Lymphedema Therapy With Sound Wave Lymphatic Drainage

Efficacy of Low Frequency Sound Waves in the Treatment of Breast Cancer Related Lymphedema: a Cross-over Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Procedure: Manual lymphatic drainage; Device: 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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital de la Esperanza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: manual lymphatic drainage; Application of manual lymphatic drainage	Procedure: Manual lymphatic drainage; Application of manual lymphatic drainage (one session every work day during two weeks, total 10 sessions); Other Names: Decongestive physiotherapy
Experimental: low frequency sound waves; Application of low frequency sound waves	Device: low frequency sound waves; Application of low frequency sound waves (one session every work day during two weeks, total 10 sessions); Other Names: Device based physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of lymphedema	Evaluation of the lymphedema volume measuring size of the extremity affected	2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion IMIM
• Investigators: Principal Investigator: Roser Belmonte, MD, Hospital de la Esperanza, Barcelona, Spain

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: LES_OBSF_DLM