Effectiveness of Cohesive Bandage on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
María Torres-Lacomba
RECRUITING
Alcalá De Henares
Contact Information
Primary
María Torres-Lacomba, PhD
maria.torres@uah.es
+34678900061
Backup
Beatriz Navarro-Brazález, PhD
b.navarrobrazalez@gmail.com
Time Frame
Start Date: 2019-01-10
Estimated Completion Date: 2024-12
Participants
Target number of participants: 90
Treatments
Active_comparator: CONTROL GROUP
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.
Experimental: COHESIVE BANDAGE GROUP
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.
Related Therapeutic Areas
Sponsors
Leads: University of Alcala

This content was sourced from clinicaltrials.gov