<?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>IRCT20191116045461N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-23</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Release of Diaphragm in Forward Head Posture and Neck Pain</public_title>
      <acronym></acronym>
      <scientific_title>Investigating  the Effect of Diaphragm Release on Posture, Pain and Function in  Women with Forward Head Posture and Neck Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Volunteer patients are randomly assigned to one of two intervention or control groups with blocked randomization method. six blocks with the size of four were considered and 26 subjects were placed in each group, Blinding description: Patients become aware of the second group when filling out the informed consent form so they will not be blind to the groups. Therapists are also aware of both groups and types of treatment, But the patients examiner and analyzer are completely unaware of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Forward head posture, Neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diaphragm release technique will be done in the interventional  group in the following way: Each subject is positioned seated erect. The therapist  stands behind the patient and passes his hands around the thoracic cage, carefully introducing fingers under the costal margin. The patient slightly rounds the trunk in order to relax rectus abdominis. As the patient exhales the therapist grasps the lower ribs and costal margin and eases their hand caudally. This traction is maintained during 5 to 7min.This techniques will only once a we completed once a week and each session will be held once. (during this 4 weeks, diaphragm release technique will be performed once a week for four weeks). Also  Patient in this group receive a specific exercise program for 3session a week for 4 weeks. This exercise program include strengthening of deep cervical flexor and shoulder retractor muscle and stretching of cervical extensor and pectoral muscles.           ExerciseMeasuresStrengthen Deep Cervical Flexors                                                                                 Lying chin tuck                                                                           Lying chin tuck with head lift(4s)                                                                                                                    Three sets of 12 repetitions                                                                                     Three sets of 12 repetitions                                                                                     Strengthen Shoulder Retractors                                       Standing shoulder pull back with elastic resistance                       Shoulder pull back with weight (2 lb)                                              Three sets of 12 repetitionsThree sets of 12 repetitionsStretch Cervical Extensors                                                Chin drop  Three repetitions with 30-sec holdStretch Pectoralis MuscleBilateral Pectoral stretchThree repetitions with 30-sec hold. Intervention 2: Control group: Patient in this group receive a specific exercise program for 3session a week for 4 weeks. This exercise program include strengthening of deep cervical flexor and shoulder retractor muscle and stretching of cervical extensor and pectoral muscles.           ExerciseMeasuresStrengthen Deep Cervical Flexors                                                                                 Lying chin tuck                                                                           Lying chin tuck with head lift(4s)                                                                                                                    Three sets of 12 repetitions                                                                                     Three sets of 12 repetitions                                                                                     Strengthen Shoulder Retractors                                       Standing shoulder pull back with elastic resistance                       Shoulder pull back with weight (2 lb)                                              Three sets of 12 repetitionsThree sets of 12 repetitionsStretch Cervical Extensors                                                Chin drop  Three repetitions with 30-sec holdStretch Pectoralis MuscleBilateral Pectoral stretchThree repetitions with 30-sec hold.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farahnaz Ghaffarnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehabilitation Faculty, Abivardi 1 st, chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۶۶۹_۷۱۳۴۸</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>ghafarif@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Ghaffarnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation, chamran Boulevard, 1 Abivardi Ave.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۳۶۶۹_۷۱۹۴۷</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>haghighatf@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>women between 18 and 45 years old
The posterior  part of the ear's lobe  is 1 cm or more anterior than plumb line.
The craniovertebral angle less than 49 degrees.
Patients who have a primary complaint of neck pain (pain in the posterior part of the cervical spine and the inter scapula region).
The subjects have tenderness in the diaphragm.
Average usage of smart phone and computer is 4 hours or more in 24 hours.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Auditory or visual impairment.
Neurological problem.
Impairment in balance.
History of neck surgery.
History of any trauma to the cervical spine such as wiplash.
Perceptual problems
Inflammatory disease such as rheumatoid arthritis.
History of any fracture in cervical  region.
History of any fracture in clavicle and ribs.
Congenital deformity in the neck such as torticollis.
Respiratory disease and Zona
Whose who have had regular, scheduled workouts in the past 6 months.
