<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/NCT03234192</url>
  </required_header>
  <id_info>
    <org_study_id>16-02176</org_study_id>
    <nct_id>NCT03234192</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.</brief_title>
  <official_title>A Randomized Clinical Controlled Study Comparing the Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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 this study is to examine the effectiveness of three common techniques for the&#xD;
      treatment of lateral epicondylosis. Through objective and subjective assessments this study&#xD;
      will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment&#xD;
      Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis.&#xD;
      It is hypothesized that the more manual Astym technique and Graston technique will produce&#xD;
      more significant results than the more frequently utilized ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruiting was halted due to methodology issues&#xD;
  </why_stopped>
  <start_date type="Actual">June 10, 2017</start_date>
  <completion_date type="Actual">May 23, 2019</completion_date>
  <primary_completion_date type="Actual">May 23, 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Rated Tennis Elbow Evaluation (PRTEE)</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This is a 15 item self-reported questionnaire to measure perceived pain and disability in people with Lateral Epicondylosis (LE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>QuickDASH</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This is an 11 item questionnaire where by participants' score themselves using a 1-5 point scale. 1 represents &quot;no difficulty&quot; in performing task whereas 5 represents &quot;unable to perform task&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This is a visual analog scale used to assess the clients view of their overall health on a scale of 0 (worst imaginable) to 100 (best imaginable). Also, clients report issues with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each is scored on a 3 point scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This will be taken at the wrist and elbow using goniometric measurements and a volar/dorsal approach at the wrist and lateral approach at the elbow. Measurements recorded will be wrist flexion and extension and elbow flexion and extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This will be measured using a hand held dynamometer and tested in the standard (arm at side) position and elbow extension position. Three trials on each UE will be reported in pounds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale for Pain</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This scale is a single point scale from 0-10. The client picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cozens Test</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This involves the examiner resisting the wrist extension force of the client with the elbow in extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mills Test</measure>
    <time_frame>30 Minutes</time_frame>
    <description>This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Lateral Epicondylitis</condition>
  <condition>Tennis Elbow</condition>
  <condition>Posterolateral Rotator Instability</condition>
  <arm_group>
    <arm_group_label>Therapeutic ultra sound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Astym Treatment Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Graston Treatment Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Therapeutic ultra sound</intervention_name>
    <description>This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.</description>
    <arm_group_label>Therapeutic ultra sound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Astym Treatment Technique</intervention_name>
    <description>This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.</description>
    <arm_group_label>Astym Treatment Technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Graston Treatment Technique</intervention_name>
    <description>This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.</description>
    <arm_group_label>Graston Treatment Technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clients who are admitted to NYULMC Center for Musculoskeletal Care for outpatient&#xD;
             occupational or physical therapy with a diagnosis of lateral epicondylosis will be&#xD;
             included. To participate in the study participants must:&#xD;
&#xD;
          -  Be able to follow a home exercise program&#xD;
&#xD;
          -  Be able to consent to participation in the research study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clients who are deemed unable to consent to participation in the research study and/or&#xD;
             unable to following a home exercise program will not be included in this study&#xD;
&#xD;
          -  Clients with additional acute orthopedic injuries and/or surgeries to the involved&#xD;
             upper extremity will not be included in this study.&#xD;
&#xD;
          -  Clients with open wounds of the involved upper extremity that will interfere with&#xD;
             treatment techniques will not be involved in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steve Vanlew, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>extensor carpi radialis brevis</keyword>
  <keyword>Therapeutic Ultrasound</keyword>
  <keyword>Astym Treatment Technique</keyword>
  <keyword>Graston Treatment Technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Anyone who wishes to access the data.</ipd_access_criteria>
  </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/NCT03234192
org study id: 16-02176
nct id: NCT03234192
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effectiveness of three common techniques for the
      treatment of lateral epicondylosis. Through objective and subjective assessments this study
      will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment
      Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis.
      It is hypothesized that the more manual Astym technique and Graston technique will produce
      more significant results than the more frequently utilized ultrasound.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Patient Rated Tennis Elbow Evaluation (PRTEE)
time frame: 30 Minutes
description: This is a 15 item self-reported questionnaire to measure perceived pain and disability in people with Lateral Epicondylosis (LE)
measure: QuickDASH
time frame: 30 Minutes
description: This is an 11 item questionnaire where by participants' score themselves using a 1-5 point scale. 1 represents "no difficulty" in performing task whereas 5 represents "unable to perform task"
measure: EQ-5D-5L
time frame: 30 Minutes
description: This is a visual analog scale used to assess the clients view of their overall health on a scale of 0 (worst imaginable) to 100 (best imaginable). Also, clients report issues with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each is scored on a 3 point scale.
measure: Range of motion
time frame: 30 Minutes
description: This will be taken at the wrist and elbow using goniometric measurements and a volar/dorsal approach at the wrist and lateral approach at the elbow. Measurements recorded will be wrist flexion and extension and elbow flexion and extension
measure: Grip strength
time frame: 30 Minutes
description: This will be measured using a hand held dynamometer and tested in the standard (arm at side) position and elbow extension position. Three trials on each UE will be reported in pounds
measure: Numeric Rating Scale for Pain
time frame: 30 Minutes
description: This scale is a single point scale from 0-10. The client picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable
measure: Cozens Test
time frame: 30 Minutes
description: This involves the examiner resisting the wrist extension force of the client with the elbow in extension
measure: Mills Test
time frame: 30 Minutes
description: This is performed by palpating the lateral epicondyle while passively pronating the forearm, flexing the wrist, and extending the elbow
arm group label: Therapeutic ultra sound
arm group type: Active Comparator
arm group label: Astym Treatment Technique
arm group type: Active Comparator
arm group label: Graston Treatment Technique
arm group type: Active Comparator
intervention type: Procedure
intervention name: Therapeutic ultra sound
description: This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.
arm group label: Therapeutic ultra sound
intervention type: Procedure
intervention name: Astym Treatment Technique
description: This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.
arm group label: Astym Treatment Technique
intervention type: Procedure
intervention name: Graston Treatment Technique
description: This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.
arm group label: Graston Treatment Technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steve Vanlew, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tennis Elbow
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after deidentification.
ipd info type: Study Protocol
ipd time frame: Immediately following publication. No end date.
ipd access criteria: Anyone who wishes to access the data.