<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/NCT03833011</url>
  </required_header>
  <id_info>
    <org_study_id>FHMCSURG01</org_study_id>
    <nct_id>NCT03833011</nct_id>
  </id_info>
  <brief_title>Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery</brief_title>
  <official_title>Postoperative Osteopathic Manipulative Treatment in Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MediSys Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MediSys Health Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Context Pain control is one of the most challenging problems encountered in postoperative&#xD;
      period in bariatric patients. Currently there are no published studies evaluating Osteopathic&#xD;
      Manipulative Treatment in bariatric surgery patients.&#xD;
&#xD;
      Objective The primary objective of this study is to determine whether Osteopathic&#xD;
      Manipulative Treatment (OMT) can decrease pain score in bariatric patients. The secondary&#xD;
      objective is whether OMT can improve patient satisfaction with overall treatment.&#xD;
&#xD;
      Design: A prospective randomized group controlled study.&#xD;
&#xD;
      Setting: A 293-bed non-for-profit teaching community hospital.&#xD;
&#xD;
      Methods Thirty-six patients scheduled for bariatric surgery as per ASMBS criteria were&#xD;
      eligible for study from January 2017 through August 2018 at Flushing Hospital Medical Center,&#xD;
      New York. Twelve patients were excluded.&#xD;
&#xD;
      Twenty-four patients were included into study and randomized to receive OMT(n=12) vs Control&#xD;
      (n=12) intervention.&#xD;
&#xD;
      In Control group, patients received standard pain control protocol with morphine patient&#xD;
      controlled analgesia pump (PCA) In OMT group, patients received standard postoperative pain&#xD;
      protocol and OMT on postoperative day one. Three techniques were used (Sub-occipital Release,&#xD;
      Thoracic Outlet Release, and Rib Raising). All patients received survey to complete prior to&#xD;
      discharge measuring pain score (1-10), patient satisfaction score 1-4 (poor, fair, good,&#xD;
      excellent) and data was analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain score</measure>
    <time_frame>pre-intervention, post-op day 1, post-op day 2</time_frame>
    <description>subjective measure of pain on a scale of 1-10</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Pain</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteopathic manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Osteopathic Manipulation</intervention_name>
    <description>Osteopathic manipulation</description>
    <arm_group_label>Osteopathic manipulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adults age 18 and older eligible for bariatric surgery as per American Society for&#xD;
             Metabolic and Bariatric Surgery guidelines:&#xD;
&#xD;
          -  BMI of at least 40, or greater than 100 pounds overweight.&#xD;
&#xD;
          -  BMI of 35 or above and at least one or more obesity-related comorbidity such as type&#xD;
             II diabetes, hypertension, sleep apnea and other respiratory disorders, non-alcoholic&#xD;
             fatty liver disease, lipid abnormalities, gastrointestinal disorders, heart disease,&#xD;
             or osteoarthritis.&#xD;
&#xD;
          -  Inability to achieve a healthy weight loss sustained for a period of time with prior&#xD;
             weight loss efforts.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age less than 18.&#xD;
&#xD;
          -  Pregnant patients.&#xD;
&#xD;
          -  Patients with history of chronic pain.&#xD;
&#xD;
          -  Patients with diagnosed psychiatric disorders.&#xD;
&#xD;
          -  Patients actively taking pain medication before surgery.&#xD;
&#xD;
          -  Patients with prior surgical history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Flushing Hospital</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833011
org study id: FHMCSURG01
nct id: NCT03833011
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Context Pain control is one of the most challenging problems encountered in postoperative
      period in bariatric patients. Currently there are no published studies evaluating Osteopathic
      Manipulative Treatment in bariatric surgery patients.

      Objective The primary objective of this study is to determine whether Osteopathic
      Manipulative Treatment (OMT) can decrease pain score in bariatric patients. The secondary
      objective is whether OMT can improve patient satisfaction with overall treatment.

      Design: A prospective randomized group controlled study.

      Setting: A 293-bed non-for-profit teaching community hospital.

      Methods Thirty-six patients scheduled for bariatric surgery as per ASMBS criteria were
      eligible for study from January 2017 through August 2018 at Flushing Hospital Medical Center,
      New York. Twelve patients were excluded.

      Twenty-four patients were included into study and randomized to receive OMT(n=12) vs Control
      (n=12) intervention.

      In Control group, patients received standard pain control protocol with morphine patient
      controlled analgesia pump (PCA) In OMT group, patients received standard postoperative pain
      protocol and OMT on postoperative day one. Three techniques were used (Sub-occipital Release,
      Thoracic Outlet Release, and Rib Raising). All patients received survey to complete prior to
      discharge measuring pain score (1-10), patient satisfaction score 1-4 (poor, fair, good,
      excellent) and data was analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in pain score
time frame: pre-intervention, post-op day 1, post-op day 2
description: subjective measure of pain on a scale of 1-10
arm group label: no intervention
arm group type: No Intervention
arm group label: Osteopathic manipulation
arm group type: Experimental
intervention type: Procedure
intervention name: Osteopathic Manipulation
description: Osteopathic manipulation
arm group label: Osteopathic manipulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No