<?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>IRCT20220519054922N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-29</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparative effects of Gongs mobilization and Maitland mobilization in frozen shoulder</public_title>
      <acronym>AC</acronym>
      <scientific_title>Comparative effects of Gongs mobilization and Maitland mobilization on pain, range of motion and functional status in frozen shoulder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63962</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Convenient sampling was utilized to collect sample and the sample was randomly allocated to treatment groups A and B by using an online randomization generator. Computer-generated randomized sheet was used to divide patients into 2 equal groups, Blinding description: Patients will be kept blind through allocation concealment to the treatment group. Patients will be unaware of their respective group treatment plans.</study_design>
      <phase>3</phase>
      <hc_freetext>Frozen shoulder, also known as adhesive capsulitis, is a condition characterized by stiffness and pain in your shoulder joint.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Baseline treatment of moist hot pack from hydro collator at 55 degrees was provided to both groups for 10 minutes on affected shoulder. Treatment was provided for 5 sessions on consecutive week days for 2 weeks. Group 1 received Gong’s mobilization. Gong’s Mobilization was performed on patient in side lying position having the problematic side facing upward on adjustable height couch. Support was provided to patient’s head with the help of pillow. The therapist pushed the problematic side of scapula with one hand from posterior to anterior direction and with the other hand pushed the head of humerus in anterior to posterior direction for correction of pushed out humeral head. The shoulder was abducted in the pain free range. Therapist added up acceleration and applied pressure on head of humerus with 90 degree abduction to end range of shoulder joint. Gong’s mobilization technique was performed for 3 sets with each set comprising of 10 to 15 repetitions. Rest for one minute was given between each set. Intervention 2: Intervention group: Baseline treatment of moist hot pack from hydro collator at 55 degrees was provided to both groups for 10 minutes on affected shoulder. Treatment was provided for 5 sessions on consecutive week days for 2 weeks. Group 2 received Maitland mobilization. Anterior to posterior oscillation of grade III was applied on the patient and was given for 30 seconds with 2-3 glides per second. 10 second rest was given after each 30 seconds and the set was repeated for 5 times (24).</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 After discussing with supervisor, it will be decided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sadia Nawaz; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hujra Road Lalian Near Muhammadi mosque  district chiniot</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>35400</zip>
        <telephone>+92 47 6610837</telephone>
        <email>dpt-fa13-045@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sadia Nawaz; PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hujra Road Lalian Near Muhammadi mosque  district chiniot</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>35400</zip>
        <telephone>+92 47 6610837</telephone>
        <email>dpt-fa13-045@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•  Individuals voluntarily wanting to sign consent form
•  Both genders
•  Age group between 40-60
•  Individuals diagnosed with adhesive capsulitis
•  Individual with restricted capsular pattern of shoulder joint (flexion, external rotation, abduction, and internal rotation)</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic disorder
Acute inflammation around the shoulder joint
Neurological ailments
Recent fracture around the shoulder girdle
Shoulder displacement
Skin problem
Surgery around the shoulder joint</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Baseline treatment of moist hot pack from hydro collator at 55 degrees was provided to both groups for 10 minutes on affected shoulder. Treatment was provided for 5 sessions on consecutive week days for 2 weeks. Group 1 received Gong’s mobilization. Gong’s Mobilization was performed on patient in side lying position having the problematic side facing upward on adjustable height couch. Support was provided to patient’s head with the help of pillow. The therapist pushed the problematic side of scapula with one hand from posterior to anterior direction and with the other hand pushed the head of humerus in anterior to posterior direction for correction of pushed out humeral head. The shoulder was abducted in the pain free range. Therapist added up acceleration and applied pressure on head of humerus with 90 degree abduction to end range of shoulder joint. Gong’s mobilization technique was performed for 3 sets with each set comprising of 10 to 15 repetitions. Rest for one minute was given between each set.</i_keyword>
      <i_keyword>Intervention group: Baseline treatment of moist hot pack from hydro collator at 55 degrees was provided to both groups for 10 minutes on affected shoulder. Treatment was provided for 5 sessions on consecutive week days for 2 weeks. Group 2 received Maitland mobilization. Anterior to posterior oscillation of grade III was applied on the patient and was given for 30 seconds with 2-3 glides per second. 10 second rest was given after each 30 seconds and the set was repeated for 5 times (24).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The VAS was used to rate the severity of pain of patients. Timepoint: 3 timepoints including Baseline, 1st week post treatment and 2nd week post treatment. Method of measurement: Visual Analogue Scale (VAS) was utilized for estimating shoulder pain.</prim_outcome>
      <prim_outcome>Universal Goniometer to measure shoulder ROM demonstrated excellent reliability  in measuring active shoulder ROM of external rotation, abduction, and internal rotation. Timepoint: 3 timepoints including Baseline, 1st week post treatment and 2nd week post treatment. Method of measurement: Universal Goniometer was used to measure shoulder ROM.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shoulder pain and disability questionnaire (SPADI) was used to measure shoulder function disability. Timepoint: 3 timepoints including Baseline, 1st week post treatment and 2nd week post treatment. Method of measurement: Shoulder pain and disability index (SPADI) was used to measure shoulder function disability.</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>Self financed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-07</approval_date>
        <contact_name>Ethical Committee of The University of Faisalabad</contact_name>
        <contact_address>Sargodha Road, Faisalabad, Punjab, Pakistan Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
