<?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>IRCT20190717044238N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-06</date_registration>
      <primary_sponsor>Ripah international university</primary_sponsor>
      <public_title>Comparative Effects of Strain Counterstain and Post-Isometric Relaxation Techniques on Pain, Range of motion and Functional Disability in Patients with Upper Cross Syndrome</public_title>
      <acronym>randomized clinical trial</acronym>
      <scientific_title>Comparative Effects of Strain Counterstain and Post-Isometric Relaxation Techniques on Pain, Range of motion and Functional Disability in Patients with Upper Cross Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68710</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study will be Randomized Clinical Trial, parallel-group,  triple blinded ( patients, assessor and data analyzer will make it triple blinded), Randomization description: As per the inclusion and exclusion criteria of the study , patients will be divided into two groups randomly by Random Number Generator table, Blinding description: The patients taking part in the study would be blinded, they would not be able to know the group they have been allocated to, either Strain Counterstain and Post -Isometric Relaxation Techniques, The assessor of the outcomes would be blinded and lastly, out data analyzer would be blinded too, making it a triple blinded clinical trial.</study_design>
      <phase>3</phase>
      <hc_freetext>Upper Cross Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group A will receive strain counterstain technique; the position of ease will be produced through positioning the muscle in relaxed/ shortened position, ease will be defined as where a reduction in pain at least 70% then, pressure is applied to Trp and it will be held for 90-120  seconds with 3-5 repetitions per treatment session ( three session per week for 3 weeks). Intervention 2: Intervention group: group B will receive post-isometric relaxation technique with 3-5 muscle contraction at sub maximal pain-free effort (20% of available strength) with 5-7 seconds for 5 repetitions per treatment session (three sessions per week for 3 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All collected identified IPD

When:
Data will be available after the completion of study and will remain available till 6 months

To whom:
Data will be available for other people almost 6 months after the completion of study

Conditions:
The data/document could be used by communicating with the principle investigator Hadiqa Naeem on email address hadiqa621@gmail.com

Where to obtain:
Hadiqa Naeem , hadiqa621@gmail.com

How to obtain:
The data/document could be used by communicating with the principle investigator Hadiqa Naeem on email address hadiqa621@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anila Ramzan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>street 2 house 84 basti rahim buksh jalil town renala khurd</address>
        <city>okara</city>
        <country1>Pakistan</country1>
        <zip>56130</zip>
        <telephone>+92 309 0841811</telephone>
        <email>anila.ramzan81@gmail.com</email>
        <affiliation>Ripah international university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Fareeha Amjad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ripah international university Madar e Millat Road, Quaid e Azam Industrial Estate Lahore,Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 334 3372779</telephone>
        <email>Fareeha.amjad@ripah.edu.pk</email>
        <affiliation>Ripah international university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with chronic neck pain from &gt; 6 weeks
Both male and female gender
Age from 20-40 years
Neck Pain on &gt; 3 on numerical pain rating scale
Individuals diagnosed with craniovertebral angle less than 50cm
Occiput to wall distance greater then 2 cm</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects who will have signs of recent surgery
Whiplash injury or open wounds
Cervical spine pathologies like radiculopathies disc herniation, spondylolisthesis, sensory changes in neck region
Any neurological defect</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group A will receive strain counterstain technique; the position of ease will be produced through positioning the muscle in relaxed/ shortened position, ease will be defined as where a reduction in pain at least 70% then, pressure is applied to Trp and it will be held for 90-120  seconds with 3-5 repetitions per treatment session ( three session per week for 3 weeks)</i_keyword>
      <i_keyword>Intervention group: group B will receive post-isometric relaxation technique with 3-5 muscle contraction at sub maximal pain-free effort (20% of available strength) with 5-7 seconds for 5 repetitions per treatment session (three sessions per week for 3 weeks).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional Disability. Timepoint: Total intervention protocol will be given for three weeks of duration,  3 sessions per week for three weeks, Outcomes will be assessed at Baseline, at the end of 3 week( last treatment session) and at the end of 6th week. Method of measurement: NDI is the self-report questionnaire that is designed to determine how the neck pain affects a patient’s daily life and the disability of patients with neck pain. It consists of 10 questions that ask about ADLS. More the score, greater was the disability. Sample questionnaire is attached at the end. Four sections relate to subjective symptoms, and the remaining 6 sections relate to activities of daily living. Each section is scored from 0 to 5 points, giving a maximum score of 50. The total score of the NDI ranges from 0 to 50 points.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Total intervention protocol will be given for three weeks of duration, 3 sessions per week for three weeks, Outcomes will be assessed at Baseline, at the end of 3 week (last treatment session) and at the end of 6th week. Method of measurement: Patient level of pain will be assessed using Numerical Pain Rating Scale ( NPRS) This scale ranges from 0 to 10. 0 indicates “no pain” and 10 indicates “worst pain”.</sec_outcome>
      <sec_outcome>Range of Motion. Timepoint: Total intervention protocol will be given for three weeks of duration, 3 sessions per week for three weeks, Outcomes will be assessed at Baseline, at the end of 3 week (last treatment session) and at the end of 6th week. Method of measurement: Changes from the Baseline ROM range of Motion of Cervical spine  will be taken with the Help of universal Goniometer.</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>Ripah international university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-02</approval_date>
        <contact_name>Ripah College of Rehabilitation and Allied Health Sciences Lahore</contact_name>
        <contact_address>F83G+V25, Madar-e-Millat Road, Quaid-e-Azam Industrial Estate Quaid e Azam Industrial Estate, Lahore, Punjab Lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
