The Effect of Manual Lymph Drainage Applied As an Adjunct to Compression Therapy on Edema Lower Extremity Lymphedema:
- Conditions
- Lower Extremity Lymphedema
- Registration Number
- NCT06750679
- Lead Sponsor
- Abant Izzet Baysal University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assessment of Fibrosis Using the SkinFibroMeter Baseline, four week later and 3 month follow-up The patient will lie in a supine position on a treatment bed with the lower extremities relaxed. The SkinFibroMeter probe will be briefly (0.5 seconds) pressed perpendicularly against the skin. Each stiffness value will be calculated as the average of five consecutive successful measurements at the same site. If the applied force or measurement duration is incorrect, a 'USER ERROR' message will be displayed, and the measurements will be repeated.
Fibrosis will be measured at 17 points on each lower extremity. Specific landmarks will be identified, including 5 cm above the joint of the second toe, 5 cm above the lateral malleolus, 10 cm below the inferior border of the patella, and 10 cm and 20 cm above the superior border of the patella. On the thigh and calf, medial, lateral, posterior, and anterior midline points corresponding to the same circumferential level as these landmarks will also be marked
- Secondary Outcome Measures
Name Time Method Assessment of Fibrosis Using Ultrasound Baseline, four week later and 3 month follow-up The individual will lie in a supine position during the assessment. The thickness of the skin and subcutaneous tissue will first be measured without compression. Following this, maximum compression will be applied using an ultrasound probe to reassess the thickness for fibrosis evaluation. Maximum compression resistance is defined as the maximum pressure exerted to compress the tissue.
Resistance to compression will be calculated in millimeters by subtracting the tissue thickness measured under maximum pressure from the initial thickness. This measurement will provide tissue compliance, enabling an indirect and objective assessment of fibrosis. A smaller difference indicates a higher propensity for fibrosis, while a larger difference suggests softer tissue.
Fibrosis will be assessed at 17 points on each lower extremity.Assessment of Skin and Subcutaneous Tissue Thickness Baseline, four week later and 3 month follow-up The evaluation of skin and subcutaneous tissue thickness will be performed by a specialized radiologist using a LOGIQ ultrasound system (GE Healthcare, USA) equipped with a 6-15 MHz linear probe. Measurements will be conducted with the individual in a supine position. To optimize the passage of ultrasound waves, ultrasound gel will be applied between the probe and the skin. The ultrasound probe will be positioned perpendicularly to the skin, and brightness mode (B-mode) images will be obtained without applying additional compression to the skin. For skin thickness, the measurement will include the distance between two fine echogenic lines encompassing the hypoechoic dermis, as described comprehensively in previous studies, and will be recorded in millimeters. The subcutaneous distance will be measured as the distance in millimeters between the posterior echogenic line of the dermis and the anterior echogenic line of the muscular fascia
Edema Assessment Baseline, four week later and 3 month follow-up Edema will be assessed by circumference measurements with the patient in a supine position. Measurements will start 10 cm from the heel. Along the lateral aspect of the leg, marks will be made at 8 cm intervals, and circumference measurements will be taken at these points along the extremity.
Using a non-elastic tape measure 1 cm in width, measurements will be conducted without compressing the tissue and ensuring the ends of the tape do not overlap. Measurements will be recorded in centimeters. This process will be performed bilaterally.
The recorded circumferences will then be converted into volume using the truncated cone formula, as extremities are considered geometrically as truncated cones for this calculation.Assessment of Quality of Life Baseline, four week later and 3 month follow-up The Lymphedema Quality of Life Questionnaire - Lower Limb (LYMQOL) will be used to assess quality of life. LYMQOL consists of 23 questions across four subdomains: function, mood, appearance, and symptoms. Each question is rated on a four-point Likert scale, where "1" indicates no impact and "4" indicates severe impact. The final question uses a numerical visual analog scale to evaluate overall quality of life.
The questionnaire score is calculated by summing the scores of all questions and dividing by the total number of questions. The total score ranges from 1 to 4, with higher scores indicating worse quality of life. The Turkish validity and reliability of the questionnaire were established by Bakar et al.
Trial Locations
- Locations (1)
Bolu Abant Izzet Baysal University
🇹🇷Bolu, Merkez, Turkey