<?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>IRCT20160531028186N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-16</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of mobilization and stabilization exercises on  treatment of neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effects of cervical mobilization techniques and neck stabilization exercises on cross-section of neck deep flexor muscles   and position sense in patients with chronic non-specific neck pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59425</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is based on permutation blocks. It is an individual randomization unit. A table of random numbers is used. Participants in the study are selected based on simple and available sampling. Each person will be selected based on the inclusion criteria. Placing people in groups is based on permutation blocks, Blinding description: The outcomes is assessed by another physiotherapist who is blind to the type of treatment being given to the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non specific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Stabilization exercises group: 18 sessions of treatment for 6 consecutive weeks, 3 times a week, each session for 25 to 30 minutes.Exercises 8-12 times for 10 seconds and with a break of 2 minutes between exercises.The first two weeks of exercise include chin tuck exercises for nerve growth (lying on your back, lying on your stomach, quadrupeds, and both legs) for the cervical spine.The second two-week exercise includes isometric neck exercises performed with a bandage. The exercises for the third two weeks include exercises that are done with the ball and with bandages. Intervention 2: Mobilization group: 18 sessions of treatment are performed for 6 consecutive weeks and 3 times per week. First, we apply a traction force to warm and relax the patient.Grade 2 and 3 mobilization will then be performed oscillatory for the C5-C6 neck segment.Two techniques of central  posterior anterior force and unilateral  posterior anterior force are used.Each technique 3 times and each time for 30 seconds and with oscillation of 1 Hz, and 1 minute rest is done between each repetition. Intervention 3: Control group: 18 treatment sessions for 6 weeks, 3 times a week and each session includes: Tens Conventional with a frequency of 80 Hz and a diversion of 120 milliseconds for 20 minutes, Hot Pack in the neck area for 20 minutes and Ultrasound with Continuous Mode and with an intensity of 1/5 watt per square centimeter.</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:
All the main outcome data can be shared.

When:
6 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers and experts in this field must ensure that data is not misused.

Where to obtain:
afsanehsamiei72@yahoo.com

How to obtain:
The applicant must be fully and transparently identified and express his intention at his request. About 2 to 4 weeks after verification, the data will reach him.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Hosseinifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy, Faculty of Rehabilitation Sciences, Razmojomoghadam Laboratory, Ayatollah Kafami St.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6485598136</zip>
        <telephone>+98 54 3342 4675</telephone>
        <email>fardash_s@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Hosseinifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy, Faculty of Rehabilitation Sciences, Razmjomoghadam Laboratory, Ayatollah Kafami St.</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6485598136</zip>
        <telephone>+98 54 3342 4675</telephone>
        <email>fardash_s@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ms. and Mr. Ages between 18-55 years
Have neck pain for which the treating physician did not state a  specific cause and in clinical examination and radiography, no specific cause has been found for it
Have neck pain that lasts 12 weeks or more
Body mass index between 18 and 30
Neck disability index score equal to or greater than 5/50
The score of pain at rest is at least 3/10</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has a contraindication to mobilization. For example: neck instability, signs or symptoms of vertebral artery insufficiency, severe osteoporosis, tumors, spinal tuberculosis, spinal diseases, etc
History of cervical spine surgery in the last 12 months
Diagnosis of serious pathological disease of the spine (inflammatory spondyloarthropathy, fracture or infection)
Existence of neurological symptoms indicating pressure on the nerve root
Have a history of any treatment in the previous 12 weeks (physiotherapy, chiropractic, acupuncture and massage)
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>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Stabilization exercises group: 18 sessions of treatment for 6 consecutive weeks, 3 times a week, each session for 25 to 30 minutes.Exercises 8-12 times for 10 seconds and with a break of 2 minutes between exercises.The first two weeks of exercise include chin tuck exercises for nerve growth (lying on your back, lying on your stomach, quadrupeds, and both legs) for the cervical spine.The second two-week exercise includes isometric neck exercises performed with a bandage. The exercises for the third two weeks include exercises that are done with the ball and with bandages.</i_keyword>
      <i_keyword>Mobilization group: 18 sessions of treatment are performed for 6 consecutive weeks and 3 times per week. First, we apply a traction force to warm and relax the patient.Grade 2 and 3 mobilization will then be performed oscillatory for the C5-C6 neck segment.Two techniques of central  posterior anterior force and unilateral  posterior anterior force are used.Each technique 3 times and each time for 30 seconds and with oscillation of 1 Hz, and 1 minute rest is done between each repetition.</i_keyword>
      <i_keyword>Control group: 18 treatment sessions for 6 weeks, 3 times a week and each session includes: Tens Conventional with a frequency of 80 Hz and a diversion of 120 milliseconds for 20 minutes, Hot Pack in the neck area for 20 minutes and Ultrasound with Continuous Mode and with an intensity of 1/5 watt per square centimeter</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The cross-sectional area of ​​the deep flexor muscles of the neck. Timepoint: Before and after the intervention period. Method of measurement: Using an ultrasonography device.</prim_outcome>
      <prim_outcome>The degree of control of the sense of position of the head and neck. Timepoint: Before and after the intervention period. Method of measurement: Using a laser pointer placed on a wire-like device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before and after the intervention period. Method of measurement: Using Visual Analog  Scale (VAS) Questionnaire.</sec_outcome>
      <sec_outcome>Disability. Timepoint: Before and after the intervention period. Method of measurement: Using Neck Disability Index (NDI) questionnaire.</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>Vice Chancellor for Research, Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-15</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
