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

NCT07810036 | Completed

• 1 other identifier: 2025-68
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postmastectomy Lymphedema

Outcome Measures

Primary Outcomes (1)

• measurement of subcutan tissue and deep fascia thickness

  3 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: November 13, 2025
• Primary Completion: June 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2025-10

Locations

TU (1)