<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/NCT01670825</url>
  </required_header>
  <id_info>
    <org_study_id>373481-3</org_study_id>
    <nct_id>NCT01670825</nct_id>
  </id_info>
  <brief_title>Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia</brief_title>
  <official_title>Randomized, Double-blind, Comparative-effectiveness Study Comparing Corticosteroid Injections to Pulsed Radiofrequency for Occipital Neuralgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Landstuhl Regional Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Madigan Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Naval Medical Center, Portsmouth</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether pulsed radiofrequency or steroids are better&#xD;
      for occipital neuralgia. Seventy-six patients with ON or migraine with tenderness over the&#xD;
      occipital nerve who respond to occipital nerve blocks (hereafter included under the broad&#xD;
      category &quot;ON&quot;) will be randomized in a 1:1 ratio to receive either corticosteroid and local&#xD;
      anesthetic injections (n=38) or local anesthetic and PRF of the occipital nerve(s) (n=38) for&#xD;
      occipital neuralgia. Both patients and the treating &amp; evaluating physicians will be blinded.&#xD;
      The first follow-up visit will be at 6 weeks. Patients who obtain significant pain relief&#xD;
      will remain in the study. Those patients who fail to obtain any benefit will exit the study&#xD;
      and be allowed to crossover to the other treatments or receive alternative care. The second&#xD;
      follow-up will be at 3 months and the final follow-up will be at 6-months post-procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 76 patients referred to one of the participating pain clinic with occipital neuralgia,&#xD;
      or migraines with occipital nerve tenderness (dual diagnoses) will be randomized in a 1:1&#xD;
      ratio by a computer generated randomization table to receive one of two treatments.&#xD;
      Treatments will be randomized at each institution. Within each group, those patients with&#xD;
      plain occipital neuralgia, and those with occipital neuralgia with migraines, will be&#xD;
      sub-randomized in the same 1:1 ratio. Diagnosis of ON will be made by low-volume (&lt; 3 mL&#xD;
      bupivacaine per nerve). Our criterion for a positive response will be &gt; 50% pain relief&#xD;
      lasting at least 3 hours. Those individuals who have symptoms in the distribution of both the&#xD;
      greater and lesser occipital nerves will receive treatment of both nerves. The greater&#xD;
      occipital nerve is more frequently affected than the lesser nerve.&#xD;
&#xD;
      Half (n=38) of the patients will be allocated to receive local anesthetic &amp; corticosteroid&#xD;
      injections at each nerve (group I), with an equal number allocated to receive local&#xD;
      anesthetic &amp; PRF at each (group II). In those patients who request sedation, an intravenous&#xD;
      will be inserted and light sedation administered with low doses of midazolam and fentanyl, in&#xD;
      accordance with our standard clinic practice. Treatment in all patients will be accomplished&#xD;
      using 20-gauge radiofrequency needles with 10 mm active tips. Prior to treating, electrical&#xD;
      stimulation will be performed to ensure ample proximity to the targeted nerve(s), with our&#xD;
      target threshold being concordant stimulation at &lt; 0.3 volts at each site.&#xD;
&#xD;
      Once proper needle position is ensured, those in group I will receive an injection at each&#xD;
      nerve containing 30 mg of depomethylprednisolone mixed with 2 mL of a 50:50 mixture of 2%&#xD;
      lidocaine and 0.5% bupivacaine (2.75 mL). Anywhere between 1 and 4 nerves can be injected,&#xD;
      with 4 nerves being targeted if a patient had bilateral lesser and greater occipital nerve&#xD;
      involvement. This will be followed by 3 cycles of sham PRF at 120 s per cycle, with slight&#xD;
      (approximately 30o electrode adjustments between cycles. For sham PRF, no electrical field or&#xD;
      heat is generated (i.e. the machine is not set to any radiofrequency cycle after&#xD;
      stimulation), but the cycle times (120 s per cycle) are adhered to (i.e. we will wait a total&#xD;
      of 6&quot;, 2&quot; per cycle). Those patients in group II will receive injections at each nerve&#xD;
      containing 2.75 mL of a solution with 2 mL of 50:50 2% lidocaine and 0.5% bupivacaine + 0.75&#xD;
      mL saline (2.75 mL), followed by 3 cycles of PRF using the following standard settings:&#xD;
      voltage output 40-60 V; 2 Hz frequency; 20 ms pulses in a 1-second cycle, 120 second duration&#xD;
      per cycle; impedance range between 150 and 400 Ohms; and 42o C plateau temperature.&#xD;
&#xD;
      No patient will be prescribed additional medications or therapy between their procedure and&#xD;
      first follow-up. However, they will be allowed to remain on their current, stable analgesic&#xD;
      regimen. Rescue medications will consist of tramadol 50 mg 1 to 2 tablets every 6 hours PRN&#xD;
      (up to 8/d) and/or acetaminophen or a non-steroidal anti-inflammatory drug such as ibuprofen,&#xD;
      diclofenac or ketorolac on an &quot;as needed&quot; basis.&#xD;
&#xD;
      Follow-ups will be performed by a physician blinded to treatment allocation. A preliminary&#xD;
      follow-up will be performed at weeks. The first full follow-up visit will be scheduled&#xD;
