Compression Bandages in Upper Limb Lymphedema (CB-ULL)

University of Alcala

Status: Completed

Conditions: Lymphedema

Treatments: Device: Kinesiotaping bandage; Device: Adhesive compression bandage; Other: Upper limb exercises; Behavioral: Educational strategy; Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression; Device: Cohesive bandage; Device: Double compression bandage; Device: Multilayer bandage

Study type: Interventional

Funder types: Other

Identifiers

NCT03250364

18/2010

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 5 patient groups

Multilayer bandage group

Experimental group

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.

Treatment:

Other: Upper limb exercises

Behavioral: Educational strategy

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression

Device: Multilayer bandage

Simplified multilayer bandage group

Experimental group

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).

Treatment:

Device: Double compression bandage

Other: Upper limb exercises

Behavioral: Educational strategy

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression

Cohesive bandage group

Experimental group

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.

Treatment:

Other: Upper limb exercises

Behavioral: Educational strategy

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression

Device: Cohesive bandage

Adhesive compression bandage group

Experimental group

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.

Treatment:

Other: Upper limb exercises

Device: Adhesive compression bandage

Behavioral: Educational strategy

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression

Kinesiotaping bandage group

Experimental group

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.

Treatment:

Other: Upper limb exercises

Device: Kinesiotaping bandage

Behavioral: Educational strategy

Other: Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression