Compression Bandages in Upper Limb Lymphedema

Overview

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.

Full Title of Study: “Compression Bandages in Upper Limb Lymphedema After Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2019

Interventions

  • Device: Multilayer bandage
    • See arm/group descriptions
  • Device: Double compression bandage
    • See arm/group descriptions
  • Device: Cohesive bandage
    • See arm/group descriptions
  • Device: Adhesive compression bandage
    • See arm/group descriptions
  • Device: Kinesiotaping bandage
    • See arm/group descriptions
  • Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
    • 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.
  • Other: Upper limb exercises
    • 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.
  • Behavioral: Educational strategy
    • 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.

Arms, Groups and Cohorts

  • Experimental: Multilayer bandage group
    • 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.
  • Experimental: Simplified multilayer bandage group
    • 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).
  • Experimental: Cohesive bandage group
    • 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.
  • Experimental: Adhesive compression bandage group
    • 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.
  • Experimental: Kinesiotaping bandage group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • 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 45ยบ 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
    • Time Frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
    • It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version

Secondary Measures

  • 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
    • Numeric scale ranging from 0-10: 0 comfortable – 10: very uncomfortable

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alcala
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Torres Lacomba, Professor – University of Alcala

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