<?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>IRCT20201209049655N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-22</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of low-level laser therapy on spontaneous nerve pain</public_title>
      <acronym></acronym>
      <scientific_title>The Effect Of LLLT(low level laser therapy) On Idiopathic Trigeminal Neuralgia Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are randomly divided into intervention and control groups. For this purpose, AABB, ABAB, BBAA, BABA, ABBA and BAAB quadruple blocks are used to balance the allocation to each group. It is also a method of selecting a random block using a table of random numbers, Blinding description: This study is a double-blind study. Due to the fact that laser treatment is performed for one group and silent laser is applied for the other group, patients are unaware of which group they are in. The researcher who meets the VAS criteria for the patient is also unaware of what group he or she belongs to.</study_design>
      <phase>3</phase>
      <hc_freetext>Neuralgia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Treatment will start with 100 mg of carbamazepine and add 100 mg to the dose once every three days (depending on the patient's pain intensity). This process continues until the pain relief (increase to the maximum allowable dose). laser therapy is performed by rays with a wavelength of 940 nm with a density energy of 10 joules per square centimeter continuously (Biolase Technology, 940 diode, CA, USA). Laser treatment is performed in 9 sessions three days a week. Laser therapy is performed at the onset of pain. Based on previous studies, in this study, the effect of laser therapy and carbamazepine on pain in the experimental group is measured simultaneously. Intervention 2: Control group: Treatment will start with 100 mg of carbamazepine and add 100 mg to the dose once every three days (depending on the patient's pain intensity). This process continues until the pain relief (increase to the maximum allowable dose). In addition, an unreal laser is used for the control group in which the laser is on but there is no radiation.</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 of data

When:
6 months after publication

To whom:
people working in academic institutions

Conditions:
no analysis are allowed

Where to obtain:
registrar email

How to obtain:
contact with registrar

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Davodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafez4 street, Ashtiani boulevard, Pardis1 alley, Ghaem-magham Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3817658896</zip>
        <telephone>+98 86 3485 0353</telephone>
        <email>Abbasdavodi@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ehsan Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak Dentistry Faculty, Navab Street, Hepco Street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3819693345</zip>
        <telephone>+98 86 3369 1355</telephone>
        <email>momeni6384@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients whose definitive diagnosis of trigeminal neuralgia is based on the IHS (International Headache Society)
People who are seeing a doctor for the first time for treatment or have received standard medication but have had no effect on their recovery.
Idiopathic disease (such as vascular malformations, brain tumors, or diseases such as multiple sclerosis that cause the disease).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Blood problem
liver functional problem
Dissatisfaction to contribute in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Trigeminal neuralgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Treatment will start with 100 mg of carbamazepine and add 100 mg to the dose once every three days (depending on the patient's pain intensity). This process continues until the pain relief (increase to the maximum allowable dose). laser therapy is performed by rays with a wavelength of 940 nm with a density energy of 10 joules per square centimeter continuously (Biolase Technology, 940 diode, CA, USA). Laser treatment is performed in 9 sessions three days a week. Laser therapy is performed at the onset of pain. Based on previous studies, in this study, the effect of laser therapy and carbamazepine on pain in the experimental group is measured simultaneously.</i_keyword>
      <i_keyword>Control group: Treatment will start with 100 mg of carbamazepine and add 100 mg to the dose once every three days (depending on the patient's pain intensity). This process continues until the pain relief (increase to the maximum allowable dose). In addition, an unreal laser is used for the control group in which the laser is on but there is no radiation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: pain score at the beginning of the study (before the intervention) and immediately after each session of laser therapy and one month after the intervention. Method of measurement: VISUAL ANALOG SCALE.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of pain relief. Timepoint: At the end of study. Method of measurement: checklist.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-01</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Basij Square, Sardasht Place Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
