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LymphedemaPhase 2NCT00155220

Treatment of Lymphedema: Application of the Kinesio Taping

A Phase 2 study testing Low Stretch Bandage and Kinesio Tape in people with Lymphedema, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 30 to 90 years, women only
Conditions the study is for
Lymphedema
What is being tested?
Low Stretch Bandage and Kinesio Tape
Type of treatment
Medical device
How many people
60 participants
Where
1 siteTaiwan
Study dates
Aug 2004to Mar 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University

    Taipei

    Jau-Yih Tsauo, PhD, 88623123456 ext. 7320, jytsauo@ntu.edu.tw

    Jau-Yih Tsauo, PhD

    Recruiting

Other trials in Taiwan

About this study

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
Read the 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.

Conditions
Lymphedema
Being tested
Low Stretch Bandage and Kinesio Tape
Medical subject headings
Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Stretch Bandage and Kinesio TapeDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The severity of swelling, such as arm circumference, volume of water displacement

  2. The evaluation will be executed 4 weeks before the interventions, before the intervention, after 4 week intervention and 3 months after intervention.

Secondary outcomes (2)
  1. Related symptoms, the upper extremity function and quality of life

  2. The evaluation time the same as primary outcomes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startAug 2004
  3. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00155220
Sponsor's protocol ID
9261701436
Status last verified
Aug 2004
First submitted
8 Sep 2005
Last updated
27 Jan 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Stretch Bandage and Kinesio Tape in people with Lymphedema, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The severity of swelling, such as arm circumference, volume of water displacement. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2006.

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