Can deep fascial thickness predict treatment response in patients with postmastectomy lymphedema? an ultrasonographic approach
NCT ID NCT07810036
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Research and Literature Summary / References (The research summary must not exceed 250 words and must be written in a clear, easily understandable form.) Lymphedema is a chronic and progressive disease that develops as a result of the accumulation of protein-rich fluid in the interstitial tissue following disruption of lymphatic drainage. Lymphedema of the upper extremity seen after breast cancer treatment is the most frequently encountered form, and it causes loss of function, restriction of movement, and deterioration in quality of life. Manual lymphatic drainage (MLD), a component of complex decongestive therapy (CDT), is a method of proven efficacy in reducing skin and subcutaneous tissue thickness. Duygu-Yıldız et al. (2023) demonstrated that compression applied at different pressures produced a significant reduction in skin and subcutaneous tissue thickness and accelerated the resolution of edema. High-resolution ultrasound is used as a reliable method for evaluating the skin, subcutaneous adipose tissue, and fascial structures in lymphedema. Pirri et al. (2024) reported that in patients with lymphedema there is thickening of the cutis and subcutaneous tissue, an increase in echogenicity, and structural changes in the fascial structures, and that these changes may show a regional distribution. In another study by the same research group, it was determined that in patients with lymphedema the superficial and deep fasciae are thinner compared with healthy individuals. It was emphasized that this may be an important clue regarding the role of fascial structure in the development of lymphedema. In this thesis study, the effect of MLD treatment on days 1 and 15 in patients with stage 1-2 lymphedema will be evaluated by ultrasound, and the relationship between changes in subcutaneous tissue thickness and deep fascia thickness will be investigated. The aim is thereby to objectively demonstrate the response given to treatment and to make clinical rehabilitation more individualized.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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42 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Sep 2026
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will include 42 patients presenting to the Istanbul Physical Therapy and Rehabilitation Training and Research Hospital who have been diagnosed with post-mastectomy lymphedema.
- Ages
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18 years and older
- Sex
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Female participants only
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Inclusion Criteria: * Women aged 18 years and older with clinically diagnosed upper extremity lymphedema * Stage I-II lymphedema according to the International Society of Lymphology (ISL) staging system (early to moderate stage, without advanced fibrosis) * History of breast cancer surgery including mastectomy and axillary lymph node dissection * Lymphedema present for at least 3 months (stable chronic phase) * Anatomy suitable for ultrasonographic measurement of deep fascia thickness Exclusion Criteria: * Exclusion Criteria: * Active infection or cellulitis of the affected limb * Stage III (advanced fibrotic) lymphedema * Lymphedema secondary to other causes (e.g., venous insufficiency, rheumatologic disease) * Systemic conditions that may cause edema, such as diabetic neuropathy, congestive heart failure, or renal disease * Severe trauma or surgery affecting the upper extremity other than the lymphedema-related surgery * Pregnancy * Contraindications to decongestive therapy (e.g., severe cardiac failure, impaired consciousness)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Istanbul Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye)
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