Reliability and Reproducibility of Bandaging in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Reliability, Reproducibility, and Efficiency of Functional Compressive Assessment in the Treatment of Secondary Lymphedema to the Treatment of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076033
• Other study ID #: 000001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. To this end, 50 volunteers will be evaluated, aged between 40 and 70 years, submitted to breast cancer treatment. The analyzes will be performed in two subprojects, conducted with randomized cross over design and seven days wash out period, so far 19 volunteers were collected. 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 (ICC2,1) will be used to determine intra- and inter-examiner reliability, with its respective 95% confidence interval, standard measurement error 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. Partial data was verified by descriptive analysis with mean and standard deviation. Data processing was performed using SPSS® software, version 13.0 (Chicago, IL, USA). A significance level of 5% was considered. The information obtained in the study aims to show the partial results of the preliminary and descriptive evaluation of the physical therapy intervention in women affected by lymphedema resulting from breast cancer treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria are age over 21 years, treatment for unilateral breast cancer, unilateral lymphedema resulting from treatment for breast cancer.

Exclusion Criteria:

• The exclusion criteria established are skin disorders; diabetes; adjuvant treatment in progress; submitted to bilateral axillary dissection; diagnosis of metastasis and at risk of peripheral arterial disease, functional change of upper limbs before breast cancer treatment.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• functional compressive bandage
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.

Locations

Country	Name	City	State
Brazil	University of São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Elaine Caldeira de Oliveira Guirro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	mmHg	2 minutes
Secondary	Blood flow	mL/s	10 minutes
Secondary	Jebsen Taylor test	time	10 minutes