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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Bolu Abant Izzet Baysal University
RECRUITING
Bolu
Contact Information
Primary
Elif DUYGU YILDIZ, PhD
elifduygu@ibu.edu.tr
+905052539010
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 30
Treatments
Active_comparator: Compression Group
In compression therapy, multicomponent inelastic compression bandages bandages will be applied (Misra et al., 2023). The individual will be fitted with a stockinet beforehand. Fingers will be bandaged. Then, the extremity will be cylindricalized with a cotton roller or sponge. Subsequently, the foot and ankle will be bandaged using a 6 cm short-stretch bandage. An 8 cm short-stretch bandage will be applied starting from the foot and progressing upward above the ankle. A 10 cm short-stretch bandage will then be applied, beginning at the ankle and wrapping upward. The next bandages will be wrapped upwards starting from the places where the pressure is low. The compression bandage will remain on the patient's leg for approximately 23 hours. When the individual arrives the next day, the bandage will be removed and reapplied. The application time of the inelastic bandage is approximately 20-30 minutes. Compression therapy will be applied 5 days a week for 4 weeks (20 sessions)
Experimental: Compression+MLD Group
Participants in the group receiving MLD in addition to compression therapy will undergo a 30-40-minute MLD session to facilitate the entry of interstitial fluid into lymphatic capillaries and enhance lymph propulsion (Misra et al., 2023). The MLD will be performed with gentle pressure of approximately 30-40 mmHg, ensuring the skin and connective tissue move together without sliding on the skin.~After the MLD session, a multilayer bandaging will be applied to the extremity, which the patient will wear for approximately 23 hours. The bandage will be removed and reapplied during the patient's visit the following day.~The combined therapy of compression and MLD will be administered five days a week for four weeks (20 sessions in total). Each session will last approximately 50-70 minutes.
Related Therapeutic Areas
Sponsors
Leads: Abant Izzet Baysal University
Collaborators: The Scientific and Technological Research Council of Turkey

This content was sourced from clinicaltrials.gov