Clinical trial NCT02369679: Effectiveness of Two Compression Methods in the Treatment of Upper Limb Lymphedema
Official title: Comparison of the Effectiveness of a Precast Adjustable Compression Wrap With the Multilayer Compression Bandage in Upper Limb Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: upper limb
lymphedema
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Hospital Universitari de Bellvitge
name: Germans Trias i Pujol Hospital
name: Hospital Vall d'Hebron
First posted: 2015-02-24
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the excess of volume of upper limb
timeFrame: Baseline to 3 months (10 sessions of treatment)
Secondary outcomes:
measure: Changes in pain, heaviness, tightness and hardness
timeFrame: Baseline to 3 months (10 sessions of treatment)
measure: Changes in skin and lymphedema condition
timeFrame: Baseline to 3 months (10 sessions of treatment)
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Baseline to 3 months (10 sessions of treatment)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall Hebron
Study officials:
affiliation: Parc de Salut Mar
name: Roser Belmonte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: