<?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>IRCT2014071615932N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-08-23</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the shoulder muscles strengthening in treatment of patients with tennis elbow.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of the shoulder-rotators strengthening exercises on grip strength and pain reduction in patients with tennis elbow.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15037</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Tennis elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group patients receive routine physical therapy treatment protocol for tennis elbow syndrome for 10 sessions over two consecutive weeks. The routine physical therapy treatment protocol contained: Ultrasound: continues mode, 1 MHz frequency, 1.5 W/Cm2 use for 5 min over the origin of common wrist extensor muscles; Transcutaneous electrical nerve stimulation: burst mode, internal frequency 70-100 Hz, 60 μs pulse width, tolerable intensity for 20 min over the pain site, around the elbow joint; Hot pack: for 20 minutes on the common wrist extensor muscles; Friction massage: for 1-2 min applied on the origin of common wrist extensor muscles, Massage apply while the patient's elbow and wrist is in flexion, forearm in pronation, hand in ulnar deviation and fingers in flexion. The friction massage perform in a direction perpendicular to the muscle fibers through the therapists thumb or index finger which support by the middle finger. Eccentric strengthening exercise for extensor muscles was performed in the seated position with elbow extension, forearm pronation, and maximum wrist extension. From this position, the patient slowly lowered wrist into flexion while holding a weight, and then using the contralateral hand to return the wrist to maximum extension (3 sets × 10 reps; 1 min rest btw sets). The forearm muscle stretching was performed while the patient lying in supine position with the shoulder in abduction and then the therapist apply passive stretching to the patients wrist extensors and forearm supinators (through flexing the wrist pronating the forearm). wrist pronating the forearm).  The intervention group receive shoulder rotator muscles strengthening exercises (Oxford method) in addition to the routine physical therapy treatment in each session. For strengthening of shoulder external rotators, the subject was positioned side-lying on a bed with involved shoulder up (lying on the healthy side), arm resting on the side of the thorax with a rolled towel under the axilla and the elbow bent at a 90° angle. The patient was instructed to keep the elbow against his side and slowly rotate the arm at the shoulder and raising the weight to a vertical position (rotate the arm toward external rotation). For strengthening of shoulder internal rotators The subject was positioned side-lying on a bed on the involved side, with the arm forward in partial flexion and the elbow bent at a 90° angle. The patient was instructed to Keep the elbow bent and slowly rotate the arm at the shoulder, lift the weight upward off the table to a vertical position (rotate the arm toward internal rotation). It should be stated that a weight cuff that is determined by 10RM for each person, fasten close to the wrist (about 20% of forearm length proximal to the wrist joint). Intervention 2: Control group: In the control group patients receive routine physical therapy treatment protocol for tennis elbow syndrome for 10 sessions over two consecutive weeks. The routine physical therapy treatment protocol contained: Ultrasound: continues mode, 1 MHz frequency, 1.5 W/Cm2 use for 5 min over the origin of common wrist extensor muscles; Transcutaneous electrical nerve stimulation: burst mode, internal frequency 70-100 Hz, 60 μs pulse width, tolerable intensity for 20 min over the pain site, around the elbow joint; Hot pack: for 20 minutes on the common wrist extensor muscles; Friction massage: for 1-2 min applied on the origin of common wrist extensor muscles, Massage apply while the patient's elbow and wrist is in flexion, forearm in pronation, hand in ulnar deviation and fingers in flexion. The friction massage perform in a direction perpendicular to the muscle fibers through the therapists thumb or index finger which support by the middle finger. Eccentric strengthening exercise for extensor muscles was performed in the seated position with elbow extension, forearm pronation, and maximum wrist extension. From this position, the patient slowly lowered wrist into flexion while holding a weight, and then using the contralateral hand to return the wrist to maximum extension (3 sets × 10 reps; 1 min rest btw sets). The forearm muscle stretching was performed while the patient lying in supine position with the shoulder in abduction and then the therapist apply passive stretching to the patients wrist extensors and forearm supinators (through flexing the wrist pronating the forearm).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeinab Shirzadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1627 1552</telephone>
        <email>shirzadi.zeinab@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Alireza Motealleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences, Abiverdi 1 Avenue, Chamran Blvd, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 1627 1552</telephone>
