<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/NCT03001908</url>
  </required_header>
  <id_info>
    <org_study_id>UNE 052316-013</org_study_id>
    <nct_id>NCT03001908</nct_id>
  </id_info>
  <brief_title>A Comparison of Electromyographic Activity &amp; Glenohumeral Motion</brief_title>
  <official_title>A Comparison of Electromyographic(EMG) Activity &amp; Glenohumeral Motion During Posterior Glide Mobilizations in Healthy &amp; Stiff Shoulders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New England</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New England</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain pressure measurements, fine wire EMG and real time imaging ultrasound will be used to&#xD;
      determine the relationships between motion, pain perception, and mobility in the glenohumeral&#xD;
      joint. Muscle activity, joint motion, and pain will be measured pre-post randomized&#xD;
      interventions to determine the response to various physical therapy techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To achieve the study aims, 88 adults (44 controls, 44 with stiff shoulders) between the ages&#xD;
      of 18-65 will be recruited. The investigators will apply a protocol based on current evidence&#xD;
      for effectiveness of mobilizations (4 bouts of 30 sec, oscillatory gr III mobilization @1 Hz&#xD;
      vs. 4 bouts of 30 seconds, static gr III mobilization), with interventions determined by&#xD;
      randomized blocked assignment. Before and after the intervention, the investigators will&#xD;
      assess levels of EMG activity of the posterior rotator cuff during a posterior glide, the&#xD;
      force required for the mobilization to reach end range stretch, the amount of humeral head&#xD;
      translation on the glenoid via US, and pain pressure thresholds (PPT). The data collected&#xD;
      will allow investigators to determine the mechanisms involved in range of motion (ROM)&#xD;
      changes and hypoalgesia produced by glenohumeral (GH) joint mobilization in both normal and&#xD;
      stiff shoulders by evaluating the main and interaction effects of: the type of mobilization&#xD;
      (static vs oscillatory), the magnitude of joint translation via imaging ultrasound, the EMG&#xD;
      response of the supraspinatus and infraspinatus muscles, and changes in local and central&#xD;
      pain processing observed via PPT testing. These data will allow investigators to evaluate&#xD;
      whether motion improvements occur due to mechanical factors (stretch of the capsule observed&#xD;
      via change in translation), neurophysiologic factors (change in translation associated with&#xD;
      reduction in EMG activity), or both. Concurrent measurements of pain processing by the&#xD;
      nervous system (local and central mechanisms) will allow evaluation of whether changes in&#xD;
      pain processing occur following oscillatory movements, sustained movements, or both. This&#xD;
      information will result in improved understanding of the mechanisms of action of joint&#xD;
      mobilization, determination of the efficacy of various modes of mobilization to improve joint&#xD;
      translation, and determination of the efficacy of various modes of mobilization to decrease&#xD;
      pain.&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      All data will be analyzed in aggregate form using quantitative statistics. Descriptive&#xD;
      statistics will be utilized for demographic data including age, height, weight, gender,&#xD;
      handedness, and side of intervention.&#xD;
&#xD;
      Groups will be measured using tests of difference based on group assignments (normal vs stiff&#xD;
      shoulder; sustained vs oscillatory mobilization) comparing peak and root mean squared EMG&#xD;
      activity, pain pressure thresholds, force of mobilization, and amount of translation measured&#xD;
      via US as well as analysis of interaction effects.&#xD;
&#xD;
      All data will be analyzed using an intention to treat model, and any missing data points were&#xD;
      replaced using imputation via means of the group.&#xD;
&#xD;
      All outliers, defined as data points beyond the 95th percentile and identified as outliers&#xD;
      during analysis in SPSS, will be Winsorized to minimize the effect of potentially spurious&#xD;
      outliers via replacement with the highest non-outlier obtained value for the group.&#xD;
&#xD;
      Descriptive statistics including means, ranges and standard deviations will be assessed for&#xD;
      each group condition.&#xD;
&#xD;
      Data will be assessed for the required assumptions for parametric testing/ Analysis of&#xD;
      variance(ANOVA) including Mauchly's test of sphericity and the Shapiro-Wilk test of&#xD;
      normality. Data not meeting the required assumptions will be assessed with the appropriate&#xD;
      non-parametric equivalent test.&#xD;
&#xD;
      Aim 1 will investigate the relationships and within and between group differences in rotator&#xD;
      cuff activity (EMG) and posterior glide mobility and mobilization force in the glenohumeral&#xD;
      joint in individuals with stiff and normal shoulders based on joint mobilization type.&#xD;
&#xD;
      To analyze within subjects main effects, interaction effects, and second order interaction&#xD;
      effects of group and mobilization condition on the DV, three-way between-between-within mixed&#xD;
      ANOVAs will be used.&#xD;
&#xD;
      IV: shoulder condition stiff vs normal; oscillation vs static posterior glide; time.&#xD;
&#xD;
      X Repeated measure Dependent variables(DV)s: EMG, US translation, force In the presence of&#xD;
      significant three way interactions, post hoc testing to determine simple two way interaction&#xD;
      effects will be performed using separate two way ANOVAs Univariate testing will be utilized&#xD;
      to determine the presence of simple main effects.&#xD;
&#xD;
      Post hoc analysis will utilize pairwise comparisons in the presence of significant main&#xD;
      effects. Bonferroni correction will be utilized due to multiple tests, with comparisons&#xD;
      within each simple-simple main effect considered a family of comparisons.&#xD;
&#xD;
      To investigate the relationships between rotator cuff activity (EMG) and posterior glide&#xD;
      mobility in individuals with stiff and normal shoulders, point bi-serial correlation will be&#xD;
      utilized to assess for meaningful relationships between the following variables:&#xD;
&#xD;
      Mobilization condition x change in EMG, US, force Group (stiff vs control) assignment x&#xD;
      change in EMG, US, force Aim 2 will investigate the within and between group differences and&#xD;
      relationships between changes in PPT and type of mobilization (static, oscillatory) in&#xD;
      individuals with stiff and normal shoulders.&#xD;
&#xD;
      Between group differences will be assessed via ind. t-tests, using the dichotomous&#xD;
      independent variables (IV) static vs. oscillatory mobilization, and the DV of PPT measures.&#xD;
&#xD;
      Within group differences will be assessed via paired t-tests, using the dichotomous IV static&#xD;
      vs. oscillatory mobilization, and the DV of PPT measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>EMG activity of posterior rotator cuff</measure>
    <time_frame>Immediate post-intervention</time_frame>
    <description>Fine wire EMG used to measure peak and mean activity of supraspinatus, infraspinatus during mobilization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>force applied during mobilization</measure>
    <time_frame>baseline, immediately post intervention (within 3 minutes)</time_frame>
    <description>force sensor used to determine force required to produce glenohumeral translation, compared pre-post intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>translation of humeral head</measure>
    <time_frame>baseline, immediately post intervention (within 3 minutes)</time_frame>
    <description>Real time US imaging to determine amount of translation, assess pre-post intervention changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain pressure threshold-bilateral deltoid</measure>
    <time_frame>baseline, immediately post intervention (within 5 minutes)</time_frame>
    <description>pain pressure threshold at deltoid bilaterally; assessed for changes pre-post intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain pressure threshold-bilateral forearm</measure>
    <time_frame>baseline, immediately post intervention (within 5 minutes)</time_frame>
    <description>pain pressure threshold at medial forearmbilaterally; assessed for changes pre-post intervention</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Orthopedic Disorder</condition>
  <arm_group>
    <arm_group_label>control oscillation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control subjects with normal shoulders will undergo the glenohumeral mobilization-oscillation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control sustained</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control subjects with normal shoulders will undergo the glenohumeral mobilization-sustained</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stiff oscillation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects with stiff shoulders will undergo the glenohumeral mobilization-oscillation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stiff sustained</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects with stiff shoulders will undergo the glenohumeral mobilization-sustained</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>glenohumeral mobilization-oscillation</intervention_name>
