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

Comparison of the Effectiveness of a Precast Adjustable Compression Wrap With the Multilayer Compression Bandage in Upper Limb Lymphedema

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Device: Precast Adjustable Compression Wrap (Circaid); Device: Multilayer Compression Bandages

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall Hebron
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Germans Trias i Pujol Hospital
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Precast Adjustable Compression Wrap; Precast Adjustable Compression Wrap will be adjusted by the physiotherapist each visit	Device: Precast Adjustable Compression Wrap (Circaid); 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).
Active Comparator: Multilayer Compression Bandages; Multilayer Compression Bandages will be adjusted by the physiotherapist each visit	Device: Multilayer Compression Bandages; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pain, heaviness, tightness and hardness	Changes in pain, heaviness, tightness and hardness will be measured by visual analogical scales. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months	Baseline to 3 months (10 sessions of treatment)
Changes in skin and lymphedema condition	The skin and lymphedema condition will be evaluated every day along the treatment phase and at 3 months of follow up. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months	Baseline to 3 months (10 sessions of treatment)
Number of Participants with Serious and Non-Serious Adverse Events	Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators. In order to evaluate tolerability patients will be asked every day about any discomfort or troubles they could feel. On the other hand, it will be daily recorded how many hours the patient had used the precast adjustable compression wrap or the multilayer compression bandages. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months	Baseline to 3 months (10 sessions of treatment)

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Germans Trias i Pujol Hospital; Hospital Universitari de Bellvitge; Hospital Vall d'Hebron
• Investigators: Principal Investigator: Roser Belmonte, MD, PhD, Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2014
• Primary Completion (Actual): January 19, 2016
• Study Completion (Actual): April 5, 2017

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: upper limb; lymphedema
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2014/5584/I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No