<?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>IRCT20210409050912N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-29</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Low Level Laser Therapy for treatment of cervical pain in patients with trigger points of upper trapezius</public_title>
      <acronym>Cervical pain    Trigger points  Upper trapezius            Neck Pain                          Neck Range of Motion                             Neck Disability Index                                           Low Level  Laser Therapy</acronym>
      <scientific_title>Effectiveness of Low Level Laser Therapy for treatment of cervical pain in patients with trigger points of upper trapezius</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55712</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated by use of computer-generated randomization sheet into two groups
One for Group A and other for B. 
2 Sets of 27 Unique Numbers per Set
Range: From 1 to 54, Blinding description: The outcome assessor will be blind and  will assess the subjects for inclusion criteria and will make assessment at the baseline ,then after 2 weeks and than after 4 weeks . Then outcome assessor will give all the recorded data to the principal investigator.</study_design>
      <phase>3</phase>
      <hc_freetext>Upper Trapezius Trigger Points.</hc_freetext>
      <i_freetext>Intervention 1: Experimental Group (Intervention group: One group  will receive low-level laser therapy. Patient position: Patient  comfortably will be seated on chair with arm rest and avoided unnecessary stretching of neck and shoulder muscles. Both physiotherapist and patient will wear  protective googles. After identification of trigger point, trigger point will be  marked with erasable marker than the treatment will be  provided by the following parameters:                                                            Wavelength 820nm,                                                                                                                                 Power 200mW,                                                                                                                                          Pulse Rate 2.5Hz                                                                                                                                       Energy Transferring 24 Jcm-2 for 15 sec and with pen probe. Intervention 2: Control group: Control group: Standard Chartered Society of Physiotherapy recommendations for neck pain will be  followed. Moving  head downwards to tuck in your chin on your chest and maintain this position for 5 seconds. Moving  head backward and upward by pushing your chin forward so that throat is stretched and maintain this position for five seconds.  All this protocol will be followed.</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:
The data document will be available on demand if any of the researcher want to use like data evaluation Performa and outcome assessment sheets.

When:
The data will be available after compilation and statistical analysis of the study.

To whom:
Researchers

Conditions:
For sake of help and research promotion .

Where to obtain:
from principal Investigator

How to obtain:
The email is provided for this purpose .

Comments:
This trial is purely based  for study purpose .It has not involved any third party and any funding except educational support from the relative institute .</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Iqra Waseem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8818334</telephone>
        <email>iqra.waseem91@gmail.com</email>
        <affiliation>Faisal Institute of Health Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Iqra Waseem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>335 Sitara Sapna City Daewoo Road</address>
        <city>Faislabad</city>
        <country1>Pakistan</country1>
        <zip>38100</zip>
        <telephone>+92 41 8818334</telephone>
        <email>iqra.waseem91@gmail.com</email>
        <affiliation>Faisal Institute of Health Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed patients with active upper trapezius trigger point
Age range from 18-55 years
Male and Females</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants having contraindications for LASER e.g. Pregnancy, Tumors, Implants, Pacemaker,
Irritable skin around the area of treatment
Past History of fracture of shoulder joint or cervical spine
Whiplash injury
Comorbid medical diagnosis e.g. osteoarthritis Psychiatric illness (e.g., schizophrenia or substance abuse).
Psychiatric illness (e.g., schizophrenia or substance abuse).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y93</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Trigger Points , Neck pain, neck ROM , Neck Functioning</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental Group (Intervention group: One group  will receive low-level laser therapy. Patient position: Patient  comfortably will be seated on chair with arm rest and avoided unnecessary stretching of neck and shoulder muscles. Both physiotherapist and patient will wear  protective googles. After identification of trigger point, trigger point will be  marked with erasable marker than the treatment will be  provided by the following parameters:                                                            Wavelength 820nm,                                                                                                                                 Power 200mW,                                                                                                                                          Pulse Rate 2.5Hz                                                                                                                                       Energy Transferring 24 Jcm-2 for 15 sec and with pen probe.</i_keyword>
      <i_keyword>Control group: Control group: Standard Chartered Society of Physiotherapy recommendations for neck pain will be  followed. Moving  head downwards to tuck in your chin on your chest and maintain this position for 5 seconds. Moving  head backward and upward by pushing your chin forward so that throat is stretched and maintain this position for five seconds.  All this protocol will be followed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Neck pain. Timepoint: It will be assessed three times  ,First at Baseline , Second after  02 weeks of treatment  and third and last at the end of 04 weeks of treatment . Method of measurement: Numeric Pain Rating Score- The numerical pain rating scale is considered as one of the best method available for the estimation of the intensity of pain. The NPRS is a categorical scale which provides a continuous scale for magnitude estimation of pain. NPRS consists of 11 points, which range from 0-10.0=no pain, 1-4=mild pain, 4-7=moderate pain 7-10=severe pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neck Range of Motion. Timepoint: First it will be assessed three times  at Baseline , then after  02 weeks and at the end of 04 weeks of treatment . Method of measurement: Universal Goniometer will used for measurement of Range of Motions of neck in all sides .</sec_outcome>
      <sec_outcome>Neck disability Index. Timepoint: First it will be assessed three times  at Baseline , then after  02 weeks and at the end of 04 weeks of treatment. Method of measurement: Neck Disability Index- The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. It is a questionnaire which measures the functional ability of the patient. It is of subjective nature i.e. patient fills the questionnaire himself by ranking his ability to do some specific task. It includes assessment of 10 tasks including personal care, pain, reading, headaches, lifting, concentration, driving, work, sleeping and recreation. Patient ranks questions according to the limitations he faces in ADLs and IADLs. NDI is most commonly used questionnaire for neck pain.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-07</approval_date>
        <contact_name>The University of Lahore</contact_name>
        <contact_address>Lahore Lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
