<?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>IRCT20191001044947N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-14</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>comparing the effect of manual and exercise therapy on pain, function and range of motion in treatment of patients with shoulder impingement syndrome</public_title>
      <acronym></acronym>
      <scientific_title>comparing the effect of manual and exercise therapy on pain, function and range of motion in treatment of patients with shoulder impingement syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42801</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are randomly allocated into two groups.  Randomization will be applied with block randomization method (4 people per block) . This method will be applied by the person how does not has any role in treatment and assessment, Blinding description: Assessor will be unaware and won't have any information about patients. 
Patients also have no information about which group they are categorized into. The evaluator and therapist will be two different people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>shoulder impingement syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: manual therapy: The treatment will last 3 sessions per week for patients. Manual therapy includes ischemic compression on trigger and Mobilization points. mobilization of acromioclavicular joint, sternoclavicular joint, glenohumeral joint, scapulothoracic and thoracic joints will be done in direction of limitation by therapists hand. This technique will be done in 3 sets and duration of each set is 30 seconds. For finding trigger points some muscles like pectoralis major, pectoralis minor, supraspinatus, infraspinatus, teres minor, teres major, deltoid and levator scapula will be assessed. Ischemic compression technique will be performed for each muscle that have trigger point and at least 3 muscles from them should have trigger points. For this technique, pressure will be applied on the trigger points by the therapist's thumb. Gradually this pressure will be  increased up to the patient's tolerance . This pressure will be applied for 5 to 15 seconds and based on the patient condition this time can increased up to 2 minutes. Intervention 2: Group2: therapeutic exercise: Treatment will last 3 months. Exercises will be done for 12 weeks.  During this period, 7 visits will be done by physiotherapists. The exercises will be done in 3 sets and the repetition of exercise in each set is 15 and therapist will emphasize on posture correction. The Emphasis is on correcting the posture.List of exercises contain these elements: Stretching of capsule 2 times in a day, each time contains 3 set between 30 to 45 seconds. As the patient use his or her healthy hand to hold the back of the involved hand and stretch it on the chest.Exercises in the first 8 weeks must done 2 times per day and after 4 weeks it will be reduced to 1 time per day by 3 sets and 15 repeats.Description of the exercises: 1- Retraction the shoulders in a standing position.2-concentric Full can Exercise for week 1 to 8 and eccentric Full can Exercise for week 9 to 12. In this exercises glenohumeral joint in scapula plane will move foe 30 to 45 degree and Dumbbell and TheraBand will be used as the patient will hold the Dumbbell in her/his hand and then lift the involved shoulder in scapula plane and then release it without help.3- eccentric exercise of infraspinatus muscle and teres minor as the patient lie down on intact   side and the involved shoulder will be upward, and elbow will bend 90 degree then Arm will stand still on body side then shoulder will turn slowly inward and then will return back to it initial position with intact hand help. From week 9 to 12 the exercise will prescription in both eccentric and concentric manner as the intact hand won’t help any longer.4- eccentric and concentric exercise for serratus anterior muscle in supine position as the patient lie down with shoulder is bend 90 degree and the elbow is straight, scapula will move upward and downward. from week 9 to 12 the push up plus exercise will substituted as the patient lie in prone position in put his/her hands palm on the ground then move shoulders forward and backward.5- external rotation of shoulders bilateral as the patient standing straight holding a TheraBand by both hands then bend both elbows as the shoulders are turning outward. From week 9 to 12 external rotation will done as both shoulders will lift up as both elbows are bended will substituted.</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:
Personal information will be included in the form. Information can be shared.

When:
Start access period 1 year after publishing results

To whom:
every one can access to information

Conditions:
Any scientific use is permitted.

