<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/NCT03838393</url>
  </required_header>
  <id_info>
    <org_study_id>H-1-2012-093</org_study_id>
    <nct_id>NCT03838393</nct_id>
  </id_info>
  <brief_title>Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program</brief_title>
  <official_title>Prognosis of Trigeminal Neuralgia When Enrolled in a Multidisciplinary Management Program - a Two-year Prospective Real-life Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danish Headache Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danish Headache Center</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>
      Background: Prognosis of medically treated trigeminal neuralgia patients is assumed to be&#xD;
      poor, but the evidence is lacking. Thus, prospective real-life studies of medical management&#xD;
      of trigeminal neuralgia are warranted.&#xD;
&#xD;
      Methods: Observational study. Patients were consecutively enrolled in a structured management&#xD;
      program at a specialist centre for facial pain. Optimisation of medical treatment,&#xD;
      physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program.&#xD;
      Medically intractable patients were referred for neurosurgery. Data-collection was&#xD;
      prospective using standardised schemes and patient surveys. The aim was to describe the&#xD;
      two-year outcome of medical treatment at the specialist centre. The primary outcome was a 50%&#xD;
      reduction in the overall burden of pain according to a Numerical Rating Scale (NRS) after two&#xD;
      years.&#xD;
&#xD;
      This study aimed to provide evidence concerning the real-life efficacy of medical management&#xD;
      of trigeminal neuralgia (TN) when directed by specialists. The investigatgors hypothesised&#xD;
      that the two-year prognosis in a group of medically managed TN patients enrolled in a&#xD;
      structured multidisciplinary management program was favourable, defined as a 50 % reduction&#xD;
      of the overall burden of pain over a two-year period&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in overall burden of pain NRS over a two-year period</measure>
    <time_frame>2 years</time_frame>
    <description>Defined as a good outcome, i.e number of patients who had a reduction of minimum 50% on the NRS two years after enrolment in the management program compared with baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>No changes of the overall burden of pain NRS over the two-year follow-up period</measure>
    <time_frame>2 years</time_frame>
    <description>Defined as poor outcome, i.e number of patients who had a no reduction the NRS two years after enrolment in the management program compared with baseline</description>
  </secondary_outcome>
  <enrollment type="Actual">186</enrollment>
  <condition>Trigeminal Neuralgia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>multidisciplinary management</intervention_name>
    <description>pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The diagnostic criteria used in this study were the beta version of the 3rd edition of the&#xD;
        International Classification of Headache Disorders (ICHD-3-beta). Until the publication of&#xD;
        IHCD-3-beta, ICHD 2 criteria were used. According to the ICHD-3 classification, this study&#xD;
        included patients with both idiopathic and classical TN; in this paper termed primary TNThe&#xD;
        number of patients enrolled in the inclusion period determined the sample size.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. recordings of the intensity of pain at enrolment of the programme (baseline&#xD;
             recording),&#xD;
&#xD;
          2. a two-year assessment (end-point recording),&#xD;
&#xD;
          3. recording of effect and side-effects of drug treatment (at baseline and endpoint).&#xD;
&#xD;
        The exclusion criteria&#xD;
&#xD;
          1. initiation of medical treatment at the DHC before May 2012,&#xD;
&#xD;
          2. neurosurgical treatment of TN within the two-year follow-up&#xD;
&#xD;
          3. incomplete two-year follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danish Headache Center</investigator_affiliation>
    <investigator_full_name>Tone Heinskou</investigator_full_name>
    <investigator_title>medical doctor</investigator_title>
  </responsible_party>
  <keyword>multidisciplinary management</keyword>
  <keyword>real-life study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigeminal Neuralgia</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03838393
org study id: H-1-2012-093
nct id: NCT03838393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Prognosis of medically treated trigeminal neuralgia patients is assumed to be
      poor, but the evidence is lacking. Thus, prospective real-life studies of medical management
      of trigeminal neuralgia are warranted.

      Methods: Observational study. Patients were consecutively enrolled in a structured management
      program at a specialist centre for facial pain. Optimisation of medical treatment,
      physiotherapy, psychotherapy, and advice from trained nurses, were parts of the program.
      Medically intractable patients were referred for neurosurgery. Data-collection was
      prospective using standardised schemes and patient surveys. The aim was to describe the
      two-year outcome of medical treatment at the specialist centre. The primary outcome was a 50%
      reduction in the overall burden of pain according to a Numerical Rating Scale (NRS) after two
      years.

      This study aimed to provide evidence concerning the real-life efficacy of medical management
      of trigeminal neuralgia (TN) when directed by specialists. The investigatgors hypothesised
      that the two-year prognosis in a group of medically managed TN patients enrolled in a
      structured multidisciplinary management program was favourable, defined as a 50 % reduction
      of the overall burden of pain over a two-year period
observational model: Cohort
time perspective: Prospective
measure: change in overall burden of pain NRS over a two-year period
time frame: 2 years
description: Defined as a good outcome, i.e number of patients who had a reduction of minimum 50% on the NRS two years after enrolment in the management program compared with baseline
measure: No changes of the overall burden of pain NRS over the two-year follow-up period
time frame: 2 years
description: Defined as poor outcome, i.e number of patients who had a no reduction the NRS two years after enrolment in the management program compared with baseline
intervention type: Other
intervention name: multidisciplinary management
description: pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Danish Headache Center
investigator full name: Tone Heinskou
investigator title: medical doctor
mesh term: Trigeminal Neuralgia
mesh term: Neuralgia
sharing ipd: No