Compression Bandages in Upper Limb Lymphedema

Not Applicable

Completed

• Conditions: Lymphedema

• Registration Number: NCT03250364
• Lead Sponsor: University of Alcala

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-10
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Primary Completion: 2019-09
• Study Completion: 2020-01-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in arm volume	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.
Change in heath related quality of life lymphedema	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 Outcome Measures

Name	Time	Method
Change in comfort of the bandage	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

Trial Locations

Locations (2)

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, Spain