- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00155220
Treatment of Lymphedema: Application of the Kinesio Taping
Treatment of Lymphedema- Application of the Kinesio Taping
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Recruiting
- School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
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Contact:
- Jau-Yih Tsauo, PhD
- Phone Number: 7320 88623123456
- Email: jytsauo@ntu.edu.tw
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Principal Investigator:
- Jau-Yih Tsauo, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The severity of swelling, such as arm circumference, volume of water displacement
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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
Outcome Measure |
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Related symptoms, the upper extremity function and quality of life
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The evaluation time the same as primary outcomes
|
Collaborators and Investigators
Investigators
- Study Chair: Jau-Yih Tsauo, PhD, NTUH
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9261701436
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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