      6-weeks from the start of treatment. A positive outcome will be defined as a &gt; 50% decrease&#xD;
      in headache coupled with a positive satisfaction rating (&gt; 3 on a 0-5 scale). Subjects who&#xD;
      obtain a positive outcome at their initial 6-week follow-up visit will remain in the study&#xD;
      and return for their 3-month follow-up visit. Those with a negative outcome will exit the&#xD;
      study &quot;per protocol&quot; to receive standard care. Subjects who obtain a positive outcome at&#xD;
      1-month but experience a recurrence before their 3-month follow-up visit will also exit the&#xD;
      study per protocol, with their final outcome measures recorded before they receive standard&#xD;
      care. Those who obtain a positive outcome at 3-months will remain in the study for their&#xD;
      final 6-month follow-up, while those who obtain a negative outcome will exit the study.&#xD;
      Unblinding for both patients and the treating physician will be after the patient exits the&#xD;
      study or after their final follow-up visit for those with continued benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Average Occipital Pain 6 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Worst Occipital Pain 6 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Average Occipital Pain 6 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Worst Occipital Pain 6 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Average Occipital Pain 3 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Worst Occipital Pain 3 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Average Occipital Pain 2 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Worst Occipital Pain 2 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Average Headache Pain 3 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Worst Headache Pain 3 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Average Headache Pain 6 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Overall Worst Headache Pain 6 Months After the Start of Treatment</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</measure>
    <time_frame>3 months</time_frame>
    <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale</measure>
    <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
    <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale</measure>
    <time_frame>From baseline to 3 months after the start of treatment</time_frame>
    <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale</measure>
    <time_frame>From baseline to 6 months after the start of treatment</time_frame>
    <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Occipital Neuralgia</condition>
  <arm_group>
    <arm_group_label>Pulsed radiofrequency + local anesthetic injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corticosteroid injection + sham pulsed radiofrequency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulsed radiofrequency</intervention_name>
    <description>Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
    <arm_group_label>Pulsed radiofrequency + local anesthetic injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid injection</intervention_name>
    <description>Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
    <arm_group_label>Corticosteroid injection + sham pulsed radiofrequency</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local anethestic injection</intervention_name>
    <arm_group_label>Corticosteroid injection + sham pulsed radiofrequency</arm_group_label>
    <arm_group_label>Pulsed radiofrequency + local anesthetic injection</arm_group_label>
    <other_name>Local anethestic injection that both arms will receive</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater or equal to 18 years&#xD;
&#xD;
          2. Occipital neuralgia diagnosed based on history &amp; physical exam and diagnostic local&#xD;
             anesthetic blocks, or migraine with occipital nerve(s) tenderness that responds to&#xD;
             diagnostic blocks.&#xD;
&#xD;
             a. Greater or equal to 50% relief based on diagnostic local anesthetic block of the&#xD;
             greater and/ or lesser occipital nerves that lasts for at least 90 minutes with&#xD;
             lidocaine or 3 hours with bupivacaine or ropivacaine 20&#xD;
&#xD;
          3. Baseline Numerical Rating Scale average pain score &gt; 4/10&#xD;
&#xD;
          4. Frequency of greater or equal to 4/10 pain for at least 10 days per month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Untreated coagulopathy&#xD;
&#xD;
          2. Automatic implantable cardiac defibrillator or pacemaker that cannot be temporarily&#xD;
             disabled for medical reasons&#xD;
&#xD;
          3. Previous pulsed radiofrequency&#xD;
&#xD;
          4. Other sources of headache, such as tension-type headache, cervicogenic headache,&#xD;
             migraine headache without occipital neuralgia, and other causes (e.g. tumors,&#xD;
             congenital abnormalities etc.). Those that can be confused with ON must be excluded&#xD;
             based on history and exam (e.g. cervicogenic headaches), symptoms (tension-type&#xD;
             headache), response to blocks (all of the above); and lab work (temporal arteritis,&#xD;
             which would be confirmed by biopsy after an elevated erythrocyte sedimentation rate).&#xD;
&#xD;
