Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001232224
Ethics application status
Approved
Date submitted
17/07/2018
Date registered
23/07/2018
Date last updated
10/08/2020
Date data sharing statement initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Kinesiotape for hand lymphoedema.
Scientific title
Effect of a single application of Kinesiotape on secondary hand lymphoedema
Secondary ID [1] 294840 0
Nil known
Universal Trial Number (UTN)
U1111-1216-7405
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary hand lymphoedema 307786 0
Condition category
Condition code
Cancer 306829 306829 0 0
Any cancer
Physical Medicine / Rehabilitation 306830 306830 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Effect of a single application of Kinesiotape on secondary hand lymphoedema.
Material: Kinesio tape
Description of procedures and activities: This study will involve two contact times. During the first contact, an initial assessment will be completed followed by the intervention. This consists of the application of Kinesiotape (TGA registered device) to the participant’s hand, applied to the back of the hand, in a specialised pattern involving wrist, and dorsum of the hand by a trained research team member on Kinesiotape. The second contact will be 2 days later, where the Kinesiotape will be removed, followed by another assessment.
The first visit will take approximately 90 minutes and the second visit approximately 60 minutes.
Intervention code [1] 301150 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306604 0
I) Changes in physical measurements (volume of extracellular fluid assessed by Bio Impedance Spectroscopy (BIS), finger and hand size assessed by tape measures). Composite primary outcome.
Timepoint [1] 306604 0
2 days post start of intervention
Primary outcome [2] 306605 0
II) Changes in dermal thickness assessed by Ultrasound (US).
Timepoint [2] 306605 0
2 days post start of intervention.
Primary outcome [3] 306606 0
III) Changes in Lymphoedema symptoms assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A) modified for the hand.
Timepoint [3] 306606 0
2 days post start of intervention.
Secondary outcome [1] 348986 0
I) Change in patient-reported outcomes assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
Timepoint [1] 348986 0
2 days post start of intervention.
Secondary outcome [2] 348987 0
II) Change in patient-reported outcomes assessed by Lymphoedema Quality of Life (LYMQOL) questionnaire modified for the hand.
Timepoint [2] 348987 0
2 days post start of intervention.
Secondary outcome [3] 348988 0
III) Change in volume of extracellular fluid in the forearm assessed by BIS.
Timepoint [3] 348988 0
2 days post start of intervention.
Secondary outcome [4] 348989 0
IV) Change tissue compliance, as assessed by pitting test and palpation for presence of fibrotic regions by clinical examination.
Timepoint [4] 348989 0
2 days post start of intervention.
Secondary outcome [5] 349743 0
V) Change in patient-reported outcomes assessed by participant nominated activities and lymphoedema perception questions.
Composite secondary outcome.
Timepoint [5] 349743 0
2 days post start of intervention.

Eligibility
Key inclusion criteria
• Adults aged over 18
• Unilateral secondary upper limb lymphoedema affecting the hand, diagnosed by a health care practitioner.
• At least 6 months since cancer-related treatments were completed (Chemotherapy, Radiation therapy or Surgery).
• No active treatment for lymphoedema at least 1 month prior to the study commencing day (CDT, bandaging).
• Capability to communicate and comprehend English language.
• Willing to not wear hand or arm compression garment for 2 days.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Active disease or infection that might lead to swelling as well as conditions such as heart or kidney disease, or pregnancy.
• Medication affecting volume changes such as diuretic therapy.
• Pacemaker or in-dwelling defibrillator.
• Allergy to Kinesiotape material (skin test required).
• Skin conditions such as wounds or infection.
• Irremovable bracelet or ring.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated to ensure that we have 80% power to detect a before-after change effect size of 0.45 with 0.05 two-tailed a. Considering the brief nature of our intervention we feel this is an appropriate effect size. Paired T-tests analysis will be used to examine the differences in BIS, tape measures, US, LSIDS-A modified for the hand, LYMQOL modified for the hand, and DASH between measurements taken before and after the intervention. Clinical presentation (pitting and fibrosis) and Patient-reported outcomes will be grouped and frequencies calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
25/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299437 0
University
Name [1] 299437 0
Faculty of Health Sciences, The University of Sydney
Country [1] 299437 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe, NSW, 2141
Country
Australia
Secondary sponsor category [1] 298726 0
None
Name [1] 298726 0
None
Address [1] 298726 0
None
Country [1] 298726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300335 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 300335 0
Ethics committee country [1] 300335 0
Australia
Date submitted for ethics approval [1] 300335 0
26/07/2018
Approval date [1] 300335 0
19/09/2018
Ethics approval number [1] 300335 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83334 0
Dr Elizabeth Dylke
Address 83334 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe, NSW, 2141
Country 83334 0
Australia
Phone 83334 0
+61 2 9351 9021
Fax 83334 0
Email 83334 0
[email protected]
Contact person for public queries
Name 83335 0
Elizabeth Dylke
Address 83335 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe, NSW, 2141
Country 83335 0
Australia
Phone 83335 0
+61 2 9351 9021
Fax 83335 0
Email 83335 0
[email protected]
Contact person for scientific queries
Name 83336 0
Elizabeth Dylke
Address 83336 0
Faculty of Health Sciences
University of Sydney
75 East Street
Lidcombe, NSW, 2141
Country 83336 0
Australia
Phone 83336 0
+61 2 9351 9021
Fax 83336 0
Email 83336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.