<?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>IRCT20191130045552N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-12</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Comparison of the effect of cervical proprioceptive exercises in addition to conventional  physiotherapy with isolated conventional physiotherapy on relative proprioceptive weighting of the cervical spine and postural control in chronic non-specific neck pain individuals.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of cervical proprioceptive exercises in addition to conventional physiotherapy with isolated conventional  physiotherapy on relative proprioceptive weighting of the cervical spine and postural control in chronic non-specific neck pain individuals.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43819</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are allocated into two groups of proprioceptive (PT) and conventional physiotherapy treatment with Randomization.com software through Random Permutations. This method provides the researcher with a predetermined random order by the software, thus prior to recruitment, the allocation of every participant is determined. Each subject will enter the study based on the order of their entry (number 1, subject 2 and ...). Randomization will be done on subjects who are all patients with neck pain and are not different in all group characteristics and independent variables, so none of our independent variables play a role in randomization, Blinding description: Grouping is associated with the patient kept unaware of being in the case or control group and the treatment regimen of the other group. The assessor will not be aware of the grouping and treatment plan of the subjects.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific chronic neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The control group will receive convential physical therapy program (CPT). Each treatment session takes 60 minutes. Patients are asked to perform conventional physiotherapy exercises at home, twice a day for 5 weeks, and record their exercises in a structural scheduled. They will receive electrotherapy intervention at clinic sessions. Intervention 2: Intervention group: The intervention group will be received proprioceptive training (PT) in addition to the conventianal  program. Each treatment session takes 120 minutes. Patients are asked to perform conventional physiotherapy exercises at home, twice a day for 5 weeks, and record their exercises in a structural scheduled. They will receive electrotherapy intervention at clinic sessions. The PT group will be additionally trained by proprioceptive exercises at clinic sessions. The patients in this group will practice head relocating exercise under supervision of a trained physical therapist.</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>Amir Hossein Kahlaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 522, Floor 5, Farabi Building, University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blve, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>amir_h_k@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Hossein Kahlaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Room 522, Floor 5, Farabi Building, University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blve, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>amir_h_k@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with nonspecific chronic neck pain with a duration of at least 3 months (either permanent or episodic).The pain should be experienced in the sub-occipital area and/or the upper trapezius muscle.
The average pain intensity during 3 weeks prior to testing session should be between 3.5 and 6.5 and pain intensity in the testing day should be less than 6.5.
based on the patient's physician's diagnosis, the neck pain should not be associated with any specific lesion or injury, with no symptoms of radicular pain and upper limbs and no pathoanatomic diagnosis.
By asking the patient, we make sure that patients do not receive any physical therapy or exercise therapy for the neck during the study.
The patient should have passed at least primary school level of education.
Included patients should have at least 60 degrees of neck extension without sever symptom exacerbation.
In the past 6 months, they have not received physiotherapy for neck pain.
Ability to stand upright.
The patients know Persian language.
The patients did not perform Jaw-Temporal surgery.
The patients should not have Severe mental illnesses requiring medication.
Not participating regular exercising.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Positive Dix Hallpike test that indicates vestibular system dysfunction.
Dissatisfaction with continuing tests.
Inability to perform or complete study tests due to exacerbation of symptoms.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54. 2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, cervical (neck), chronic, more than 3 months. Discomfort or more intense forms of pain that are localized to the cervical region. This term generally refers to pain in the posterior or lateral regions of the neck.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The control group will receive convential physical therapy program (CPT). Each treatment session takes 60 minutes. Patients are asked to perform conventional physiotherapy exercises at home, twice a day for 5 weeks, and record their exercises in a structural scheduled. They will receive electrotherapy intervention at clinic sessions.</i_keyword>
      <i_keyword>Intervention group: The intervention group will be received proprioceptive training (PT) in addition to the conventianal  program. Each treatment session takes 120 minutes. Patients are asked to perform conventional physiotherapy exercises at home, twice a day for 5 weeks, and record their exercises in a structural scheduled. They will receive electrotherapy intervention at clinic sessions. The PT group will be additionally trained by proprioceptive exercises at clinic sessions. The patients in this group will practice head relocating exercise under supervision of a trained physical therapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sway Velocity. Timepoint: Up to one week before and after the intervention. Method of measurement: Force Plate.</prim_outcome>
      <prim_outcome>Sway Range. Timepoint: Up to one week before and after the intervention. Method of measurement: Force Plate.</prim_outcome>
      <prim_outcome>Relative Proprioceptive Weighting. Timepoint: Up to one week before and after the intervention. Method of measurement: Force Plate.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain Intensity. Timepoint: Up to one week before and after the intervention. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Disability. Timepoint: Up to one week before and after the intervention. Method of measurement: Neck Disability Index.</sec_outcome>
      <sec_outcome>Fear Avoidance. Timepoint: Up to one week before and after the intervention. Method of measurement: Tampa Scale for Kinesiophobia.</sec_outcome>
      <sec_outcome>Sway Area. Timepoint: Up to one week before and after the intervention. Method of measurement: Force Plate.</sec_outcome>
      <sec_outcome>Sway Path Length. Timepoint: Up to one week before and after the intervention. Method of measurement: Force Plate.</sec_outcome>
      <sec_outcome>Maximum Lyapunov Exponent. Timepoint: Up to one week before and after the intervention. Method of measurement: Force Plate.</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>2019-10-21</approval_date>
        <contact_name>Ethics Committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>University of Social Welfare and Rehabilitation Sciences, Koodakyar Ave, Daneshjoo Blve, Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
