<?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>IRCT20200204046373N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-28</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>High-energy extracorporeal shockwave therapy in patients with calcified rotator cuff tendinopathy</public_title>
      <acronym>CRCTT</acronym>
      <scientific_title>Effectiveness of high-energy extracorporeal shockwave therapy along with routine physical therapy on subjective and objective measures in patients with calcified rotator cuff tendinopathy; a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Parallel groups, single blinded, single setting, Randomization description: The patients having diagnosed calcified rotator cuff tendinopathy will be recruited in the study by convenient sampling, and the patients who fulfilled the inclusion and exclusion criteria will be selected, with similar baseline characteristics. The consent will be taken from the subjects to participate in the study.
It will be a single blinded trial in which the assessor will be kept blind. The subjects will be randomly assigned to one of two groups by using a table of random numbers generated the randomization sequence, using a restricted randomization scheme to assure equal numbers in each group. Random allocation to all groups will be ensured, from all study personnel and participants by entry of data into computer randomization program immediately, Blinding description: It will be a single blinded trial in which the assessor will be kept blind. Assessor will be senior physiotherapist who will take measurements after giving consent to participate in study. He will be blind; not confirmed about the group of intervention.</study_design>
      <phase>2</phase>
      <hc_freetext>Rotator cuff tendinopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Shockwave therapy along with routine physical therapy. It will receive routine physical therapy treatment and high-energy extra-corporeal shockwave therapy. Routine physiotherapy treatment will be administered to the patients which includes these: ⦁	General exercise plan (range of motion, strengthening, and stretching exercises of shoulder abductors and flexors). Each exercise will be performed once a day with ten repetitions, three times a week.32⦁	Advice rest, avoiding overuse or heavy weight lifting⦁. Intervention 2: Control group: It will be give same routine treatment methods given generally to treat such patients for same time.</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 collected IPD for all outcome measures

When:
starting in November 2020
6 months after publication

To whom:
persons in academic institutes

Conditions:
it could be used on request

Where to obtain:
03414391882

How to obtain:
can call or mail

Comments:
data can bee provided on request</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arooj Fatima</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km, Raiwind road</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 341 4391882</telephone>
        <email>aruj43@hotmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arooj Fatima</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1 km, raiwind road</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>0923414391882</telephone>
        <email>aruj43@hotmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with calcified rotator cuff tendinopathy referred by orthopedic surgeons or rheumatologists ofeither gender, age ranges from 30-55 years
Having at least 3 months history of shoulder pain located in the proximal lateral aspect of the upper arm
Radiological evidence of type A or B calcification(≥1cm or 10mm)
2 of 3 impingement test positive - Neer’s test, Hawkins tests and/or Jobe test</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients having primary joint trauma or infection in shoulder region•
Frozen shoulder or symptoms from cervical spine, glenohumeral osteoarthritis
History of Shoulder instabilities, malignancies and nerve injuries, Chronic diabetic patients, diabetic neuropathy
Patients with metallic implant, Pregnant female, Severe renal or cardiovascular diseases
Patients having clotting disorders or having anticoagulant treatment
History of any fracture or surgery in the shoulder complex or Full thickness rupture in the rotator cuff tendon</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Shoulder lesions</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Shockwave therapy along with routine physical therapy. It will receive routine physical therapy treatment and high-energy extra-corporeal shockwave therapy. Routine physiotherapy treatment will be administered to the patients which includes these: ⦁	General exercise plan (range of motion, strengthening, and stretching exercises of shoulder abductors and flexors). Each exercise will be performed once a day with ten repetitions, three times a week.32⦁	Advice rest, avoiding overuse or heavy weight lifting⦁</i_keyword>
      <i_keyword>Control group: It will be give same routine treatment methods given generally to treat such patients for same time</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Baseline, 6th and 12th week. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional mobility. Timepoint: Baseline, 6 and 12 week. Method of measurement: Constant and Murley score.</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>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2641-06-20</approval_date>
        <contact_name>Institutional Review Board Committee</contact_name>
        <contact_address>1 km, Bhobatiyan chowk, Raiwind road Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
