<?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>IRCT20230216057434N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-03</date_registration>
      <primary_sponsor>Self funded</primary_sponsor>
      <public_title>Active release technique in frozen shoulder</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of active release technique on pain, range of motion and functional disability in patients with grade 1 adhesive capsulitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68724</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through a computer software "Random allocation". The total sample size will be entered with requirement to be allocated in two groups. An automated randomization list will be achieved with attrition rate included, Blinding description: Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will receive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Frozen shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Group A: (Active Release group) 26 Patients in Group A will receive active release technique after conservative treatment. Conservative treatment will be given in form of hot pack for 15 minutes around the shoulder girdle followed by pendular movements. Patients will perform these movements in standing with trunk in flexed forward position and affected limb will be hanging downward and patient will lean over good arm supported on table or chair. Patients will be instructed to utilize momentum of trunk movements without involvement of shoulder girdle muscles. Patients will be advised to move their arms in forward, backward, side to side direction and in circular motion in clockwise and anticlockwise direction. Each movement will be performed by patient for 30 seconds with rest period of 5 sec in each set comprising of 3 sets. Following pendular exercises patients will be instructed to perform active assisted exercises using a wand or cane comprising of 3 sets, 10 repetitions with 10 second’s hold. Active assisted shoulder abduction using wand: Patient will be instructed to hold wand or cane on affected side with palm facing up of that side and with hand on unaffected side with palm facing down. Patient will slowly raise his or her arm slowly to the side away from the body. Patient will hold wand for 10 seconds for 10 repetitions comprising of 3 sets. Active assisted flexion using Wand: Patient will be in standing position with holding wand in both hands. Patient will raise his arm upward towards ceiling. All effort will be provided by unaffected arm. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted exercises for Wand rotation on either side: Patient will be in standing position with cane holding in both hands with bent elbows. Patient will be instructed to move wand sideways with most of the effort performed by unaffected side. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted extension B using Wand: patient will be in standing position with holding wand sideway. Patient will use the unaffected arm so that affected arm will be push backward. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted external rotation using wand: Patient will be in standing position holding wand or cane in both hands, by keeping elbows bent and tucked so that patients will move the wand away from the body. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted internal rotation using wand: Patient will be in standing position holding wand or cane behind their back and patient will slowly move the affected arm towards the center of back. Patients will hold this position for 10 seconds for 10 times comprising of 3 sets. Following application of Conventional Physical Therapy treatment patients will receive active release technique by Physiotherapist. Physiotherapist will target the affected rotator cuff muscles and deltoid by applying deep pressure over the tender area or trigger points for 20 seconds with 15 second rest interval between the session while patient will actively perform the movement throughout the maneuver. This technique will be repeated 3 times per session and total treatment duration will be 40 to 45 minutes. It will comprise of 12 sessions, twice a week for 4 weeks. Active Release Technique for Infraspinatus/Teres Minor: Patient will be in sitting position, patient arm will be in abducted at 90 degrees and elbow flexed at 90 degrees. Therapist will apply pressure or deep tension over the muscles if trigger points present, meanwhile patient will actively move his arm overhead Active release technique for supraspinatus: Patient will be in sitting position with his or her arm will be in abducted position above 90 degrees where muscle will be maximally shortened.  Therapist will apply pressure over the trigger points formed in the supraspinatus muscle if present, meanwhile patient will actively move his arm from abducted position to downward direction towards the floor. Active release technique for Subscapularis: Patient will be in supine lying with arm internally rotated and elbow flexed to 90 degrees. Therapist will apply pressure or deep tension to the trigger points if present in the subscapularis muscle, meanwhile patient will be instructed to actively externally rotate his arm maximally to lengthen subscapularis. Active release technique for Anterior Deltoid muscle: Patient will be in sitting position with arm in full flexion. Therapist will apply pressure over the trigger points if present in anterior deltoid muscle whereas patient will be instructed to bring his arm from flexion into extension position. Active release technique for posterior deltoid muscle: Patient will be in sitting position, with his arm into extended position., Therapist will apply pressure on the trigger formed on the posterior deltoid muscle fibers if present meanwhile patient will actively move his arm into forward flexion position and then into adducted position (bring it across the body).Active release technique for middle / lateral muscle: Patient will be in sitting position, with arm into slight abduction, therapist will apply pressure to the trigger points formed at the middle deltoid if present mean while patient will actively move his arm from