<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/NCT03241095</url>
  </required_header>
  <id_info>
    <org_study_id>FMCH-2017-25925</org_study_id>
    <nct_id>NCT03241095</nct_id>
  </id_info>
  <brief_title>The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Golf Swing</brief_title>
  <official_title>The Efficacy of Osteopathic Manipulative Treatment (OMT) on the Swing Via Objective Data From Golf Simulator Swing Analysis and Subjective Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</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>
      The purpose of the study is to investigate if osteopathic manipulative treatment (OTM)&#xD;
      improves the golf swing of the participants. Study participants will be randomized into three&#xD;
      groups, we will stratify by age and gender to make them as uniform as possible. One group&#xD;
      will receive no intervention other than a 10-minute break between the pre and post&#xD;
      measurements. A second group will receive a sham intervention where the doctor will pretend&#xD;
      to give the participant OTM. The third group will receive real OTM.&#xD;
&#xD;
      Participants will perform a sample of 10 golf swings pre and post intervention which will be&#xD;
      measured by a golf simulator. They will also complete a brief health history and pre/post&#xD;
      self-evaluation of their swing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Strength of golf swing as measured by the carry distance (the distance the ball flies in the air)</measure>
    <time_frame>30 minutes</time_frame>
    <description>The participant will perform 10 swings into a golf simulator using a 5 iron. The simulator will record the information for each swing. Measurements include: Club head speed (Mph), Ball speed (Mph), Launch angle (Deg), Azimuth (Deg), Side spin (Rpm), Back spin (Rpm), Total spin (Rpm), Descent angle (Deg), Carry (Yds),Total distance (Yds), Offline (Yds), Peak height (Yds). We will be looking at the 'Carry' variable, before and after the intervention.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Manipulation, Osteopathic</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham OMT</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>OMT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>OMT (Osteopathic Manipulative Treatment)</intervention_name>
    <description>The co-hort will receive OMT. Each participant will perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. This co-hort will then be evaluated by the physician and be given OMT.</description>
    <arm_group_label>OMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham intervention</intervention_name>
    <description>The co-hort participants will each perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. Theythen be given a sham OMT procedure.</description>
    <arm_group_label>Sham OMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Adult golfers (18 years old or over) -&#xD;
&#xD;
        Exclusion Criteria: Anyone under 18 years, people that do not golf.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Buffington, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Health System - Family Medicine Clinic</name>
      <address>
        <city>Mankato</city>
        <state>Minnesota</state>
        <zip>56001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteopathic Manipulation Treatment</keyword>
  <keyword>Golf</keyword>
  <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/NCT03241095
org study id: FMCH-2017-25925
nct id: NCT03241095
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to investigate if osteopathic manipulative treatment (OTM)
      improves the golf swing of the participants. Study participants will be randomized into three
      groups, we will stratify by age and gender to make them as uniform as possible. One group
      will receive no intervention other than a 10-minute break between the pre and post
      measurements. A second group will receive a sham intervention where the doctor will pretend
      to give the participant OTM. The third group will receive real OTM.

      Participants will perform a sample of 10 golf swings pre and post intervention which will be
      measured by a golf simulator. They will also complete a brief health history and pre/post
      self-evaluation of their swing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Strength of golf swing as measured by the carry distance (the distance the ball flies in the air)
time frame: 30 minutes
description: The participant will perform 10 swings into a golf simulator using a 5 iron. The simulator will record the information for each swing. Measurements include: Club head speed (Mph), Ball speed (Mph), Launch angle (Deg), Azimuth (Deg), Side spin (Rpm), Back spin (Rpm), Total spin (Rpm), Descent angle (Deg), Carry (Yds),Total distance (Yds), Offline (Yds), Peak height (Yds). We will be looking at the 'Carry' variable, before and after the intervention.
arm group label: Control
arm group type: No Intervention
arm group label: Sham OMT
arm group type: Sham Comparator
arm group label: OMT
arm group type: Active Comparator
intervention type: Procedure
intervention name: OMT (Osteopathic Manipulative Treatment)
description: The co-hort will receive OMT. Each participant will perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. This co-hort will then be evaluated by the physician and be given OMT.
arm group label: OMT
intervention type: Procedure
intervention name: Sham intervention
description: The co-hort participants will each perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. Theythen be given a sham OMT procedure.
arm group label: Sham OMT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Angela Buffington, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No