<?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>IRCT20210223050476N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-28</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of diaphragmatic exercises and physiotherapy on chronic neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of combining diaphragmatic exercises and physiotherapy treatment with physiotherapy treatment alone in patients with chronic neck pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The second therapist obtains a random sequence through http://www.graphpad.com/ quickcalcs / index.cfm which contains the number with the name of one of the groups (group A or B). Then each person with their eyes closed takes a number from the basket containing numbers from 1 to 30 to be placed in the group specified by the site. To maintain confidentiality, the type of group will not be known before assigning the person in each group.
To make the type of treatment random in groups A and B, the second therapist rewrites the type of treatment on two separate cards and puts it in opaque sealed envelopes with a random sequence and then removes one of the envelopes with his eyes closed. The envelope that we will get first will be the type of group A treatment, Blinding description: Participants will be blinded to the type of intervention and the people in each group will not know about the other group. Variables are evaluated by the outcome assessor who is not aware of the grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Study condition: Women with chronic neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: includes a combination of diaphragmatic exercises and physiotherapy treatment (TENS, IR and Exercise). Diaphragmatic exercises: In the first session, the subjects of the experimental group will be trained in diaphragmatic breathing. In the supine position, the trunk is in a position of 30-50 degrees of flexion and the knees are in a comfortable position of flexion. The person is asked to place their hands on the abdomen and breathe slowly and deeply using the nose for 10 seconds. The subjects held the diaphragmatic exercise while holding the 2.5 kg weight in the first 5 sessions and the 5 kg weight on the abdomen in the second 5 sessions, in three sets with ten repetitions in the ratio of one second to two seconds of exhalation, three The next set consists of 15 repetitions with a two-second to four-second exhalation ratio, and the final three sets consist of 20 repetitions with a three-second to six-second exhalation ratio. A period of 60 seconds is rested between sets. These exercises are done 5 days a week in 10 sessions. Electrical stimulation of TENS: TENS is made by Novin Multistimulator735X made in Iran for 30 minutes (four electrodes on painful areas around the patient's neck with a frequency of 80 Hz, square pulse, duration of each pulse is less than 150 microseconds and the intensity is increased to the point of contraction. Not seen) is used. Infrared rays (IR): The IR of the Tavanbakhsh Novin made in Iran is placed on the neck and back for 20 minutes. Exercise: The Sternocleidomastoid and Upper Trapezious muscles stretching exercises are performed on both sides for 30 seconds with two to three repetitions in each session while sitting on a chair with the soles of the feet on the floor. Chin tuck head lift exercise with Hold and Rest for 10 and 15 seconds, respectively, in the first 5 sessions of each person on the bed with the angle of the head of the bed with the horizon line 60 degrees, and in each session, after each ten-second hold, we reduce the inclination of the head of the bed by ten degrees to apply a load, so that at the end this angle reaches a slope of 30 degrees, and in the second 5 sessions, to apply more load, each person on the bed has an angle. The head of the bed is placed with a horizon line of 30 degrees. And again in each session after each hold for ten seconds, we reduce the inclination of the head of the bed ten degrees until the end of the head of the bed is completely flat (the angle of the head of the bed with the horizon line reaches zero degrees) and each session of this exercise It is repeated ten times in all 4 types of head angle. The duration of each session is 60 to 70 minutes. Intervention 2: Control group: In the control group, only physiotherapy treatment (TENS, IR and Exercise) similar to the experimental group is used. The duration of each session is 60 to 70 minutes.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Mosallaiezadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pich Shemiran, Enghelab St., District 12, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111489-65111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>smosallaie1072@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Mosallaiezadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pich Shemiran, Enghelab St., District 12, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11489-65111</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>smosallaie1072@gmil.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with chronic neck pain without headache who have pain and discomfort in the back of the neck for at least three months
Have forward head posture (CVA angle less than 49 degrees)
Breathe paradoxically.
Have a rating of 3 or higher in the visual analogue scales
Have not undergone physiotherapy in the past three months to treat neck pain
Be 20 to 35 years old.
