<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/NCT03253523</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00148116</org_study_id>
    <nct_id>NCT03253523</nct_id>
  </id_info>
  <brief_title>Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management</brief_title>
  <official_title>Post-traumatic Occipital Neuralgia - Surgical Versus Medical Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Occipital neuralgia and subsequent headaches are associated with significant morbidity and&#xD;
      impact quality of life and ability to work. Treatment is primarily medical and consists of&#xD;
      non-steroidal anti-inflammatory medications and medications to treat neuropathic pain. Many&#xD;
      patient exhaust medical management options and suffer from persistent symptoms.&#xD;
&#xD;
      Surgical management of chronic headaches including occipital neuralgia is emerging as a tool&#xD;
      to relieve pain and the burden of morbidity associated with this condition. Dr. Bahman&#xD;
      Guyuron has been reporting positive results in the literature for the past 20 years. In a&#xD;
      systematic review of 14 papers it has been demonstrated that peripheral nerve surgery for&#xD;
      migraines is effective and leads to an improvement of symptoms for 86% of patients.&#xD;
      Complication rates were low across all studies included. Additionally, Dr Ivica Ducic has&#xD;
      reported success specifically treating occipital neuralgia headaches, with significant&#xD;
      improvements in subjective pain outcomes post-operatively. The mechanism behind this is&#xD;
      thought to be similar to carpal tunnel syndrome, whereby peripheral nerve compression causes&#xD;
      nerve irritation and pain. The ensuing inflammatory response to tissue injury can cause&#xD;
      sensitization of nociceptors, resulting in hyperalgesia or allodynia. Surgical release of&#xD;
      tight surrounding soft tissues results in nerve decompression and relief of symptoms.&#xD;
&#xD;
      Although there are multiple case series and empiric evidence supporting the safety and&#xD;
      efficacy of occipital migraine surgery, there are no randomized controlled studies comparing&#xD;
      surgical intervention with continued medical management.&#xD;
&#xD;
      As part of the present study, the investigators intend to randomize patients who have&#xD;
      exhausted maximal medical treatment of post-traumatic occipital headaches to either a&#xD;
      surgical management group or a continued medical management group. Surgical intervention will&#xD;
      consist of neurolysis, or release, of the occipital nerves.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Patients did not want to take part in the experimental arm of the study as all have opted for&#xD;
    the current standard of care procedure.&#xD;
  </why_stopped>
  <start_date type="Actual">September 30, 2019</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average visual analogue scale of pain intensity</measure>
    <time_frame>6 months</time_frame>
    <description>Assess patient's average headache on a visual analog scale from 1-10, 10 being the worst pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Headache days per month</measure>
    <time_frame>6 months</time_frame>
    <description>Assess patient-reported number of days with headaches per month, in days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of average headache</measure>
    <time_frame>6 months</time_frame>
    <description>Assess patient-reported average duration of headaches, in hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Migraine Headache Index (the multiple of scores 1-3) at 6 months</measure>
    <time_frame>from baseline to 6 months</time_frame>
    <description>The Migraine Headache Index (MHI) is a commonly used metric in the plastic and reconstructive surgery literature to assess pre- and postoperative headache severity. The score is a product of headache duration (in days), frequency (in days per month), and severity (on a scale from 1 to 10). The score ranges from 0 to 300, with higher scores corresponding to worse migraine symptoms. Change in MHI score between pre-operative and 6-month postoperatively will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective patient recorded outcomes of quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of quality of life using the Headache Impact Test (HIT-6) tool. The scores range from 36 to 78, with scores over 50 indicating some degree of impact of headaches on quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication intake</measure>
    <time_frame>6 months</time_frame>
    <description>Patient-reported average intake of analgesic medications for occipital neuralgia pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in activity pre- and post-operatively</measure>
    <time_frame>6 months</time_frame>
    <description>Patient-reported ability to return to daily work and recreational activities. Outcome will be measured in days per month when patient stays home and is unable to work or otherwise engage in recreational activities secondary to migraine symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>6 months</time_frame>
    <description>Reported as the number of patients that answer &quot;Yes&quot; to question: 'Would you have the surgery again?'</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Post-Traumatic Neuralgia</condition>
  <condition>Occipital Neuralgia</condition>
  <arm_group>
    <arm_group_label>Continued maximal medical management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical occipital nerve neurolysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Occipital neurolysis</intervention_name>
    <description>Surgical occipital nerve decompression</description>
    <arm_group_label>Surgical occipital nerve neurolysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of head or neck trauma as an inciting event for occipital headaches&#xD;
&#xD;
          -  Occipital neuralgia headache, as diagnosed by neurologist, and as defined by the&#xD;
             International Classification of Headache Disorders (ICHD-3). 13.4 - occipital&#xD;
             neuralgia:&#xD;
&#xD;
        Description:&#xD;
&#xD;
        Unilateral or bilateral paroxysmal, shooting or stabbing pain in the posterior part of the&#xD;
        scalp, in the distribution of the greater, lesser or third occipital nerves, sometimes&#xD;
        accompanied by diminished sensation or dysaesthesia in the affected area and commonly&#xD;
        associated with tenderness over the involved nerve(s).&#xD;
&#xD;
        Diagnostic criteria:&#xD;
&#xD;
          -  Unilateral or bilateral pain fulfilling criteria B-E&#xD;
&#xD;
          -  Pain is located in the distribution of the greater, lesser and/or third occipital&#xD;
             nerves&#xD;
&#xD;
          -  Pain has two of the following three characteristics:&#xD;
&#xD;
               -  recurring in paroxysmal attacks lasting from a few seconds to minutes&#xD;
&#xD;
               -  severe intensity&#xD;
&#xD;
               -  shooting, stabbing or sharp in quality&#xD;
&#xD;
          -  Pain is associated with both of the following:&#xD;
&#xD;
               -  dysaesthesia and/or allodynia apparent during innocuous stimulation of the scalp&#xD;
                  and/or hair&#xD;
&#xD;
          -  either or both of the following:&#xD;
&#xD;
               -  tenderness over the affected nerve branches&#xD;
&#xD;
               -  trigger points at the emergence of the greater occipital nerve or in the area of&#xD;
                  distribution of C2&#xD;
&#xD;
          -  Pain is eased temporarily by local anaesthetic block of the affected nerve&#xD;
&#xD;
          -  Not better accounted for by another ICHD-3 diagnosis.&#xD;
&#xD;
        Comments:&#xD;
&#xD;
        The pain of 13.4 Occipital neuralgia may reach the fronto-orbital area through&#xD;
        trigeminocervical interneuronal connections in the trigeminal spinal nuclei.&#xD;
&#xD;
        13.4 Occipital neuralgia must be distinguished from occipital referral of pain arising from&#xD;
        the atlantoaxial or upper zygapophyseal joints or from tender trigger points in neck&#xD;
        muscles or their insertions.&#xD;
&#xD;
          -  Age: 18-65&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Headache of any etiology other than specified in the inclusion criteria.&#xD;
&#xD;
          -  Patients with occipital referral of pain arising from the atlantoaxial or upper&#xD;
             zygapophyseal joints or from tender trigger points in neck muscles or their insertions&#xD;
&#xD;
          -  Pregnant or breastfeeding females&#xD;
&#xD;
          -  Patients with significant comorbidities including short life expectancy, malignancy,&#xD;
             degenerative central nervous system diseases, infection, severe psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amir Dorafshar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03253523
org study id: IRB00148116
nct id: NCT03253523
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Occipital neuralgia and subsequent headaches are associated with significant morbidity and
      impact quality of life and ability to work. Treatment is primarily medical and consists of
      non-steroidal anti-inflammatory medications and medications to treat neuropathic pain. Many
      patient exhaust medical management options and suffer from persistent symptoms.

