<?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>IRCT20201031049207N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-25</date_registration>
      <primary_sponsor>None</primary_sponsor>
      <public_title>Shockwave Therapy in Tennis Elbow</public_title>
      <acronym>SWT</acronym>
      <scientific_title>Effects of Extra Corporeal Shock Wave Therapy versus Ultrasonic Therapy and deep friction message in the management of Lateral Epicondylitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52749</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups. In Group A (Experimental group) patients will have shock wave treatment  and in patients Group B (Experimental group) will have ultrasonic therapy and deep friction massage using coin toss method and allocation sequence will be concealed through sealed envelopes.
Concealment of allocation: will be achieved with sequentially numbered, opaque, sealed, envelopes (SNOSE). SNOSE will be used according to guidelines of Doig and Simpson (25). An independent researcher with no clinical involvement in the trial will make the concealed envelopes. 60 Envelopes will be prepared. Half envelops will contain folded papers with Treatment A written on them and the remaining half will contain folded papers with Treatment B written on them. A carbon paper will be inserted in each envelop with carbon side facing the paper so the allocation sequence, patient name, date of birth of participant and other information can be transferred onto allocation paper inside the envelope. A piece of tin foil is also inserted into envelop so the treatment card cannot be read against light. Envelops will be sealed and signed by the maker. A unique randomized number will be allocated to these envelops and shuffled vigorously. Then the envelops will be arranged sequentially and handed over to another independent researcher. Assessor will pretest the participant and if eligible envelope will be allocated to subject. Therapist will record the information on the envelope and open it afterwards to maintain the concealment. Assessor will record the post treatment findings and another independent analyst will analyze the data. This allocation of concealment will ensure the unpredictability of treatment allocation by investigators and patients, Blinding description: In these patients assessor will be blinded to allocation of treatment groups in this study. Patient will be blinded to treatment allocation as treatment will be given in separate rooms for each group. Therapist who is not blinded will not take the outcome measurements.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lateral Epicondylitis or Tennis Elbow.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group-A shock wave therapy group will be administered shockwave therapy with decompression on lateral side of elbow, with frequency 1Hz, energy level 2.0, for 7 sessions with gap of 4 days in each session. Intervention 2: Intervention group: Group-B Ultrasonic therapy and deep friction massage group. patients will be provided with ultrasonic therapy 2.5w/sec2 (intermittent)  3 times a week for four weeks. deep friction massage will be an adjunct to ultrasonic therapy.</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 there is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Wajida Perveen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Umer Street</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+92 52 3250520</telephone>
        <email>wjda_noor@yahoo.com</email>
        <affiliation>Sialkot College of Physical Therapy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Riaz Hashmi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Commissioner Road</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+92 52 4598056</telephone>
        <email>riazhashmiphysio@gmail.com</email>
        <affiliation>Syed Medical Complex</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both Males and Females.
Age between 30-60 years.
pain in twisting and turning movements of forearm.
Difficulty in holding weight in the affected side and walk.
Range of wrist extension complete but painful
Strength of extensor muscles Grade-IV
Positive Mill's test.
Positive Cozen's test</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of trauma in the region of Elbow complex.
Presence of any metal implant.
Any Neurological Deficits on the treatment sides
Symptoms of Cervical Radiculopathies.
Any sensory deficits.
strength of extensors less than Grade-IV</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 - Devices</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group-A shock wave therapy group will be administered shockwave therapy with decompression on lateral side of elbow, with frequency 1Hz, energy level 2.0, for 7 sessions with gap of 4 days in each session.</i_keyword>
      <i_keyword>Intervention group: Group-B Ultrasonic therapy and deep friction massage group. patients will be provided with ultrasonic therapy 2.5w/sec2 (intermittent)  3 times a week for four weeks. deep friction massage will be an adjunct to ultrasonic therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient Rated Tennis Elbow Evaluation. Timepoint: one Pre-Treatment, one after 3rd visit and 3rd after 7th visit. Method of measurement: subjective assessment of the patient.</prim_outcome>
      <prim_outcome>Pain. Timepoint: before 1st treatment session, after 3rd treatment session and after 7th session. Method of measurement: Numeric Pain Rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: before 1st treatment session and after last treatment session. Method of measurement: questionnaire SF-36.</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>none</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-16</approval_date>
        <contact_name>SCPT-IRB</contact_name>
        <contact_address>Umer Street Sialkot Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
