<?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>IRCT20190104042229N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Acupuncture in Neck Pain</public_title>
      <acronym></acronym>
      <scientific_title>English: Comparison of The Immediate Effects of Electroacupuncture and Laseracupuncture on Pain and Dysfunction Following Chronic Myofascial Neck Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36615</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced Block Randomizatin
According to the study of three groups in this RCT, six blocks are used to randomize each group , group A, B, C
Then, we write the different modes of the six blocks of the AABBCC and place it in the  package and the first patient in the study will select one of the packets. For example: ABABCC In this case, the first patient enters group A and the rest of the patients entering the study will be placed in subsequent groups, respectively, Blinding description: Single Blind Which assessor is blind about the type of intervention in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Neck pain. Condition 2: Myofascial pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Electroacupuncture:In this group, 8 acupuncture points are introduced to reduce the myofscial neck pain. The needle is applied and the electrical current is connected to the needles with specific therapeutic parameters and exposed to electrical stimulation for 20 minutes. Intervention 2: Intervention group: Laseracupuncture:In this group, low-power laser waves with specific parameters will radiate at 8 acupuncture points which is similar to the first group. Intervention 3: Control group: Sham Laser-acupuncture:in This group the off laser probe will be use at the similar points of the last two groups .</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>Atefe Bahadori Bozchelooee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 72 , Sayyar Ave, Rahimi Blvd, 1sth Sadeghie Square,Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1518932555</zip>
        <telephone>+98 21 4420 6707</telephone>
        <email>bahadori_atefe@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Bahadori Bozchelooee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 72 , Sayyar Ave, Rahimi Blvd, 1sth Sadeghie Square,Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1518932555</zip>
        <telephone>+98 21 4420 6707</telephone>
        <email>bahadori_atefe@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 35 years old
Having more than 12 weeks of history of Myofascial Neck Pain
Having pain above 3 is based on the VAS scale, which is considered as moderate pain
Satisfaction to participate in the research project "Comparison of The Immediate Effects of Electroacupuncture and Laseracupuncture on Pain and Dysfunction Following Chronic Myofascial Neck Pain"</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of Injection,Dry needling and Acupuncture In last month
History of Muscular Disease such as Fibromyalgia and myopathy
History of Neurological Disorders
Neck Discopathy and Radiculopathy
History of Neck Surgery
History of Negative response to Acupuncture or Dry needling
Needle Phobia
Malignancy and Patients susceptible to infection
Having vascular diseases and using anticoagulants
pregnancy
History of epilepsy or seizure
Diabetes
During menstruation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.2</hc_code>
      <hc_code>S16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervicalgia</hc_keyword>
      <hc_keyword>Injury of muscle, fascia and tendon at neck level</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Electroacupuncture:In this group, 8 acupuncture points are introduced to reduce the myofscial neck pain. The needle is applied and the electrical current is connected to the needles with specific therapeutic parameters and exposed to electrical stimulation for 20 minutes.</i_keyword>
      <i_keyword>Intervention group: Laseracupuncture:In this group, low-power laser waves with specific parameters will radiate at 8 acupuncture points which is similar to the first group.</i_keyword>
      <i_keyword>Control group: Sham Laser-acupuncture:in This group the off laser probe will be use at the similar points of the last two groups .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The pain score of people based on the Visual Analog scale. Timepoint: Before the intervention, immediately after the intervention and one week after the intervention. Method of measurement: Visual Analog scale.</prim_outcome>
      <prim_outcome>Pain pressure threshold. Timepoint: Before the intervention, immediately after the intervention and one week after the intervention. Method of measurement: pressure algometer.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before the intervention, immediately after the intervention and one week after the intervention. Method of measurement: Neck Disability index Questionnaire.</prim_outcome>
      <prim_outcome>Cervical range of motion. Timepoint: Before the intervention, immediately after the intervention and one week after the intervention. Method of measurement: Goniometer.</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>2019-04-28</approval_date>
        <contact_name>Ethics committee of Faculty of Nursing and Midwifery, Faculty of Rehabilitation, Tehran University o</contact_name>
        <contact_address>No 72 ,Sayyar Ave ,Rahimi street, 1th Sadeghie Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
