Clinical trial NCT06750679: The Effect of Manual Lymph Drainage Applied As an Adjunct to Compression Therapy on Edema Lower Extremity Lymphedema:
Official title: The Effect of Manual Lymph Drainage Applied As an Adjunct to Compression Therapy on Edema and Fibrosis in Individuals with Lower Extremity Lymphedema: a Single Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lower Extremity Lymphedema
Keywords: lower extremity lymphedema
fibrosis
manual lymphatic drainage
Complex decongestive physiotherapy
Quality of life
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-12-27
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lymphedema is much more than a disease with edema. Impaired lymphatic drainage triggers adipose tissue deposition and fibrosis. Fibrosis causes lymphatic vessel dysfunction. Therefore, treatment of fibrosis is important. The gold standard of treatment for lymphedema is complex decongestive physiotherapy. In this treatment method consisting of two phases and four components in each phase, each component has its own effect. Compression is the main component of these components in terms of edema reduction. The effect of manual lymph drainage, another component, on edema and fibrosis is contradictory. Although there are studies evaluating fibrosis in lower extremity lymphedema in the literature, there is no study evaluating the effect of treatment on fibrosis and comparing two different methods evaluating fibrosis.

Research question: What is the effect of manual lymph drainage in addition to compression therapy on fibrosis, edema, skin and subcutaneous tissue thickness, and quality of life.

The primary aim of this study was to evaluate the effect of manual lymph drainage applied as an adjunct to compression therapy on fibrosis in individuals with lower extremity lymphedema. The secondary aim of the study was to evaluate the effect of manual lymph drainage in addition to compression therapy on skin and subcutaneous tissue thickness, edema and quality of life.

Patients with lower extremity lymphedema will be randomly allocated to the compression group and manual lymph drainage + compression group. Fibrosis in the tissues of the individuals will be evaluated by ultrasound and SkinFibrometer device, skin and subcutaneous tissue thickness will be evaluated by ultrasound, edema perimeter measurement will be converted to volume, and quality of life will be evaluated by Lymphedema Quality of Life Questionnaire-Lower Extremity before and after treatment. Individuals will be randomized to either 20 sessions of compression bandage or 20 sessions of compression bandage with manual lymph drainage. Both groups will include skin care and exercise components of complex decongestive physiotherapy.

This study will provide important data on whether manual lymph drainage is clinically necessary in the treatment of lower limb lymphedema.

Detailed description: Lower extremity lymphedema (LE) is a chronic disease characterized by the accumulation of protein-rich fluid in the interstitial space and inflammation. It is classified as primary and secondary lymphedema. Primary LE is caused by developmental defects of the lymphatic system, whereas secondary LE is caused by subsequent damage to the lymphatic system. The biggest cause of secondary LE in western countries is cancer surgery.

Lower extremity LE is not a disease characterized only by edema. As the disease progresses, adipose tissue increases and fibrosis is observed. Fibrosis is defined as excessive accumulation of extracellular matrix products. Fibrosis is a well-known cause of organ dysfunction in many systems, including the liver, kidney, heart, and skin. This condition also occurs in limb LL and is a characteristic pathological change seen in LL. The increase in adipose tissue and fibrosis triggered by the presence of lymph fluid leads to increased skin and subcutaneous tissue thickness. These changes increase as the duration and stage of the disease progress.

