<?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>IRCT20220513054835N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-18</date_registration>
      <primary_sponsor>Faisal Institute of Health Sciences Faisalabad</primary_sponsor>
      <public_title>Effect of Scapulothoracic Joint Mobilization and Acromioclavicular Joint Mobilization In Patients With Adhesive Capsulitis</public_title>
      <acronym>none</acronym>
      <scientific_title>Comparative Effects of Scapulothoracic Joint Mobilization and Acromioclavicular Joint Mobilization In Patients With Adhesive Capsulitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63506</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Frozen shoulder also known as adhesive capsulitis (AC) is an inflammatory condition of the glenohumeral joint where there is gradual progressive stiffness, loss of external rotation with restriction of movement and pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: After the baseline treatment, group specific treatment was given.Starting position of the patient was in sitting position and acromioclavicular joint was in resting position. Patient's scapula was fixed by gripping the acromion process from the ventral side and the spine of scapula from the dorsal side. Clavicle was gripped with the finger just proximal to joint space. Clavicle was pressed in a ventral direction to apply a grade 2 and 3 ventral glide movement. When testing use your right index finger to palpate in the joint space.Acromioclavicular joint mobilization was performed three times per week for four weeks, for a total of 12 sessions Acromioclavicular joint mobilization and baseline treatment was take 40 minutes in total. Intervention 2: Intervention group B: After the baseline treatment, group specific treatment was given.Starting position the patient was prone. Scapula was in resting position. Stable hand (left) was fixate the patient's scapula by placing our hand around the inferior angle of scapula. While with the right hand we'll grip the patient's scapula from ventral side. Scapula was lifted in a dorsal-medial-caudal direction to apply a grade 3 caudal glide joint play movement. Scapulothoracic mobilization was performed three times per week for four weeks, for a total of 12 sessions Scapulothoracic mobilization and baseline treatment was take 40 minutes in total.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Wajiha Waheed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street 18, Bazaar Number 2, Razabad, faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>03892</zip>
        <telephone>+92 302 9509078</telephone>
        <email>wajihajeeya@gmail.com</email>
        <affiliation>Faisal Institute of Health sciences Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramesha Tahir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9-Y-B, Block Madina Town, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8502460</telephone>
        <email>ramisha.alvi@gmail.com</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female participants of age between 40-60 years old
Participants having idiopathic Adhesive capsulitis (phase I &amp; II)
Participants with limitations in shoulder lateral rotation (&lt;45 degrees), abduction (&lt;80 degrees) and medial rotation (&lt;70 degrees)
Participants with a complain of pain score of minimum 3 or more on NPRS and minimum 30 percent disability scores on SPADI questionnaire</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients suffering from shoulder pain due to a severe trauma
Participants with rotator cuff pathologies, calcification tendinitis
Participants with history of osteoarthritis, malignancies of the shoulder region
Participants with neurological disorders
Congenital disorders such as winging of scapula
Participants with a history of upper limb or spinal fracture
Patients having cardiac issues, or having radiating pain going towards the affected shoulder
Participants having multiple fractures of the shoulder</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: After the baseline treatment, group specific treatment was given.Starting position of the patient was in sitting position and acromioclavicular joint was in resting position. Patient's scapula was fixed by gripping the acromion process from the ventral side and the spine of scapula from the dorsal side. Clavicle was gripped with the finger just proximal to joint space. Clavicle was pressed in a ventral direction to apply a grade 2 and 3 ventral glide movement. When testing use your right index finger to palpate in the joint space.Acromioclavicular joint mobilization was performed three times per week for four weeks, for a total of 12 sessions Acromioclavicular joint mobilization and baseline treatment was take 40 minutes in total.</i_keyword>
      <i_keyword>Intervention group B: After the baseline treatment, group specific treatment was given.Starting position the patient was prone. Scapula was in resting position. Stable hand (left) was fixate the patient's scapula by placing our hand around the inferior angle of scapula. While with the right hand we'll grip the patient's scapula from ventral side. Scapula was lifted in a dorsal-medial-caudal direction to apply a grade 3 caudal glide joint play movement. Scapulothoracic mobilization was performed three times per week for four weeks, for a total of 12 sessions Scapulothoracic mobilization and baseline treatment was take 40 minutes in total.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shoulder Pain. Timepoint: 3 timepoints including baseline, after 2nd week and 4th week. Method of measurement: Numerical Pain Rating Scale (NPRS) to measure pain.</prim_outcome>
      <prim_outcome>Shoulder Range of Motion (Flexion, Lateral rotation, Medial rotation and Abduction) will be measured by means of universal goniometer. Timepoint: 3 timepoints including baseline, after 2nd week and 4th week. Method of measurement: Goniometer is used to measure the ROM.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shoulder Functional Disability. Timepoint: 3 timepoints including baseline, after 2nd week and 4th week. Method of measurement: Shoulder Pain and Disability Index Scale (SPADI) is used to measure shoulder pain and 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>2022-03-25</approval_date>
        <contact_name>Ethical committee of Faisal Institute of Health Sciences Faisalabad</contact_name>
        <contact_address>673-A Lower Canal Rd E, Block A People's Colony No 1, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
