randomized controlled trial or RCT, the evaluator and the therapist are two different people. Therefore, this study is a single-blind study. Also, the statistical analyst is not aware of the grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tennis elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Counterforce Brace group: Patients will be asked to show the pain point on the elbow, and then we will tie the Counterforce Brace 5 cm below the elbow crease. Next, patients are requested to perform elbow flexion and extension movements in order to ensure that the range of motion of the elbow is not limited following the use of the Counterforce Brace. Patients will also be asked to grip with a lot of force to make sure the brace is not too tight. Each patient will use Counterforce Brace for two weeks. The patient only removes the Counterforce brace from the elbow while sleeping and washing. The Counterforce brace available in the market will be used in this study. Intervention 2: Intervention group: Kinesiotape group: To use kinesiotape to restrain the muscle, we use two Y-shaped bands. The main strip along the length of the extensor carpi radialis brevis muscle and the common extensor from the distal part of the muscle to its proximal side and the second strip is attached in order to correct the fascia, with maximum tension perpendicular to the main strip in the upper part of the forearm. The position of the patient's upper limb is placed in the form of elbow extension and flexion and wrist deviation to the ulnar side. The beginning and end of the main group must be connected without tension. But in placing the tape along the length of the muscle, it should be attached with 30% tension. Types are changed every 3 days for two weeks. In total, each patient receives kinesiotape 4 times. The patients in this group were asked to avoid direct contact of the forearm with water as much as possible. In this study, kinesiotape brand bio balance tape will be used. Intervention 3: Intervention group: Corticosteroid injection group: In this group, after the initial assessment, the orthopedic doctor administered a single corticosteroid injection to the patients along with lidocaine (one milliliter of methylprednisolone ten milligrams and one milliliter of two percent perilucaine) at the pain site. will be The patient's elbow is placed in a position of 45 degrees of flexion and forearm pronation on a hard place. The needle is inserted vertically into the pain area to hit the bone. Then half of the amount that entered the body is removed and the injection is performed. No other intervention methods, including physiotherapy and oral drugs, are prescribed to patients.</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:
All data can potentially be shared after unidentified individuals

When:
Access period starts 2 months after the results are published

To whom:
Researchers working in academic, scientific and medical institutions

Conditions:
To cite other researchers from the results of our research

Where to obtain:
Dr. Mohammad Taghipour, Babol University of medical sciences, college of Rehabilitation, 00989126899352 ,taghipour@mubabol.ac.ir
Seyyed Mohammadreza Hoseini. Babol University of medical sciences, college of Rehabilitation ,00989361182439mohammadreza.seyyed.1377@gmail.com

How to obtain:
2-4 weeks after request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Mohammadreza Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university of medical science, college of Rehabilitation</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47745-47176</zip>
        <telephone>+98 11 3219 4641</telephone>
        <email>Mohammadreza.seyyed.1377@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Taghipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol university of medical science, college of Rehabilitation</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47745-47176</zip>
        <telephone>+98 11 3219 4641</telephone>
        <email>taghipour@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Tenderness and pain in the external epicondyle
Positive tests (Maudsley's test/ Mill's test/ Cozen's test)
Age above 18 years
Having symptoms of the disease for at least 4 weeks to 6 months (patients with mild to moderate severity of this disease)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Radiculopathy pains and cervical spondylolysis
Diabetes
Polyneuropathy or entrapment neuropathies
History of surgery or acute trauma to the elbow
Rheumatoid arthritis diseases
History of steroid injection or physiotherapy in the lateral epicondyle of the humerus
Acuteness of the condition (severe tenderness, pain during normal active movements, warmth of the epicondyle position)
History of surgery or elbow sprain
Pregnancy
Cancer</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Counterforce Brace group: Patients will be asked to show the pain point on the elbow, and then we will tie the Counterforce Brace 5 cm below the elbow crease. Next, patients are requested to perform elbow flexion and extension movements in order to ensure that the range of motion of the elbow is not limited following the use of the Counterforce Brace. Patients will also be asked to grip with a lot of force to make sure the brace is not too tight. Each patient will use Counterforce Brace for two weeks. The patient only removes the Counterforce brace from the elbow while sleeping and washing. The Counterforce brace available in the market will be used in this study.</i_keyword>
      <i_keyword>Intervention group: Kinesiotape group: To use kinesiotape to restrain the muscle, we use two Y-shaped bands. The main strip along the length of the extensor carpi radialis brevis muscle and the common extensor from the distal part of the muscle to its proximal side and the second strip is attached in order to correct the fascia, with maximum tension perpendicular to the main strip in the upper part of the forearm. The position of the patient's upper limb is placed in the form of elbow extension and flexion and wrist deviation to the ulnar side. The beginning and end of the main group must be connected without tension. But in placing the tape along the length of the muscle, it should be attached with 30% tension. Types are changed every 3 days for two weeks. In total, each patient receives kinesiotape 4 times. The patients in this group were asked to avoid direct contact of the forearm with water as much as possible. In this study, kinesiotape brand bio balance tape will be used.</i_keyword>
      <i_keyword>Intervention group: Corticosteroid injection group: In this group, after the initial assessment, the orthopedic doctor administered a single corticosteroid injection to the patients along with lidocaine (one milliliter of methylprednisolone ten milligrams and one milliliter of two percent perilucaine) at the pain site. will be The patient's elbow is placed in a position of 45 degrees of flexion and forearm pronation on a hard place. The needle is inserted vertically into the pain area to hit the bone. Then half of the amount that entered the body is removed and the injection is performed. No other intervention methods, including physiotherapy and oral drugs, are prescribed to patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of the thickness of the common extensor tendon. Timepoint: Before treatment. After treatment and two weeks after treatment. Method of measurement: Ultrasound machine.</prim_outcome>
      <prim_outcome>Pain measurement. Timepoint: Before treatment. After treatment and two weeks after treatment. Method of measurement: visual analogue scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Timepoint: Before treatment. After treatment two weeks after treatment. Method of measurement: DASH questionnaire.</sec_outcome>
      <sec_outcome>Measurement of wrist and finger flexsor muscle strength. Timepoint: Before treatment. After treatment two weeks after treatment. Method of measurement: Dynamometer device.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-25</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Mazandaran, Babol, Ganj Afrooz St., Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
