Treatment of Lymphedema: Application of the Kinesio Taping
Primary Purpose
Lymphedema
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Low Stretch Bandage and Kinesio Tape
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema
Eligibility Criteria
Inclusion Criteria: Female breast cancer lymphedema Unilateral lymphedema Lymphedema onset 3 months ago Moderate to severe lymphedema At least one measurement point greater than 2 cm Good compliance Exclusion Criteria: Port-a-cath on affected side of chest with adhesion Skin disease Restriction of active range of motion Affected upper extremity (UE) Other diseases or medication might lead to swelling Irremovable bracelet or ring
Sites / Locations
- School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan UniversityRecruiting
Outcomes
Primary Outcome Measures
The severity of swelling, such as arm circumference, volume of water displacement
The evaluation will be executed 4 weeks before the interventions, before the intervention, after 4 week intervention and 3 months after intervention.
Secondary Outcome Measures
Related symptoms, the upper extremity function and quality of life
The evaluation time the same as primary outcomes
Full Information
NCT ID
NCT00155220
First Posted
September 8, 2005
Last Updated
January 25, 2006
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00155220
Brief Title
Treatment of Lymphedema: Application of the Kinesio Taping
Official Title
Treatment of Lymphedema- Application of the Kinesio Taping
Study Type
Interventional
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief Summary
There are 2 parts to this study.
First part:
Reliability of water displacement, circumference, tonometer.
Effect of taping: lifting effect measured with sonography
Effect of taping: peripheral circulation measured with DRT4
Second part:
Effects of different intervention models including decongestive lymphatic therapy (DLT) and modified DLT
Detailed Description
First part:
To investigate the reliability study of water displacement and circumference measurement and the change in thickness of subcutaneous space measured by sonography and blood flow measured by DRT4 in normal subjects after applying K-tape.
Second part:
The incidence of breast carcinoma is in the second place in women in Taiwan. Lymphedema is a common complication after treatment of breast carcinoma; it will lead not only to cosmetic problems but is also uncomfortable, and causes functional limitation for patients. The common management for lymphedema is decongestive lymphatic therapy (DLT) including skin care, manual lymph drainage, remedial exercises and compression therapies. At present, all possible compression therapies for lymphedema have limitations. Patients have poor compliance in using short-stretch bandage and compression garments due to the climate in Taiwan. Applying kinesio tape (K-tape) became a new treatment method in physical therapy; the inventor Dr. Kase claimed that the K-tape can improve circulation and remove congestion. Besides, it demonstrated good therapeutic effects in clinical application. However, there are few studies to show the clinical effects of K-tape. This restricts the further application of K-tape. Following the previous study, the purpose is to compare the effects among traditional DLT, modified DLT which replaces bandage with K-tape, and DLT combined K-tape in patients with lymphedema.
A randomized control study will be executed. Sixty patients with post-mastectomy lymphedema will be randomly grouped into taping, bandage and mixed groups. Each subject will go through 4 weeks of a control period, 4 weeks of an intervention period, and followed by 3 months of an observation period. The evaluation items include physical therapy assessment, the severity of swelling, such as arm circumference, volume of water displacement, related symptoms, the upper extremity function and quality of life. The evaluation will be executed 4 weeks before the interventions (start of control period), before the intervention (start of intervention period), after a 4 week intervention and 3 months after the intervention to compare the effects among 3 kinds of treatment. Subjects in each group will receive treatments including skin care, manual lymphatic drainage, pneumatic compression therapy and exercise during the intervention period; the taping group's patients will receive additional K-tape treatment; the mixed group's patients will receive K-tape combined bandage treatment. Each group will be treated 2 hours/time, 5 times/week; the entire course will take 4 weeks.
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
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Low Stretch Bandage and Kinesio Tape
Primary Outcome Measure Information:
Title
The severity of swelling, such as arm circumference, volume of water displacement
Title
The evaluation will be executed 4 weeks before the interventions, before the intervention, after 4 week intervention and 3 months after intervention.
Secondary Outcome Measure Information:
Title
Related symptoms, the upper extremity function and quality of life
Title
The evaluation time the same as primary outcomes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female breast cancer lymphedema
Unilateral lymphedema
Lymphedema onset 3 months ago
Moderate to severe lymphedema
At least one measurement point greater than 2 cm
Good compliance
Exclusion Criteria:
Port-a-cath on affected side of chest with adhesion
Skin disease
Restriction of active range of motion
Affected upper extremity (UE)
Other diseases or medication might lead to swelling
Irremovable bracelet or ring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD
Organizational Affiliation
NTUH
Official's Role
Study Chair
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD
Phone
88623123456
Ext
7320
Email
jytsauo@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD
12. IPD Sharing Statement
Learn more about this trial
Treatment of Lymphedema: Application of the Kinesio Taping
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