upward direction to downward direction. Intervention 2: Group B : (Conventional  group) 26 Patients in Group B will receive conventional Physical Therapy treatment in form of hot pack for 15 minutes around the shoulder girdle followed by pendular movements. Patients will perform these movements in standing with trunk in flexed forward position and affected limb will be hanging downward and patient will lean over good arm supported on table or chair. Patients will be instructed to utilize momentum of trunk movements without involvement of shoulder girdle muscles. Patients will be advised to move their arms in forward, backward, side to side direction and in circular motion in clockwise and anticlockwise direction. Each movement will be performed by patient for 30 seconds with rest period of 5 sec in each set comprising of 3 sets. Following pendular exercises patients will be instructed to perform active assisted exercises using a wand or cane comprising of 3 sets, 10 repetitions with 10 second’s hold. Active assisted shoulder abduction using wand: Patient will be instructed to hold wand or cane on affected side with palm facing up of that side and with hand on unaffected side with palm facing down. Patient will slowly raise his or her arm slowly to the side away from the body. Patient will hold wand for 10 seconds for 10 repetitions comprising of 3 sets. Active assisted flexion using Wand: Patient will be in standing position with holding wand in both hands. Patient will raise his arm upward towards ceiling. All effort will be provided by unaffected arm. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted exercises for Wand rotation on either side: Patient will be in standing position with cane holding in both hands with bent elbows. Patient will be instructed to move wand sideways with most of the effort performed by unaffected side. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted extension B using Wand: patient will be in standing position with holding wand sideway. Patient will use the unaffected arm so that affected arm will be push backward. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted external rotation using wand: Patient will be in standing position holding wand or cane in both hands , by keeping elbows bent and tucked so that patients will move the wand away from the body. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted internal rotation using wand: Patient will be in standing position holding wand or cane behind their back and patient will slowly move the affected arm towards the center of back. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Total duration of session will be 25 to 30 minutes, twice 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Real patient involved</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8777210</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University, Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab Sheraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8777210</telephone>
        <email>zainab.48@hotmail.com</email>
        <affiliation>Riphah International University, Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both gender
Age of 40 to 65 years
Unilateral shoulder adhesive capsulitis.
grade 1 diagnosed by orthopedic specialist</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients having rotator cuff injury.
Cervical radiculopathy
Autoimmune diseases
Fractures of upper limb</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group A: (Active Release group) 26 Patients in Group A will receive active release technique after conservative treatment. Conservative treatment will be given in form of hot pack for 15 minutes around the shoulder girdle followed by pendular movements. Patients will perform these movements in standing with trunk in flexed forward position and affected limb will be hanging downward and patient will lean over good arm supported on table or chair. Patients will be instructed to utilize momentum of trunk movements without involvement of shoulder girdle muscles. Patients will be advised to move their arms in forward, backward, side to side direction and in circular motion in clockwise and anticlockwise direction. Each movement will be performed by patient for 30 seconds with rest period of 5 sec in each set comprising of 3 sets. Following pendular exercises patients will be instructed to perform active assisted exercises using a wand or cane comprising of 3 sets, 10 repetitions with 10 second’s hold. Active assisted shoulder abduction using wand: Patient will be instructed to hold wand or cane on affected side with palm facing up of that side and with hand on unaffected side with palm facing down. Patient will slowly raise his or her arm slowly to the side away from the body. Patient will hold wand for 10 seconds for 10 repetitions comprising of 3 sets. Active assisted flexion using Wand: Patient will be in standing position with holding wand in both hands. Patient will raise his arm upward towards ceiling. All effort will be provided by unaffected arm. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted exercises for Wand rotation on either side: Patient will be in standing position with cane holding in both hands with bent elbows. Patient will be instructed to move wand sideways with most of the effort performed by unaffected side. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted extension B using Wand: patient will be in standing position with holding wand sideway. Patient will use the unaffected arm so that affected arm will be push backward. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted external rotation using wand: Patient will be in standing position holding wand or cane in both hands, by keeping elbows bent and tucked so that patients will move the wand away from the body. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted internal rotation using wand: Patient will be in standing position holding wand or cane behind their back and patient will slowly move the affected arm towards the center of back. Patients will hold this position for 10 seconds for 10 times comprising of 3 sets. Following application of Conventional Physical Therapy treatment patients will receive active release technique by Physiotherapist. Physiotherapist will target the affected rotator cuff muscles and deltoid by applying deep pressure over the tender area or trigger points for 20 seconds with 15 second rest interval between the session while patient will actively perform the movement throughout the maneuver. This technique will be repeated 3 times per session and total treatment duration will be 40 to 45 minutes. It will comprise of 12 sessions, twice a week for 4 weeks. Active Release Technique for Infraspinatus/Teres Minor: Patient will be in sitting position, patient arm will be in abducted at 90 degrees and elbow flexed at 90 degrees. Therapist will apply pressure or deep tension over the muscles if trigger points present, meanwhile patient will actively move his arm overhead Active release technique for supraspinatus: Patient will be in sitting position with his or her arm will be in abducted position above 90 degrees where muscle will be maximally shortened.  Therapist will apply pressure over the trigger points formed in the supraspinatus muscle if present, meanwhile patient will actively move his arm from abducted position to downward direction towards the floor. Active release technique for Subscapularis: Patient will be in supine lying with arm internally rotated and elbow flexed to 90 degrees. Therapist will apply pressure or deep tension to the trigger points if present in the subscapularis muscle, meanwhile patient will be instructed to actively externally rotate his arm maximally to lengthen subscapularis. Active release technique for Anterior Deltoid muscle: Patient will be in sitting position with arm in full flexion. Therapist will apply pressure over the trigger points if present in anterior deltoid muscle whereas patient will be instructed to bring his arm from flexion into extension position. Active release technique for posterior deltoid muscle: Patient will be in sitting position, with his arm into extended position., Therapist will apply pressure on the trigger formed on the posterior deltoid muscle fibers if present meanwhile patient will actively move his arm into forward flexion position and then into adducted position (bring it across the body).Active release technique for middle / lateral muscle: Patient will be in sitting position, with arm into slight abduction, therapist will apply pressure to the trigger points formed at the middle deltoid if present mean while patient will actively move his arm from upward direction to downward direction</i_keyword>
      <i_keyword>Group B : (Conventional  group) 26 Patients in Group B will receive conventional Physical Therapy treatment in form of hot pack for 15 minutes around the shoulder girdle followed by pendular movements. Patients will perform these movements in standing with trunk in flexed forward position and affected limb will be hanging downward and patient will lean over good arm supported on table or chair. Patients will be instructed to utilize momentum of trunk movements without involvement of shoulder girdle muscles. Patients will be advised to move their arms in forward, backward, side to side direction and in circular motion in clockwise and anticlockwise direction. Each movement will be performed by patient for 30 seconds with rest period of 5 sec in each set comprising of 3 sets. Following pendular exercises patients will be instructed to perform active assisted exercises using a wand or cane comprising of 3 sets, 10 repetitions with 10 second’s hold. Active assisted shoulder abduction using wand: Patient will be instructed to hold wand or cane on affected side with palm facing up of that side and with hand on unaffected side with palm facing down. Patient will slowly raise his or her arm slowly to the side away from the body. Patient will hold wand for 10 seconds for 10 repetitions comprising of 3 sets. Active assisted flexion using Wand: Patient will be in standing position with holding wand in both hands. Patient will raise his arm upward towards ceiling. All effort will be provided by unaffected arm. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted exercises for Wand rotation on either side: Patient will be in standing position with cane holding in both hands with bent elbows. Patient will be instructed to move wand sideways with most of the effort performed by unaffected side. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted extension B using Wand: patient will be in standing position with holding wand sideway. Patient will use the unaffected arm so that affected arm will be push backward. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted external rotation using wand: Patient will be in standing position holding wand or cane in both hands , by keeping elbows bent and tucked so that patients will move the wand away from the body. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Active assisted internal rotation using wand: Patient will be in standing position holding wand or cane behind their back and patient will slowly move the affected arm towards the center of back. Patient will hold this position for 10 seconds for 10 times comprising of 3 sets. Total duration of session will be 25 to 30 minutes, twice a week for 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Assessment will be performed at o week(baseline) and at completion of 4 weeks of treatment. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Shoulder range of motion. Timepoint: Assessment will be performed at o week(baseline) and at completion of 4 weeks of treatment. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Disability. Timepoint: Assessment will be performed at o week(baseline) and at completion of 4 weeks of treatment. Method of measurement: Quick DASH (Disability of arm, shoulder and hand questionnaire).</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>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-26</approval_date>
        <contact_name>Ethics committee of Riphah International University Faisalabad</contact_name>
        <contact_address>Riphah International University, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
