Effectiveness of Two Compression Methods in the Treatment of Upper Limb Lymphedema

Parc de Salut Mar

Status: Completed

Conditions: Lymphedema

Treatments: Device: Multilayer Compression Bandages; Device: Precast Adjustable Compression Wrap (Circaid)

Study type: Interventional

Funder types: Other

Identifiers

NCT02369679

2014/5584/I

Details and patient eligibility

About

Treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately.The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system.

The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema.

Full description

The gold standard of the treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately. With the multilayer compression bandage the upper limb lymphedema volume decreased a 37.2%.

The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system.

Decreasing compression is achieved by controlling the tension applied to each Velcro through a visual color guide. The Precast Adjustable Compression Wrap has proved to be safe and effective to treat lower limb lymphedema, but there is little information about its effectiveness in the treatment of the upper limb lymphedema.

The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema.

Enrollment: 47 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Upper limb lymphedema after axillary lymph node dissection for breast cancer.
• Lymphedema must affect at least the arm or the forearm.
• The lymphedema volume excess must be at least 10%
• The lymphedema must have not been previously treated or have been at least 1 year without treatment.

Exclusion criteria

• Bilateral upper limb lymphedema
• Cognitive or sensorial impairments which could interfere collaboration
• Plexopathy post radiotherapy
• Breast cancer in progression Pregnancy or Lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Precast Adjustable Compression Wrap

Experimental group

Description:

Precast Adjustable Compression Wrap will be adjusted by the physiotherapist each visit

Treatment:

Device: Precast Adjustable Compression Wrap (Circaid)

Multilayer Compression Bandages

Active Comparator group

Description:

Multilayer Compression Bandages will be adjusted by the physiotherapist each visit

Treatment:

Device: Multilayer Compression Bandages