Have expressed their informed consent to participate in the research project.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Discontinuation of cooperation by the patient for any reason
Feeling uncomfortable and intolerant of treatment by the patient
History of heart disease and heart surgery
Spine and chest surgeries
History of smoking
Traumatic neck injuries
BMI &gt; 40
Diabetes
Acute neuromuscular pain and cervical disc prolapse with neurological symptoms
Congenital malformations
Cancer or tumor in the last 5 years
Patients with sensory impairment
Pregnancy</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: includes a combination of diaphragmatic exercises and physiotherapy treatment (TENS, IR and Exercise). Diaphragmatic exercises: In the first session, the subjects of the experimental group will be trained in diaphragmatic breathing. In the supine position, the trunk is in a position of 30-50 degrees of flexion and the knees are in a comfortable position of flexion. The person is asked to place their hands on the abdomen and breathe slowly and deeply using the nose for 10 seconds. The subjects held the diaphragmatic exercise while holding the 2.5 kg weight in the first 5 sessions and the 5 kg weight on the abdomen in the second 5 sessions, in three sets with ten repetitions in the ratio of one second to two seconds of exhalation, three The next set consists of 15 repetitions with a two-second to four-second exhalation ratio, and the final three sets consist of 20 repetitions with a three-second to six-second exhalation ratio. A period of 60 seconds is rested between sets. These exercises are done 5 days a week in 10 sessions. Electrical stimulation of TENS: TENS is made by Novin Multistimulator735X made in Iran for 30 minutes (four electrodes on painful areas around the patient's neck with a frequency of 80 Hz, square pulse, duration of each pulse is less than 150 microseconds and the intensity is increased to the point of contraction. Not seen) is used. Infrared rays (IR): The IR of the Tavanbakhsh Novin made in Iran is placed on the neck and back for 20 minutes. Exercise: The Sternocleidomastoid and Upper Trapezious muscles stretching exercises are performed on both sides for 30 seconds with two to three repetitions in each session while sitting on a chair with the soles of the feet on the floor. Chin tuck head lift exercise with Hold and Rest for 10 and 15 seconds, respectively, in the first 5 sessions of each person on the bed with the angle of the head of the bed with the horizon line 60 degrees, and in each session, after each ten-second hold, we reduce the inclination of the head of the bed by ten degrees to apply a load, so that at the end this angle reaches a slope of 30 degrees, and in the second 5 sessions, to apply more load, each person on the bed has an angle. The head of the bed is placed with a horizon line of 30 degrees. And again in each session after each hold for ten seconds, we reduce the inclination of the head of the bed ten degrees until the end of the head of the bed is completely flat (the angle of the head of the bed with the horizon line reaches zero degrees) and each session of this exercise It is repeated ten times in all 4 types of head angle. The duration of each session is 60 to 70 minutes.</i_keyword>
      <i_keyword>Control group: In the control group, only physiotherapy treatment (TENS, IR and Exercise) similar to the experimental group is used. The duration of each session is 60 to 70 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: The first, tenth and two weeks later. Method of measurement: Visual Analogue Scales.</prim_outcome>
      <prim_outcome>Disability. Timepoint: The first, tenth and two weeks later. Method of measurement: Neck Disability Index.</prim_outcome>
      <prim_outcome>Active and passive neck range of motion. Timepoint: The first, tenth and two weeks later. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Chest movement during maximal inhalation and exhalation. Timepoint: The first, tenth and two weeks later. Method of measurement: Tape meter.</prim_outcome>
      <prim_outcome>Forward Head Posture. Timepoint: The first, tenth and two weeks later. Method of measurement: Samsung Galaxy Tab A SM-T355 camera.</prim_outcome>
      <prim_outcome>Upper Thoracic Angle. Timepoint: The first, tenth and two weeks later. Method of measurement: Samsung Galaxy Tab A SM-T355 camera.</prim_outcome>
      <prim_outcome>Age. Timepoint: Before starting the intervention. Method of measurement: ID card or national card.</prim_outcome>
      <prim_outcome>Height. Timepoint: Before starting the intervention. Method of measurement: Tape meter.</prim_outcome>
      <prim_outcome>Weight. Timepoint: Before starting the intervention. Method of measurement: Digital bathroom scale.</prim_outcome>
      <prim_outcome>Body Mass Index. Timepoint: Before starting the intervention. Method of measurement: Ratio of weight to height squared.</prim_outcome>
      <prim_outcome>Duration of chronic neck pain. Timepoint: Before starting the intervention. Method of measurement: Question from the person.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-18</approval_date>
        <contact_name>Ethics Committee in Research School of Nursing and Midwifery and School of Rehabilitation - Tehran U</contact_name>
        <contact_address>Block A, 13th floor, Iran TV St, Between South Flamek and Zarafshan, Ghods Town (West), Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