          5. Serious medical or uncontrolled or severe psychiatric -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Huang JH, Galvagno SM Jr, Hameed M, Wilkinson I, Erdek MA, Patel A, Buckenmaier C 3rd, Rosenberg J, Cohen SP. Occipital nerve pulsed radiofrequency treatment: a multi-center study evaluating predictors of outcome. Pain Med. 2012 Apr;13(4):489-97. doi: 10.1111/j.1526-4637.2012.01348.x. Epub 2012 Mar 5.</citation>
    <PMID>22390409</PMID>
  </reference>
  <reference>
    <citation>Vanelderen P, Rouwette T, De Vooght P, Puylaert M, Heylen R, Vissers K, Van Zundert J. Pulsed radiofrequency for the treatment of occipital neuralgia: a prospective study with 6 months of follow-up. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):148-51. doi: 10.1097/aap.0b013e3181d24713.</citation>
    <PMID>20301822</PMID>
  </reference>
  <reference>
    <citation>Choi HJ, Oh IH, Choi SK, Lim YJ. Clinical outcomes of pulsed radiofrequency neuromodulation for the treatment of occipital neuralgia. J Korean Neurosurg Soc. 2012 May;51(5):281-5. doi: 10.3340/jkns.2012.51.5.281. Epub 2012 May 31.</citation>
    <PMID>22792425</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <results_first_submitted>August 10, 2016</results_first_submitted>
  <results_first_submitted_qc>January 10, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2017</results_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Steven P. Cohen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Occipital neuralgia</keyword>
  <keyword>corticosteroid injection</keyword>
  <keyword>pulsed radiofrequency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
          <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
        </group>
        <group group_id="P2">
          <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
          <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
          <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
        </group>
        <group group_id="B2">
          <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
          <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="81"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.67" spread="10.72"/>
                    <measurement group_id="B2" value="41.08" spread="13.61"/>
                    <measurement group_id="B3" value="41.37" spread="12.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Average Occipital Pain 6 Weeks After the Start of Treatment</title>
        <description>The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Occipital Pain 6 Weeks After the Start of Treatment</title>
          <description>The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.068" spread="2.431"/>
                    <measurement group_id="O2" value="3.738" spread="2.415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Worst Occipital Pain 6 Weeks After the Start of Treatment</title>
        <description>The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve&#xD;
Local anethestic injection</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve&#xD;
Local anethestic injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Worst Occipital Pain 6 Weeks After the Start of Treatment</title>
          <description>The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.354" spread="3.165"/>
                    <measurement group_id="O2" value="6.064" spread="3.226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Average Occipital Pain 6 Months After the Start of Treatment</title>
        <description>The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Occipital Pain 6 Months After the Start of Treatment</title>
          <description>The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.312" spread="2.232"/>
                    <measurement group_id="O2" value="4.765" spread="1.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Worst Occipital Pain 6 Months After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Worst Occipital Pain 6 Months After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.705" spread="2.892"/>
                    <measurement group_id="O2" value="7.541" spread="2.416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Average Occipital Pain 3 Months After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Occipital Pain 3 Months After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.791" spread="2.573"/>
                    <measurement group_id="O2" value="4.441" spread="2.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Worst Occipital Pain 3 Months After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Worst Occipital Pain 3 Months After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.850" spread="3.292"/>
                    <measurement group_id="O2" value="7.149" spread="2.967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Average Occipital Pain 2 Weeks After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Occipital Pain 2 Weeks After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.495" spread="2.094"/>
                    <measurement group_id="O2" value="3.694" spread="2.221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Worst Occipital Pain 2 Weeks After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Worst Occipital Pain 2 Weeks After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.726" spread="2.528"/>
                    <measurement group_id="O2" value="5.846" spread="2.618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.392" spread="2.106"/>
                    <measurement group_id="O2" value="4.220" spread="2.496"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 2 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.540" spread="2.669"/>
