<?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>IRCT20211010052722N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-26</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of muscles strengthening on treatment of patients with tennis elbow</public_title>
      <acronym></acronym>
      <scientific_title>The effect of proprioception training on pain, grip force and proprioception in patients with tennis elbow</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59235</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples via Block randomizer application and Block size=4 will be placed in one of the two groups of  routine physical therapy and routine physical therapy plus proprioception training, Blinding description: Patients are blind to group therapy
assessments and treatment will be performed by two independent individuals, and the assessor is blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Choronic Tennis elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The first group  patients receive routine physical therapy treatment protocol include ultrasound (puls mode, 1 MHz frequency, 1 W/Cm2) use for 5 min over the origin of common wrist extensor muscles, friction massage for 5 min applied on the origin of common wrist extensor muscles and strengthening (concentric and eccentric) and stretching exercises 3 sessions per week for 6 weeks. Intervention 2: Intervention group: The second group receive proprioception training exercises in addition to the routine physical therapy treatment in each session for 3 sessions per week for 6 weeks. proprioception training include: week 1: 30 seconds hold Rhythmic stabilization plus 30 seconds hold Quadruped position;  week 2 : 1 min hold Rhythmic stabilization plus 1 min hold Quadruped position plus 30 seconds hold kneel push up position plus 30 seconds hold prone on elbows position;  week 3: 2 min hold Rhythmic stabilization plus 2 min hold Quadruped position plus 1 min hold kneel push up position plus 1min hold prone on elbows plus 30 seconds hold  push up position plus 30 seconds hold Full push up feet elevated position; week 4: 2 min hold kneel push up position plus 2 min hold prone on elbows plus 1 min hold  push up position plus 1min hold Full push up feet elevated position plus 30 seconds hold  Hands on wobble board plus 30 seconds hold Hands on bosu ball position; week 5: 2 min hold  push up position plus 2 min hold Full push up feet elevated position plus 1 min hold  Hands on wobble board plus 1 min hold Hands on bosu ball position plus 1 min hold elbows on gym ball; week 6: 2 min hold  Hands on wobble board plus 2 min hold Hands on bosu ball position plus 2 min hold elbows on gym ball plus 1 min hold Hands on gym ball.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is no additional information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nastaran Mollazehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>nstrn.mollazehi@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Razeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz, Fars</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>razeghm@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Presence of symptoms exist at least for 3 months and up to 36 months;
Feeling of pain and burning in the lateral elbow
Feeling pain greater than 3 and less than 8 on the VAS criteria when touched lateral epicondyle by physiotherapist
At least 2 positive tests from 4 tennis elbow tests: A) Thomson test   B) Maudsely test C) Mills tset D) Dynamometer test.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of fracture or dislocation at shoulder or elbow
The history of surgery at shoulder or elbow for reasons other than fracture or dislocation
Degenerative changes at elbow or shoulder
Untreated infection or tumors at elbow or shoulder
Pressure on the cervical nerve roots
Person with radial tunnel syndrome or carpal tunnel syndrome
Impingement nerves at arm and forearm
History or symptoms of rheumatoid diseases
History of getting Gout
History of Diabetic neuropathy
Any disease or disorder of the central nervous system including: stroke, head injury, MS and .....
Any injury at elbow that interferes with use physiotherapy modalities</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>Intervention group:The first group  patients receive routine physical therapy treatment protocol include ultrasound (puls mode, 1 MHz frequency, 1 W/Cm2) use for 5 min over the origin of common wrist extensor muscles, friction massage for 5 min applied on the origin of common wrist extensor muscles and strengthening (concentric and eccentric) and stretching exercises 3 sessions per week for 6 weeks.</i_keyword>
      <i_keyword>Intervention group: The second group receive proprioception training exercises in addition to the routine physical therapy treatment in each session for 3 sessions per week for 6 weeks. proprioception training include: week 1: 30 seconds hold Rhythmic stabilization plus 30 seconds hold Quadruped position;  week 2 : 1 min hold Rhythmic stabilization plus 1 min hold Quadruped position plus 30 seconds hold kneel push up position plus 30 seconds hold prone on elbows position;  week 3: 2 min hold Rhythmic stabilization plus 2 min hold Quadruped position plus 1 min hold kneel push up position plus 1min hold prone on elbows plus 30 seconds hold  push up position plus 30 seconds hold Full push up feet elevated position; week 4: 2 min hold kneel push up position plus 2 min hold prone on elbows plus 1 min hold  push up position plus 1min hold Full push up feet elevated position plus 30 seconds hold  Hands on wobble board plus 30 seconds hold Hands on bosu ball position; week 5: 2 min hold  push up position plus 2 min hold Full push up feet elevated position plus 1 min hold  Hands on wobble board plus 1 min hold Hands on bosu ball position plus 1 min hold elbows on gym ball; week 6: 2 min hold  Hands on wobble board plus 2 min hold Hands on bosu ball position plus 2 min hold elbows on gym ball plus 1 min hold Hands on gym ball</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Proprioception. Timepoint: Before and after intervention; one month after the end intervention. Method of measurement: Biodex system isokinetic dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain and function. Timepoint: Before and after intervention; one month after the end intervention. Method of measurement: Patient rate elbow evaluation questionnaire.</sec_outcome>
      <sec_outcome>Dexterity. Timepoint: Before and after intervention; one month after the end intervention. Method of measurement: Purduepeg Bord test.</sec_outcome>
      <sec_outcome>Grip strength. Timepoint: Before and after intervention; one month after the end intervention. Method of measurement: Hand dynamometer.</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>2021-10-09</approval_date>
        <contact_name>Shiraz Univercity of Medical Siences</contact_name>
        <contact_address>Central building of Shiraz University of Medical Sciences, Zand avenue, Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
