<?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>IRCT20210730052017N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-29</date_registration>
      <primary_sponsor>District Head Quarter (DHQ) Hospital, Sargodha</primary_sponsor>
      <public_title>Effect of Proprioceptive Neuromuscular Facilitation Stretching with and without Scapular Mobilization in Frozen Shoulder.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Proprioceptive Neuromuscular Facilitation Stretching with and without Scapular Mobilization in Frozen Shoulder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57836</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After enrollment into study, patient will be allocated either to group A or Group B by lottery method. Each patient will be requested to draw a chit from the box. Number of chits will be equal to total sample size, odd numbers will be allocated to Group A and even number will be allocated to Group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Frozen shoulder also known as Adhesive Capsulitis limits the gleno-humeral joint mobility. The joint capsule becomes thickened, inflamed, and fibrotic and the intra-articular volume is also reduced which leads to pain, loss of range of motion (ROM), and functional disability. There is painful restriction in forward elevation and external rotation in the shoulder joint of these patients..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Subjects will be treated with hot pack on affected shoulder for 10 minutes. PNF will be applied by a therapist in two diagonals, anterior elevation and posterior depression, and posterior elevation and anterior depression with 2 sets of 20 repetitions per session. Rhythmic initiation and repeated contractions facilitation techniques will be applied in all patterns. Intervention 2: Intervention group 2: Subjects will be treated with hot pack for 10 minutes. PNF will be applied by a therapist in two diagonals, anterior elevation and posterior depression, and posterior elevation and anterior depression with 2 sets of 20 repetitions per session.   Rhythmic initiation and repeated contractions facilitation techniques will be applied in all patterns. In addition to this, scapular mobilization will be given in 2 sets of 20 repetitions with a rest interval of 30 seconds between sets. There will be superior scapular glides, inferior scapular glides, upper scapular glides, and downward scapular glides applied to the patient after PNF technique.</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 decision and information decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aisha Munawar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>117-C Zafar Ullah Rd, Satellite town</address>
        <city>Sargodha</city>
        <country1>Pakistan</country1>
        <zip>40100</zip>
        <telephone>+92 48 3252717</telephone>
        <email>aishamunawar1122@gmail.com</email>
        <affiliation>Sargodha Institute Of Health sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aisha Munawar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>117-C Zafar Ullah Rd, Satellite town</address>
        <city>Sargodha</city>
        <country1>Pakistan</country1>
        <zip>40100</zip>
        <telephone>+92 48 3252717</telephone>
        <email>aishamunawar1122@gmail.com</email>
        <affiliation>Sargodha Institute of Health Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age: 40-60
Unilateral Shoulder ROM limited passively (loss less than or equal to 50% in physiological movement available abduction, flexion, and external rotation movement)
Resting pain at shoulder and not less than 4 at NPRS
Pain in shoulder for at least 2 months
Gender : both males and females
Unable to do rest at involved shoulder joint</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of shoulder surgery or manipulation under anesthesia
Any history of RA, OA, osteoporosis at shoulder joint
Local corticosteroid injection into the affected shoulder over the last three months
Any history of malignancy at shoulder or chest region
Trauma to affected shoulder
Pain or disorders of cervical spine, elbow, wrist or hand
Other pathological conditions involving the shoulder (tendonitis, rotator cuff tear etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of unspecified shoulder</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 1: Subjects will be treated with hot pack on affected shoulder for 10 minutes. PNF will be applied by a therapist in two diagonals, anterior elevation and posterior depression, and posterior elevation and anterior depression with 2 sets of 20 repetitions per session. Rhythmic initiation and repeated contractions facilitation techniques will be applied in all patterns.</i_keyword>
      <i_keyword>Intervention group 2: Subjects will be treated with hot pack for 10 minutes. PNF will be applied by a therapist in two diagonals, anterior elevation and posterior depression, and posterior elevation and anterior depression with 2 sets of 20 repetitions per session.   Rhythmic initiation and repeated contractions facilitation techniques will be applied in all patterns. In addition to this, scapular mobilization will be given in 2 sets of 20 repetitions with a rest interval of 30 seconds between sets. There will be superior scapular glides, inferior scapular glides, upper scapular glides, and downward scapular glides applied to the patient after PNF technique.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, after treatment (4th week). Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion. Timepoint: Before treatment, after treatment (4 weeks). Method of measurement: Universal Goniometer (UG).</sec_outcome>
      <sec_outcome>Functional Performance. Timepoint: Before treatment, after treatment (4 weeks). Method of measurement: Shoulder  Pain and Disability Index (SPADI).</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>District Head Quarter (DHQ) Hospital, Sargodha</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-16</approval_date>
        <contact_name>Sargodha Institute of Health Sciences (SIHS), Research Ethical Committee. (REC).</contact_name>
        <contact_address>117-C Zafar Ullah Rd, Satellite town Sargodha Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
