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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Axillary Web Syndrome
• Intervention / Treatment: Other: Manual drainage & arm therapeutic exercise; Other: Cohesive bandaging & arm therapeutic exercise

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Torres-Lacomba, PhD; Phone Number: +34678900061; Email: maria.torres@uah.es
• Study Contact Backup: Name: Beatriz Navarro-Brazález, PhD; Email: b.navarrobrazalez@gmail.com

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28005
      • Recruiting
      • María Torres-Lacomba
      • Contact: Beatriz Navarro-Brazález, PhD; Email: b.navarrobrazalez@gmail.com
      • Contact: María Torres-Lacomba, PhD; Phone Number: 678900061; Email: maria.torres@uah.es
      • Sub-Investigator: Beatriz Arranz Martín, MsC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Manual drainage & arm therapeutic exercise; See arm/group descriptions.
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.	Other: Cohesive bandaging & arm therapeutic exercise; See arm/group descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Range of shoulder motion	Inclinometer (measured in grades)	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	Oxford Shoulder Score. The OSS is a unidimensional score comprising 12 questions about pain and disability involving activities of daily routine. Thus, each of the 12 questions is scored from 0 to 4, with 4 representing best outcome/least symptoms. Scores from each question are summed so the overall score run from 0 to 48 with 48 being the best outcome; so that the lower scores indicate more pain and disability. The OSS Spanish version is applicable, reliable, valid, and responsive to assess shoulder disability in Spanish women after breast cancer treatment	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	FACTB+4. Health-related quality of life (HRQoL): HRQoL was measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B) Spanish version 4. FACT-Bv4 is a 40-item questionnaire designed to measure multidimensional HRQoL in women with breast cancer. The 40 items cover four generic scales of well-being (Physical, Emotional, Social, and Functional) and two side-specific subscales: Breast Cancer (9 items) and Arm (4 items). The Arm-specific subscale assesses arm morbidity: 1) pain, 2) poor range of arm movements, 3) numbness, and 4) stiffness. The Breast Cancer subscale plus the arm subscale range from 0 to 56 points. The Trial Outcome Index (TOI) is the sum of Physical and Functional wellbeing plus Breast Cancer Subscale (range 0-92 points). The FACT-B total score can range from 0 to 144, with a higher score indicating better HRQoL.	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.

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: María Torres-Lacomba, PhD, University of Alcalá

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Estimated): September 10, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 4, 2020
• First Submitted That Met QC Criteria: April 4, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Physical Therapy; Cohesive bandage
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: OE20/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No