Reliability and Reproducibility of Bandaging in Breast Cancer

NCT04076033 | Completed DMC

• 1 other identifier: 000001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Functional Compressive Bandage (ECF) is a widely used therapeutic resource in the control of lymphedema resulting from the treatment of breast cancer, however, the effects inherent to the technique depend on the quality of the application. The aim of the study is to evaluate the reliability, reproducibility, and efficiency of treatment with different techniques in two studies. The first step aims to evaluate the reliability and reproducibility of the technique. The analysis of the pressure exerted by the four-layer bandage, applied by two evaluators previously trained and familiar with the ECF technique will perform the evaluations on the same volunteers in two moments, with an interval of one week between them. The intraclass correlation coefficient will be used to determine intra- and inter-examiner reliability, with its respective 95% confidence interval, standard error of measurement and minimum detectable change. The second stage aims to verify the efficiency of different ECF techniques in the functionality and circulation of the upper limb affected by lymphedema. This step is being performed by a single evaluator, and the ECF efficiency tested by the random application of two different techniques (spiral and eight), with a seven-day interval, and pressure assessment in mmHg. Upper limb functionality analysis is being performed using the Jebsen Taylor test performed before and with ECF on both limbs. The evaluation of the influence of the bandage in the circulation evaluated by Doppler ultrasound, before and after the test application. Member dominance assessed using the Edinburgh inventory.

Conditions

Breast Cancer

Keywords

Functional Compressive Bandage; Lymphedema; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  mmHg

  2 minutes

Secondary Outcomes (2)

• Blood flow

  10 minutes

• Jebsen Taylor test

  10 minutes

Study Arms (2)

ECF ESPIRAL

EXPERIMENTAL

The volunteer is submitted to four-layer spiral functional compressive bandage, then performs Taylor's Jebsen manual function test with comprehensive functional bandage (ECF).

Other: functional compressive bandage

ECF OITO

EXPERIMENTAL

The volunteer is submitted to functional compressive bandage in eight with four layers, then performs the Taylor Jebsen manual function test with the comprehensive functional bandage (ECF).

Other: functional compressive bandage

Interventions

functional compressive bandage OTHER

The functional compressive bandage is being performed with the volunteer sitting with the upper limb homolateral to the surgery supported by a support. After hydration of the limb, a cotton mesh is being used to prevent friction of the 1 cm density foam band being wrapped around the limb. No therapeutic procedure is being performed prior to functional compressive bandage. The bandage of the limb is being performed with 5 cm, 10 cm, 15 cm elastic cotton bandages from the fingers to the axillary region in four layers.

ECF ESPIRAL; ECF OITO

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Elaine Caldeira de Oliveira Guirro: lead

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Elaine Caldeira de Oliveira Guirro, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: January 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: December 30, 2021
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

BR (1)