                    <measurement group_id="O2" value="6.650" spread="2.744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.678" spread="2.448"/>
                    <measurement group_id="O2" value="4.410" spread="2.544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.583" spread="3.202"/>
                    <measurement group_id="O2" value="6.825" spread="3.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Average Headache Pain 3 Months After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Average Headache Pain 3 Months After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.000" spread="2.870"/>
                    <measurement group_id="O2" value="4.694" spread="2.480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Worst Headache Pain 3 Months After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Worst Headache Pain 3 Months After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.522" spread="3.232"/>
                    <measurement group_id="O2" value="7.417" spread="2.952"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Average Headache Pain 6 Months After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Average Headache Pain 6 Months After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.761" spread="3.096"/>
                    <measurement group_id="O2" value="7.556" spread="2.623"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Overall Worst Headache Pain 6 Months After the Start of Treatment</title>
        <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Worst Headache Pain 6 Months After the Start of Treatment</title>
          <description>This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.761" spread="3.096"/>
                    <measurement group_id="O2" value="7.556" spread="2.623"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.</title>
        <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.</title>
          <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.025" spread="5.972"/>
                    <measurement group_id="O2" value="8.132" spread="5.297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.</title>
        <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.</title>
          <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.539" spread="6.043"/>
                    <measurement group_id="O2" value="9.069" spread="5.955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.</title>
        <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.</title>
          <description>This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.256" spread="6.210"/>
                    <measurement group_id="O2" value="9.431" spread="5.765"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory</title>
        <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory</title>
          <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.775" spread="11.079"/>
                    <measurement group_id="O2" value="10.842" spread="9.945"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory</title>
        <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory</title>
          <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.333" spread="10.207"/>
                    <measurement group_id="O2" value="11.972" spread="10.287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory</title>
        <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory</title>
          <description>This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.590" spread="10.684"/>
                    <measurement group_id="O2" value="12.250" spread="10.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.</title>
        <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.</title>
          <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.708" spread="1.958"/>
                    <measurement group_id="O2" value="1.810" spread="2.421"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
        <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
          <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.436" spread="2.237"/>
                    <measurement group_id="O2" value="1.436" spread="2.087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
        <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
          <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.087" spread="2.109"/>
                    <measurement group_id="O2" value="2.263" spread="2.232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
        <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
          <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.846" spread="2.335"/>
                    <measurement group_id="O2" value="1.919" spread="2.046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
        <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
          <description>This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.044" spread="2.099"/>
                    <measurement group_id="O2" value="2.368" spread="2.409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
        <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit</title>
          <description>This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.128" spread="2.308"/>
                    <measurement group_id="O2" value="2.162" spread="2.154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale</title>
        <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
        <time_frame>From baseline to 6 weeks after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale</title>