    <description>posterior glide mobilizations oscillated at 1hz, 4 x 30 seconds</description>
    <arm_group_label>control oscillation</arm_group_label>
    <arm_group_label>stiff oscillation</arm_group_label>
    <other_name>musculoskeletal manipulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>glenohumeral mobilization-sustained</intervention_name>
    <description>posterior glide mobilization, sustained 4 x 30 seconds</description>
    <arm_group_label>control sustained</arm_group_label>
    <arm_group_label>stiff sustained</arm_group_label>
    <other_name>musculoskeletal manipulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  both healthy volunteers, as well as individuals with shoulder stiffness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  shoulder surgery within the past 6 months&#xD;
&#xD;
          -  history of shoulder fractures&#xD;
&#xD;
          -  rheumatoid arthritis&#xD;
&#xD;
          -  osteoporosis&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  active cancer&#xD;
&#xD;
          -  blood clotting or connective tissue disorders&#xD;
&#xD;
          -  receiving workman's compensation benefits for your shoulder injury&#xD;
&#xD;
          -  pending litigation for your shoulder injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian T Swanson, PT, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New England</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New England</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New England</investigator_affiliation>
    <investigator_full_name>Brian T Swanson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>shoulder</keyword>
  <keyword>mobilization</keyword>
  <keyword>electromyography</keyword>
  <keyword>imaging ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT03001908
org study id: UNE 052316-013
nct id: NCT03001908
lead sponsor: 
has dmc: No
Pain pressure measurements, fine wire EMG and real time imaging ultrasound will be used to
      determine the relationships between motion, pain perception, and mobility in the glenohumeral
      joint. Muscle activity, joint motion, and pain will be measured pre-post randomized
      interventions to determine the response to various physical therapy techniques.
To achieve the study aims, 88 adults (44 controls, 44 with stiff shoulders) between the ages
      of 18-65 will be recruited. The investigators will apply a protocol based on current evidence
      for effectiveness of mobilizations (4 bouts of 30 sec, oscillatory gr III mobilization @1 Hz
      vs. 4 bouts of 30 seconds, static gr III mobilization), with interventions determined by
      randomized blocked assignment. Before and after the intervention, the investigators will
      assess levels of EMG activity of the posterior rotator cuff during a posterior glide, the
      force required for the mobilization to reach end range stretch, the amount of humeral head
      translation on the glenoid via US, and pain pressure thresholds (PPT). The data collected
      will allow investigators to determine the mechanisms involved in range of motion (ROM)
      changes and hypoalgesia produced by glenohumeral (GH) joint mobilization in both normal and
      stiff shoulders by evaluating the main and interaction effects of: the type of mobilization
      (static vs oscillatory), the magnitude of joint translation via imaging ultrasound, the EMG
      response of the supraspinatus and infraspinatus muscles, and changes in local and central
      pain processing observed via PPT testing. These data will allow investigators to evaluate
      whether motion improvements occur due to mechanical factors (stretch of the capsule observed
      via change in translation), neurophysiologic factors (change in translation associated with
      reduction in EMG activity), or both. Concurrent measurements of pain processing by the
      nervous system (local and central mechanisms) will allow evaluation of whether changes in
      pain processing occur following oscillatory movements, sustained movements, or both. This
      information will result in improved understanding of the mechanisms of action of joint
      mobilization, determination of the efficacy of various modes of mobilization to improve joint
      translation, and determination of the efficacy of various modes of mobilization to decrease
      pain.

