Breast Cancer-Related Lymphedema
Conditions
Keywords
Lymphedema, Breast Cancer, Myoton, Skin Stiffness, Ultrasound, Reliability
Brief summary
This study aims to evaluate the intra- and inter-rater reliability of the MyotonPRO, a handheld device that measures the viscoelastic properties of the skin, in patients with breast cancer-related lymphedema. Twenty women with unilateral upper extremity lymphedema will be included. Each participant will undergo repeated skin assessments using the MyotonPRO by two independent raters. Additionally, ultrasonographic tissue characteristics and limb volume measurements will be performed. The findings are expected to contribute to the validation of the MyotonPRO for use in clinical lymphedema evaluation.
Detailed description
The study will be conducted at a single center with 20 women diagnosed with unilateral upper extremity lymphedema after mastectomy. Participants will be evaluated using the MyotonPRO device by two trained raters to assess intra- and inter-rater reliability. Ultrasonographic grading of subcutaneous echogenicity and echo-free space, as well as circumference and volume measurements, will be conducted to explore correlations with biomechanical tissue properties. Statistical analysis will include intraclass correlation coefficient (ICC) for reliability and Pearson correlation for validity. This study is expected to support the clinical use of MyotonPRO in lymphedema assessment.
Interventions
DEVICEMyotonPRO
The MyotonPRO is a non-invasive handheld device that assesses the mechanical and viscoelastic properties of soft tissue (e.g., skin stiffness, elasticity, and relaxation time). In this study, it is used in patients with breast cancer-related lymphedema (BCRL). Each participant is evaluated by two blinded raters to determine intra- and inter-rater reliability.
Sponsors
Fatih Sultan Mehmet Training and Research Hospital
Kahramanmaras Sutcu Imam University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Although the study is single-arm, outcome assessments were performed by two blinded assessors to evaluate measurement reliability. No group assignment or treatment comparison is involved.
Intervention model description
Single group assignment. All participants will receive repeated MyotonPRO and ultrasound evaluations for skin biomechanical properties. No randomization or comparison between groups will be performed.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female participants aged 18-80 years * Unilateral upper extremity lymphedema secondary to breast cancer surgery * Diagnosed with lymphedema at International Society of Lymphology (ISL) Stage 0, I, II, or III * Willing and able to provide informed consent
Exclusion criteria
* Bilateral upper extremity lymphedema * Cognitive or mental disorders that interfere with cooperation * Neurological diseases * Active infection * Scleroderma or other skin disorders affecting elasticity * Significant cardiac conditions that may interfere with assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra- and Inter-Rater Reliability of MyotonPRO Measurements | Within 1 day | The reliability of the MyotonPRO device will be evaluated through repeated measurements of skin stiffness parameters by two independent raters on the same day. The primary outcome is the intraclass correlation coefficient (ICC) for intra- and inter-rater agreement. |
Contacts
Primary ContactEsra Nur Türkmen, MSc, PT
Outcome results
None listed