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Compression Bandages in Upper Limb Lymphedema (CB-ULL)

Primary Purpose

Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multilayer bandage
Double compression bandage
Cohesive bandage
Adhesive compression bandage
Kinesiotaping bandage
Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
Upper limb exercises
Educational strategy
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women after breast cancer surgery undergoing upper limb lymphedema not previously treated
  • Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb
  • The presence of heaviness, tension or fovea in the affected limb
  • More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema

Exclusion criteria will be:

  • Bilateral breast cancer surgery
  • Only hand lymphedema
  • Active cutaneous infection
  • A loco-regional cancer recurrence
  • The impossibility of complete all the physical therapy sessions
  • A primary lymphedema
  • Women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points
  • Any contraindication to physiotherapy

Sites / Locations

  • Physiotherapy in women´s health research group. University of Alcalà
  • University of Alcalá. FPSM research group. HUPA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Multilayer bandage group

Simplified multilayer bandage group

Cohesive bandage group

Adhesive compression bandage group

Kinesiotaping bandage group

Arm 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.

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).

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in arm volume
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.
Change in heath related quality of life lymphedema
It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version

Secondary Outcome Measures

Change in comfort of the bandage
Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable

Full Information

First Posted
August 4, 2017
Last Updated
June 2, 2020
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT03250364
Brief Title
Compression Bandages in Upper Limb Lymphedema
Acronym
CB-ULL
Official Title
Compression Bandages in Upper Limb Lymphedema After Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
January 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
5 goups: Multilayer bandage group; Double compression bandage group; Cohesive bandage group; Adhesive compression bandage group; Kinesiotaping bandage group
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multilayer bandage group
Arm Type
Experimental
Arm 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 Title
Simplified multilayer bandage group
Arm Type
Experimental
Arm 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 Title
Cohesive bandage group
Arm Type
Experimental
Arm 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 Title
Adhesive compression bandage group
Arm Type
Experimental
Arm 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 Title
Kinesiotaping bandage group
Arm Type
Experimental
Arm 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(s)
Multilayer bandage
Intervention Description
See arm/group descriptions
Intervention Type
Device
Intervention Name(s)
Double compression bandage
Intervention Description
See arm/group descriptions
Intervention Type
Device
Intervention Name(s)
Cohesive bandage
Intervention Description
See arm/group descriptions
Intervention Type
Device
Intervention Name(s)
Adhesive compression bandage
Intervention Description
See arm/group descriptions
Intervention Type
Device
Intervention Name(s)
Kinesiotaping bandage
Intervention Description
See arm/group descriptions
Intervention Type
Other
Intervention Name(s)
Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Upper limb exercises
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Educational strategy
Intervention 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.
Primary Outcome Measure Information:
Title
Change in arm volume
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.
Time Frame
3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Title
Change in heath related quality of life lymphedema
Description
It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version
Time Frame
3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Secondary Outcome Measure Information:
Title
Change in comfort of the bandage
Description
Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable
Time Frame
3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women after breast cancer surgery undergoing upper limb lymphedema not previously treated Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb The presence of heaviness, tension or fovea in the affected limb More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema Exclusion criteria will be: Bilateral breast cancer surgery Only hand lymphedema Active cutaneous infection A loco-regional cancer recurrence The impossibility of complete all the physical therapy sessions A primary lymphedema Women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points Any contraindication to physiotherapy
Facility Information:
Facility Name
Physiotherapy in women´s health research group. University of Alcalà
City
Alcalà de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
Facility Name
University of Alcalá. FPSM research group. HUPA
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Compression Bandages in Upper Limb Lymphedema

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