Effectiveness of Cohesive Bandage on Axillary Web Syndrome After

NCT ID: NCT04338334

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-10

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Axillary Web Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Manual drainage & arm therapeutic exercise

Intervention Type OTHER

See arm/group descriptions.

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.

Group Type EXPERIMENTAL

Cohesive bandaging & arm therapeutic exercise

Intervention Type OTHER

See arm/group descriptions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual drainage & arm therapeutic exercise

See arm/group descriptions.

Intervention Type OTHER

Cohesive bandaging & arm therapeutic exercise

See arm/group descriptions.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alcala

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maria Torres Lacomba

Principal investigator & Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

María Torres-Lacomba, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

María Torres-Lacomba

Alcalá de Henares, Madrid, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

María Torres-Lacomba, PhD

Role: CONTACT

+34678900061

Beatriz Navarro-Brazález, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

María Torres-Lacomba, PhD

Role: primary

678900061

Beatriz Navarro-Brazález, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OE20/2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.