NCT02707835

Brief Summary

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. 1.The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.
  2. 2.The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.
  3. 3.The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.
  4. 4.Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

March 9, 2016

Last Update Submit

March 15, 2016

Conditions

Breast Cancer

Keywords

Edema,taping,ultrasound

Outcome Measures

Primary Outcomes (1)

  • thickness of epidermis and dermis

    10 mins

Study Arms (3)

control group

ACTIVE COMPARATOR

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

Other: self massage

manual lymph drainage group

ACTIVE COMPARATOR

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

Other: manual lymph drainage

experimental group

EXPERIMENTAL

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

Other: epidermis fascia taping

Interventions

self massageOTHER

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

control group
manual lymph drainageOTHER

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

manual lymph drainage group
epidermis fascia tapingOTHER

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

experimental group

Eligibility Criteria

Age30 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsEdema

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Officials

  • Jing-Lan Yang

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Lan Yang

CONTACT

886-2-23123456-67564yangjinglan@gmail.com

SHU-FEN WANG, PhD

CONTACT

886-972651068shwufenwang@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 14, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

TW(1)