Professional athletes</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Diaphragm release technique will be done in the interventional  group in the following way: Each subject is positioned seated erect. The therapist  stands behind the patient and passes his hands around the thoracic cage, carefully introducing fingers under the costal margin. The patient slightly rounds the trunk in order to relax rectus abdominis. As the patient exhales the therapist grasps the lower ribs and costal margin and eases their hand caudally. This traction is maintained during 5 to 7min.This techniques will only once a we completed once a week and each session will be held once. (during this 4 weeks, diaphragm release technique will be performed once a week for four weeks). Also  Patient in this group receive a specific exercise program for 3session a week for 4 weeks. This exercise program include strengthening of deep cervical flexor and shoulder retractor muscle and stretching of cervical extensor and pectoral muscles.           ExerciseMeasuresStrengthen Deep Cervical Flexors                                                                                 Lying chin tuck                                                                           Lying chin tuck with head lift(4s)                                                                                                                    Three sets of 12 repetitions                                                                                     Three sets of 12 repetitions                                                                                     Strengthen Shoulder Retractors                                       Standing shoulder pull back with elastic resistance                       Shoulder pull back with weight (2 lb)                                              Three sets of 12 repetitionsThree sets of 12 repetitionsStretch Cervical Extensors                                                Chin drop  Three repetitions with 30-sec holdStretch Pectoralis MuscleBilateral Pectoral stretchThree repetitions with 30-sec hold</i_keyword>
      <i_keyword>Control group: Patient in this group receive a specific exercise program for 3session a week for 4 weeks. This exercise program include strengthening of deep cervical flexor and shoulder retractor muscle and stretching of cervical extensor and pectoral muscles.           ExerciseMeasuresStrengthen Deep Cervical Flexors                                                                                 Lying chin tuck                                                                           Lying chin tuck with head lift(4s)                                                                                                                    Three sets of 12 repetitions                                                                                     Three sets of 12 repetitions                                                                                     Strengthen Shoulder Retractors                                       Standing shoulder pull back with elastic resistance                       Shoulder pull back with weight (2 lb)                                              Three sets of 12 repetitionsThree sets of 12 repetitionsStretch Cervical Extensors                                                Chin drop  Three repetitions with 30-sec holdStretch Pectoralis MuscleBilateral Pectoral stretchThree repetitions with 30-sec hold</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The extent of postural changes is determined by neck imaging and cranio-vertebral angle determination. Such a Copenhagen questionnaire on functional pain in the neck, whose validity and reliability of the Persian version has been confirmed, is completed by the patients. Timepoint: Before the interventiont and after the intervention. Method of measurement: The Craniovertebral angle (CVA) will be measured in order to asses the posture. The CVA is the angle made by the line that drawn from the seventh cervical spine to the tragus and the horizontal line of the seventh cervical spine, This angle represents the position of the head relative to the C7 vertebra, which is less than 49 degrees in people with forward head posture.  The lowering this angle measured, the greater the forward head. In this research the CVA angle is measured by Left-sided profile photograph. For this purpose a camera with 35-70mm zoom lens is mounted on a tripod and loaded with slid film will be used. The lens aperture is set at F-stop 8, zooms to 7Omm, and the camera is placed  so that the center of the lens is 4m from the subject, with the subject in approximately the center of the lens so as to reduce lens error, and in order to observe this distance, At a distance of 4 meters from the camera, a line is drawn on the ground, and the person standing must make sure that the toe tip is on that line, ie the legs are completely behind the line. The front of the camera stand is located 120 cm from the wall, and the location of the camera stand on the ground is marked, as well as the location of the rear camera stand on each test run.and  with the camera perpendicular to the ground, parallel to the facing plane of the subject, and approximately level with the subject’s pelvis to minimize parallax error.(Gonia is used to determine the camera frame, which is plotted 90 degrees on the wall using a Gonia angle, and the angles are colored on the wall), to ensure that the head does not rotate, A circular frame, parallel to the patient's eye, is mounted on the wall in front of the patient and the patient is asked to look at it.The patient's neck and upper thoracic area will be naked and will be photographed from the same range. The same conditions will apply to everyone taking photos. To commence, Bony landmarks are palpated and marked with adhesive skin markers that will be visible in photographs. Subjects stand in comfortable erect standing, the instructions being to place their weight evenly on both feet, with knees straight, hands at their sides, and with their eyes looking forward. For to touch the C7 bends the head forward, in which case the C7 vertebrae can be touched, and the patient is then asked to bring his head back, in which case the C7 vertebrae should not  disappear underneath. The palpation and marking is carried out in the same standing position as the subject will later adopt for the photographs, to reduce any error that might have occurred from skin movement. If clothing is overlying a bony landmark it is moved aside Until Landmark is clear. White adhesive dots of 14mm diameter are used as skin markers. Since marking the subjects required them to stand still, they are encouraged to walk around after the markers are applied, to prevent them from feeling uncomfortable or becoming faint. In order to be photographed, the subjects are next instructed to stand comfortably, in their “normal, loose, or habitual” posture for two photographs, with their weight evenly on both feet and looking straight ahead. They are asked not to stand erect, or in a “best posture,” because the purpose of the photograph is to capture their habitual or usual standing posture. Subjects are given time to adopt a relaxed, comfortable posture, and then photograph is taken from the left side.The Persian version of the Copenhagen Scale is used to assess the severity of functional neck pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Chest expansion. Timepoint: Before the intervention and after the  intervention. Method of measurement: Chest expansion: Chest expansion is measured with the subject standing, hands on head and the tape is placed circumferentially over the xiphoid. The subjec is inhaled maximally, then exhaled, and a value is recorded; the subject then  is inhaled maximally and a second value    is recorded. Total change is re- corded as the value at maximum inspiration minus the value at maximum expiration.</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>Shiraz University of Medical Siences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-18</approval_date>
        <contact_name>Ethics committee of research of Shiraz Faculty of  Rehabilitation Sciences</contact_name>
        <contact_address>Abivardi 1 Street., Chamran Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
