<?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>IRCT20190717044238N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-01</date_registration>
      <primary_sponsor>Riphah International University Lahore</primary_sponsor>
      <public_title>Comparative Effects of Gong’s Mobilization and Mobilization with Movement on Pain, Range of Motion and Functional Disability in Patients with Adhesive Capsulitis</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effects of Gong’s Mobilization and Mobilization  with Movement on Pain, Range of Motion and Functional  Disability in Patients with Adhesive Capsulitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68708</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: As per the inclusion and exclusion criteria of the study, patients will be divided into two groups 
randomly by Random Number Generator table, Blinding description: The patients taking part in the study would be blinded, they would not be able to know the group they have been allocated to, either Gongs or Mobilization with Movement, The assessor of the outcomes would be blinded and lastly, our data analyzer would be blinded too, making it a triple blinded clinical trial.</study_design>
      <phase>3</phase>
      <hc_freetext>Adhesive Capsulitis of Shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Gong's Mobilization. Procedure: Gong’s mobilization will be performed in a sitting/side-lying position.• The therapist will stand on the unaffected side of the subject and will place one hand on the affected side of the patient, pushing the humeral head in an anterior to a posterior direction, parallel to the joint plain.• Simultaneously the subject will be asked to quickly and powerfully perform the restricted movement (Abduction). During the above-mentioned movement, the therapist will keep pressing the humeral head along the long axis of the humerus. The therapist will follow the movement of the subject’s shoulder when they will be performing abduction. The speed of the movement is kept constant by the therapist from the beginning until the end range maintaining little distraction throughout the movement. At the end range of movement, the therapist will accelerate the movement. The procedure will be performed in 3 sets of 10 repetitions each and the technique will be applied 3 days a week for 4 weeks. Intervention 2: Intervention group 2: Mobilization with Movement -----Procedure (for improving shoulder abduction): Patient position: sitting on a chair with effected shoulder by the side and head in neutral position.• Therapist position and procedure: therapist will stand posterolateral to the affected side, placing the belt across the humeral head and to his waist.• Leaning backward, therapist will apply a posterolateral glide and patient will actively perform shoulder abduction, then overpressure will be applied.• will Therapist maintain the posterolateral glide throughout and return to neutral. Therapist will ensure that the movement is pain free.• The intervention will be given in 3 sets of 10 repetitions each------------ Procedure(for improving Internal Rotation and External Rotation): Patient position: supine lying with scapula at the edge of the plinth• Therapist position: standing lateral to the affected joint.• Hand placement: patients shoulder and elbow will be placed at 90 degrees of flexion. Therapist will grasp distal humerus with both hands.• Belt placement: Belt will be secured around therapist waist and should be parallel to floor and perpendicular to humerus. Therapist will distract the joint laterally and will ask the patient to perform external and internal rotation actively and passive overpressure would be applied at end range.• The procedure will be performed in 3 sets of 10 repetitions each and the technique will be applied 3 days a week for 4 weeks.</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:
Consent Form in its original format with no information about any participant
study protocol- how the intervention was given to both groups

When:
Data would be available after the completion of the research at the end of 2023

To whom:
People working in an academic and clinical setting can have access to the above-mentioned information/documents

Conditions:
Data can only be used for Research Purposes

Where to obtain:
Data can be asked for at the following email address: drhashaasghar@gmail.com

How to obtain:
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hasha Asghar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No, P240, shadab colony jhang road faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 317 0070706</telephone>
        <email>drhashaasghar@gmail.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 334 3372779</telephone>
        <email>fari_fairy22@yahoo.com</email>
        <affiliation>Riphah International University, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male &amp; female patients
Age group 40 to 60 years
Subjects clinically diagnosed with grade 2 adhesive capsulitis
Painful and limited active and passive glenohumeral ROM &gt;25% in capsular pattern (limited external rotation then abduction and then flexion
Pain in the shoulder for at least 3 months</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of surgery on effected shoulder.
History of fracture around shoulder complex.
History of pain or disorders of the cervical spine, elbow, wrist, or hand.
History of any other pathological conditions involving the shoulder (rotator cuff tear, tendinitis, etc.) Hawkins-Kennedy test, empty can test will be used to exclude other shoulder conditions.
History of neurological deficits limiting shoulder during activities of daily living</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of 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: Gong's Mobilization. Procedure: Gong’s mobilization will be performed in a sitting/side-lying position.• The therapist will stand on the unaffected side of the subject and will place one hand on the affected side of the patient, pushing the humeral head in an anterior to a posterior direction, parallel to the joint plain.• Simultaneously the subject will be asked to quickly and powerfully perform the restricted movement (Abduction). During the above-mentioned movement, the therapist will keep pressing the humeral head along the long axis of the humerus. The therapist will follow the movement of the subject’s shoulder when they will be performing abduction. The speed of the movement is kept constant by the therapist from the beginning until the end range maintaining little distraction throughout the movement. At the end range of movement, the therapist will accelerate the movement. The procedure will be performed in 3 sets of 10 repetitions each and the technique will be applied 3 days a week for 4 weeks.</i_keyword>
      <i_keyword>Intervention group 2: Mobilization with Movement -----Procedure (for improving shoulder abduction): Patient position: sitting on a chair with effected shoulder by the side and head in neutral position.• Therapist position and procedure: therapist will stand posterolateral to the affected side, placing the belt across the humeral head and to his waist.• Leaning backward, therapist will apply a posterolateral glide and patient will actively perform shoulder abduction, then overpressure will be applied.• will Therapist maintain the posterolateral glide throughout and return to neutral. Therapist will ensure that the movement is pain free.• The intervention will be given in 3 sets of 10 repetitions each------------ Procedure(for improving Internal Rotation and External Rotation): Patient position: supine lying with scapula at the edge of the plinth• Therapist position: standing lateral to the affected joint.• Hand placement: patients shoulder and elbow will be placed at 90 degrees of flexion. Therapist will grasp distal humerus with both hands.• Belt placement: Belt will be secured around therapist waist and should be parallel to floor and perpendicular to humerus. Therapist will distract the joint laterally and will ask the patient to perform external and internal rotation actively and passive overpressure would be applied at end range.• The procedure will be performed in 3 sets of 10 repetitions each and the technique will be applied 3 days a week for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes will be assessed at baseline, at the end of 2 week (6th session) and at the end of 4th week (12th session). Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Range of Motion (ROM). Timepoint: Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes will be assessed at baseline, at the end of 2 week (6th session) and at the end of 4th week (12th session). Method of measurement: Universal Goniometer.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Total intervention protocol will be given for four weeks of duration, 3 sessions per week with total 12 sessions. Outcomes will be assessed at baseline, at the end of 2 week (6th session) and at the end of 4th week (12th session). Method of measurement: SPADI- Shoulder pain and disability index.</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>Riphah International University Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-02</approval_date>
        <contact_name>Research and Ethical Review Committee</contact_name>
        <contact_address>Riphah Quaid e Azam Campus, 28-M Quaid-e-Azam industrial Estate, kot lakhpat, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
