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

NCT02369679 | Completed

• 1 other identifier: 2014/5584/I
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

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.

Conditions

Lymphedema

Keywords

upper limb; lymphedema

Outcome Measures

Primary Outcomes (1)

• Change in the excess of volume of upper limb

  Change in the excess of volume of the affected upper limb. The excess of volume is the difference in volume between the affected and the unaffected upper limb. The upper limb volumes will be obtained from the perimeters of the upper limbs and applying the truncate cone formula. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months

  Baseline to 3 months (10 sessions of treatment)

Secondary Outcomes (3)

• Changes in pain, heaviness, tightness and hardness

  Baseline to 3 months (10 sessions of treatment)

• Changes in skin and lymphedema condition

  Baseline to 3 months (10 sessions of treatment)

• Number of Participants with Serious and Non-Serious Adverse Events

  Baseline to 3 months (10 sessions of treatment)

Study Arms (2)

Precast Adjustable Compression Wrap

EXPERIMENTAL

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

Device: Precast Adjustable Compression Wrap (Circaid)

Multilayer Compression Bandages

ACTIVE COMPARATOR

Multilayer Compression Bandages will be adjusted by the physiotherapist each visit

Device: Multilayer Compression Bandages

Interventions

Precast Adjustable Compression Wrap (Circaid) DEVICE

A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the precast adjustable compression wrap to the patient. The patient would maintain the precast adjustable compression wrap until the next session of treatment. The first 10 sessions will be daily from Monday to Friday. After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days).

Precast Adjustable Compression Wrap

Multilayer Compression Bandages DEVICE

A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the multilayer bandage to the patient. The patient would maintain the multilayer compression bandage until the next session of treatment. The first 10 sessions will be daily from Monday to Friday. After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days).

Multilayer Compression Bandages

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Hospital Universitari de Bellvitge: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (3)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital Vall Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Roser Belmonte, MD, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 24, 2015
• Study Start: October 13, 2014
• Primary Completion: January 19, 2016
• Study Completion: April 5, 2017
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

ES (3)