<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/NCT03250364</url>
  </required_header>
  <id_info>
    <org_study_id>18/2010</org_study_id>
    <nct_id>NCT03250364</nct_id>
  </id_info>
  <brief_title>Compression Bandages in Upper Limb Lymphedema</brief_title>
  <acronym>CB-ULL</acronym>
  <official_title>Compression Bandages in Upper Limb Lymphedema After Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Despite different types of bandages are using in the lymphedema treatment, numerous of them&#xD;
      have not been directly compared. The aim of this study is to compare the efficacy of five&#xD;
      different kinds of bandages on limb volume and lymphedema-related symptoms. It was also&#xD;
      measured as secondary variables the comfort of the bandage related by the participants and&#xD;
      the directly cost of each kind of bandage during the treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2014</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 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>
    <intervention_model_description>5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in arm volume</measure>
    <time_frame>3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention</time_frame>
    <description>To assess the volume of the limb it will be used the circumference measurement. The assessment will be with the subject in upright position with the arm placed on a table, the forearm relaxed on the table, the shoulder in a neutral rotation, a flexion of 45º of the elbow, and forearms in supine position. The reference will be the elbow fold where was measure the circumference of the limb in 5cm intervals. The circumference measurements will be converted into volume values with the truncated cone formula in each 5 centimeters long.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in heath related quality of life lymphedema</measure>
    <time_frame>3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention</time_frame>
    <description>It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in comfort of the bandage</measure>
    <time_frame>3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention</time_frame>
    <description>Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>Multilayer bandage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + multilayer bandage consisting of three layers. The first was a 100% cotton tubular bandage which will be directly placed on the skin to prevent any injury (&quot;Tubinylex TM&quot;). The second layer is a paddle with the purpose of unify and increase pressure (Emulsified Latex FoamTM 8mm, Thuasne, France); and the third layer of inelastic bandages (6, 8 and/or 10 cm Rosidal K Short Stretch Bandage, Germany). All the bandage layers will be placed from caudal to cranial in a circular disposition, overlapping in one third the previous layer for a correctly cover of the limb and not to leave open spaces. The cotton tubular bandage and the short-stretch bandage could be cleaned without losing their material properties.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simplified multilayer bandage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + double compression bandage consisting of two layers, made up of a first rigid cotton bandage (11 cm Bande coton Short Stretch; Thuasne, France) and a second elastic bandage (&quot;BiflexTM&quot; 16 light; Thuasne, France). The two layers will be placed caudal to cranial in a circular manner, overlapping in one third the previous layer. The elastic bandage have squares drawn to help to the physiotherapist to control the stretch they given to the bandage. The two bandages could be cleaning without losing their properties. If there was any oedema concentration or a fibrous place, a paddle pad will be put in these places (&quot;Mobiderm TM&quot;, Thuasne, France).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohesive bandage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + cohesive bandage consisting of a single short-stretched layer that will be put directly on the subject skin and stick on itself (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States). It will be placed in a circular manner distal to cranial with a paddle pad in the elbow fold not to damage this moving part. This bandage will be reused twice in the same subject.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adhesive compression bandage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + adhesive compression bandage consisting of an elastic bandage (&quot;BiplastTM&quot; Thuasne, France. Measures: 10cm x 2,5 m) which will put over a pre-tape bandage not to damage the skin. It will be placed in a circular disposition from distal to cranial. In each physiotherapy session, the bandage has to be replaced with a new one.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kinesiotaping bandage group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + kinesiotaping bandage consisting of K-Active&quot; Tape. The k-tape will be pasted directly on the skin and put longitudinally in thin bands in a cranio-caudal disposition. The width of the bandage will be of 5cm, and will be cut in four bands that will cover all the upper limb cranial to caudal in a spiral way surrounded it. The bandage will be placed moving the limb into internal and external rotation for putting the skin in a little stretch without lengthen the tape.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multilayer bandage</intervention_name>
    <description>See arm/group descriptions</description>
    <arm_group_label>Multilayer bandage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double compression bandage</intervention_name>
    <description>See arm/group descriptions</description>
    <arm_group_label>Simplified multilayer bandage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cohesive bandage</intervention_name>
    <description>See arm/group descriptions</description>
    <arm_group_label>Cohesive bandage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adhesive compression bandage</intervention_name>
    <description>See arm/group descriptions</description>
    <arm_group_label>Adhesive compression bandage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinesiotaping bandage</intervention_name>
    <description>See arm/group descriptions</description>
    <arm_group_label>Kinesiotaping bandage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression</intervention_name>
