Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping

NCT ID: NCT02707835

Last Updated: 2016-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-01-31

Brief Summary

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The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown.

The purpose of this study is to investigate

1. The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.
2. The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.

Our hypothesis :

1. The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.
2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

self massage, skin care education, manual lymph drainage exercise, compression garment

Group Type ACTIVE_COMPARATOR

self massage

Intervention Type OTHER

self massage, skin care education, manual lymph drainage exercise, compression garment

manual lymph drainage group

manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

Group Type ACTIVE_COMPARATOR

manual lymph drainage

Intervention Type OTHER

manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

experimental group

epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

Group Type EXPERIMENTAL

epidermis fascia taping

Intervention Type OTHER

epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

Interventions

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self massage

self massage, skin care education, manual lymph drainage exercise, compression garment

Intervention Type OTHER

manual lymph drainage

manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

Intervention Type OTHER

epidermis fascia taping

epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. age:20\~80 y/o
2. female patients with unilateral breast cancer after surgery
3. unilateral lymph edema ( circumference of affected side 2cm bigger than sound side)

Exclusion Criteria

1\. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing-Lan Yang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jing-Lan Yang

Role: CONTACT

886-2-23123456-67564

SHU-FEN WANG, PhD

Role: CONTACT

886-972651068

Facility Contacts

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Jing-Lan Yang

Role: primary

886-2-23123456-67564

Other Identifiers

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201505100RIND

Identifier Type: -

Identifier Source: org_study_id

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