<?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>IRCT20230216057434N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-12</date_registration>
      <primary_sponsor>Self Funded</primary_sponsor>
      <public_title>Comparison of two manual techniques in elbow</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Mulligan Mobilization with movement versus eccentric concentric exercise on pain, range of motion and functional disability in patients with lateral epicondylitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68807</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through a computer software "Random allocation". The total sample size will be entered with requirement to be allocated in two groups. An automated randomization list will be achieved with attrition rate included, Blinding description: Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will received.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral Epicondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A (Mulligan Mobilization with movement) 47 patients in group A will receive Mulligan Mobilization with Movement after conservative treatment. Conservative treatment will be applied in form of ultrasound and tens. Physiotherapist will apply ultrasound for 8 minutes in continuous mode in circular manner on lateral condyle of humerus with frequency of 1MHz followed by application of tens. 1 pad of tens will be placed on above lateral condyle of humerus and other on below the lateral condyle of humerus for 15 minutes. Patient will be in supine position with elbow in full extension and forearm in pronation with stabilization will be provided by therapist at distal part of the arm while therapist will apply Mulligan Mobilization with movement technique by adding lateral glide at elbow by using the belt. Patient will be instructed to make a fist and open the fist while therapist will maintain glide by belt during the movement. Mobilization technique will be carried for total 36 times. After 12repetitions, a short rest period will be given for 15 seconds. Each session will last for 35-45 minutes. The session will repeat three times a week, 12 sessions over 4 weeks. Intervention 2: Intervention group B (Eccentric concentric exercise) 47 patients in Group B will receive eccentric concentric exercise after the conservative treatment. Conservative treatment will be applied in form of ultrasound and tens. Physiotherapist will apply ultrasound for 8 minutes in continuous mode in circular manner on lateral condyle of humerus with frequency of 1MHz followed by application of tens. 1 pad of tens will be placed on above lateral condyle of humerus and other on below the lateral condyle of humerus for 15 minutes. For eccentric concentric exercises patients will be in sitting position with elbow flexed to 90 degree and forearm in pronation with hand over the edge of the table. Therapist will instruct the patient to hold 1 lb. weight in hand while keeping the forearm supported at the armrest of chair or on their knee so that they can move their hand freely. Patient will be instructed to raise or lift wrist up towards the ceiling slowly for concentric contraction and lower the wrist slowly toward the floor for eccentric contraction. Patient will be instructed to gradually increase the weight up to 100 gm on weekly basis. Each session will last for 35-45 minutes. The session will repeat three times a week, 12 sessions over 4 weeks.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Real patient involved</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 6600141</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University, Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 335 6600141</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University, Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 25- 55 years
Gender: Both gender
Tenderness on palpation over the lateral epicondyle of humerus
Patients has pain for at least 3 month or more duration
Patients with positive cozen test</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dysfunction in shoulder, neck and thoracic region
Cervical radiculopathy
Corticosteroid injection within 3 months
Patients who had received any conservative treatment in the last 4 weeks before enring in the study.
Recent surgery of elbow joint
Fracture
Soft tissue injury in elbow region</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M77.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lateral epicondylitis, unspecified elbow</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A (Mulligan Mobilization with movement) 47 patients in group A will receive Mulligan Mobilization with Movement after conservative treatment. Conservative treatment will be applied in form of ultrasound and tens. Physiotherapist will apply ultrasound for 8 minutes in continuous mode in circular manner on lateral condyle of humerus with frequency of 1MHz followed by application of tens. 1 pad of tens will be placed on above lateral condyle of humerus and other on below the lateral condyle of humerus for 15 minutes. Patient will be in supine position with elbow in full extension and forearm in pronation with stabilization will be provided by therapist at distal part of the arm while therapist will apply Mulligan Mobilization with movement technique by adding lateral glide at elbow by using the belt. Patient will be instructed to make a fist and open the fist while therapist will maintain glide by belt during the movement. Mobilization technique will be carried for total 36 times. After 12repetitions, a short rest period will be given for 15 seconds. Each session will last for 35-45 minutes. The session will repeat three times a week, 12 sessions over 4 weeks</i_keyword>
      <i_keyword>Intervention group B (Eccentric concentric exercise) 47 patients in Group B will receive eccentric concentric exercise after the conservative treatment. Conservative treatment will be applied in form of ultrasound and tens. Physiotherapist will apply ultrasound for 8 minutes in continuous mode in circular manner on lateral condyle of humerus with frequency of 1MHz followed by application of tens. 1 pad of tens will be placed on above lateral condyle of humerus and other on below the lateral condyle of humerus for 15 minutes. For eccentric concentric exercises patients will be in sitting position with elbow flexed to 90 degree and forearm in pronation with hand over the edge of the table. Therapist will instruct the patient to hold 1 lb. weight in hand while keeping the forearm supported at the armrest of chair or on their knee so that they can move their hand freely. Patient will be instructed to raise or lift wrist up towards the ceiling slowly for concentric contraction and lower the wrist slowly toward the floor for eccentric contraction. Patient will be instructed to gradually increase the weight up to 100 gm on weekly basis. Each session will last for 35-45 minutes. The session will repeat three times a week, 12 sessions over 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Assessment will be performed at o week(baseline) and at completion of 4 weeks treatment. Method of measurement: Numeric Pain rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion at elbow joint. Timepoint: Assessment will be performed at o week(baseline) and at completion of 4 weeks treatment. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Functional disability. Timepoint: Assessment will be performed at o week(baseline) and at completion of 4 weeks treatment. Method of measurement: Patient Rated Tennis Elbow Scale(PRTEE).</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>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-26</approval_date>
        <contact_name>Ethics committee of Riphah International University Faisalabad</contact_name>
        <contact_address>Riphah International University, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