      Data analysis:

      All data will be analyzed in aggregate form using quantitative statistics. Descriptive
      statistics will be utilized for demographic data including age, height, weight, gender,
      handedness, and side of intervention.

      Groups will be measured using tests of difference based on group assignments (normal vs stiff
      shoulder; sustained vs oscillatory mobilization) comparing peak and root mean squared EMG
      activity, pain pressure thresholds, force of mobilization, and amount of translation measured
      via US as well as analysis of interaction effects.

      All data will be analyzed using an intention to treat model, and any missing data points were
      replaced using imputation via means of the group.

      All outliers, defined as data points beyond the 95th percentile and identified as outliers
      during analysis in SPSS, will be Winsorized to minimize the effect of potentially spurious
      outliers via replacement with the highest non-outlier obtained value for the group.

      Descriptive statistics including means, ranges and standard deviations will be assessed for
      each group condition.

      Data will be assessed for the required assumptions for parametric testing/ Analysis of
      variance(ANOVA) including Mauchly's test of sphericity and the Shapiro-Wilk test of
      normality. Data not meeting the required assumptions will be assessed with the appropriate
      non-parametric equivalent test.

      Aim 1 will investigate the relationships and within and between group differences in rotator
      cuff activity (EMG) and posterior glide mobility and mobilization force in the glenohumeral
      joint in individuals with stiff and normal shoulders based on joint mobilization type.

      To analyze within subjects main effects, interaction effects, and second order interaction
      effects of group and mobilization condition on the DV, three-way between-between-within mixed
      ANOVAs will be used.

      IV: shoulder condition stiff vs normal; oscillation vs static posterior glide; time.

      X Repeated measure Dependent variables(DV)s: EMG, US translation, force In the presence of
      significant three way interactions, post hoc testing to determine simple two way interaction
      effects will be performed using separate two way ANOVAs Univariate testing will be utilized
      to determine the presence of simple main effects.

      Post hoc analysis will utilize pairwise comparisons in the presence of significant main
      effects. Bonferroni correction will be utilized due to multiple tests, with comparisons
      within each simple-simple main effect considered a family of comparisons.

      To investigate the relationships between rotator cuff activity (EMG) and posterior glide
      mobility in individuals with stiff and normal shoulders, point bi-serial correlation will be
      utilized to assess for meaningful relationships between the following variables:

      Mobilization condition x change in EMG, US, force Group (stiff vs control) assignment x
      change in EMG, US, force Aim 2 will investigate the within and between group differences and
      relationships between changes in PPT and type of mobilization (static, oscillatory) in
      individuals with stiff and normal shoulders.

      Between group differences will be assessed via ind. t-tests, using the dichotomous
      independent variables (IV) static vs. oscillatory mobilization, and the DV of PPT measures.

      Within group differences will be assessed via paired t-tests, using the dichotomous IV static
      vs. oscillatory mobilization, and the DV of PPT measures.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: EMG activity of posterior rotator cuff
time frame: Immediate post-intervention
description: Fine wire EMG used to measure peak and mean activity of supraspinatus, infraspinatus during mobilization
measure: force applied during mobilization
time frame: baseline, immediately post intervention (within 3 minutes)
description: force sensor used to determine force required to produce glenohumeral translation, compared pre-post intervention
measure: translation of humeral head
time frame: baseline, immediately post intervention (within 3 minutes)
description: Real time US imaging to determine amount of translation, assess pre-post intervention changes
measure: pain pressure threshold-bilateral deltoid
time frame: baseline, immediately post intervention (within 5 minutes)
description: pain pressure threshold at deltoid bilaterally; assessed for changes pre-post intervention
measure: pain pressure threshold-bilateral forearm
time frame: baseline, immediately post intervention (within 5 minutes)
description: pain pressure threshold at medial forearmbilaterally; assessed for changes pre-post intervention
arm group label: control oscillation
arm group type: Active Comparator
description: control subjects with normal shoulders will undergo the glenohumeral mobilization-oscillation
arm group label: control sustained
arm group type: Active Comparator
description: control subjects with normal shoulders will undergo the glenohumeral mobilization-sustained
arm group label: stiff oscillation
arm group type: Experimental
description: subjects with stiff shoulders will undergo the glenohumeral mobilization-oscillation
arm group label: stiff sustained
arm group type: Experimental
description: subjects with stiff shoulders will undergo the glenohumeral mobilization-sustained
intervention type: Other
intervention name: glenohumeral mobilization-oscillation
description: posterior glide mobilizations oscillated at 1hz, 4 x 30 seconds
arm group label: control oscillation
arm group label: stiff oscillation
other name: musculoskeletal manipulation
intervention type: Other
intervention name: glenohumeral mobilization-sustained
description: posterior glide mobilization, sustained 4 x 30 seconds
arm group label: control sustained
arm group label: stiff sustained
other name: musculoskeletal manipulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brian T Swanson, PT, DSc
role: Principal Investigator
affiliation: University of New England
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New England
investigator full name: Brian T Swanson
investigator title: Assistant Professor
mesh term: Musculoskeletal Diseases
sharing ipd: No