<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/NCT02232334</url>
  </required_header>
  <id_info>
    <org_study_id>Brown - 1</org_study_id>
    <nct_id>NCT02232334</nct_id>
  </id_info>
  <brief_title>Effects of Global Osteopathic Manual Treatments in Patients With Idiopathic Gastroparesis</brief_title>
  <official_title>Effects of Global Osteopathic Manual Treatments on Patients With Idiopathic Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kathleen Brannan Brown, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kathleen Brannan Brown, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Global osteopathic manual treatments will decrease the severity score of the Gastroparesis&#xD;
      Cardinal Symptom Index tool of patients with idiopathic gastroparesis.&#xD;
&#xD;
      In this longitudinal controlled pre-test post-test group design, subjects with idiopathic&#xD;
      gastroparesis (IG) will be utilized to see if global osteopathic manual treatments can&#xD;
      decrease their symptoms. Patients with IG suffer from varying degrees of nausea, vomiting and&#xD;
      abdominal pain secondary to delayed gastric emptying. There is no known cause for people&#xD;
      suffering from IG.&#xD;
&#xD;
      According to the power analysis, the population will be utilized as the experiment group and&#xD;
      the control group. The measuring tool to be used is the Gastroparesis Cardinal Symptom Index&#xD;
      (GCSI) which is the most widely used symptom score questionnaire for gastroparesis. The&#xD;
      subjects in the population will each fill out the GCSI initially and again after an two (2)&#xD;
      week period to measure their symptoms during a control period. The same subjects will then be&#xD;
      treated with global osteopathic manual treatments one (1) treatment every two (2) weeks for&#xD;
      four (4) weeks (day 1, 14, and 28). The GCSI will be filled out on the day of the first (1st)&#xD;
      treatment (which is the last day of the control period) and then two (2) weeks after the last&#xD;
      treatment (day 42). In order to reject the null hypothesis, with a p value of &lt; 0.05 and a&#xD;
      power of 0.8, a minimum of ten (10) subjects in the treatment group is required with a&#xD;
      treatment effect of 1 or more. A 'Treatment effect of 1' is defined by Cohen's d, where d =&#xD;
      mean difference/standard deviation.&#xD;
&#xD;
      It is expected that the results will show improvement of symptoms through the data collected&#xD;
      from the GCSI questionnaires in the treatment group. The results of this study could be&#xD;
      significant and contribute to the osteopathic community validating the effectiveness of&#xD;
      traditional osteopathic manual therapy as well as giving non-invasive options to people&#xD;
      suffering from the disease since those who struggle with it have minimal treatment&#xD;
      options--medicines with significant side effects, full or total stomach removal or gastric&#xD;
      electrical stimulator implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastroparesis is a disorder that presents with delayed gastric emptying, abdominal pain,&#xD;
      nausea, and vomiting. This condition can be found in people with complications from&#xD;
      diabetes-neuropathy of the vagus nerve and gastric surgery-damage to the vagus nerve. With&#xD;
      idiopathic gastroparesis (IG), the cause is poorly understood with theories suggesting viral&#xD;
      infections affecting gut motility, pyloric valve spasm as well as damage to the specialized&#xD;
      cells within the wall of the stomach. Unfortunately the treatment options are minimal for&#xD;
      people suffering from gastroparesis regardless of what type.&#xD;
&#xD;
      It is the action of food propulsion that is poorly understood in regards to IG - specifically&#xD;
      smooth muscle, autonomic and enteric nerves and specialized cells in the gut named&#xD;
      Interstitial Cells of Cajal (ICC). ICC are the pacemakers cells in the gut that conduct&#xD;
      motility.&#xD;
&#xD;
      The objective of this study is to normalize structural abnormalities in patients with&#xD;
      idiopathic gastroparesis with global osteopathic manual treatments, using a quantitative&#xD;
      research method with a longitudinal controlled pre-test post-test design.&#xD;
&#xD;
      The principal investigator (PI), having a background as an emergency medicine registered&#xD;
      nurse, has seen patients in the emergency department suffering from idiopathic gastroparesis.&#xD;
      The acute attacks appear intense and debilitating often requiring anti-nausea, pain and&#xD;
      anti-anxiety medications. As an osteopathic student, the PI would often wonder what could be&#xD;
      achieved with osteopathic manual treatments (OMT) to help these people in the emergency&#xD;
      department suffering from these symptoms.&#xD;
&#xD;
      Current treatment available for people suffering from gastroparesis is limited. In his&#xD;
      article, Gastroparesis - Current Concepts and Considerations (2008), Dr. Hasler, summarized&#xD;
      research and the different treatment options for gastroparesis. There are several medications&#xD;
      available for gastroparesis however as discussed by Dr. Hasler, the side effects from these&#xD;
