Lymphedema Therapy With Sound Wave Lymphatic Drainage

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115374
• Other study ID #: LES_OBSF_DLM
• Status: Completed
• Phase: N/A
• First received: March 30, 2010
• Last updated: February 3, 2016
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2016
• Source: Fundacion IMIM
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

Procedure:
• Manual lymphatic drainage
Application of manual lymphatic drainage (one session every work day during two weeks, total 10 sessions)

Device:
• low frequency sound waves
Application of low frequency sound waves (one session every work day during two weeks, total 10 sessions)

Locations

Country	Name	City	State
Spain	Hospital de la Esperanza	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion IMIM

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of lymphedema	Evaluation of the lymphedema volume measuring size of the extremity affected	2 months	No
Secondary	Pain	Visual Analog Scales of pain	2 months	No
Secondary	Quality of life	Quality of life using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4)	2 months	No