<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/NCT01704625</url>
  </required_header>
  <id_info>
    <org_study_id>11-013</org_study_id>
    <nct_id>NCT01704625</nct_id>
  </id_info>
  <brief_title>Will the Use of Osteopathic Manipulative Treatments Help Alleviate Headache Pain</brief_title>
  <official_title>Will the Use of Osteopathic Manipulative Treatments on Patients With Headache in the Emergency Department Result in Decreased Pain on 100 Point Pain Scale?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Good Samaritan Hospital Medical Center, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Good Samaritan Hospital Medical Center, New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PURPOSE The purpose of this research is to determine whether osteopathic manipulative therapy&#xD;
      (OMT) is a useful adjunct in evaluation and treatment of headaches.&#xD;
&#xD;
      PROCEDURES If a practitioner determines that a patient has a significant headache he/she may&#xD;
      order tests. He/ She may give the patient medications to treat the headache.&#xD;
&#xD;
      The investigators will also ask permission to evaluate and treat the headache using&#xD;
      osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation&#xD;
      and treatment will be performed by an emergency medicine resident. Osteopathic evaluation and&#xD;
      OMT is not standard of care for this condition. The investigators also may call the patient&#xD;
      in 7 days to see how they are doing.&#xD;
&#xD;
      The investigators wish to see if emergency medicine physicians can use osteopathic evaluation&#xD;
      and OMT to reliably treat headaches. The results of the examination and treatment will be&#xD;
      recorded, but will not be used to change treatment or to change additional tests. The&#xD;
      investigators wish to see whether in the future they can use OMT in certain cases instead of&#xD;
      or in conjunction with medications. The investigators plan on asking 50 patients to&#xD;
      participate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Will the Use of Osteopathic Manipulative Treatments on Patients with Headache in the&#xD;
      Emergency Department Result in Decreased Pain on 100 Point Pain Scale? PROTOCOL&#xD;
&#xD;
      Patients will be triaged to the appropriate part of the Emergency Department in the usual&#xD;
      fashion. A healthcare provider will evaluate the patient and if the patient's chief complaint&#xD;
      is headache the provider will determine if they are a candidate for the study utilizing&#xD;
      exclusion criteria for the study TABLE 1.&#xD;
&#xD;
      ___ Table 1. Exclusion Criteria for the Study&#xD;
&#xD;
        -  Temperature 100.4 or greater&#xD;
&#xD;
        -  Healthcare provider suspects meningitis, brain abscess, encephalitis&#xD;
&#xD;
        -  Altered mental status&#xD;
&#xD;
        -  History of trauma&#xD;
&#xD;
        -  Cyclic vomiting&#xD;
&#xD;
        -  Abdominal migraines&#xD;
&#xD;
        -  Analgesic medication taken prior to treatment within an hour&#xD;
&#xD;
        -  Providing physician suspects intracranial hemorrhage&#xD;
&#xD;
        -  Focal deficits or other neurological abnormalities that lead providing physician to&#xD;
           suspect a pathologic process in which osteopathic treatment would not be safe for the&#xD;
           patient&#xD;
&#xD;
        -  Providing physician feels osteopathic treatment would not be safe for the patient&#xD;
&#xD;
      If patients have none of the above criteria, they may be selected for the study by the&#xD;
      Providing Physician.&#xD;
&#xD;
      The provider will ask the patient to rate their initial pain by drawing a vertical line on&#xD;
      the 100 mm visual analog scale (VAS) on the Physician Provider Data Form.&#xD;
&#xD;
      The provider will then alert an osteopathic emergency medicine resident to enroll the patient&#xD;
      into the study. The resident will then obtain informed consent from the patient and will then&#xD;
      take an envelope containing a piece of paper stating whether the patient is to receive the&#xD;
      actual osteopathic treatment or if the patient will receive placebo/sham treatment.&#xD;
&#xD;
      Treatment will be performed by osteopathic emergency medicine residents. Each resident has&#xD;
      undergone training in Osteopathic Manipulative Techniques (OMT) in their respective medical&#xD;
      schools and has fulfilled the requirements for competency in these techniques for graduation.&#xD;
&#xD;
      The osteopathic treatment group will have performed on them 3 standardized osteopathic&#xD;
      manipulative treatments. These treatments are muscle energy to the occipital area; muscle&#xD;
      energy to the paraspinal muscles bilaterally and facilitated positional release without axial&#xD;
      compression. If at any time the patient is unable to tolerate a treatment secondary to pain&#xD;
      that particular study will be stopped. At no time will the patient's medical treatment in the&#xD;
      emergency department be delayed to perform OMT.For example, if the patient's nurse enters the&#xD;
      room with medication, the study will be stopped and patient will not be included in the&#xD;
      study. The sham group will receive 3 sham treatments. The patient consent form and&#xD;