      medications are significant.&#xD;
&#xD;
      There are invasive treatments, such as injection of botulinum toxin into the pyloric&#xD;
      sphincter, gastric electrical stimulator and gastric resection which have shown some&#xD;
      improvement in symptoms but carry heavy risks if utilized.&#xD;
&#xD;
      The research method used to determine if global osteopathic manual treatments can help&#xD;
      patients who suffer from idiopathic gastroparesis is a longitudinal pre-test post-test&#xD;
      controlled quantitative study. The tool used to measure data is the Gastroparesis Cardinal&#xD;
      Index Score (GCSI), which was created by Janssen Global Services, LLC. The GCSI is a reliable&#xD;
      and validated tool rating symptom intensity of fullness-early satiety, nausea-vomiting, and&#xD;
      bloating. The validation of this tool was tested with 169 subjects who filled out the GCSI&#xD;
      and those results were compared with clinician symptom ratings. Total scores of the GCSI were&#xD;
      &quot;responsive to changes in overall gastroparesis symptoms as assessed by clinicians (P =&#xD;
      0.0002) and patients (P = 0.002).&#xD;
&#xD;
      A minimum of ten (10) subjects are required for the population according to the power&#xD;
      analysis, and at lease twelve (12) subjects will be enrolled to account for the potential 20%&#xD;
      drop out rate. However, (20) twenty subjects will be the goal for recruitment for this study.&#xD;
      Approval from an Institutional Review Board (IRB) has been acquired through Aspire-IRB,&#xD;
      gastroenterologists and family medicine physicians in the Sonoma County and Santa Rosa&#xD;
      California area will be given recruitment letters and consent forms with study information to&#xD;
      give to patients who qualify for the study. Flyers will be distributed throughout the&#xD;
      community (grocery stores, community centers, pharmacies etc.). Social media might be&#xD;
      utilized to acquire subjects as there appears to be a strong presence of support groups&#xD;
      online of people with gastroparesis.&#xD;
&#xD;
      The entire population, during the control group period, will fill out the GCSI initially and&#xD;
      then again at two (2) weeks. Those subjects will transition to the experimental group period&#xD;
      of the study-the GCSI filled out on the last day of the control period will be used as the&#xD;
      first day of treatment GCSI results. IN the experiment period: the subjects will receive&#xD;
      three (3) separate global osteopathic manual treatments over four (4) weeks (day 1, 14, and&#xD;
      28). Two weeks after the third (3rd) treatment (day 42), the subjects will fill out the GCSI&#xD;
      a final time. The subjects are waiting two (2) weeks to allow for full integration of the&#xD;
      last treatment and the GCSI is designed to record the prior two (2) weeks of patients&#xD;
      symptoms.&#xD;
&#xD;
      The subjects in the population will be screened via email and or telephone assuring they meet&#xD;
      the inclusion/exclusion criteria. Once consented, each participant will be instructed to fill&#xD;
      out the first (1st) GCSI questionnaires and email the completed form back to the PI. The data&#xD;
      of the first GCSI completion establishes day one (1) of the two (2) week control period.&#xD;
      During the two (2) week control period, subjects are to continue their regular treatments for&#xD;
      IG (dietary, medicine). They are not to obtain any new therapies such as massage,&#xD;
      acupuncture, osteopathy or start any new conventional medical treatments. If there is an&#xD;
      acute attack requiring an emergency room visit, the subject will have to be excluded from the&#xD;
      study. At the end of the two (2) week period, those subjects will fill out the GCSI again and&#xD;
      those results will be anonymously stored for future data analysis. The subjects then will be&#xD;
      transitioned into the experimental period and assigned to have their first treatment. The&#xD;
      last day of the control period will start the experimental period. All treatments will occur&#xD;
      at the office/clinic of the PI in Santa Rosa California, USA. The PI will be working under&#xD;
      her massage practitioner license with malpractice insurance under Associated Bodywork and&#xD;
      Massage Professionals (ABMP) as well as Manual Therapy Insurance Plus through the Barral&#xD;
      Institute. Both of these institutions cover general and professional liability for massage&#xD;
      therapy as well as various forms of manual therapy.&#xD;
&#xD;
      At the first treatment, day one (1) of the experimental period, the GCSI (Appendix A) and&#xD;
      health history questionnaire (Appendix I) will have been completed. An anamnesis will be&#xD;
      taken and the subject will then be assessed and treated with a global osteopathic manual&#xD;
      treatment to treat the lesions found in the assessment. The data from the GCSI will be&#xD;
      collected and stored anonymously for data analysis. The lesions found in assessment and&#xD;
      techniques used to treat will be stored for use in discussion if appropriate. The process&#xD;
      will be repeated at two (2) weeks and four (4) weeks from the first (1st) visit for each&#xD;
      participant except without the GCSI and without the health questionnaire as it is only&#xD;
      required on the first visit. Each treatment will last ninety (90) minutes. To keep results as&#xD;
      consistent as possible, subjects will be seen at the same time of the day for each treatment.&#xD;
      The results from two (2) weeks and four (4) weeks will be stored for possible discussion. To&#xD;
      allow time for integration of the treatments each participant will fill out the GCSI two (2)&#xD;
      weeks after the fourth (4th) week of the experimental period. The data from all GCSI tools&#xD;
      filled out from the control and experimental periods will be sent to the PI via email for&#xD;
      data analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastroparesis Cardinal Symptom index</measure>
    <time_frame>56 days</time_frame>
    <description>The GCSI is a reliable and validated tool rating symptom intensity of fullness-early satiety, nausea-vomiting, and bloating. The validation of this tool was tested with 169 subjects who filled out the GCSI and those results were compared with clinician symptom ratings. Total scores of the GCSI were &quot;responsive to changes in overall gastroparesis symptoms as assessed by clinicians.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Idiopathic Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Osteopathic manual treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Global Osteopathic Manual treatment: each subject will be treated according to what restrictions or areas of poor mobility are found individually. No two subjects will receive the same overall treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control--no change in current treatment of subject</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The population will act as their own control prior to intervention of osteopathy, their will be a control period where the subject maintains current treatment of their gastroparesis. During that period they will fill out the GCSI measuring tool at the beginning of the control period and at the end. Those measurements will be compared to the GSCI results during the intervention period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Global Osteopathic Manual Treatment</intervention_name>
    <description>subtle manipulations of the body according to the methodology of osteopathic manual therapy will be the intervention on subjects in the study. The global treatments will take into consideration the past medical history of each subject as well as what is found on assessment. Focus is on the position, mobililty and quality of each subjects anatomy.</description>
    <arm_group_label>Osteopathic manual treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for the population is the following: English speaking females or&#xD;
             males between the ages of 18-65 with moderate to severe IG--diagnosed by a primary&#xD;
             physician or gastro-intestinal physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria for the population: diagnosis of gastroparesis with known cause:&#xD;
             secondary to diabetes, post surgical or isolated disorders of motility (Parkinson's&#xD;
             disease, non-obstructive pancreatic carcinoma, post-abdominal irradiation, atrophic&#xD;
             gastritis, celiac arterial occlusion, Crohn's disease, Chagas disease, varicella&#xD;
             zoster), active regular/daily marijuana users or have a diagnosis of cyclical&#xD;
             nausea/vomiting abdominal pain secondary to regular marijuana use, alcoholics, history&#xD;
             of gastrectomy or current gastric electrical stimulator implant, pregnancy, have any&#xD;
             schizoaffective or borderline personality disorder, or received osteopathic manual&#xD;
             treatment within the last year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kathleen B Brown, MSN, DOMP-candidate</last_name>
    <phone>707-659-6090</phone>
    <email>Kathleenbrannanbrown@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kathleen Brannan Brown INC</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen B Brown, MSN, DOMP candidate</last_name>
      <phone>7076596090</phone>
      <email>kathleenbrannanbrown@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.IGstudy.com</url>
    <description>inclusion and exclusion criteria, contact to PI for potential subjects</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kathleen Brannan Brown, Inc.</investigator_affiliation>
    <investigator_full_name>Kathleen Brannan Brown</investigator_full_name>
    <investigator_title>RN, FNP, CMP DOMP-thesis candidate</investigator_title>
  </responsible_party>
  <keyword>Idiopathic Gastroparesis, Nausea, Vomiting, Abdominal Pain, Gastrectomy, Osteopathy, Gastroparesis Cardinal Symptom Index, GCSI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</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/NCT02232334
org study id: Brown - 1
nct id: NCT02232334
lead sponsor: 
has dmc: No
Global osteopathic manual treatments will decrease the severity score of the Gastroparesis
      Cardinal Symptom Index tool of patients with idiopathic gastroparesis.

      In this longitudinal controlled pre-test post-test group design, subjects with idiopathic
      gastroparesis (IG) will be utilized to see if global osteopathic manual treatments can
      decrease their symptoms. Patients with IG suffer from varying degrees of nausea, vomiting and
      abdominal pain secondary to delayed gastric emptying. There is no known cause for people
      suffering from IG.

      According to the power analysis, the population will be utilized as the experiment group and
      the control group. The measuring tool to be used is the Gastroparesis Cardinal Symptom Index
      (GCSI) which is the most widely used symptom score questionnaire for gastroparesis. The
      subjects in the population will each fill out the GCSI initially and again after an two (2)
      week period to measure their symptoms during a control period. The same subjects will then be
      treated with global osteopathic manual treatments one (1) treatment every two (2) weeks for
      four (4) weeks (day 1, 14, and 28). The GCSI will be filled out on the day of the first (1st)
      treatment (which is the last day of the control period) and then two (2) weeks after the last
      treatment (day 42). In order to reject the null hypothesis, with a p value of < 0.05 and a
      power of 0.8, a minimum of ten (10) subjects in the treatment group is required with a
      treatment effect of 1 or more. A 'Treatment effect of 1' is defined by Cohen's d, where d =
      mean difference/standard deviation.

      It is expected that the results will show improvement of symptoms through the data collected
      from the GCSI questionnaires in the treatment group. The results of this study could be
      significant and contribute to the osteopathic community validating the effectiveness of
      traditional osteopathic manual therapy as well as giving non-invasive options to people
      suffering from the disease since those who struggle with it have minimal treatment
      options--medicines with significant side effects, full or total stomach removal or gastric
      electrical stimulator implants.
Gastroparesis is a disorder that presents with delayed gastric emptying, abdominal pain,
      nausea, and vomiting. This condition can be found in people with complications from
      diabetes-neuropathy of the vagus nerve and gastric surgery-damage to the vagus nerve. With
      idiopathic gastroparesis (IG), the cause is poorly understood with theories suggesting viral
      infections affecting gut motility, pyloric valve spasm as well as damage to the specialized
      cells within the wall of the stomach. Unfortunately the treatment options are minimal for
      people suffering from gastroparesis regardless of what type.

