<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/NCT02224261</url>
  </required_header>
  <id_info>
    <org_study_id>11/032</org_study_id>
    <nct_id>NCT02224261</nct_id>
  </id_info>
  <brief_title>Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery</brief_title>
  <acronym>PTaws</acronym>
  <official_title>Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario Principe de Asturias</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in&#xD;
      improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized&#xD;
      single-blinded controlled trial. Follow-up: five physical therapy assessments:&#xD;
      pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention.&#xD;
      Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing&#xD;
      unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in&#xD;
      Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two&#xD;
      groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy&#xD;
      composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific&#xD;
      thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in&#xD;
      conjunction with progressive active and action-assisted arm exercises; Control group:&#xD;
      standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2016</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention</measure>
    <time_frame>Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention</time_frame>
    <description>Visual Analogue Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention</measure>
    <time_frame>Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention</time_frame>
    <description>Inclinometer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in QoL related to shoulder pain at one month (post-intervention); and 3 and 6 months post-intervention</measure>
    <time_frame>Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention</time_frame>
    <description>Oxford Shoulder Score</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Axillary Web Syndrome</condition>
  <arm_group>
    <arm_group_label>Physical Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises &quot;stretching&quot; cords and patient education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control protocol includes standard progressive active and action-assisted arm exercises &amp; patient education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy protocol</intervention_name>
    <description>Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises &quot;stretching&quot; cords, and patient education.</description>
    <arm_group_label>Physical Therapy</arm_group_label>
    <other_name>PT-AWS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Control protocol includes standard progressive active and action-assisted arm exercises &amp; patient education.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>CG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral breast cancer;&#xD;
&#xD;
          -  Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;&#xD;
&#xD;
          -  Axillary web syndrome in chest and / or upper limb of the operated side;&#xD;
&#xD;
          -  VAS&gt;3&#xD;
&#xD;
          -  Consent to participate in the study;&#xD;
&#xD;
          -  No contraindications for physical therapy (infection, metastasis);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment;&#xD;
&#xD;
          -  Visual impairment for reading;&#xD;
&#xD;
          -  Lymphedema;&#xD;
&#xD;
          -  Bilateral breast cancer;&#xD;
&#xD;
          -  Systemic disease (metastases),&#xD;
&#xD;
          -  Infection;&#xD;
&#xD;
          -  Locoregional recurrence.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Physiotherapy in women´s health research group. University of Alcalà</name>
      <address>
        <city>Alcalà de Henares</city>
        <state>Madrid</state>
        <zip>28871</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.</citation>
    <PMID>19306057</PMID>
  </reference>
  <results_reference>
    <citation>Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.</citation>
    <PMID>35079831</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Maria Torres Lacomba</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Axillary web syndrome</keyword>
  <keyword>cording</keyword>
  <keyword>physical therapy</keyword>
  <keyword>breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</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/NCT02224261
org study id: 11/032
nct id: NCT02224261
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in
      improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized
      single-blinded controlled trial. Follow-up: five physical therapy assessments:
      pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention.
      Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing
      unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in
      Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two
      groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy
      composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific
      thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in
      conjunction with progressive active and action-assisted arm exercises; Control group:
      standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
description: Visual Analogue Scale
measure: Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention
time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
description: Inclinometer
measure: Change from baseline in QoL related to shoulder pain at one month (post-intervention); and 3 and 6 months post-intervention
time frame: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
description: Oxford Shoulder Score
arm group label: Physical Therapy
arm group type: Experimental
description: Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords and patient education.
arm group label: Control
arm group type: Active Comparator
description: Control protocol includes standard progressive active and action-assisted arm exercises & patient education.
intervention type: Other
intervention name: Physical Therapy protocol
description: Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises "stretching" cords, and patient education.
arm group label: Physical Therapy
other name: PT-AWS
intervention type: Other
intervention name: Control
description: Control protocol includes standard progressive active and action-assisted arm exercises & patient education.
arm group label: Control
other name: CG
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Spain
citation: Torres Lacomba M, Mayoral Del Moral O, Coperias Zazo JL, Yuste Sanchez MJ, Ferrandez JC, Zapico Goni A. Axillary web syndrome after axillary dissection in breast cancer: a prospective study. Breast Cancer Res Treat. 2009 Oct;117(3):625-30. doi: 10.1007/s10549-009-0371-8. Epub 2009 Mar 21.
PMID: 19306057
citation: Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314.
PMID: 35079831
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Maria Torres Lacomba
investigator title: Professor
mesh term: Syndrome