      information as to whether or not the patient received osteopathic manipulative treatment will&#xD;
      be kept in a locked file. The information will be transferred to a password-protected&#xD;
      computer file.&#xD;
&#xD;
      After the standardized treatment or sham treatment is performed, the resident will leave the&#xD;
      patient and the providing physician will then ask the patient to draw a vertical line on the&#xD;
      VAS to again rate their pain.&#xD;
&#xD;
      The providing physician will then place the data form into the envelope that also contains&#xD;
      the information about whether the patient received the osteopathic treatment vs. the sham&#xD;
      treatment, without seeing the actual information.&#xD;
&#xD;
      Data will then be analyzed and kept in a password-protected file.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Headache Pain as Measured by a VAS</measure>
    <time_frame>Immediately before and after intervention (less than 30 minutes)</time_frame>
    <description>The primary outcome will be the change in pain before and immediately after intervention as measured by a 100 mm visual analog scale (VAS) for pain in patients with headaches that meet the inclusion criteria.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Headache</condition>
  <arm_group>
    <arm_group_label>Osteopathic Manipulative Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The osteopathic treatment group will have performed on them 3 standardized osteopathic manipulative treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Osteopathic Manipulative Treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The sham group will receive 3 sham treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Osteopathic Manipulative Treatment</intervention_name>
    <description>The investigators wish to see if emergency medicine physicians can use osteopathic evaluation and OMT to reliably treat headaches. The results of the examination and treatment will be recorded, but will not be used to change treatment or to change additional tests.</description>
    <arm_group_label>Osteopathic Manipulative Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Osteopathic Manipulative Treatment</intervention_name>
    <description>The sham group will receive 3 sham treatments.</description>
    <arm_group_label>Sham Osteopathic Manipulative Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be triaged to the appropriate part of the Emergency Department in the usual&#xD;
        fashion. A healthcare provider will evaluate the patient and if the patient's chief&#xD;
        complaint is headache the provider will determine if they are a candidate for the study&#xD;
        utilizing exclusion criteria for the study -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria for the Study&#xD;
&#xD;
        Temperature 100.4 or greater&#xD;
&#xD;
        Healthcare provider suspects meningitis, brain abscess, encephalitis&#xD;
&#xD;
        Altered mental status&#xD;
&#xD;
        History of trauma&#xD;
&#xD;
        Cyclic vomiting&#xD;
&#xD;
        Abdominal migraines&#xD;
&#xD;
        Analgesic medication taken prior to treatment within an hour&#xD;
&#xD;
        Providing physician suspects intracranial hemorrhage&#xD;
&#xD;
        Focal deficits or other neurological abnormalities that lead providing physician to suspect&#xD;
        a pathologic process in which osteopathic treatment would not be safe for the patient&#xD;
&#xD;
        Providing physician feels osteopathic treatment would not be safe for the patient&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Genevieve McGerald, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Good Samaritan Hospital Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ronald Dvorkin, MD</last_name>
    <phone>631-376-4094</phone>
    <email>ronald.dvorkin@chsli.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Genevieve McGerald, DO</last_name>
    <phone>631-376-4094</phone>
    <email>genevieve.mcgerald@chsli.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Good Samaritan Hospital Medical Center</name>
      <address>
        <city>West Islip</city>
        <state>New York</state>
        <zip>11795</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Genevieve McGerald, DO</last_name>
      <phone>631-376-4094</phone>
      <email>genevieve.mcgerald@chsli.org</email>
    </contact>
    <contact_backup>
      <last_name>Ronald Dvorkin, MD</last_name>
      <phone>631-376-4094</phone>
      <email>ronald.dvorkin@chsli.org</email>
    </contact_backup>
    <investigator>
      <last_name>Genevieve McGerald, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ronald Dvorkin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jacob Bair, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laura Fil, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Donie Marie Sergerivas, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shannon Weinstein, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>headache</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704625
org study id: 11-013
nct id: NCT01704625
lead sponsor: 
has dmc: No
PURPOSE The purpose of this research is to determine whether osteopathic manipulative therapy
      (OMT) is a useful adjunct in evaluation and treatment of headaches.

      PROCEDURES If a practitioner determines that a patient has a significant headache he/she may
      order tests. He/ She may give the patient medications to treat the headache.

      The investigators will also ask permission to evaluate and treat the headache using
      osteopathic evaluation and Osteopathic Manipulative Treatment (OMT). The bedside evaluation
      and treatment will be performed by an emergency medicine resident. Osteopathic evaluation and
      OMT is not standard of care for this condition. The investigators also may call the patient
      in 7 days to see how they are doing.

      The investigators wish to see if emergency medicine physicians can use osteopathic evaluation
      and OMT to reliably treat headaches. The results of the examination and treatment will be
      recorded, but will not be used to change treatment or to change additional tests. The
      investigators wish to see whether in the future they can use OMT in certain cases instead of
      or in conjunction with medications. The investigators plan on asking 50 patients to
      participate.
Will the Use of Osteopathic Manipulative Treatments on Patients with Headache in the
      Emergency Department Result in Decreased Pain on 100 Point Pain Scale? PROTOCOL

      Patients will be triaged to the appropriate part of the Emergency Department in the usual
      fashion. A healthcare provider will evaluate the patient and if the patient's chief complaint
      is headache the provider will determine if they are a candidate for the study utilizing
      exclusion criteria for the study TABLE 1.

      ___ Table 1. Exclusion Criteria for the Study

        -  Temperature 100.4 or greater

        -  Healthcare provider suspects meningitis, brain abscess, encephalitis

        -  Altered mental status

        -  History of trauma

        -  Cyclic vomiting

        -  Abdominal migraines

        -  Analgesic medication taken prior to treatment within an hour

        -  Providing physician suspects intracranial hemorrhage

        -  Focal deficits or other neurological abnormalities that lead providing physician to
           suspect a pathologic process in which osteopathic treatment would not be safe for the
           patient

        -  Providing physician feels osteopathic treatment would not be safe for the patient

      If patients have none of the above criteria, they may be selected for the study by the
      Providing Physician.

      The provider will ask the patient to rate their initial pain by drawing a vertical line on
      the 100 mm visual analog scale (VAS) on the Physician Provider Data Form.

      The provider will then alert an osteopathic emergency medicine resident to enroll the patient
      into the study. The resident will then obtain informed consent from the patient and will then
      take an envelope containing a piece of paper stating whether the patient is to receive the
      actual osteopathic treatment or if the patient will receive placebo/sham treatment.

      Treatment will be performed by osteopathic emergency medicine residents. Each resident has
      undergone training in Osteopathic Manipulative Techniques (OMT) in their respective medical
      schools and has fulfilled the requirements for competency in these techniques for graduation.

      The osteopathic treatment group will have performed on them 3 standardized osteopathic
      manipulative treatments. These treatments are muscle energy to the occipital area; muscle
      energy to the paraspinal muscles bilaterally and facilitated positional release without axial
      compression. If at any time the patient is unable to tolerate a treatment secondary to pain
      that particular study will be stopped. At no time will the patient's medical treatment in the
      emergency department be delayed to perform OMT.For example, if the patient's nurse enters the
      room with medication, the study will be stopped and patient will not be included in the
      study. The sham group will receive 3 sham treatments. The patient consent form and
      information as to whether or not the patient received osteopathic manipulative treatment will
      be kept in a locked file. The information will be transferred to a password-protected
      computer file.

      After the standardized treatment or sham treatment is performed, the resident will leave the
      patient and the providing physician will then ask the patient to draw a vertical line on the
      VAS to again rate their pain.

      The providing physician will then place the data form into the envelope that also contains
      the information about whether the patient received the osteopathic treatment vs. the sham
      treatment, without seeing the actual information.

      Data will then be analyzed and kept in a password-protected file.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Headache Pain as Measured by a VAS
time frame: Immediately before and after intervention (less than 30 minutes)
description: The primary outcome will be the change in pain before and immediately after intervention as measured by a 100 mm visual analog scale (VAS) for pain in patients with headaches that meet the inclusion criteria.
arm group label: Osteopathic Manipulative Treatment
arm group type: Experimental
description: The osteopathic treatment group will have performed on them 3 standardized osteopathic manipulative treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT
arm group label: Sham Osteopathic Manipulative Treatment
arm group type: Sham Comparator
description: The sham group will receive 3 sham treatments. If at any time the patient is unable to tolerate a treatment secondary to pain that particular study will be stopped. If the patient's nurse enters the room with medication, the study will be stopped and patient will not be included in the study. At no time will the patient's medical treatment in the emergency department be delayed to perform OMT.
intervention type: Procedure
intervention name: Osteopathic Manipulative Treatment
description: The investigators wish to see if emergency medicine physicians can use osteopathic evaluation and OMT to reliably treat headaches. The results of the examination and treatment will be recorded, but will not be used to change treatment or to change additional tests.
arm group label: Osteopathic Manipulative Treatment
intervention type: Procedure
intervention name: Sham Osteopathic Manipulative Treatment
description: The sham group will receive 3 sham treatments.
arm group label: Sham Osteopathic Manipulative Treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Genevieve McGerald, DO
role: Principal Investigator
affiliation: Good Samaritan Hospital Medical Center
last name: Ronald Dvorkin, MD
phone: 631-376-4094
email: ronald.dvorkin@chsli.org
last name: Genevieve McGerald, DO
phone: 631-376-4094
email: genevieve.mcgerald@chsli.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Headache