Reliability of Myoton in Evaluating Skin Biomechanics in Breast Cancer-Related Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer-Related Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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Lymphedema Assessment Group

Patients with breast cancer-related lymphedema will undergo MyotonPRO and ultrasound measurements by two blinded raters to evaluate intra- and inter-rater reliability. No therapeutic intervention will be performed.

Group Type EXPERIMENTAL

MyotonPRO

Intervention Type DEVICE

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.

Interventions

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MyotonPRO

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No