Where to obtain:
email:zeynabazin@yahoo.com
09352595647

How to obtain:
Send an email to the listed alert and Call after 3 days if you do not receive a reply. Files will be sent within 2 weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab azin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO31,Alley 4,Isar street,Modares boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153743897</zip>
        <telephone>0987137352664</telephone>
        <email>stud2281423808@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeynab azin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO31,Alley 4,Isar street,Modares boulevard</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153743897</zip>
        <telephone>0987137352664</telephone>
        <email>stud2281423808@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1.reports of pain in overhead movement                                                      2.reports of pain in active shoulder movements                  3.containing positive Neer/Hawkin Kennedy test                                         4.the Duration of pain lasts more than 3 months  5.having no traumatic pain                                                              6.feeling the pain in  60 to 120 degree of flexion                                                7.visual analogue scale must be between 4-10</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>62 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. having any Red flags                                                             2. history of frozen shoulder                                               3.AC joint dysfunction                                                                     4.G.H joint DJD                                                             5.the existence of calcification in the shoulder tendons                                                                      6. shoulder Instability  7.Traumatic shoulder disorder                               8.Surgery in shoulder, elbow, wrist, neck or scapula 9.Disc bulging                                                                               10.Systematic disease such as rheumatoid arthritis.  11.Taking painkillers, cartilage and anti-inflammatory drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: manual therapy: The treatment will last 3 sessions per week for patients. Manual therapy includes ischemic compression on trigger and Mobilization points. mobilization of acromioclavicular joint, sternoclavicular joint, glenohumeral joint, scapulothoracic and thoracic joints will be done in direction of limitation by therapists hand. This technique will be done in 3 sets and duration of each set is 30 seconds. For finding trigger points some muscles like pectoralis major, pectoralis minor, supraspinatus, infraspinatus, teres minor, teres major, deltoid and levator scapula will be assessed. Ischemic compression technique will be performed for each muscle that have trigger point and at least 3 muscles from them should have trigger points. For this technique, pressure will be applied on the trigger points by the therapist's thumb. Gradually this pressure will be  increased up to the patient's tolerance . This pressure will be applied for 5 to 15 seconds and based on the patient condition this time can increased up to 2 minutes.</i_keyword>
      <i_keyword>Group2: therapeutic exercise: Treatment will last 3 months. Exercises will be done for 12 weeks.  During this period, 7 visits will be done by physiotherapists. The exercises will be done in 3 sets and the repetition of exercise in each set is 15 and therapist will emphasize on posture correction. The Emphasis is on correcting the posture.List of exercises contain these elements: Stretching of capsule 2 times in a day, each time contains 3 set between 30 to 45 seconds. As the patient use his or her healthy hand to hold the back of the involved hand and stretch it on the chest.Exercises in the first 8 weeks must done 2 times per day and after 4 weeks it will be reduced to 1 time per day by 3 sets and 15 repeats.Description of the exercises: 1- Retraction the shoulders in a standing position.2-concentric Full can Exercise for week 1 to 8 and eccentric Full can Exercise for week 9 to 12. In this exercises glenohumeral joint in scapula plane will move foe 30 to 45 degree and Dumbbell and TheraBand will be used as the patient will hold the Dumbbell in her/his hand and then lift the involved shoulder in scapula plane and then release it without help.3- eccentric exercise of infraspinatus muscle and teres minor as the patient lie down on intact   side and the involved shoulder will be upward, and elbow will bend 90 degree then Arm will stand still on body side then shoulder will turn slowly inward and then will return back to it initial position with intact hand help. From week 9 to 12 the exercise will prescription in both eccentric and concentric manner as the intact hand won’t help any longer.4- eccentric and concentric exercise for serratus anterior muscle in supine position as the patient lie down with shoulder is bend 90 degree and the elbow is straight, scapula will move upward and downward. from week 9 to 12 the push up plus exercise will substituted as the patient lie in prone position in put his/her hands palm on the ground then move shoulders forward and backward.5- external rotation of shoulders bilateral as the patient standing straight holding a TheraBand by both hands then bend both elbows as the shoulders are turning outward. From week 9 to 12 external rotation will done as both shoulders will lift up as both elbows are bended will substituted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement Shoulder pain and disability index (SPADI), Goniometry, Visual analogue scale (VAS). Timepoint: pre treatment, post treatment and 1 month after treatment. Method of measurement: Shoulder pain and disability index , Goniometry, Visual analogue scale.</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>Shiraz university of medical science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-18</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>No. 31, Alley 4, Isar Street, Shiraz, Boulevard Modares Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
