Compression Bandages in Upper Limb Lymphedema

Lymphedema Clinical Trial

— CB-ULL  

Official title:

Compression Bandages in Upper Limb Lymphedema After Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250364
• Other study ID #: 18/2010
• Status: Completed
• Phase: N/A
• Start date: August 10, 2014
• Est. completion date: January 10, 2020

Study information

• Verified date: June 2020
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 10, 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• Multilayer bandage
See arm/group descriptions
• Double compression bandage
See arm/group descriptions
• Cohesive bandage
See arm/group descriptions
• Adhesive compression bandage
See arm/group descriptions
• Kinesiotaping bandage
See arm/group descriptions

Other:
• Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression
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
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.

Behavioral:
• Educational strategy
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.

Locations

Country	Name	City	State
Spain	Physiotherapy in women´s health research group. University of Alcalà	Alcalà de Henares	Madrid
Spain	University of Alcalá. FPSM research group. HUPA	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arm volume	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.	3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Primary	Change in heath related quality of life lymphedema	It will be assessed by Lymphedema specific PRO instrument: Upper Limb Lymphedema (ULL)27 spanish validated version	3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention
Secondary	Change in comfort of the bandage	Numeric scale ranging from 0-10: 0 comfortable - 10: very uncomfortable	3 assessments to evaluate changes: at baseline (before intervention), after intervention (1 month from baseline) and 6 months after intervention