Lymphedema Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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