<?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>IRCT2017091620787N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-11</date_registration>
      <primary_sponsor>University of Social Welfare and Rehabilitation Sciences</primary_sponsor>
      <public_title>The effects of neck specific and general exercises on pain and functional indices in patients with neck pain</public_title>
      <acronym></acronym>
      <scientific_title>The effects of deep neck muscles specific training compared to general training on pain, disability, functional indices and neck muscles thicknesses in patients with chronic non-specific neck pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18381</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using sealed envelopes. Each participant will choose one of the sealed envelopes to be allocated to one of the exercise groups. The envelope will then be returned to the envelope box. Randomization will be carried out by someone who is not involved in evaluation or treatment, Blinding description: None of the participants will be aware of the other training group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic non-specific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Deep neck muscles specific exercises:&#13;
1) IN the supine position, the participant moves his/her eyes upward without any movement on the head and neck as much as possible and holds it for 5 seconds. Then the participant moves his/her eyes downward as much as possible and holds it for 5 seconds.&#13;
2) In the supine position the participant performs a light isometric nodding along with moving his/her eyes from forward to downward. A gentle pressure will be applied to the participant’s chin with his/her own hand. This exercise will be held for 5 seconds.&#13;
3) In the supine position the participant presses his/her occiput area with submaximal pressure to the bed and holds it for 5 seconds.&#13;
4) In the supine position the participant performs the nodding exercise by closing his/her chin to the sternum and holds it for 5 seconds.&#13;
&#13;
All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial. Intervention 2: General exercises:&#13;
1) Neck active free range of motion in flexion, extension, bilateral side flexion and bilateral rotation while the participant is seated.&#13;
2) Shoulder active free range of motion in flexion, extension, abduction, adduction and internal and external rotation while the participant is seated.&#13;
3) Seated push-ups.&#13;
4) Seated shoulder shrug exercise while the participant holds a one Kg weight in his/her hands.&#13;
&#13;
All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pegah Kashfi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>velengak, koudakyar dead end</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۳۴</zip>
        <telephone>+98 22180084</telephone>
        <email>pegah.kashfi@yahoo.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Leila Rahnama</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>velenjak, koudakyar dead end</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۳۴</zip>
        <telephone>+98 22180084</telephone>
        <email>l.rahnama@uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Scienses</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A positive history of neck pain for at least three months in the past year
Pain intensity of more than 30 mm on visual analogue scale
Non-specific neck pain</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute neck pain
A positive history of spine surgery
Cervical Fracture or tumor
Discopathy or radicular pain distributed in to shoulder or presence of any neurogenic signs
History of cervical trauma or car accident
Congenital spinal abnormality
Systemic inflammatory diseases
Vertigo and vestibular disorders
Diabetes
Receiving any shoulder or neck muscles training , physiotherapy or manual therapy on the neck in the past 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other Chronic Pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Deep neck muscles specific exercises:&#13;
1) IN the supine position, the participant moves his/her eyes upward without any movement on the head and neck as much as possible and holds it for 5 seconds. Then the participant moves his/her eyes downward as much as possible and holds it for 5 seconds.&#13;
2) In the supine position the participant performs a light isometric nodding along with moving his/her eyes from forward to downward. A gentle pressure will be applied to the participant’s chin with his/her own hand. This exercise will be held for 5 seconds.&#13;
3) In the supine position the participant presses his/her occiput area with submaximal pressure to the bed and holds it for 5 seconds.&#13;
4) In the supine position the participant performs the nodding exercise by closing his/her chin to the sternum and holds it for 5 seconds.&#13;
&#13;
All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial.</i_keyword>
      <i_keyword>General exercises:&#13;
1) Neck active free range of motion in flexion, extension, bilateral side flexion and bilateral rotation while the participant is seated.&#13;
2) Shoulder active free range of motion in flexion, extension, abduction, adduction and internal and external rotation while the participant is seated.&#13;
3) Seated push-ups.&#13;
4) Seated shoulder shrug exercise while the participant holds a one Kg weight in his/her hands.&#13;
&#13;
All exercises will be performed three times a week, three trials in a day, and five repetitions in each trial. One trial will be performed under the examiner supervision and the other two trials will be performed by the participants themselves. The aim is to improve the exercises to 20 repetitions in each trial.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Pain will also be measured before and immediately after each exercise session. Method of measurement: visual analog scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Neck disability index (NDI) questionnaire, Persian version.</prim_outcome>
      <prim_outcome>Neck muscle thickness. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Ultrasound device with a 45-millimeter linear array probe and frequency of 12 MHz for neck flexor muscles and 6 MHz for neck extensor muscles.</prim_outcome>
      <prim_outcome>Cervical Joint Position Error. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Subjects had to rotate their head from a relaxed position, turn to one direction and return to the original position. A laser pointer was used to measure the cervical joint repositioning error. The angle between the target and reference point in degrees will be defined as the joint position error. This variable has been added to the trial when IRB approval was received for the additions to the main protocol.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Pittsburgh Sleep Quality Index, Persian version.</sec_outcome>
      <sec_outcome>Neck range of motion. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Goniameter.</sec_outcome>
      <sec_outcome>Neck Muscles Maximum Isometric Voluntary Contraction. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Tensiometer unit for extensor muscles and Pressure Biofeedback Unit for flexor muscles.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Sf-36 questionnaire, Persian version.</sec_outcome>
      <sec_outcome>Fear avoidance. Timepoint: One day before the starting the exercise program and one day after finalizing the 8-week exercise program. Method of measurement: Tampa Scale of Kinesiophobia, Persian version.</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>University of Social Welfare and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-25</approval_date>
        <contact_name>Ethic Board, University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Velenjak, Koudakyar dead end Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
