<?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>IRCT20191208045652N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-03</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of upper trapezius active trigger points dry needling in women with chronic non-specific neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of upper trapezius active trigger points dry needling on postural control and clinical signs in women with chronic non-specific neck pain (a single blind  randomized clinical trial)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44167</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple block random allocation method will be used. In order to balance the number of samples in each group, a blocking method with random sizes of 6 will be used and non-transparent envelopes will be used to hide the random assignment. It should be noted that steps are taken to create a randomization sequence by a person who is not involved in any other stage of the research, Blinding description: treatment and assessment will be done by separate persons. Analyzer and assessor will be blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>nonspecific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:dry needling (Dang bang South Korea, 50*0.3 millimeter) with upper trapezius passive stretch and postural correction education based on pamphlet during 5 sessions, 2 times in a week. Intervention 2: Control group:  upper trapezius passive stretch and postural correction education based on pamphlet during 5 sessions, 2 times in a week.</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 data will be shared after unidentified persons

When:
accessibility will be 6 months after printing the result

To whom:
all researchers and scientists, working in academic and scientific institutions, can access to data

Conditions:
Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.

Where to obtain:
connect to Fereshteh Navaee by email: fereshte.navaei@gmail.com

How to obtain:
if data is used in scientific and therapeutic activities, information will be provided as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Navaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No3, Niayesh St, Sattarkhan St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1443773488</zip>
        <telephone>+98 21 6651 8660</telephone>
        <email>fereshte.navaei@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Yassin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physical therapy department, Rasoul Akram hospital, Niayesh St, Sattarkhan St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 2222 8052</telephone>
        <email>m.yassin.pt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range from 18-35 years
History of neck pain in the last 3 months
Presence of neck pain at least 3 and not more than 6 based on visual analogue scale during last week
Presence of at last 3 active trigger points in upper Trapezius muscle, based on Simons et al criteria: 1) presence of palpable taut band  2) presence of hyperirritable spots in a taut band based on participants' history 3) presence of referral pain in a specific pattern during compression or stretch 4) Patient’s recognition of current pain complaint by pressure on the tender nodule 5) jump sign during palpation of spot</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of cervical spine or upper limb surgery during the last year
History of traumatic injuries in cervical region including fracture, wiplash during the last year
Presence of radiculopathic signs
Presence of pain in hip, knee &amp; ankle during the last 3 months
Presence of neurological disorders including Neuropathy, Myopathy, Parkinson &amp; Cerebellar lesion
Presence of vestibular disorders
Presence of uncorrected visual &amp; hearing disorders
Presence of acute cognitive disorders ( result number &lt; 23 from MMSE questionnaire)
Presence of acute psychopathy (based on acquired number from DASS-21 questionnaire)
History of rheumatic disorders
History of  ﬁbromyalgia syndrome based on Rheumatology faculty of USA (1990)
History of coagulopathy
Pregnancy
Diabetes
History of any treatment or injection of trigger points during the last 3 months
Visible severe postural disorders including kyphosis or scoliosis
Skin infection or inflammation
History of anti coagulant or immuno suppressive drugs
Fear of needle</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M70.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified soft tissue disorder related to use, overuse and pressure</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:dry needling (Dang bang South Korea, 50*0.3 millimeter) with upper trapezius passive stretch and postural correction education based on pamphlet during 5 sessions, 2 times in a week.</i_keyword>
      <i_keyword>Control group:  upper trapezius passive stretch and postural correction education based on pamphlet during 5 sessions, 2 times in a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural control. Timepoint: Before intervention, 2 days and 2 months after intervention. Method of measurement: Force plate, kistler, Germany.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain. Timepoint: Before intervention, 2 days and 2 months after intervention. Method of measurement: visual analogue scale.</sec_outcome>
      <sec_outcome>Pain pressure threshold. Timepoint: Before intervention, 2 days and 2 months after intervention. Method of measurement: Algometer, JTECK, USA.</sec_outcome>
      <sec_outcome>Side bending &amp; rotation range of motion. Timepoint: Before intervention, 2 days and 2 months after intervention. Method of measurement: iPhone 8 application, goniometer.</sec_outcome>
      <sec_outcome>Functional rating scale. Timepoint: Before intervention, 2 days and 2 months after intervention. Method of measurement: Persian version of functional rating scale 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-05</approval_date>
        <contact_name>ethics committee of Iran university of medical sciences</contact_name>
        <contact_address>Iran university of medical sciences, next to Milad tower, Hemmat highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
