<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/NCT03756155</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004723</org_study_id>
    <nct_id>NCT03756155</nct_id>
  </id_info>
  <brief_title>Isometric Intervention for Lateral Elbow Tendinopathy</brief_title>
  <official_title>The Immediate Effects on Pain Levels After an Isometric Intervention for Individuals With Lateral Elbow Tendinopathy</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal&#xD;
      is to determine if a one-time isometric intervention will positively change the level of pain&#xD;
      and strength as compared to baseline measurements. After determining baseline strength and&#xD;
      pain level, an intervention consisting of several trials of isometric hand/wrist contractions&#xD;
      will be performed by the participant. Pain and strength will again be assessed immediately&#xD;
      after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized into two different groups in 10 participant blocks, meaning&#xD;
      after every 10 participants eligible and completing the study, there will be 5 participants&#xD;
      assigned to each group. Group 1 will complete a protocol with 10 sets of 10 second isometric&#xD;
      holds followed by 10 second rest intervals between sets. Each repetition will be performed as&#xD;
      closely to the targeted 30%-40% value. Group 2 will complete a protocol with 5 sets of 20&#xD;
      second isometric holds followed by 20 second rest intervals between sets. Each repetition&#xD;
      will be performed as closely to the targeted 30% value. Resistance for both testing&#xD;
      conditions will be performed against the examiner's external resistance/against the Microfet&#xD;
      hand held dynamometer. Immediately after the intervention, all participants will again repeat&#xD;
      their maximal grip on their affected arm using the Jamar hand held dynamometer and will grade&#xD;
      their pain level. (The protocol will be identical to the pre testing procedure from above).&#xD;
      The pain score and force output will be obtained and documented. Once these steps are&#xD;
      complete, testing will cease. All participants will be instructed to follow their referring&#xD;
      provider's treatment intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI no longer at the institution; departmental permission to deactivate study&#xD;
  </why_stopped>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <intervention_model_description>Participants will be randomized into two different groups (Group 1 and Group 2) in 10 participant blocks, meaning after every 10 participants eligible and completing the study, there will be 5 participants assigned to each group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess efficacy: NRS</measure>
    <time_frame>Randomization through 12 months</time_frame>
    <description>To assess the immediate effects of an isometric intervention on pain levels for individuals with lateral elbow tendinopathy. The primary outcome measure that will be utilized is the Numeric Pain Rating Scale (NRS) which will measure pain intensity using the 11 point scale with values ranging from 0 (no pain) to 10 (worst imaginable pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess correlation between force output during max grip strength testing and reported pain levels</measure>
    <time_frame>Randomization through 12 months</time_frame>
    <description>To determine if there is a correlation between force output during max grip strength testing and reported pain levels, and to determine if there is a correlation between two different time under tension protocols and max grip strength and reported pain levels. The secondary outcome measure with be grip strength, both pain free and max grip strength which will be measured in pounds using a Jamar handheld dynamometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lateral Elbow Tendinopathy</condition>
  <condition>Elbow Pain</condition>
  <condition>Elbows Tendonitis</condition>
  <condition>Elbow Sprain</condition>
  <condition>Elbow Injury</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 will complete a protocol with 10 sets of 10 second isometric holds followed by 10 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30%-40% value.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 will complete a protocol with 5 sets of 20 second isometric holds followed by 20 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30% value.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>isometric intervention</intervention_name>
    <description>The research participants will perform isometric repetitions against the hand held dynamometer</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <other_name>Midrofet hand held dynamometer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - 18 years old or older&#xD;
&#xD;
          -  Currently has lateral elbow pain&#xD;
&#xD;
          -  If bilateral lateral elbow pain is present, the more symptomatic side will be assessed&#xD;
&#xD;
          -  At the time of presentation, individuals have been evaluated as having clinical&#xD;
             diagnosed LET for at least 4 weeks&#xD;
&#xD;
          -  AND: Positive pain response to at least two of the following tests:&#xD;
&#xD;
               -  Pain with palpation on the affected elbow&#xD;
&#xD;
