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Completed

NCT Number: NCT03250364

Compression Bandages in Upper Limb Lymphedema

Despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. The aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. It was also measured as secondary variables the comfort of the bandage related by the participants and the directly cost of each kind of bandage during the treatment.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy in women´s health research group. University of Alcalà, Alcalà de Henares, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women after breast cancer surgery undergoing upper limb lymphedema not previously treated
  • Having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb
  • The presence of heaviness, tension or fovea in the affected limb
  • More than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema

Exclusion criteria

will be:

  • Bilateral breast cancer surgery
  • Only hand lymphedema
  • Active cutaneous infection
  • A loco-regional cancer recurrence
  • The impossibility of complete all the physical therapy sessions
  • A primary lymphedema
  • Women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points
  • Any contraindication to physiotherapy

Treatment and study plan

Multilayer bandage

Device

See arm/group descriptions

Double compression bandage

Device

See arm/group descriptions

Cohesive bandage

Device

See arm/group descriptions

Adhesive compression bandage

Device

See arm/group descriptions

Kinesiotaping bandage

Device

See arm/group descriptions

Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression

Other

MLD using a modification of the strokes described by Leduc will be applied to lymphedema "resorption". It will be included resorption maneuver in the oedematous areas of the affected limb, in cranial to caudal direction, since the physiotherapist seeing a change in the tissue qualities of the oedema. Then, the subjects will be received thirty minutes of Intermittent Pneumatic Compression ("EureducTM") with a pression of 40 mmHg.

Upper limb exercises

Other

After the bandage will be put, proprioceptive neuromuscular facilitation exercises without resistance in two diagonal in asymmetrical reciprocal patterns with the affected limb will be taught. The first diagonal into flexion from hitch hike to swat fly, and into extension from swat fly to hitch hike, and the second diagonal from hand in opposite pocket to carry tray, and into extension from carry tray to hand in opposite pocket. These exercises must be done at home two times per day, ten repetitions each exercise.

Educational strategy

Behavioral

Instructions about lymphatic system anatomy and pato-physiology, the prevention and identification of possible lymphedema complication or infection, how to use and exercise this arm, avoidance of trauma, injury, an excess of heat and arm constriction.

Primary outcomes

  1. Change in arm volume

    Time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention

    To assess the volume of the limb it will be used the circumference measurement. The assessment will be with the subject in upright position with the arm placed on a table, the forearm relaxed on the table, the shoulder in a neutral rotation, a flexion of 45º of the elbow, and forearms in supine position. The reference will be the elbow fold where was measure the circumference of the limb in 5cm intervals. The circumference measurements will be converted into volume values with the truncated cone formula in each 5 centimeters long.

  2. Change in heath related quality of life lymphedema

    Time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention

    It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version

Secondary outcomes

  1. Change in comfort of the bandage

    Time frame: 3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention

    Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

Compression Bandages in Upper Limb Lymphedema After Breast Cancer

Acronym: CB-ULL

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Aug 15, 2017
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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