xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021561</url>
    </required_header>
    <id_info>
      <org_study_id>21062023</org_study_id>
      <nct_id>NCT06021561</nct_id>
    </id_info>
    <brief_title>Orofacial Pain in Multiple Sclerosis</brief_title>
    <official_title>Orofacial Pain in Multiple Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Varazdin General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Varazdin General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Although the orofacial pain is not typical symptom of multiple sclerosis, more than 50% of&#xD;
        the patients experience some kind of pain. Acute pain usually in form of trigeminal&#xD;
        neuralgia, that occurred in 2-3% of patients with multiple sclerosis. Chronic pain occurred&#xD;
        in 40-50% of patients and most common forms are headache. Aim of this study is to investigate&#xD;
        prevalence and evaluate the form of orofacial pain in patients with multiple sclerosis&#xD;
        treated in General hospital Varaždin in period from 01.01. 2017. to 31.12.2022. Results of&#xD;
        this investigation will determine better understanding orofacial pain , treatment and impact&#xD;
        on everyday life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Multiple sclerosis is a chronic autoimmune disease with an unknown mechanism of origin.&#xD;
        Although pain is not a typical symptom of multiple sclerosis, it occurs in more than 50% of&#xD;
        patients and has significant impact on the quality of life of patients. Pain syndromes that&#xD;
        patients with multiple sclerosis initially have characteristics of somatic and nociceptive&#xD;
        pain, and later neuropathic, including trigeminal neuralgia, headaches, Lhermitte's syndrome.&#xD;
  &#xD;
        Pain is also often associated with anxiety and depression, which occurs in almost one third&#xD;
        of patients.&#xD;
  &#xD;
        Pain therapy in these patients is a challenge for many doctors involved in the treatment.&#xD;
        Many patients do not have adequate pain therapy due to the disproportion between the fear of&#xD;
        interaction with other drugs and side effects, and on the other hand the treatment of basic&#xD;
        diseases with the aim of controlling the immune response.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 4, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The frequency of orofacial pain in patients with multiple sclerosis</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the frequency of orofacial pain (expressed in number and proportion of all patients)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The location of orofacial pain in patients with multiple sclerosis</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the loacation of orofacial pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The duration of orofacial pain in patients with multiple sclerosis</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the duration of orofacial pain (in months)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>MS therapy's influence to pain</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate connection between orofacial pain and multiple sclerosis therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MS orofacial pain and the duration of the disease</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate the connection between orofacial pain and the duration of the disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain and patients' characteristics</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate the pain characteristics in relation to age, sex, form of the disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Other chronic diseases and orofacial pain</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate the influence of other chronic diseases on orofacial pain in patients with multiple sclerosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain and daily functioning</measure>
      <time_frame>3 months</time_frame>
      <description>To investigate the impact of pain on the daily functioning of patients with multiple sclerosis</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Multiple Sclerosis</condition>
    <arm_group>
      <arm_group_label>Multiple sclerosis group</arm_group_label>
      <description>Multiple sclerosis patients registered in Varazdin General Hospital from 1 January 2017 - 31 December 2022</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Diagnosis of pain</intervention_name>
      <description>Pain will be investigated - type, origin, level</description>
      <arm_group_label>Multiple sclerosis group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Multiple sclerosis patients aged 18-65 years registered in Varazdin General Hospital from 1&#xD;
          January 2017 to 31 December 2022&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  multiple scerosis&#xD;
  &#xD;
            -  age 18-85 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  records with missing data&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Monika Kocman Panic, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Varazdin General Hospital, Varazdin, Croatia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Monika Kocman Panic, MD</last_name>
      <phone>+385915743215</phone>
      <email>monika.kocman88@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Varazdin General Hospital</name>
        <address>
          <city>Varaždin</city>
          <zip>42000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Monika Kocman Panic, MD</last_name>
        <phone>+385915743215</phone>
        <email>monika.kocman88@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Monika Kocman Panic, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Croatia</country>
    </location_countries>
    <reference>
      <citation>Putzki N, Pfriem A, Limmroth V, Yaldizli O, Tettenborn B, Diener HC, Katsarava Z. Prevalence of migraine, tension-type headache and trigeminal neuralgia in multiple sclerosis. Eur J Neurol. 2009 Feb;16(2):262-7. doi: 10.1111/j.1468-1331.2008.02406.x. Epub 2008 Dec 9.</citation>
      <PMID>19138330</PMID>
    </reference>
    <reference>
      <citation>Young J, Amatya B, Galea MP, Khan F. Chronic pain in multiple sclerosis: A 10-year longitudinal study. Scand J Pain. 2017 Jul;16:198-203. doi: 10.1016/j.sjpain.2017.04.070. Epub 2017 May 24.</citation>
      <PMID>28850402</PMID>
    </reference>
    <reference>
      <citation>Hirsh AT, Turner AP, Ehde DM, Haselkorn JK. Prevalence and impact of pain in multiple sclerosis: physical and psychologic contributors. Arch Phys Med Rehabil. 2009 Apr;90(4):646-51. doi: 10.1016/j.apmr.2008.10.019.</citation>
      <PMID>19345781</PMID>
    </reference>
    <reference>
      <citation>Di Stefano G, Maarbjerg S, Truini A. Trigeminal neuralgia secondary to multiple sclerosis: from the clinical picture to the treatment options. J Headache Pain. 2019 Feb 19;20(1):20. doi: 10.1186/s10194-019-0969-0.</citation>
      <PMID>30782116</PMID>
    </reference>
    <reference>
      <citation>Kahraman T, Ozdogar AT, Ertekin O, Ozakbas S. Frequency, type, distribution of pain and related factors in persons with multiple sclerosis. Mult Scler Relat Disord. 2019 Feb;28:221-225. doi: 10.1016/j.msard.2019.01.002. Epub 2019 Jan 3.</citation>
      <PMID>30623861</PMID>
    </reference>
    <reference>
      <citation>Mazhari A. Multiple Sclerosis-Related Pain Syndromes: An Imaging Update. Curr Pain Headache Rep. 2016 Dec;20(12):63. doi: 10.1007/s11916-016-0594-4.</citation>
      <PMID>27864731</PMID>
    </reference>
    <reference>
      <citation>Fallata A, Salter A, Tyry T, Cutter GR, Marrie RA. Trigeminal Neuralgia Commonly Precedes the Diagnosis of Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):240-246. doi: 10.7224/1537-2073.2016-065.</citation>
      <PMID>29070964</PMID>
    </reference>
    <reference>
      <citation>Danesh-Sani SA, Rahimdoost A, Soltani M, Ghiyasi M, Haghdoost N, Sabzali-Zanjankhah S. Clinical assessment of orofacial manifestations in 500 patients with multiple sclerosis. J Oral Maxillofac Surg. 2013 Feb;71(2):290-4. doi: 10.1016/j.joms.2012.05.008. Epub 2012 Jun 27.</citation>
      <PMID>22742955</PMID>
    </reference>
    <reference>
      <citation>Kister I, Caminero AB, Monteith TS, Soliman A, Bacon TE, Bacon JH, Kalina JT, Inglese M, Herbert J, Lipton RB. Migraine is comorbid with multiple sclerosis and associated with a more symptomatic MS course. J Headache Pain. 2010 Oct;11(5):417-25. doi: 10.1007/s10194-010-0237-9. Epub 2010 Jul 13.</citation>
      <PMID>20625916</PMID>
    </reference>
    <reference>
      <citation>Zhang GQ, Meng Y. Oral and craniofacial manifestations of multiple sclerosis: implications for the oral health care provider. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4610-20.</citation>
      <PMID>26698259</PMID>
    </reference>
    <reference>
      <citation>Foley PL, Vesterinen HM, Laird BJ, Sena ES, Colvin LA, Chandran S, MacLeod MR, Fallon MT. Prevalence and natural history of pain in adults with multiple sclerosis: systematic review and meta-analysis. Pain. 2013 May;154(5):632-642. doi: 10.1016/j.pain.2012.12.002. Epub 2012 Dec 14.</citation>
      <PMID>23318126</PMID>
    </reference>
    <reference>
      <citation>Solaro C, Brichetto G, Amato MP, Cocco E, Colombo B, D'Aleo G, Gasperini C, Ghezzi A, Martinelli V, Milanese C, Patti F, Trojano M, Verdun E, Mancardi GL; PaIMS Study Group. The prevalence of pain in multiple sclerosis: a multicenter cross-sectional study. Neurology. 2004 Sep 14;63(5):919-21. doi: 10.1212/01.wnl.0000137047.85868.d6.</citation>
      <PMID>15365151</PMID>
    </reference>
    <reference>
      <citation>Hadjimichael O, Kerns RD, Rizzo MA, Cutter G, Vollmer T. Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain. 2007 Jan;127(1-2):35-41. doi: 10.1016/j.pain.2006.07.015. Epub 2006 Sep 1.</citation>
      <PMID>16949751</PMID>
    </reference>
    <reference>
      <citation>Labuz-Roszak B, Niewiadomska E, Kubicka-Baczyk K, Skrzypek M, Tyrpien-Golder K, Majewska A, Matejczyk A, Dobrakowski P, Pierzchala K. Prevalence of pain in patients with multiple sclerosis and its association with anxiety, depressive symptoms and quality of life. Psychiatr Pol. 2019 Apr 30;53(2):475-486. doi: 10.12740/PP/94469. Epub 2019 Apr 30. English, Polish.</citation>
      <PMID>31317971</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>facial pain</keyword>
    <keyword>craniofacial pain</keyword>
    <keyword>multiple sclerosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
      <mesh_term>Facial Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021561
  org study id: 21062023
  nct id: NCT06021561
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although the orofacial pain is not typical symptom of multiple sclerosis, more than 50% of
        the patients experience some kind of pain. Acute pain usually in form of trigeminal
        neuralgia, that occurred in 2-3% of patients with multiple sclerosis. Chronic pain occurred
        in 40-50% of patients and most common forms are headache. Aim of this study is to investigate
        prevalence and evaluate the form of orofacial pain in patients with multiple sclerosis
        treated in General hospital Varaždin in period from 01.01. 2017. to 31.12.2022. Results of
        this investigation will determine better understanding orofacial pain , treatment and impact
        on everyday life.
  Multiple sclerosis is a chronic autoimmune disease with an unknown mechanism of origin.
        Although pain is not a typical symptom of multiple sclerosis, it occurs in more than 50% of
        patients and has significant impact on the quality of life of patients. Pain syndromes that
        patients with multiple sclerosis initially have characteristics of somatic and nociceptive
        pain, and later neuropathic, including trigeminal neuralgia, headaches, Lhermitte's syndrome.
  
        Pain is also often associated with anxiety and depression, which occurs in almost one third
        of patients.
  
        Pain therapy in these patients is a challenge for many doctors involved in the treatment.
        Many patients do not have adequate pain therapy due to the disproportion between the fear of
        interaction with other drugs and side effects, and on the other hand the treatment of basic
        diseases with the aim of controlling the immune response.
  observational model: Cohort
  time perspective: Retrospective
  measure: The frequency of orofacial pain in patients with multiple sclerosis
  time frame: 3 months
  description: To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the frequency of orofacial pain (expressed in number and proportion of all patients)
  measure: The location of orofacial pain in patients with multiple sclerosis
  time frame: 3 months
  description: To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the loacation of orofacial pain
  measure: The duration of orofacial pain in patients with multiple sclerosis
  time frame: 3 months
  description: To investigate that, hospital records will be reviewed. Additionally, all of the patients will be approached with the questionnaire investigating the duration of orofacial pain (in months)
  measure: MS therapy's influence to pain
  time frame: 3 months
  description: To investigate connection between orofacial pain and multiple sclerosis therapy
  measure: MS orofacial pain and the duration of the disease
  time frame: 3 months
  description: To investigate the connection between orofacial pain and the duration of the disease
  measure: Pain and patients' characteristics
  time frame: 3 months
  description: To investigate the pain characteristics in relation to age, sex, form of the disease
  measure: Other chronic diseases and orofacial pain
  time frame: 3 months
  description: To investigate the influence of other chronic diseases on orofacial pain in patients with multiple sclerosis
  measure: Pain and daily functioning
  time frame: 3 months
  description: To investigate the impact of pain on the daily functioning of patients with multiple sclerosis
  arm group label: Multiple sclerosis group
  description: Multiple sclerosis patients registered in Varazdin General Hospital from 1 January 2017 - 31 December 2022
  intervention type: Diagnostic Test
  intervention name: Diagnosis of pain
  description: Pain will be investigated - type, origin, level
  arm group label: Multiple sclerosis group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Monika Kocman Panic, MD
  role: Principal Investigator
  affiliation: Varazdin General Hospital, Varazdin, Croatia
  last name: Monika Kocman Panic, MD
  phone: +385915743215
  email: monika.kocman88@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Croatia
  citation: Putzki N, Pfriem A, Limmroth V, Yaldizli O, Tettenborn B, Diener HC, Katsarava Z. Prevalence of migraine, tension-type headache and trigeminal neuralgia in multiple sclerosis. Eur J Neurol. 2009 Feb;16(2):262-7. doi: 10.1111/j.1468-1331.2008.02406.x. Epub 2008 Dec 9.
  PMID: 19138330
  citation: Young J, Amatya B, Galea MP, Khan F. Chronic pain in multiple sclerosis: A 10-year longitudinal study. Scand J Pain. 2017 Jul;16:198-203. doi: 10.1016/j.sjpain.2017.04.070. Epub 2017 May 24.
  PMID: 28850402
  citation: Hirsh AT, Turner AP, Ehde DM, Haselkorn JK. Prevalence and impact of pain in multiple sclerosis: physical and psychologic contributors. Arch Phys Med Rehabil. 2009 Apr;90(4):646-51. doi: 10.1016/j.apmr.2008.10.019.
  PMID: 19345781
  citation: Di Stefano G, Maarbjerg S, Truini A. Trigeminal neuralgia secondary to multiple sclerosis: from the clinical picture to the treatment options. J Headache Pain. 2019 Feb 19;20(1):20. doi: 10.1186/s10194-019-0969-0.
  PMID: 30782116
  citation: Kahraman T, Ozdogar AT, Ertekin O, Ozakbas S. Frequency, type, distribution of pain and related factors in persons with multiple sclerosis. Mult Scler Relat Disord. 2019 Feb;28:221-225. doi: 10.1016/j.msard.2019.01.002. Epub 2019 Jan 3.
  PMID: 30623861
  citation: Mazhari A. Multiple Sclerosis-Related Pain Syndromes: An Imaging Update. Curr Pain Headache Rep. 2016 Dec;20(12):63. doi: 10.1007/s11916-016-0594-4.
  PMID: 27864731
  citation: Fallata A, Salter A, Tyry T, Cutter GR, Marrie RA. Trigeminal Neuralgia Commonly Precedes the Diagnosis of Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):240-246. doi: 10.7224/1537-2073.2016-065.
  PMID: 29070964
  citation: Danesh-Sani SA, Rahimdoost A, Soltani M, Ghiyasi M, Haghdoost N, Sabzali-Zanjankhah S. Clinical assessment of orofacial manifestations in 500 patients with multiple sclerosis. J Oral Maxillofac Surg. 2013 Feb;71(2):290-4. doi: 10.1016/j.joms.2012.05.008. Epub 2012 Jun 27.
  PMID: 22742955
  citation: Kister I, Caminero AB, Monteith TS, Soliman A, Bacon TE, Bacon JH, Kalina JT, Inglese M, Herbert J, Lipton RB. Migraine is comorbid with multiple sclerosis and associated with a more symptomatic MS course. J Headache Pain. 2010 Oct;11(5):417-25. doi: 10.1007/s10194-010-0237-9. Epub 2010 Jul 13.
  PMID: 20625916
  citation: Zhang GQ, Meng Y. Oral and craniofacial manifestations of multiple sclerosis: implications for the oral health care provider. Eur Rev Med Pharmacol Sci. 2015 Dec;19(23):4610-20.
  PMID: 26698259
  citation: Foley PL, Vesterinen HM, Laird BJ, Sena ES, Colvin LA, Chandran S, MacLeod MR, Fallon MT. Prevalence and natural history of pain in adults with multiple sclerosis: systematic review and meta-analysis. Pain. 2013 May;154(5):632-642. doi: 10.1016/j.pain.2012.12.002. Epub 2012 Dec 14.
  PMID: 23318126
  citation: Solaro C, Brichetto G, Amato MP, Cocco E, Colombo B, D'Aleo G, Gasperini C, Ghezzi A, Martinelli V, Milanese C, Patti F, Trojano M, Verdun E, Mancardi GL; PaIMS Study Group. The prevalence of pain in multiple sclerosis: a multicenter cross-sectional study. Neurology. 2004 Sep 14;63(5):919-21. doi: 10.1212/01.wnl.0000137047.85868.d6.
  PMID: 15365151
  citation: Hadjimichael O, Kerns RD, Rizzo MA, Cutter G, Vollmer T. Persistent pain and uncomfortable sensations in persons with multiple sclerosis. Pain. 2007 Jan;127(1-2):35-41. doi: 10.1016/j.pain.2006.07.015. Epub 2006 Sep 1.
  PMID: 16949751
  citation: Labuz-Roszak B, Niewiadomska E, Kubicka-Baczyk K, Skrzypek M, Tyrpien-Golder K, Majewska A, Matejczyk A, Dobrakowski P, Pierzchala K. Prevalence of pain in patients with multiple sclerosis and its association with anxiety, depressive symptoms and quality of life. Psychiatr Pol. 2019 Apr 30;53(2):475-486. doi: 10.12740/PP/94469. Epub 2019 Apr 30. English, Polish.
  PMID: 31317971
  responsible party type: Sponsor
  mesh term: Multiple Sclerosis
  mesh term: Sclerosis
  mesh term: Facial Pain
  sharing ipd: No