Treatment of Lymphedema: Application of the Kinesio Taping

Lymphedema Clinical Trial

Official title:

Treatment of Lymphedema- Application of the Kinesio Taping

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00155220
• Other study ID #: 9261701436
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: January 25, 2006
• Start date: August 2004
• Est. completion date: March 2006

Study information

• Verified date: August 2004
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• Low Stretch Bandage and Kinesio Tape

Locations

Country	Name	City	State
Taiwan	School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of swelling, such as arm circumference, volume of water displacement
Primary	The evaluation will be executed 4 weeks before the interventions, before the intervention, after 4 week intervention and 3 months after intervention.
Secondary	Related symptoms, the upper extremity function and quality of life
Secondary	The evaluation time the same as primary outcomes