          <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.087" spread="7.972"/>
                    <measurement group_id="O2" value="59.553" spread="9.093"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale</title>
        <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
        <time_frame>From baseline to 3 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale</title>
          <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.718" spread="9.761"/>
                    <measurement group_id="O2" value="60.556" spread="10.814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale</title>
        <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
        <time_frame>From baseline to 6 months after the start of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
            <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
          </group>
          <group group_id="O2">
            <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
            <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
          </group>
        </group_list>
        <measure>
          <title>Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale</title>
          <description>This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.641" spread="10.251"/>
                    <measurement group_id="O2" value="61.389" spread="8.800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Pulsed Radiofrequency + Local Anesthetic Injection</title>
          <description>Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve&#xD;
Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve</description>
        </group>
        <group group_id="E2">
          <title>Corticosteroid Injection + Sham Pulsed Radiofrequency</title>
          <description>Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus &quot;sham&quot; pulsed radiofrequency&#xD;
Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting/blurred vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Swelling at injection site</sub_title>
                <description>2 people in the steroid group had swelling at the injection site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizzines</sub_title>
                <description>1 person in the steroid group experienced dizziness after the procedure.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Worsening of headached</sub_title>
                <description>2 people in the steroid group and 1 in the PRF group experienced worsening of headache after procedure.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Steven Cohen</name_or_title>
      <organization>Johns Hopkins Hospital</organization>
      <phone>410-955-1818</phone>
      <email>scohen40@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01670825
org study id: 373481-3
nct id: NCT01670825
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is to determine whether pulsed radiofrequency or steroids are better
      for occipital neuralgia. Seventy-six patients with ON or migraine with tenderness over the
      occipital nerve who respond to occipital nerve blocks (hereafter included under the broad
      category "ON") will be randomized in a 1:1 ratio to receive either corticosteroid and local
      anesthetic injections (n=38) or local anesthetic and PRF of the occipital nerve(s) (n=38) for
      occipital neuralgia. Both patients and the treating & evaluating physicians will be blinded.
      The first follow-up visit will be at 6 weeks. Patients who obtain significant pain relief
      will remain in the study. Those patients who fail to obtain any benefit will exit the study
      and be allowed to crossover to the other treatments or receive alternative care. The second
      follow-up will be at 3 months and the final follow-up will be at 6-months post-procedure.
Up to 76 patients referred to one of the participating pain clinic with occipital neuralgia,
      or migraines with occipital nerve tenderness (dual diagnoses) will be randomized in a 1:1
      ratio by a computer generated randomization table to receive one of two treatments.
      Treatments will be randomized at each institution. Within each group, those patients with
      plain occipital neuralgia, and those with occipital neuralgia with migraines, will be
      sub-randomized in the same 1:1 ratio. Diagnosis of ON will be made by low-volume (< 3 mL
      bupivacaine per nerve). Our criterion for a positive response will be > 50% pain relief
      lasting at least 3 hours. Those individuals who have symptoms in the distribution of both the
      greater and lesser occipital nerves will receive treatment of both nerves. The greater
      occipital nerve is more frequently affected than the lesser nerve.

      Half (n=38) of the patients will be allocated to receive local anesthetic & corticosteroid
      injections at each nerve (group I), with an equal number allocated to receive local
      anesthetic & PRF at each (group II). In those patients who request sedation, an intravenous
      will be inserted and light sedation administered with low doses of midazolam and fentanyl, in
      accordance with our standard clinic practice. Treatment in all patients will be accomplished
      using 20-gauge radiofrequency needles with 10 mm active tips. Prior to treating, electrical
      stimulation will be performed to ensure ample proximity to the targeted nerve(s), with our
      target threshold being concordant stimulation at < 0.3 volts at each site.

