Treatment of Lymphedema: Application of the Kinesio Taping

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155220
First received: September 8, 2005
Last updated: January 25, 2006
Last verified: August 2004
  Purpose

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

Condition Intervention Phase
Lymphedema
Device: Low Stretch Bandage and Kinesio Tape
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Treatment of Lymphedema- Application of the Kinesio Taping

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 60
Study Start Date: August 2004
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female breast cancer lymphedema
  2. Unilateral lymphedema
  3. Lymphedema onset 3 months ago
  4. Moderate to severe lymphedema
  5. At least one measurement point greater than 2 cm
  6. Good compliance

Exclusion Criteria:

  1. Port-a-cath on affected side of chest with adhesion
  2. Skin disease
  3. Restriction of active range of motion
  4. Affected upper extremity (UE)
  5. Other diseases or medication might lead to swelling
  6. Irremovable bracelet or ring
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00155220

Locations
Taiwan
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University Recruiting
Taipei, Taiwan
Contact: Jau-Yih Tsauo, PhD    88623123456 ext 7320    jytsauo@ntu.edu.tw   
Principal Investigator: Jau-Yih Tsauo, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Jau-Yih Tsauo, PhD NTUH
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155220     History of Changes
Other Study ID Numbers: 9261701436
Study First Received: September 8, 2005
Last Updated: January 25, 2006
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014