Clinical trial · Interventional
Reliability and Reproducibility of Bandaging in Breast Cancer
Reliability, Reproducibility, and Efficiency of Functional Compressive Assessment in the Treatment of Secondary Lymphedema to the Treatment of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| functional compressive bandage | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ECF ESPIRAL
- description
- The volunteer is submitted to four-layer spiral functional compressive bandage, then performs Taylor's Jebsen manual function test with comprehensive functional bandage (ECF).
- interventionNames
- Other: functional compressive bandage
- type
- EXPERIMENTAL
- label
- ECF OITO
- description
- 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).
- interventionNames
- Other: functional compressive bandage
Primary outcomes (1)
- measure
- Blood Pressure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available