Inflammation due to impaired lymph drainage triggers the fibrosis process. Histological and immunohistochemical specimens from clinical and experimental skin tissues of patients with LE reveal an increase in collagen fibers in edematous skin due to fibrosis. Fibrosis in LE is not limited to the skin but has also been detected in subcutaneous tissue, including adipose tissue. It has been reported that adipocytes in adipose tissue with LE have hypertrophic changes and larger adipose tissue lobules, and these lobules are surrounded by thick collagen fibers and interstitial lymphatic fluid. It has been reported that collagen accumulation in subcutaneous fat was observed in mouse models of LE. This leads to hardening of the tissue , resulting in non-depressed edema. Fibrosis in the tissue causes lymphatic vessel dysfunction and reduces lymphatic capacity, leading to worsening of LE. It has been reported that fibrotic changes in lymphedema can be partially reversed with complex decongestive physiotherapy (CDF). CDF is a conservative treatment method accepted as the gold standard in the treatment of LE. It consists of two phases: discharge and protection. While the unloading phase aims to reduce limb volume, the preservation phase aims to maintain the reduced volume. The unloading phase consists of 4 main components: manual lymph drainage (MLD), skin care, compression, and exercise. In the protection phase, compression bandages are replaced by compression garments, and manual lymph drainage is replaced by self/simple lymph drainage. The drainage phase lasts at least 2-4 weeks, and the protection phase lasts for life Each treatment component has a unique mechanism of action in the treatment of lymphedema. MLD is a gentle massage technique that aims to move the skin and connective tissue, thus stretching the anchor filaments connected to the lymphatic capillaries and opening the lymphatic capillaries without causing hyperemia. There are different holding techniques. MLD is thought to increase the transport rate of lymphatic fluid, develop new pathways for lymphatic drainage from edematous areas to adjacent non-edematous areas, remove protein deposits from the tissue, and break down fibrotic tissue. Compression is to create more tissue pressure during contractions by resisting muscle activity. This is the strongest stimulation for lymph drainage. Compression also prevents fluid accumulation in the tissue by reducing capillary filtration. It allows resorption of fluid in the interstitial space. It displaces fluid to non-compressed areas where drainage is normal. Compression is also thought to be effective in the destruction of fibrosclerotic tissue.

In the literature, the effect of MLD and compression applications on edema has been frequently evaluated, and the effectiveness of compression bandaging has been shown, although the effect of MLD on edema reduction is contradictory. Nevertheless, it has been suggested that MLD may also be effective in fibrotic tissue. However, although there are evaluation studies showing fibrosis in tissue with LE, there are no randomized controlled trials showing the effect of MLD and compression on fibrotic tissue in lower extremity LE. Similarly, there are no studies comparing the effect of lymphedema treatments on fibrosis using two different assessment methods. The primary aim of this study was to evaluate the effect of MLD applied as an adjunct to compression therapy on fibrosis in individuals with lower extremity LE. The secondary aim of the study was to evaluate the effect of MLD applied in addition to compression bandage on skin and subcutaneous tissue thickness, edema, and quality of life.

Eligibility criteria: Inclusion Criteria:

* According to the criteria of the International Society of Lymphology Stage 2 and 3 lower extremity LE to volunteer to participate in the study
* To be between the ages of 18-80
* LE involving the entire lower extremity

Exclusion Criteria:

* Acute deep vein thrombosis
* Acute infection
* Peripheral arterial disease in the lower extremity
* To have systemic diseases that may cause edema other than LE (renal failure, liver failure, heart failure, etc.)
* Chronic venous insufficiency
* Allergy to materials used in treatment
* Mental/cognitive problems that will affect cooperation
* Loss of sensation
* Presence of scleroderma in the treatment area
* Active cancer
* Radiogenic fibrosis in the treatment area

Primary outcomes:
measure: Assessment of Fibrosis Using the SkinFibroMeter
timeFrame: Baseline, four week later and 3 month follow-up
Secondary outcomes:
measure: Assessment of Fibrosis Using Ultrasound
timeFrame: Baseline, four week later and 3 month follow-up
measure: Assessment of Skin and Subcutaneous Tissue Thickness
timeFrame: Baseline, four week later and 3 month follow-up
measure: Edema Assessment
timeFrame: Baseline, four week later and 3 month follow-up
measure: Assessment of Quality of Life
timeFrame: Baseline, four week later and 3 month follow-up
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
state: Merkez
Study officials:
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