Effectiveness of Cohesive Bandage on Axillary Web Syndrome After

NCT04338334 | Unknown

• 1 other identifier: OE20/2020
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Axillary Web Syndrome

Keywords

Cohesive bandage; Physical Therapy; Pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Subjective pain

  Visual Analogue Scale (0-10 cm)

  4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention.

Secondary Outcomes (3)

• Change from baseline in Range of shoulder motion

  4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.

• Change from baseline in perceived shoulder disability

  4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.

• Change from baseline in QoL

  4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.

Study Arms (2)

CONTROL GROUP

ACTIVE COMPARATOR

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.

Other: Manual drainage & arm therapeutic exercise

COHESIVE BANDAGE GROUP

EXPERIMENTAL

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.

Other: Cohesive bandaging & arm therapeutic exercise

Interventions

Manual drainage & arm therapeutic exercise OTHER

See arm/group descriptions.

CONTROL GROUP

Cohesive bandaging & arm therapeutic exercise OTHER

See arm/group descriptions.

COHESIVE BANDAGE GROUP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

María Torres-Lacomba

Alcalá de Henares, Madrid, 28005, Spain

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• María Torres-Lacomba, PhD

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Torres-Lacomba, PhD

CONTACT

+34678900061; maria.torres@uah.es

Beatriz Navarro-Brazález, PhD

CONTACT

b.navarrobrazalez@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator & Professor

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 8, 2020
• Study Start: January 10, 2019
• Primary Completion: September 10, 2024
• Study Completion: December 1, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)