      Surgical management of chronic headaches including occipital neuralgia is emerging as a tool
      to relieve pain and the burden of morbidity associated with this condition. Dr. Bahman
      Guyuron has been reporting positive results in the literature for the past 20 years. In a
      systematic review of 14 papers it has been demonstrated that peripheral nerve surgery for
      migraines is effective and leads to an improvement of symptoms for 86% of patients.
      Complication rates were low across all studies included. Additionally, Dr Ivica Ducic has
      reported success specifically treating occipital neuralgia headaches, with significant
      improvements in subjective pain outcomes post-operatively. The mechanism behind this is
      thought to be similar to carpal tunnel syndrome, whereby peripheral nerve compression causes
      nerve irritation and pain. The ensuing inflammatory response to tissue injury can cause
      sensitization of nociceptors, resulting in hyperalgesia or allodynia. Surgical release of
      tight surrounding soft tissues results in nerve decompression and relief of symptoms.

      Although there are multiple case series and empiric evidence supporting the safety and
      efficacy of occipital migraine surgery, there are no randomized controlled studies comparing
      surgical intervention with continued medical management.

      As part of the present study, the investigators intend to randomize patients who have
      exhausted maximal medical treatment of post-traumatic occipital headaches to either a
      surgical management group or a continued medical management group. Surgical intervention will
      consist of neurolysis, or release, of the occipital nerves.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average visual analogue scale of pain intensity
time frame: 6 months
description: Assess patient's average headache on a visual analog scale from 1-10, 10 being the worst pain
measure: Headache days per month
time frame: 6 months
description: Assess patient-reported number of days with headaches per month, in days
measure: Duration of average headache
time frame: 6 months
description: Assess patient-reported average duration of headaches, in hours
measure: Change in Migraine Headache Index (the multiple of scores 1-3) at 6 months
time frame: from baseline to 6 months
description: The Migraine Headache Index (MHI) is a commonly used metric in the plastic and reconstructive surgery literature to assess pre- and postoperative headache severity. The score is a product of headache duration (in days), frequency (in days per month), and severity (on a scale from 1 to 10). The score ranges from 0 to 300, with higher scores corresponding to worse migraine symptoms. Change in MHI score between pre-operative and 6-month postoperatively will be assessed.
measure: Subjective patient recorded outcomes of quality of life
time frame: 6 months
description: Assessment of quality of life using the Headache Impact Test (HIT-6) tool. The scores range from 36 to 78, with scores over 50 indicating some degree of impact of headaches on quality of life.
measure: Medication intake
time frame: 6 months
description: Patient-reported average intake of analgesic medications for occipital neuralgia pain
measure: Engagement in activity pre- and post-operatively
time frame: 6 months
description: Patient-reported ability to return to daily work and recreational activities. Outcome will be measured in days per month when patient stays home and is unable to work or otherwise engage in recreational activities secondary to migraine symptoms.
measure: Patient satisfaction
time frame: 6 months
description: Reported as the number of patients that answer "Yes" to question: 'Would you have the surgery again?'
arm group label: Continued maximal medical management
arm group type: No Intervention
arm group label: Surgical occipital nerve neurolysis
arm group type: Experimental
intervention type: Procedure
intervention name: Occipital neurolysis
description: Surgical occipital nerve decompression
arm group label: Surgical occipital nerve neurolysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Amir Dorafshar
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neuralgia