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.
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
- 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
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.
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 outcomes (2)
Related symptoms, the upper extremity function and quality of life
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.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jau-Yih Tsauo, PhD, Study chair, NTUH
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lymphedema- Application of the Kinesio Taping
- ClinicalTrials.gov ID
- NCT00155220
- Acronym / sponsor ID
- 9261701436
- Conditions
- Lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Mar 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female breast cancer lymphedema
- Unilateral lymphedema
- Lymphedema onset 3 months ago
- Moderate to severe lymphedema
- At least one measurement point greater than 2 cm
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Stretch Bandage and Kinesio Tape | Device | – |
Primary outcome
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.
2 secondary outcomes
Related symptoms, the upper extremity function and quality of life
The evaluation time the same as primary outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2006.
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
Taipei, Taiwan
Jau-Yih Tsauo, PhD study chair
NTUH
1 site in 1 country: see every site and its status.
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.