<?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>IRCT20230526058291N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-12</date_registration>
      <primary_sponsor>The University of Lahore, Lahore Pakistan</primary_sponsor>
      <public_title>Effects of manual therapy in addition to stretching and strengthening exercises in patients with shoulder impingement syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effects of manual therapy in addition to stretching and strengthening exercises to improve scapular range of motion, functional capacity and pain in patients with shoulder impingement syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70401</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a total of 36 participants were enrolled, and they were assigned to two treatment groups using computer-generated randomization. Simple randomization process was performed using Microsoft Excel which is a computer-based random number generator . Each participant received a unique identifier, and a sequence of 36 random numbers was generated by the computer. These random numbers were then used to allocate participants to either Group A or Group B.Group A consisted of participants who received manual therapy along with stretching and strengthening exercises. On the other hand, Group B included participants who received only the stretching and strengthening exercises without manual therapy. Unit of randomization was individual.The utilization of computer-generated randomization ensured that the assignment of participants to treatment groups was unbiased and fair. 
To further eliminate biasness, researchers also employed the concealed envelope method. For each participant, a sealed envelope was prepared, containing the information about which group (Group A or Group B) the participant would be assigned to, Blinding description: This was a single blinded study in which It is difficult to blind patients and therapists so only the assessor who was also a health care provider was kept blinded due to treatment regime. It is believed that while measuring effectiveness of an intervention, it is difficult to blind patients and therapists, so, outcome assessor  blinding is done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shoulder Impingement Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Group A (Intervention group): Group A was treated with exercises and 45 minutes of manual therapy session was given to each patient. The participants were assessed within a week before intervention (pre-intervention) and the end of the 4 week intervention (post-intervention). Patient got 3 sessions per week.The total duration of intervention was 1 month. Manual therapy was employed only at the involved side. The grade lll and lV mobilization were performed including arthrokinematic movements for different sub-joints at the shoulder such as glenohumeral, scapulothoracic, sternoclavicular and acromioclavicular joints and cervical spine as well.The manual therapy was applied by a certified physical therapist according to each patient’s need. Intervention 2: Control group: Group B was given only strengthening and stretching exercises for both involved and uninvolved sides. The upper trapezious, the pectoralis minor and the posterior part of the shoulder were targeted for the stretching and strengthening. For strengthening of the muscles, exercises were performed with an external rotation of the shoulder, initiating with elbow flexion at 90° in the scapular plane. Shoulder extension in prone position was performed for the lower trapezious muscle.For pectoralis minor, wall push-ups were instructed to the participants. The frequency of each exercise was 5x3 initially that was progressed later.Frequency of intervention : Number of sessions 3 per week for 4 weeks. Interval: session lasted for 25-30mins with rest interval of 1 minute. The total duration of intervention was 1 month.</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 This study may or may not be available for other researchers. It may e available for just physiotherapists</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sana Tauqeer</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>5400</zip>
        <telephone>+92 324 4294807</telephone>
        <email>sana.tauqeer@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore, Lahore Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana Tauqeer</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>5400</zip>
        <telephone>+92 324 4294807</telephone>
        <email>sana.tauqeer@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore, Lahore Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Shoulder Impingement Syndrome from more than 3 months
Non Traumatic Onset of Shoulder Pain
Painful Arc is Positive
One or More Shoulder Impingement Test is positive
Pain during passive or isometric resisted external rotation of the arm at 90 degree of abduction</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Fracture (clavicle, humerus or scapular)
Numbness and Tingling Sensation in Upper limb after Cervical Compression Test
Sulcus test is positive
Positive drop arm test is positive
systematic illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impingement syndrome of shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A (Intervention group): Group A was treated with exercises and 45 minutes of manual therapy session was given to each patient. The participants were assessed within a week before intervention (pre-intervention) and the end of the 4 week intervention (post-intervention). Patient got 3 sessions per week.The total duration of intervention was 1 month. Manual therapy was employed only at the involved side. The grade lll and lV mobilization were performed including arthrokinematic movements for different sub-joints at the shoulder such as glenohumeral, scapulothoracic, sternoclavicular and acromioclavicular joints and cervical spine as well.The manual therapy was applied by a certified physical therapist according to each patient’s need.</i_keyword>
      <i_keyword>Control group: Group B was given only strengthening and stretching exercises for both involved and uninvolved sides. The upper trapezious, the pectoralis minor and the posterior part of the shoulder were targeted for the stretching and strengthening. For strengthening of the muscles, exercises were performed with an external rotation of the shoulder, initiating with elbow flexion at 90° in the scapular plane. Shoulder extension in prone position was performed for the lower trapezious muscle.For pectoralis minor, wall push-ups were instructed to the participants. The frequency of each exercise was 5x3 initially that was progressed later.Frequency of intervention : Number of sessions 3 per week for 4 weeks. Interval: session lasted for 25-30mins with rest interval of 1 minute. The total duration of intervention was 1 month</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain was measured with  in the week before treatment and at the end of 4 week intervention. Method of measurement: Numeric Pain Rating Scale(NPRS).</prim_outcome>
      <prim_outcome>Functional Capacity. Timepoint: Functional Capacity was measured with  in the week before treatment and at the end of 4 week intervention. Method of measurement: DASH(Disability of Hand, Shoulder and Arm Questionnaire).</prim_outcome>
      <prim_outcome>Scapular Range of Motion (scapular protraction and upward rotation. ). Timepoint: Scapular Ranges was measured with  in the week before treatment and at the end of 4 week intervention. Method of measurement: Goniometer was used to measure Scapular Ranges.</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>The University of Lahore, Lahore Pakistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-12</approval_date>
        <contact_name>Ethics Committee of The University of Lahore, Lahore Pakistan</contact_name>
        <contact_address>1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
