Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01115374
Enrollment
34
Registered
2010-05-04
Start date
2008-05-31
Completion date
2009-07-31
Last updated
2016-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

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.

Interventions

PROCEDUREManual lymphatic drainage

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

DEVICElow frequency sound waves

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

Sponsors

Fundacion IMIM
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Volume of lymphedema2 monthsEvaluation of the lymphedema volume measuring size of the extremity affected

Secondary

MeasureTime frameDescription
Pain2 monthsVisual Analog Scales of pain
Quality of life2 monthsQuality of life using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026