Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155220
Status:
UNKNOWN
Last Update Posted:
2006-01-27
First Post:
2005-09-08
Brief Title:
Treatment of Lymphedema Application of the Kinesio Taping
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Treatment of Lymphedema- Application of the Kinesio Taping
Status:
UNKNOWN
Status Verified Date:
2004-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 groups patients will receive additional K-tape treatment the mixed groups patients will receive K-tape combined bandage treatment Each group will be treated 2 hourstime 5 timesweek the entire course will take 4 weeks
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 groups patients will receive additional K-tape treatment the mixed groups patients will receive K-tape combined bandage treatment Each group will be treated 2 hourstime 5 timesweek the entire course will take 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None