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Trial record 2 of 288 for:    Lymphedema

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

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ClinicalTrials.gov Identifier: NCT02369679
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : April 7, 2017
Sponsor:
Collaborators:
Hospital Universitari de Bellvitge
Germans Trias i Pujol Hospital
Hospital Vall d'Hebron
Information provided by (Responsible Party):
Roser Belmonte, Parc de Salut Mar

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.


Condition or disease Intervention/treatment Phase
Lymphedema Device: Precast Adjustable Compression Wrap (Circaid) Device: Multilayer Compression Bandages Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of a Precast Adjustable Compression Wrap With the Multilayer Compression Bandage in Upper Limb Lymphedema
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : January 19, 2016
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

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).





Primary Outcome Measures :
  1. Change in the excess of volume of upper limb [ Time Frame: Baseline to 3 months (10 sessions of treatment) ]

    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 :
  1. Changes in pain, heaviness, tightness and hardness [ Time Frame: Baseline to 3 months (10 sessions of treatment) ]
    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

  2. Changes in skin and lymphedema condition [ Time Frame: Baseline to 3 months (10 sessions of treatment) ]
    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

  3. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Baseline to 3 months (10 sessions of treatment) ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369679


Locations
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Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Vall Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Parc de Salut Mar
Hospital Universitari de Bellvitge
Germans Trias i Pujol Hospital
Hospital Vall d'Hebron
Investigators
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Principal Investigator: Roser Belmonte, MD, PhD Parc de Salut Mar

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Responsible Party: Roser Belmonte, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02369679     History of Changes
Other Study ID Numbers: 2014/5584/I
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Keywords provided by Roser Belmonte, Parc de Salut Mar:
upper limb
lymphedema

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases