Lymphedema Therapy With Sound Wave Lymphatic Drainage

This study has been completed.
Sponsor:
Information provided by:
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01115374
First received: March 30, 2010
Last updated: May 3, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Lymphedema
Procedure: Manual lymphatic drainage
Device: low frequency sound waves

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Low Frequency Sound Waves in the Treatment of Breast Cancer Related Lymphedema: a Cross-over Randomized Trial

Resource links provided by NLM:


Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • Volume of lymphedema [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Evaluation of the lymphedema volume measuring size of the extremity affected


Secondary Outcome Measures:
  • Pain [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Visual Analog Scales of pain

  • Quality of life [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Quality of life using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4)


Enrollment: 34
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Device based physiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115374

Locations
Spain
Hospital de la Esperanza
Barcelona, Spain
Sponsors and Collaborators
Fundacion IMIM
Investigators
Principal Investigator: Roser Belmonte, MD Hospital de la Esperanza, Barcelona, Spain
  More Information

No publications provided

Responsible Party: Roser Belmonte, Hospital de la Esperanza (IMAS-Fundacion IMIM)
ClinicalTrials.gov Identifier: NCT01115374     History of Changes
Other Study ID Numbers: LES_OBSF_DLM
Study First Received: March 30, 2010
Last Updated: May 3, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014