      Once proper needle position is ensured, those in group I will receive an injection at each
      nerve containing 30 mg of depomethylprednisolone mixed with 2 mL of a 50:50 mixture of 2%
      lidocaine and 0.5% bupivacaine (2.75 mL). Anywhere between 1 and 4 nerves can be injected,
      with 4 nerves being targeted if a patient had bilateral lesser and greater occipital nerve
      involvement. This will be followed by 3 cycles of sham PRF at 120 s per cycle, with slight
      (approximately 30o electrode adjustments between cycles. For sham PRF, no electrical field or
      heat is generated (i.e. the machine is not set to any radiofrequency cycle after
      stimulation), but the cycle times (120 s per cycle) are adhered to (i.e. we will wait a total
      of 6", 2" per cycle). Those patients in group II will receive injections at each nerve
      containing 2.75 mL of a solution with 2 mL of 50:50 2% lidocaine and 0.5% bupivacaine + 0.75
      mL saline (2.75 mL), followed by 3 cycles of PRF using the following standard settings:
      voltage output 40-60 V; 2 Hz frequency; 20 ms pulses in a 1-second cycle, 120 second duration
      per cycle; impedance range between 150 and 400 Ohms; and 42o C plateau temperature.

      No patient will be prescribed additional medications or therapy between their procedure and
      first follow-up. However, they will be allowed to remain on their current, stable analgesic
      regimen. Rescue medications will consist of tramadol 50 mg 1 to 2 tablets every 6 hours PRN
      (up to 8/d) and/or acetaminophen or a non-steroidal anti-inflammatory drug such as ibuprofen,
      diclofenac or ketorolac on an "as needed" basis.

      Follow-ups will be performed by a physician blinded to treatment allocation. A preliminary
      follow-up will be performed at weeks. The first full follow-up visit will be scheduled
      6-weeks from the start of treatment. A positive outcome will be defined as a > 50% decrease
      in headache coupled with a positive satisfaction rating (> 3 on a 0-5 scale). Subjects who
      obtain a positive outcome at their initial 6-week follow-up visit will remain in the study
      and return for their 3-month follow-up visit. Those with a negative outcome will exit the
      study "per protocol" to receive standard care. Subjects who obtain a positive outcome at
      1-month but experience a recurrence before their 3-month follow-up visit will also exit the
      study per protocol, with their final outcome measures recorded before they receive standard
      care. Those who obtain a positive outcome at 3-months will remain in the study for their
      final 6-month follow-up, while those who obtain a negative outcome will exit the study.
      Unblinding for both patients and the treating physician will be after the patient exits the
      study or after their final follow-up visit for those with continued benefit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Average Occipital Pain 6 Weeks After the Start of Treatment
time frame: From baseline to 6 weeks after the start of treatment
description: The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Worst Occipital Pain 6 Weeks After the Start of Treatment
time frame: From baseline to 6 weeks after the start of treatment
description: The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Average Occipital Pain 6 Months After the Start of Treatment
time frame: From baseline to 6 months after the start of treatment
description: The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Worst Occipital Pain 6 Months After the Start of Treatment
time frame: From baseline to 6 months after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Average Occipital Pain 3 Months After the Start of Treatment
time frame: From baseline to 3 months after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Worst Occipital Pain 3 Months After the Start of Treatment
time frame: From baseline to 3 months after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Average Occipital Pain 2 Weeks After the Start of Treatment
time frame: From baseline to 2 weeks after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Worst Occipital Pain 2 Weeks After the Start of Treatment
time frame: From baseline to 2 weeks after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment
time frame: From baseline to 2 weeks after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment
time frame: From baseline to 2 weeks after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment
time frame: From baseline to 6 weeks after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment
time frame: From baseline to 6 weeks after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Average Headache Pain 3 Months After the Start of Treatment
time frame: From baseline to 3 months after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Worst Headache Pain 3 Months After the Start of Treatment
time frame: From baseline to 3 months after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Average Headache Pain 6 Months After the Start of Treatment
time frame: From baseline to 6 months after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in Overall Worst Headache Pain 6 Months After the Start of Treatment
time frame: From baseline to 6 months after the start of treatment
description: This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.