               -  Pain with resisted wrist or middle finger extension&#xD;
&#xD;
               -  Pain while stretching the lateral forearm muscles (Mills Test)&#xD;
&#xD;
               -  At least 30% deficit of pain-free grip compared with the unaffected side&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Radicular/Cervical conditions reproducing elbow symptoms&#xD;
&#xD;
          -  rheumatoid arthritis&#xD;
&#xD;
          -  Other elbow pathologies: bursitis, medial epicondylalgia, radial nerve entrapment,&#xD;
             posterolateral rotary instability&#xD;
&#xD;
          -  History of fracture to the radius, ulna, or humerus with resultant deformity of the&#xD;
             involved extremity&#xD;
&#xD;
          -  History of an injection within 6 months&#xD;
&#xD;
          -  Inability to place the shoulder, elbow and wrist in the required testing position&#xD;
&#xD;
          -  The affected elbow had been operated on&#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>Chee Vang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>March 25, 2022</last_update_submitted>
  <last_update_submitted_qc>March 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Elbow Tendinopathy</mesh_term>
    <mesh_term>Elbow Injuries</mesh_term>
  </condition_browse>
  <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/NCT03756155
org study id: STUDY00004723
nct id: NCT03756155
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal
      is to determine if a one-time isometric intervention will positively change the level of pain
      and strength as compared to baseline measurements. After determining baseline strength and
      pain level, an intervention consisting of several trials of isometric hand/wrist contractions
      will be performed by the participant. Pain and strength will again be assessed immediately
      after the intervention.
Participants will be randomized into two different groups in 10 participant blocks, meaning
      after every 10 participants eligible and completing the study, there will be 5 participants
      assigned to each group. Group 1 will complete a protocol with 10 sets of 10 second isometric
      holds followed by 10 second rest intervals between sets. Each repetition will be performed as
      closely to the targeted 30%-40% value. Group 2 will complete a protocol with 5 sets of 20
      second isometric holds followed by 20 second rest intervals between sets. Each repetition
      will be performed as closely to the targeted 30% value. Resistance for both testing
      conditions will be performed against the examiner's external resistance/against the Microfet
      hand held dynamometer. Immediately after the intervention, all participants will again repeat
      their maximal grip on their affected arm using the Jamar hand held dynamometer and will grade
      their pain level. (The protocol will be identical to the pre testing procedure from above).
      The pain score and force output will be obtained and documented. Once these steps are
      complete, testing will cease. All participants will be instructed to follow their referring
      provider's treatment intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized into two different groups (Group 1 and Group 2) in 10 participant blocks, meaning after every 10 participants eligible and completing the study, there will be 5 participants assigned to each group.
primary purpose: Treatment
masking: None (Open Label)
measure: Assess efficacy: NRS
time frame: Randomization through 12 months
description: To assess the immediate effects of an isometric intervention on pain levels for individuals with lateral elbow tendinopathy. The primary outcome measure that will be utilized is the Numeric Pain Rating Scale (NRS) which will measure pain intensity using the 11 point scale with values ranging from 0 (no pain) to 10 (worst imaginable pain).
measure: Assess correlation between force output during max grip strength testing and reported pain levels
time frame: Randomization through 12 months
description: To determine if there is a correlation between force output during max grip strength testing and reported pain levels, and to determine if there is a correlation between two different time under tension protocols and max grip strength and reported pain levels. The secondary outcome measure with be grip strength, both pain free and max grip strength which will be measured in pounds using a Jamar handheld dynamometer.
arm group label: Group 1
arm group type: Experimental
description: Group 1 will complete a protocol with 10 sets of 10 second isometric holds followed by 10 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30%-40% value.
arm group label: Group 2
arm group type: Experimental
description: Group 2 will complete a protocol with 5 sets of 20 second isometric holds followed by 20 second rest intervals between sets. Each repetition will be performed as closely to the targeted 30% value.
intervention type: Procedure
intervention name: isometric intervention
description: The research participants will perform isometric repetitions against the hand held dynamometer
arm group label: Group 1
arm group label: Group 2
other name: Midrofet hand held dynamometer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chee Vang, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy
mesh term: Elbow Tendinopathy
mesh term: Elbow Injuries
sharing ipd: No