search
Back to results

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

Primary Purpose

Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Precast Adjustable Compression Wrap (Circaid)
Multilayer Compression Bandages
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring upper limb, lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Germans Trias i Pujol Hospital
  • Hospital Universitari de Bellvitge
  • Hospital Vall Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Precast Adjustable Compression Wrap

Multilayer Compression Bandages

Arm Description

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

Multilayer Compression Bandages will be adjusted by the physiotherapist each visit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
February 4, 2015
Last Updated
April 5, 2017
Sponsor
Parc de Salut Mar
Collaborators
Hospital Universitari de Bellvitge, Germans Trias i Pujol Hospital, Hospital Vall d'Hebron
search

1. Study Identification

Unique Protocol Identification Number
NCT02369679
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
January 19, 2016 (Actual)
Study Completion Date
April 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Hospital Universitari de Bellvitge, Germans Trias i Pujol Hospital, Hospital Vall d'Hebron

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
upper limb, lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precast Adjustable Compression Wrap
Arm Type
Experimental
Arm Description
Precast Adjustable Compression Wrap will be adjusted by the physiotherapist each visit
Arm Title
Multilayer Compression Bandages
Arm Type
Active Comparator
Arm Description
Multilayer Compression Bandages will be adjusted by the physiotherapist each visit
Intervention Type
Device
Intervention Name(s)
Precast Adjustable Compression Wrap (Circaid)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Multilayer Compression Bandages
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in the excess of volume of upper limb
Description
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
Time Frame
Baseline to 3 months (10 sessions of treatment)
Secondary Outcome Measure Information:
Title
Changes in pain, heaviness, tightness and hardness
Description
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
Time Frame
Baseline to 3 months (10 sessions of treatment)
Title
Changes in skin and lymphedema condition
Description
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
Time Frame
Baseline to 3 months (10 sessions of treatment)
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
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
Time Frame
Baseline to 3 months (10 sessions of treatment)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roser Belmonte, MD, PhD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Vall Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs