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OpenTrials
Completed

NCT Number: NCT07810036

Can Deep Fascial Thickness Predict Treatment Response in Patients With Postmastectomy Lymphedema? An Ultrasonographic Approach

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. 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.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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Manual Lymphatic Drainage

Procedure

Manual lymphatic drainage (MLD) was applied by a physiotherapist experienced in lymphedema management. Sessions lasted [45] minutes and were performed 5 days per week for 3 weeks, for a total of 15 sessions. Treatment started with proximal clearing of the neck, contralateral axillary and inguinal nodes, followed by distal- to-proximal drainage of the affected upper limb. MLD was combined with multilayer short-stretch compression bandaging, skin care and remedial exercises as part of complete decongestive therapy.Limb circumference and ultrasonographic measurements of subcutaneous tissue and deep fascia thickness were obtained on day 1 and day 15.

Primary outcomes

  1. measurement of subcutan tissue and deep fascia thickness

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 11, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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