        <email>pmotealeh@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: pain in the origin of common wrist extensor muscles in the lateral elbow; presence of symptoms exist at least for 2 months; age between 20-50 years; functional assessment scores between 9 to 22  on the base of "standardized method for assessment    of elbow function"; at least 2 positive tests from 4 tennis elbow tests: Cozen's, resistive tennis elbow test, passive tennis elbow test and chair lift test. exclusion criteria: surgery on any part of the upper extremity in the past 12 months; history of any fracture or dislocation in the upper limb; history or symptoms of rheumatoid diseases and osteoarthritis in the upper extremity joints; any disease or disorder of the central nervous system including: stroke, MS and ...; any disease of peripheral nervous system which may affect the study results such as: Neuropathies, carpal tunnel  syndrome, Guyan tunnel syndrome and cervical Radiculopathy (specially the seventh cervical root)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 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, Tennis elbow</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group patients receive routine physical therapy treatment protocol for tennis elbow syndrome for 10 sessions over two consecutive weeks. The routine physical therapy treatment protocol contained: Ultrasound: continues mode, 1 MHz frequency, 1.5 W/Cm2 use for 5 min over the origin of common wrist extensor muscles; Transcutaneous electrical nerve stimulation: burst mode, internal frequency 70-100 Hz, 60 μs pulse width, tolerable intensity for 20 min over the pain site, around the elbow joint; Hot pack: for 20 minutes on the common wrist extensor muscles; Friction massage: for 1-2 min applied on the origin of common wrist extensor muscles, Massage apply while the patient's elbow and wrist is in flexion, forearm in pronation, hand in ulnar deviation and fingers in flexion. The friction massage perform in a direction perpendicular to the muscle fibers through the therapists thumb or index finger which support by the middle finger. Eccentric strengthening exercise for extensor muscles was performed in the seated position with elbow extension, forearm pronation, and maximum wrist extension. From this position, the patient slowly lowered wrist into flexion while holding a weight, and then using the contralateral hand to return the wrist to maximum extension (3 sets × 10 reps; 1 min rest btw sets). The forearm muscle stretching was performed while the patient lying in supine position with the shoulder in abduction and then the therapist apply passive stretching to the patients wrist extensors and forearm supinators (through flexing the wrist pronating the forearm). wrist pronating the forearm).  The intervention group receive shoulder rotator muscles strengthening exercises (Oxford method) in addition to the routine physical therapy treatment in each session. For strengthening of shoulder external rotators, the subject was positioned side-lying on a bed with involved shoulder up (lying on the healthy side), arm resting on the side of the thorax with a rolled towel under the axilla and the elbow bent at a 90° angle. The patient was instructed to keep the elbow against his side and slowly rotate the arm at the shoulder and raising the weight to a vertical position (rotate the arm toward external rotation). For strengthening of shoulder internal rotators The subject was positioned side-lying on a bed on the involved side, with the arm forward in partial flexion and the elbow bent at a 90° angle. The patient was instructed to Keep the elbow bent and slowly rotate the arm at the shoulder, lift the weight upward off the table to a vertical position (rotate the arm toward internal rotation). It should be stated that a weight cuff that is determined by 10RM for each person, fasten close to the wrist (about 20% of forearm length proximal to the wrist joint).</i_keyword>
      <i_keyword>Control group: In the control group patients receive routine physical therapy treatment protocol for tennis elbow syndrome for 10 sessions over two consecutive weeks. The routine physical therapy treatment protocol contained: Ultrasound: continues mode, 1 MHz frequency, 1.5 W/Cm2 use for 5 min over the origin of common wrist extensor muscles; Transcutaneous electrical nerve stimulation: burst mode, internal frequency 70-100 Hz, 60 μs pulse width, tolerable intensity for 20 min over the pain site, around the elbow joint; Hot pack: for 20 minutes on the common wrist extensor muscles; Friction massage: for 1-2 min applied on the origin of common wrist extensor muscles, Massage apply while the patient's elbow and wrist is in flexion, forearm in pronation, hand in ulnar deviation and fingers in flexion. The friction massage perform in a direction perpendicular to the muscle fibers through the therapists thumb or index finger which support by the middle finger. Eccentric strengthening exercise for extensor muscles was performed in the seated position with elbow extension, forearm pronation, and maximum wrist extension. From this position, the patient slowly lowered wrist into flexion while holding a weight, and then using the contralateral hand to return the wrist to maximum extension (3 sets × 10 reps; 1 min rest btw sets). The forearm muscle stretching was performed while the patient lying in supine position with the shoulder in abduction and then the therapist apply passive stretching to the patients wrist extensors and forearm supinators (through flexing the wrist pronating the forearm).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: before and after intervention. Method of measurement: visual analogue scale.</prim_outcome>
      <prim_outcome>Strength of shoulder rotator muscles. Timepoint: before and after  intervention. Method of measurement: Newton scale with digital dynamometer.</prim_outcome>
      <prim_outcome>Maximum grip strength. Timepoint: before and after  intervention. Method of measurement: Newton scale with digital dynamometer.</prim_outcome>
      <prim_outcome>Pain free grip strength. Timepoint: before and after  intervention. Method of measurement: Newton scale with digital dynamometer.</prim_outcome>
      <prim_outcome>Function of upper limb. Timepoint: before and after intervention. Method of measurement: The questionnaire of Standardized method for assessment of elbow function.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-10</approval_date>
        <contact_name>Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
