Lymphedema Therapy With Sound Wave Lymphatic Drainage

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Procedure: Manual lymphatic drainage; Device: low frequency sound waves

• Registration Number: NCT01115374
• Lead Sponsor: Fundacion IMIM

Brief Summary

Lymphedema is a frequent sequela of breast cancer treatment, that can develop up to 40% of patients. Lymphedema is the accumulation of protein-rich fluid (lymph) in the interstitial spaces of the affected body part due to a blockage or malfunction in the lymph system. It can appear in the arm, shoulder, breast, or thoracic area. Lymphedema swelling causes discomfort and sometimes disability. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy.

In this study two treatments will be compared to reduce lymphedema: the manual lymphatic drainage (standard care) versus the low frequency sound waves.

Detailed Description

Lymphedema, a sequela of breast cancer and breast cancer therapy, changes functional abilities and may affect a patient's psychosocial adjustment and overall quality of life. Lymphedema is the accumulation of lymph fluid in the interstitial space. Fluid accumulation in the limbs causes enlargement, often with a feeling of heaviness.Chronic inflammation leads to fibrosis of the lymphatics, which compounds the problem. Several studies have examined the incidence of lymphedema when axillary radiation is given after axillary dissection vs radiation to an undissected axilla. The risk of lymphedema is higher in women treated with axillary dissection and adjuvant radiation to the axilla, with edema reported in 9% to 40% of patients. Patients with lymphedema may report symptoms such as a sensation of arm fullness and mild discomfort, which are seen in the early stages of the condition. Joint immobility, pain, and skin changes are noted frequently in the later stages of lymphedema. Patients also may be predisposed to infections involving the affected extremity. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy. Manual lymphatic drainage is the standard decongestive therapy. Recently, low frequency sound waves has been used to reduce lymphedema. The aim of this study is to compare the efficacy of the manual lymphatic drainage versus the low frequency sound waves.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

• Lymphedema presence at least for 1 year
• No previous treatments for lymphedema in the last 6 months

Exclusion Criteria

• Electronic devices or metalic implants
• Cardiac failure or hypertension
• Epilepsy
• Local infection
• Pregnancy
• Thrombophlebitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
manual lymphatic drainage	Manual lymphatic drainage	Application of manual lymphatic drainage
low frequency sound waves	low frequency sound waves	Application of low frequency sound waves

Primary Outcome Measures

Name	Time	Method
Volume of lymphedema	2 months	Evaluation of the lymphedema volume measuring size of the extremity affected

Secondary Outcome Measures

Name	Time	Method
Pain	2 months	Visual Analog Scales of pain
Quality of life	2 months	Quality of life using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4)

Trial Locations

Locations (1)

Hospital de la Esperanza; 🇪🇸 Barcelona, Spain