measure: Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.
time frame: From baseline to 6 weeks after the start of treatment
description: This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.
measure: Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.
time frame: From baseline to 3 months after the start of treatment
description: This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.
measure: Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.
time frame: From baseline to 6 months after the start of treatment
description: This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.
measure: Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory
time frame: From baseline to 6 weeks after the start of treatment
description: This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.
measure: Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory
time frame: From baseline to 3 months after the start of treatment
description: This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.
measure: Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory
time frame: From baseline to 6 months after the start of treatment
description: This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.
measure: Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.
time frame: From baseline to 6 weeks after the start of treatment
description: This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
measure: Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit
time frame: From baseline to 6 weeks after the start of treatment
description: This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
measure: Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit
time frame: From baseline to 3 months after the start of treatment
description: This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
measure: Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit
time frame: 3 months
description: This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
measure: Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit
time frame: From baseline to 6 months after the start of treatment
description: This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
measure: Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit
time frame: From baseline to 6 months after the start of treatment
description: This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.
measure: Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale
time frame: From baseline to 6 weeks after the start of treatment
description: This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.
measure: Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale
time frame: From baseline to 3 months after the start of treatment
description: This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.
measure: Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale
time frame: From baseline to 6 months after the start of treatment
description: This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.
arm group label: Pulsed radiofrequency + local anesthetic injection
arm group type: Experimental
description: Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
arm group label: Corticosteroid injection + sham pulsed radiofrequency
arm group type: Active Comparator
description: Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus "sham" pulsed radiofrequency
intervention type: Procedure
intervention name: Pulsed radiofrequency
description: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve
arm group label: Pulsed radiofrequency + local anesthetic injection
intervention type: Drug
intervention name: Corticosteroid injection
description: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve
arm group label: Corticosteroid injection + sham pulsed radiofrequency
intervention type: Drug
intervention name: Local anethestic injection
arm group label: Corticosteroid injection + sham pulsed radiofrequency
arm group label: Pulsed radiofrequency + local anesthetic injection
other name: Local anethestic injection that both arms will receive
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
facility: 
country: United States
citation: Huang JH, Galvagno SM Jr, Hameed M, Wilkinson I, Erdek MA, Patel A, Buckenmaier C 3rd, Rosenberg J, Cohen SP. Occipital nerve pulsed radiofrequency treatment: a multi-center study evaluating predictors of outcome. Pain Med. 2012 Apr;13(4):489-97. doi: 10.1111/j.1526-4637.2012.01348.x. Epub 2012 Mar 5.
PMID: 22390409
citation: Vanelderen P, Rouwette T, De Vooght P, Puylaert M, Heylen R, Vissers K, Van Zundert J. Pulsed radiofrequency for the treatment of occipital neuralgia: a prospective study with 6 months of follow-up. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):148-51. doi: 10.1097/aap.0b013e3181d24713.
PMID: 20301822
citation: Choi HJ, Oh IH, Choi SK, Lim YJ. Clinical outcomes of pulsed radiofrequency neuromodulation for the treatment of occipital neuralgia. J Korean Neurosurg Soc. 2012 May;51(5):281-5. doi: 10.3340/jkns.2012.51.5.281. Epub 2012 May 31.
PMID: 22792425
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Steven P. Cohen
investigator title: Professor
mesh term: Neuralgia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 