Effectiveness of Cohesive Bandage on Axillary Web Syndrome After (CBaws)

University of Alcala

Status: Enrolling

Conditions: Axillary Web Syndrome

Treatments: Other: Cohesive bandaging & arm therapeutic exercise; Other: Manual drainage & arm therapeutic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04338334

OE20/2020

Details and patient eligibility

About

Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Control group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral breast cancer;
• Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
• Axillary web syndrome in upper limb of the operated side;
• Consent to participate in the study;
• No contraindications.

Exclusion criteria

• Cognitive impairment;
• Visual impairment for reading;
• Lymphedema;
• Bilateral breast cancer;
• Systemic disease (metastases),
• Infection;
• Locoregional recurrence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

CONTROL GROUP

Active Comparator group

Description:

Control group includes physical therapy protocol composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active arm therapeutic exercises.

Treatment:

Other: Manual drainage & arm therapeutic exercise

COHESIVE BANDAGE GROUP

Experimental group

Description:

Cohesive bandage is a self-adherent lightweight bandage, made of a porous nonwoven polyester material. A single self-adherent inelastic bandage will be directly applied at full stretch on cleaned and dried skin (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States) in a spiral method around the limb, starting at the hand and a layer overlap of 50%, so that the greatest compression was located at the distal points, gradually decreasing toward the proximal shoulder part. Cohesive latex-free bandages will be available for those allergic women. Women will do progressive active arm therapeutic exercises with bandaging.

Treatment:

Other: Cohesive bandaging & arm therapeutic exercise