      It is the action of food propulsion that is poorly understood in regards to IG - specifically
      smooth muscle, autonomic and enteric nerves and specialized cells in the gut named
      Interstitial Cells of Cajal (ICC). ICC are the pacemakers cells in the gut that conduct
      motility.

      The objective of this study is to normalize structural abnormalities in patients with
      idiopathic gastroparesis with global osteopathic manual treatments, using a quantitative
      research method with a longitudinal controlled pre-test post-test design.

      The principal investigator (PI), having a background as an emergency medicine registered
      nurse, has seen patients in the emergency department suffering from idiopathic gastroparesis.
      The acute attacks appear intense and debilitating often requiring anti-nausea, pain and
      anti-anxiety medications. As an osteopathic student, the PI would often wonder what could be
      achieved with osteopathic manual treatments (OMT) to help these people in the emergency
      department suffering from these symptoms.

      Current treatment available for people suffering from gastroparesis is limited. In his
      article, Gastroparesis - Current Concepts and Considerations (2008), Dr. Hasler, summarized
      research and the different treatment options for gastroparesis. There are several medications
      available for gastroparesis however as discussed by Dr. Hasler, the side effects from these
      medications are significant.

      There are invasive treatments, such as injection of botulinum toxin into the pyloric
      sphincter, gastric electrical stimulator and gastric resection which have shown some
      improvement in symptoms but carry heavy risks if utilized.

      The research method used to determine if global osteopathic manual treatments can help
      patients who suffer from idiopathic gastroparesis is a longitudinal pre-test post-test
      controlled quantitative study. The tool used to measure data is the Gastroparesis Cardinal
      Index Score (GCSI), which was created by Janssen Global Services, LLC. The GCSI is a reliable
      and validated tool rating symptom intensity of fullness-early satiety, nausea-vomiting, and
      bloating. The validation of this tool was tested with 169 subjects who filled out the GCSI
      and those results were compared with clinician symptom ratings. Total scores of the GCSI were
      "responsive to changes in overall gastroparesis symptoms as assessed by clinicians (P =
      0.0002) and patients (P = 0.002).

      A minimum of ten (10) subjects are required for the population according to the power
      analysis, and at lease twelve (12) subjects will be enrolled to account for the potential 20%
      drop out rate. However, (20) twenty subjects will be the goal for recruitment for this study.
      Approval from an Institutional Review Board (IRB) has been acquired through Aspire-IRB,
      gastroenterologists and family medicine physicians in the Sonoma County and Santa Rosa
      California area will be given recruitment letters and consent forms with study information to
      give to patients who qualify for the study. Flyers will be distributed throughout the
      community (grocery stores, community centers, pharmacies etc.). Social media might be
      utilized to acquire subjects as there appears to be a strong presence of support groups
      online of people with gastroparesis.

      The entire population, during the control group period, will fill out the GCSI initially and
      then again at two (2) weeks. Those subjects will transition to the experimental group period
      of the study-the GCSI filled out on the last day of the control period will be used as the
      first day of treatment GCSI results. IN the experiment period: the subjects will receive
      three (3) separate global osteopathic manual treatments over four (4) weeks (day 1, 14, and
      28). Two weeks after the third (3rd) treatment (day 42), the subjects will fill out the GCSI
      a final time. The subjects are waiting two (2) weeks to allow for full integration of the
      last treatment and the GCSI is designed to record the prior two (2) weeks of patients
      symptoms.

      The subjects in the population will be screened via email and or telephone assuring they meet
      the inclusion/exclusion criteria. Once consented, each participant will be instructed to fill
      out the first (1st) GCSI questionnaires and email the completed form back to the PI. The data
      of the first GCSI completion establishes day one (1) of the two (2) week control period.
      During the two (2) week control period, subjects are to continue their regular treatments for
      IG (dietary, medicine). They are not to obtain any new therapies such as massage,
      acupuncture, osteopathy or start any new conventional medical treatments. If there is an
      acute attack requiring an emergency room visit, the subject will have to be excluded from the
      study. At the end of the two (2) week period, those subjects will fill out the GCSI again and
      those results will be anonymously stored for future data analysis. The subjects then will be
      transitioned into the experimental period and assigned to have their first treatment. The
      last day of the control period will start the experimental period. All treatments will occur
      at the office/clinic of the PI in Santa Rosa California, USA. The PI will be working under
      her massage practitioner license with malpractice insurance under Associated Bodywork and
      Massage Professionals (ABMP) as well as Manual Therapy Insurance Plus through the Barral
      Institute. Both of these institutions cover general and professional liability for massage
      therapy as well as various forms of manual therapy.

      At the first treatment, day one (1) of the experimental period, the GCSI (Appendix A) and
      health history questionnaire (Appendix I) will have been completed. An anamnesis will be
      taken and the subject will then be assessed and treated with a global osteopathic manual
      treatment to treat the lesions found in the assessment. The data from the GCSI will be
      collected and stored anonymously for data analysis. The lesions found in assessment and
      techniques used to treat will be stored for use in discussion if appropriate. The process
      will be repeated at two (2) weeks and four (4) weeks from the first (1st) visit for each
      participant except without the GCSI and without the health questionnaire as it is only
      required on the first visit. Each treatment will last ninety (90) minutes. To keep results as
      consistent as possible, subjects will be seen at the same time of the day for each treatment.
      The results from two (2) weeks and four (4) weeks will be stored for possible discussion. To
      allow time for integration of the treatments each participant will fill out the GCSI two (2)
      weeks after the fourth (4th) week of the experimental period. The data from all GCSI tools
      filled out from the control and experimental periods will be sent to the PI via email for
      data analysis.
allocation: Non-Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Gastroparesis Cardinal Symptom index
time frame: 56 days
description: The GCSI is a reliable and validated tool rating symptom intensity of fullness-early satiety, nausea-vomiting, and bloating. The validation of this tool was tested with 169 subjects who filled out the GCSI and those results were compared with clinician symptom ratings. Total scores of the GCSI were "responsive to changes in overall gastroparesis symptoms as assessed by clinicians.
arm group label: Osteopathic manual treatment
arm group type: Experimental
description: Global Osteopathic Manual treatment: each subject will be treated according to what restrictions or areas of poor mobility are found individually. No two subjects will receive the same overall treatment.
arm group label: Control--no change in current treatment of subject
arm group type: No Intervention
description: The population will act as their own control prior to intervention of osteopathy, their will be a control period where the subject maintains current treatment of their gastroparesis. During that period they will fill out the GCSI measuring tool at the beginning of the control period and at the end. Those measurements will be compared to the GSCI results during the intervention period.
intervention type: Other
intervention name: Global Osteopathic Manual Treatment
description: subtle manipulations of the body according to the methodology of osteopathic manual therapy will be the intervention on subjects in the study. The global treatments will take into consideration the past medical history of each subject as well as what is found on assessment. Focus is on the position, mobililty and quality of each subjects anatomy.
arm group label: Osteopathic manual treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kathleen B Brown, MSN, DOMP-candidate
phone: 707-659-6090
email: Kathleenbrannanbrown@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.IGstudy.com
description: inclusion and exclusion criteria, contact to PI for potential subjects
responsible party type: Principal Investigator
investigator affiliation: Kathleen Brannan Brown, Inc.
investigator full name: Kathleen Brannan Brown
investigator title: RN, FNP, CMP DOMP-thesis candidate
mesh term: Gastroparesis