    <description>MLD using a modification of the strokes described by Leduc will be applied to lymphedema &quot;resorption&quot;. It will be included resorption maneuver in the oedematous areas of the affected limb, in cranial to caudal direction, since the physiotherapist seeing a change in the tissue qualities of the oedema. Then, the subjects will be received thirty minutes of Intermittent Pneumatic Compression (&quot;EureducTM&quot;) with a pression of 40 mmHg.</description>
    <arm_group_label>Adhesive compression bandage group</arm_group_label>
    <arm_group_label>Cohesive bandage group</arm_group_label>
    <arm_group_label>Kinesiotaping bandage group</arm_group_label>
    <arm_group_label>Multilayer bandage group</arm_group_label>
    <arm_group_label>Simplified multilayer bandage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Upper limb exercises</intervention_name>
    <description>After the bandage will be put, proprioceptive neuromuscular facilitation exercises without resistance in two diagonal in asymmetrical reciprocal patterns with the affected limb will be taught. The first diagonal into flexion from hitch hike to swat fly, and into extension from swat fly to hitch hike, and the second diagonal from hand in opposite pocket to carry tray, and into extension from carry tray to hand in opposite pocket. These exercises must be done at home two times per day, ten repetitions each exercise.</description>
    <arm_group_label>Adhesive compression bandage group</arm_group_label>
    <arm_group_label>Cohesive bandage group</arm_group_label>
    <arm_group_label>Kinesiotaping bandage group</arm_group_label>
    <arm_group_label>Multilayer bandage group</arm_group_label>
    <arm_group_label>Simplified multilayer bandage group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational strategy</intervention_name>
    <description>Instructions about lymphatic system anatomy and pato-physiology, the prevention and identification of possible lymphedema complication or infection, how to use and exercise this arm, avoidance of trauma, injury, an excess of heat and arm constriction.</description>
    <arm_group_label>Adhesive compression bandage group</arm_group_label>
    <arm_group_label>Cohesive bandage group</arm_group_label>
    <arm_group_label>Kinesiotaping bandage group</arm_group_label>
    <arm_group_label>Multilayer bandage group</arm_group_label>
    <arm_group_label>Simplified multilayer bandage group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women after breast cancer surgery undergoing upper limb lymphedema not previously&#xD;
             treated&#xD;
&#xD;
          -  Having more than two centimeters between two adjacent measurements between the&#xD;
             lymphedematous and the contralateral upper limb&#xD;
&#xD;
          -  The presence of heaviness, tension or fovea in the affected limb&#xD;
&#xD;
          -  More than six months post-surgery or radiation to eliminate the possibility of being a&#xD;
             post-chirurgical oedema&#xD;
&#xD;
        Exclusion criteria will be:&#xD;
&#xD;
          -  Bilateral breast cancer surgery&#xD;
&#xD;
          -  Only hand lymphedema&#xD;
&#xD;
          -  Active cutaneous infection&#xD;
&#xD;
          -  A loco-regional cancer recurrence&#xD;
&#xD;
          -  The impossibility of complete all the physical therapy sessions&#xD;
&#xD;
          -  A primary lymphedema&#xD;
&#xD;
          -  Women with lymphedema symptoms like thickness and heaviness in the upper limb but&#xD;
             without a difference of two centimeters in two adjacent points&#xD;
&#xD;
          -  Any contraindication to physiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 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>
    <facility>
      <name>University of Alcalá. FPSM research group. HUPA</name>
      <address>
        <city>Alcalá de Henares</city>
        <state>Madrid</state>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphedema</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/NCT03250364
org study id: 18/2010
nct id: NCT03250364
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite different types of bandages are using in the lymphedema treatment, numerous of them
      have not been directly compared. The aim of this study is to compare the efficacy of five
      different kinds of bandages on limb volume and lymphedema-related symptoms. It was also
      measured as secondary variables the comfort of the bandage related by the participants and
      the directly cost of each kind of bandage during the treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in arm volume
time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
description: To assess the volume of the limb it will be used the circumference measurement. The assessment will be with the subject in upright position with the arm placed on a table, the forearm relaxed on the table, the shoulder in a neutral rotation, a flexion of 45º of the elbow, and forearms in supine position. The reference will be the elbow fold where was measure the circumference of the limb in 5cm intervals. The circumference measurements will be converted into volume values with the truncated cone formula in each 5 centimeters long.
measure: Change in heath related quality of life lymphedema
time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
description: It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version
measure: Change in comfort of the bandage
time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
description: Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable
arm group label: Multilayer bandage group
arm group type: Experimental
description: Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + multilayer bandage consisting of three layers. The first was a 100% cotton tubular bandage which will be directly placed on the skin to prevent any injury ("Tubinylex TM"). The second layer is a paddle with the purpose of unify and increase pressure (Emulsified Latex FoamTM 8mm, Thuasne, France); and the third layer of inelastic bandages (6, 8 and/or 10 cm Rosidal K Short Stretch Bandage, Germany). All the bandage layers will be placed from caudal to cranial in a circular disposition, overlapping in one third the previous layer for a correctly cover of the limb and not to leave open spaces. The cotton tubular bandage and the short-stretch bandage could be cleaned without losing their material properties.
arm group label: Simplified multilayer bandage group
arm group type: Experimental
description: Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + double compression bandage consisting of two layers, made up of a first rigid cotton bandage (11 cm Bande coton Short Stretch; Thuasne, France) and a second elastic bandage ("BiflexTM" 16 light; Thuasne, France). The two layers will be placed caudal to cranial in a circular manner, overlapping in one third the previous layer. The elastic bandage have squares drawn to help to the physiotherapist to control the stretch they given to the bandage. The two bandages could be cleaning without losing their properties. If there was any oedema concentration or a fibrous place, a paddle pad will be put in these places ("Mobiderm TM", Thuasne, France).
arm group label: Cohesive bandage group
arm group type: Experimental
description: Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + cohesive bandage consisting of a single short-stretched layer that will be put directly on the subject skin and stick on itself (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States). It will be placed in a circular manner distal to cranial with a paddle pad in the elbow fold not to damage this moving part. This bandage will be reused twice in the same subject.
arm group label: Adhesive compression bandage group
arm group type: Experimental
description: Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + adhesive compression bandage consisting of an elastic bandage ("BiplastTM" Thuasne, France. Measures: 10cm x 2,5 m) which will put over a pre-tape bandage not to damage the skin. It will be placed in a circular disposition from distal to cranial. In each physiotherapy session, the bandage has to be replaced with a new one.
arm group label: Kinesiotaping bandage group
arm group type: Experimental
description: Manual lymphatic drainage (MLD) + upper limb (UL) exercises + educational strategy + kinesiotaping bandage consisting of K-Active" Tape. The k-tape will be pasted directly on the skin and put longitudinally in thin bands in a cranio-caudal disposition. The width of the bandage will be of 5cm, and will be cut in four bands that will cover all the upper limb cranial to caudal in a spiral way surrounded it. The bandage will be placed moving the limb into internal and external rotation for putting the skin in a little stretch without lengthen the tape.
intervention type: Device
intervention name: Multilayer bandage
description: See arm/group descriptions
arm group label: Multilayer bandage group
intervention type: Device
intervention name: Double compression bandage
description: See arm/group descriptions
arm group label: Simplified multilayer bandage group
intervention type: Device
intervention name: Cohesive bandage
description: See arm/group descriptions
arm group label: Cohesive bandage group
intervention type: Device
intervention name: Adhesive compression bandage
description: See arm/group descriptions
arm group label: Adhesive compression bandage group
intervention type: Device
intervention name: Kinesiotaping bandage
description: See arm/group descriptions
arm group label: Kinesiotaping bandage group
intervention type: Other
intervention name: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
description: MLD using a modification of the strokes described by Leduc will be applied to lymphedema "resorption". It will be included resorption maneuver in the oedematous areas of the affected limb, in cranial to caudal direction, since the physiotherapist seeing a change in the tissue qualities of the oedema. Then, the subjects will be received thirty minutes of Intermittent Pneumatic Compression ("EureducTM") with a pression of 40 mmHg.
arm group label: Adhesive compression bandage group
arm group label: Cohesive bandage group
arm group label: Kinesiotaping bandage group
arm group label: Multilayer bandage group
arm group label: Simplified multilayer bandage group
intervention type: Other
intervention name: Upper limb exercises
description: After the bandage will be put, proprioceptive neuromuscular facilitation exercises without resistance in two diagonal in asymmetrical reciprocal patterns with the affected limb will be taught. The first diagonal into flexion from hitch hike to swat fly, and into extension from swat fly to hitch hike, and the second diagonal from hand in opposite pocket to carry tray, and into extension from carry tray to hand in opposite pocket. These exercises must be done at home two times per day, ten repetitions each exercise.
arm group label: Adhesive compression bandage group
arm group label: Cohesive bandage group
arm group label: Kinesiotaping bandage group
arm group label: Multilayer bandage group
arm group label: Simplified multilayer bandage group
intervention type: Behavioral
intervention name: Educational strategy
description: Instructions about lymphatic system anatomy and pato-physiology, the prevention and identification of possible lymphedema complication or infection, how to use and exercise this arm, avoidance of trauma, injury, an excess of heat and arm constriction.
arm group label: Adhesive compression bandage group
arm group label: Cohesive bandage group
arm group label: Kinesiotaping bandage group
arm group label: Multilayer bandage group
arm group label: Simplified multilayer bandage group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Maria Torres Lacomba
investigator title: Professor
mesh term: Lymphedema
sharing ipd: No