<?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>IRCT20190912044754N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-19</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>COMPARATIVE EFFECTIVENESS OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION IN PATIENTS WITH NECK PAIN DUE TO UPPER CROSSED SYNDROME</public_title>
      <acronym></acronym>
      <scientific_title>COMPARATIVE EFFECTIVENESS OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION IN PATIENTS WITH NECK PAIN DUE TO UPPER CROSSED SYNDROME</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2640-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/42079</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects fulfilling the inclusion criteria will be enrolled after independent outcome assessor .Then coin toss method is being used for randomization .The coin thrown in air having two sides with label "A" and "B".
The subjects randomization method reduces the chances of bias group  allocation , Blinding description: It will be single blind and assessor will be blind .All assessments before and after the intervention will be done by Independent assessor and only eligible subjects will be enrolled . Neck Range of Motion ,Neck disability Index and  Pain will be measured .Then subjects will be  kept confidential and only it will be given after the assessor has completed an assessment at baseline , after 02 weeks and 04 weeks.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Upper Crossed Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Instrument Assisted Soft Tissue Mobilization. Intervention 2: Routine Physical Therapy : Routine physical Therapy exercise.</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:
Effectiveness of  routine physical therapy with and without IASTM  in patients with neck pain due to upper crossed syndrome
Instrument Assisted Soft Tissue Mobilization Technique for Upper crossed Syndrome

When:
It will be available after study completion

To whom:
To researchers for study only.Patient data will not be shown .

Conditions:
under the usage with terms in which  journal is accessed /processed for publication

Where to obtain:
from the University office and Responsible supervisor and from journal we will process in future

How to obtain:
It will be only used in confidential way for improving research and benefit of humanity

Comments:
It will be first study of such type in pakistan using Soft Tissue mobilization technique which is instrument assisted that is the only reason study has a motivational factor and researchers are waiting for its results .</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahir Mahmood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Noor Mahal Road</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 62 2888596</telephone>
        <email>tahirmahmoodphysio@gmail.com</email>
        <affiliation>Agile Institute of Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Noor Mahal Road Bahawalpur</address>
        <city>Bahawapur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>0920622888596</telephone>
        <email>drhafeezarain@gmail.com</email>
        <affiliation>Agile Institute of Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed patients complaining neck pain with forwarded head posture,
Both Females and Males in age of 18-40,
Chronic Neck pain from at least 3 months,
Neck pain Scoring More than 3 on Visual Analogue Scale
Limited Cervical ROM</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with history of•
Any previous surgery
Any  type of Infection
Any type  of Hypersensitive Skin
Diabetes Mellitus type II
Any  type Traumatic Injury
Any type Psychological Disorder
Manual therapy contraindicated like osteoporosis, infection, disc-Herniation, neoplasm•
Rheumatoid Arthritis
Acute Inflammation
Burn Scars
Osteoporosis
Unhealed , closed and non complicated fractures
Osteomyelitis, Ulcers, open wound including all in which IASTM is contraindicated</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R29.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal posture</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: Instrument Assisted Soft Tissue Mobilization</i_keyword>
      <i_keyword>Routine Physical Therapy : Routine physical Therapy exercise</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: on baseline ,then after 2 weeks and then after weeks. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Neck range of Motion. Timepoint: On baseline ,then after 2 weeks and then after weeks. Method of measurement: Inclinometer.</prim_outcome>
      <prim_outcome>Neck Disability Index. Timepoint: On baseline ,then after 2 weeks and then after weeks. Method of measurement: Neck disability Index Tool.</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>Academic support Only</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2640-11-20</approval_date>
        <contact_name>Ethics Committee of The University of Lahore "Institutional Review Board"</contact_name>
        <contact_address>defence road campus,new campus ,The University of Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
