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Lymphedema Therapy With Sound Wave Lymphatic Drainage

Primary Purpose

Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual lymphatic drainage
low frequency sound waves
Sponsored by
Fundacion IMIM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de la Esperanza

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

manual lymphatic drainage

low frequency sound waves

Arm Description

Application of manual lymphatic drainage

Application of low frequency sound waves

Outcomes

Primary Outcome Measures

Volume of lymphedema
Evaluation of the lymphedema volume measuring size of the extremity affected

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2010
Last Updated
February 3, 2016
Sponsor
Fundacion IMIM
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1. Study Identification

Unique Protocol Identification Number
NCT01115374
Brief Title
Lymphedema Therapy With Sound Wave Lymphatic Drainage
Official Title
Efficacy of Low Frequency Sound Waves in the Treatment of Breast Cancer Related Lymphedema: a Cross-over Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion IMIM

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
manual lymphatic drainage
Arm Type
Active Comparator
Arm Description
Application of manual lymphatic drainage
Arm Title
low frequency sound waves
Arm Type
Experimental
Arm Description
Application of low frequency sound waves
Intervention Type
Procedure
Intervention Name(s)
Manual lymphatic drainage
Other Intervention Name(s)
Decongestive physiotherapy
Intervention Description
Application of manual lymphatic drainage (one session every work day during two weeks, total 10 sessions)
Intervention Type
Device
Intervention Name(s)
low frequency sound waves
Other Intervention Name(s)
Device based physiotherapy
Intervention Description
Application of low frequency sound waves (one session every work day during two weeks, total 10 sessions)
Primary Outcome Measure Information:
Title
Volume of lymphedema
Description
Evaluation of the lymphedema volume measuring size of the extremity affected
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Pain
Description
Visual Analog Scales of pain
Time Frame
2 months
Title
Quality of life
Description
Quality of life using the Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B+4)
Time Frame
2 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roser Belmonte, MD
Organizational Affiliation
Hospital de la Esperanza, Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Esperanza
City
Barcelona
Country
Spain

12. IPD Sharing Statement

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Lymphedema Therapy With Sound Wave Lymphatic Drainage

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