<?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>IRCT20240525061892N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-22</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Comparative Effects Of ELDOA Versus Upper Thoracic Mobilization And Mobility Exercise For Treatment of FHP</public_title>
      <acronym>ELDOA,FHP</acronym>
      <scientific_title>Comparative Effects Of Elongation Longitudinaux Avec Decoaption Osteo Articulaire Versus Upper Thoracic Mobilization And Mobility Exercise For Treatment of Forward Head Posture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77003</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Study Design: Parallel Two-Group Randomized Controlled Trial, Group A (ELDOA): Specific ELDOA exercises for FHP Group B (UpperThoracic Mobilization): Exercises targeting thoracic mobility and FHP, Randomization description: participants were allocated into two groups, using lottery methods. The lottery method for randomization is a straightforward technique used in this research to ensure unbiased group assignments. To implement this method, we first defined the groups required for the study. An equal number of tickets were prepared for each group, ensuring the total number of tickets matched the number of participants. All the tickets were then placed into a container and mixed thoroughly to ensure randomness. Each participant drew a ticket from the container, and their assignment to the indicated group was recorded. This method ensures fairness and simplicity, making it suitable for small to medium-sized samples. However, it requires careful execution to avoid human error and may not be practical for very large samples. This approach maintains the integrity of randomization, which is crucial for the validity of experimental results.</study_design>
      <phase>3</phase>
      <hc_freetext>Forward Head Posture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group A . Group A will receive Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) exercises. At first hot pack will applied for 7-8 mins after that participants will explain specific body movements . Four ELDOA position will once show to the participants than ask them to make these positions. Once they make these positions stop watch will be set for 1 minute for each position. The positions will apply for three times per week for four week. Each session will take 20-25 mins. Intervention 2: Intervention  Group B:Group B will receive Upper Thoracic Mobilization and thoracic mobility exercises. At first hot pack will applied for 7-8 mins after that, The Participant will prone position and physiotherapist will stand toward the side where mobilization will be applied. The index and middle finger of the left hand of the physiotherapist will be placed on the vertebral transverse process of the participants to the caudal side. The lateral side of the palm of right hand place over left hand index and middle finger and then applies thoracic mobilization toward ventral to caudal direction. After thoracic mobilization thoracic mobility exercise will be perform, participant will ask to put both hand on cervical spine and slowly lift his upper body,  until gaining the feeling that the occipital bone pushed upward after moving the chin inward.</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:
IPD collected for the primary outcome measure only

When:
After the completion of Study. In October 2024

To whom:
With academic researchers.

Conditions:
For only the purpose of Research

Where to obtain:
physiofai@gmail.com 
faiza khalid

How to obtain:
An email request describing the purpose of study, with complete evidence showing person doing academic research.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahvish Musharaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West Canal Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8868326</telephone>
        <email>studentaffairshsw@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faiza Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faisal Town, West Canal Road, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 8750971</telephone>
        <email>2022-ms-pt-009@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both males and females.
Age between 20 to 40 years.
Patients have complained of neck pain.
Patients having forward head posture.
Patients having limited Cervical range of motion.
Patients having Craniovertebral angle CVA less than 50.
Pain more than 3 on NPRS scale with FHP.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of whiplash injury within 3 months of examination.
History of tumor
History of surgery of cervical or thoracic spine.•
Positive neurological signs•
Patients having pathology and infection in spine.
• Patients having severe osteoporosis
Congenital deformity</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group A . Group A will receive Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) exercises. At first hot pack will applied for 7-8 mins after that participants will explain specific body movements . Four ELDOA position will once show to the participants than ask them to make these positions. Once they make these positions stop watch will be set for 1 minute for each position. The positions will apply for three times per week for four week. Each session will take 20-25 mins</i_keyword>
      <i_keyword>Intervention  Group B:Group B will receive Upper Thoracic Mobilization and thoracic mobility exercises. At first hot pack will applied for 7-8 mins after that, The Participant will prone position and physiotherapist will stand toward the side where mobilization will be applied. The index and middle finger of the left hand of the physiotherapist will be placed on the vertebral transverse process of the participants to the caudal side. The lateral side of the palm of right hand place over left hand index and middle finger and then applies thoracic mobilization toward ventral to caudal direction. After thoracic mobilization thoracic mobility exercise will be perform, participant will ask to put both hand on cervical spine and slowly lift his upper body,  until gaining the feeling that the occipital bone pushed upward after moving the chin inward</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>CVA, Craniovertebral angle. Timepoint: Before intervention, 2, 4 weeks after intervention. Method of measurement: Calculated using each participant's profile photo. The self-balanced posture assessment method was used to force the participants to maintain their typical head posture. By drawing a vertical line from Targus to the seventh cervical vertebrae and a horizontal line across them, the angle between them may be calculated to determine the CVA angle.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ranges of neck movements ( CROM) cervical flexion, extension, right Side bending, left Side bending, right rotation and left rotation were measured using a goniometer. Timepoint: before intervention and 2, 4 weeks after intervention. Method of measurement: using a goniometer.</sec_outcome>
      <sec_outcome>The NPRS (Numeric Pain Rating Scale). Timepoint: before intervention and 2, 4 weeks after intervention. Method of measurement: The NPRS scale, which has good reliability and validity in prior research, was utilized to measure the degree of present pain. It consists 11 points that range from 0 to 10.</sec_outcome>
      <sec_outcome>NDI (Neck Disability Index). Timepoint: before intervention and 2, 4 weeks after intervention. Method of measurement: The Neck Disability Index (NDI) is a 10-item questionnaire designed to provide information about how neck discomfort affects an individual's capacity to carry out activities of daily living.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>NCT06440720</sec_id>
        <issuing_authority>Clinical trials.gov</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-17</approval_date>
        <contact_name>RESEARCH AND ETHICS / TECHNICAL COMMITTEE/ The University of Faisalabad</contact_name>
        <contact_address>University Avenue, Faisal Town Canal Road, Faisalabad, Punjab Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
