<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/NCT01729065</url>
  </required_header>
  <id_info>
    <org_study_id>09-007403</org_study_id>
    <nct_id>NCT01729065</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Efficacy of Early Physical Therapy Intervention Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer</brief_title>
  <official_title>A Randomized Study to Assess the Efficacy of Early Physical Therapy Intervention on Upper Quarter Strength and Mobility, and Reported Upper Extremity Disability and Quality of Life Measures Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine whether patients who receive regular physical therapy immediately&#xD;
      following a modified neck dissection surgery will report decreased shoulder disability,&#xD;
      decreased pain, improved or maintained shoulder range of motion and strength, and improved&#xD;
      quality of life than those who receive only home instruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disability of the Arm Shoulder and Hand</measure>
    <time_frame>12, 24, 36 weeks</time_frame>
    <description>A standardized outcome tool which will be used to measure change in the level of disability related to involvement of the upper extremity at 12, 24, and 36 weeks compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>12, 24, 36 weeks</time_frame>
    <description>General health survey.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>12, 24, 36 weeks</time_frame>
    <description>Pain Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Strength, range of motion of the neck and shoulder</measure>
    <time_frame>12, 24, 36 weeks</time_frame>
    <description>Measurements of shoulder range of motion and strength, cervical range of motion</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Shoulder Weakness Following Neck Dissection Surgery</condition>
  <arm_group>
    <arm_group_label>Home Program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants perform home program only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Therapy Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical therapy intervention provided for first 12 weeks following surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical therapy intervention</intervention_name>
    <description>Exercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization.</description>
    <arm_group_label>Physical Therapy Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18-85, able to give informed consent&#xD;
&#xD;
          -  Subject has provided written informed consent&#xD;
&#xD;
          -  Received Modified Unilateral Neck Dissection with sparing of the SAN&#xD;
&#xD;
          -  Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain&#xD;
             relieving modality&#xD;
&#xD;
          -  Not currently receiving acupuncture as a pain relieving modality&#xD;
&#xD;
          -  Able to participate with treatment group protocol including physical therapy&#xD;
             appointment every other week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior shoulder injury or surgery including rotator cuff repair or total&#xD;
             shoulder arthroplasty.&#xD;
&#xD;
          -  History of CVA with hemi paresis&#xD;
&#xD;
          -  Bilateral neck dissection&#xD;
&#xD;
          -  Known severed SAN&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa M Eden, PT, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Melissa M. Eden</investigator_full_name>
    <investigator_title>Physical Therapist, Orthopedic Clinical Specialist, Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</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/NCT01729065
org study id: 09-007403
nct id: NCT01729065
lead sponsor: 
has dmc: No
This study will determine whether patients who receive regular physical therapy immediately
      following a modified neck dissection surgery will report decreased shoulder disability,
      decreased pain, improved or maintained shoulder range of motion and strength, and improved
      quality of life than those who receive only home instruction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disability of the Arm Shoulder and Hand
time frame: 12, 24, 36 weeks
description: A standardized outcome tool which will be used to measure change in the level of disability related to involvement of the upper extremity at 12, 24, and 36 weeks compared to baseline.
measure: SF-36
time frame: 12, 24, 36 weeks
description: General health survey.
measure: Visual Analog Scale
time frame: 12, 24, 36 weeks
description: Pain Scale
measure: Strength, range of motion of the neck and shoulder
time frame: 12, 24, 36 weeks
description: Measurements of shoulder range of motion and strength, cervical range of motion
arm group label: Home Program
arm group type: No Intervention
description: Participants perform home program only.
arm group label: Physical Therapy Intervention
arm group type: Experimental
description: Physical therapy intervention provided for first 12 weeks following surgery.
intervention type: Other
intervention name: Physical therapy intervention
description: Exercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization.
arm group label: Physical Therapy Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Melissa M Eden, PT, DPT
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Melissa M. Eden
investigator title: Physical Therapist, Orthopedic Clinical Specialist, Primary Investigator
mesh term: Head and Neck Neoplasms