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Trial registered on ANZCTR


Registration number
ACTRN12613001173785
Ethics application status
Approved
Date submitted
18/10/2013
Date registered
25/10/2013
Date last updated
25/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kinesiology Taping in breast cancer-related lymphedema
Scientific title
Effect of Kinesiology Taping on breast cancer-related lymphedema: a randomized single blind controlled pilot study
Secondary ID [1] 283414 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kinesiology Taping 290324 0
breast cancer-related lymphedema 290341 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290725 290725 0 0
Physiotherapy
Cancer 290738 290738 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study is to assess the efficacy of Kinesiology Taping (KT) for treating breast cancer-related lymphedema. The endpoints are the reduction of limb volume and percentage edema size after a month therapy.

Intervention:
Subjects from all three groups receive a routine treatment, including skin care, 45-min pneumatic compression therapy (at 90 mmHg, 12 chambers), 1-h manual lymphatic drainage, application of a multi-layered short-stretch bandages (50-60 mmHg). The tape groups (KT and Quasi KT groups also receive standard therapy - only skin care, pneumatic compression and manual drainage - the same as in MCT group), but K or Quasi tapes are used instead of a bandages. Each groups are treated 3 times weekly (bandages or K-tapes are applied and changed on Mondays, Wednesdays and Fridays) for in the 4-week intervention period. One physical therapist (PTs) provides treatment. The program is standardized, following the same protocol for lymphatic drainage to the anterior trunk, posterior trunk and affected arm, always moving fluid from the affected side toward the unimpaired side. After lymphatic drainage and before either the short-stretch bandages or the K-tape are applied by the physical therapist. In KT group the fan tape anchor starts at the anterior aspect of the hand with no tension. The tails of the tape are applied to the anterior, medial and posterior aspects of the forearm and arm with 5 – 15% tension, and then on anterior part of chest. The tapes are left on the patient’s skin for the next three days. In Quasi KT group we use tapes without therapeutic effects (tapes were apllied without any tension) with the same methodology as in KT group (anatomical placement of tapes on upper limb was the same in both groups). In MCT group we use 4-layered compression bandaging. The first layer is applied to the skin directly with Tubula orthopedic sleeve. Then a supporting bandage Matoplast is applied to the fingers and on hand. Another layer is cotton RoltaSoft covering whole limb. The external layer consists of short – stretch Hartmann bandages.

Measurements:
To assess the volume of limb we use an optoelectronic Perometer 400 T, co - operating with a personal computer. This method allows to estimate the volume of the measuring error for only 0.5%. The assessment technique is based on a special ring, equipped with a system of 378 LED diodes (emitting the infrared radiation). Within the ring are also the optical sensors that receive electromagnetic stimuli. In the course of measuring the limb is located inside the ring on the diode - sensor lines. The registered light pulses on the detectors is turned into electronic signals. The ring moves during measurement to cover the entire limb. Measurements of the limb volume (both affected and healthy upper limb) are made for all three groups of patients before and after therapy
Intervention code [1] 288137 0
Rehabilitation
Comparator / control treatment
patients treated in use of quasi-KT and multi-layered bandaging
Control group
Active

Outcomes
Primary outcome [1] 290726 0
Reduction of limb volume

Tests/methods: perometer
Timepoint [1] 290726 0
after 1 month therapy
Secondary outcome [1] 305101 0
Percentage edema size

Tests/methods: perometer
Timepoint [1] 305101 0
After 1 month therapy

Eligibility
Key inclusion criteria
(1) unilateral breast cancer-related lymphedema for at least one year, (2) moderate to severe lymphedema (stage II and III of upper limb edema, the volume difference between affected and healthy extremity more than 20%), (3) lack of chemo- or radiation therapy for at least 6 months, (4) good compliance and willingness to sign the written consent form.
Minimum age
18 Years
Maximum age
100 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) active cancer or disease that might lead to swelling and presently taking diuretic therapy or other lymphedema-influencing drugs, (2) skin disease, (3) irremovable bracelet or ring, (4) marked restriction of active range of motion in the affected upper extremity, (5) the presence of a pacemaker, heart disease, pregnancy, metallic devices in the limb to be treated, infectious disease, epilepsy, cartilage growth, thrombophlebitis, arterial hypertension or metastases, which are the treatment contraindications, and (6) the presence of mental, sensorial or language problems, which could make cooperation difficult.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are randomly allocated to the groups. Computer-generated random numbers were sealed in sequentially numbered envelopes, and the group allocation was independent of the time and person delivering the treatment. The physician (main coordinator) who allocated the patients to groups had envelopes, each containing a piece of paper marked with either group KT, Quasi KT, or MCT. The physician would select and open an envelope in the presence of a physiotherapist to see the symbol and would then direct the patient to the corresponding group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer and numbered envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis and evaluation of the results are be based on the comparison of intra- and intergroup results. Statistical analysis of these results is performed by means of the Statistica 10 software, manufactured by StatSoft (licence of Academy School of Physical Education).

To compare the individual parameters that characterized the study groups, the non-parametric Kruskal-Wallis test for countable variables and the chi-squared test for categorical variables is used (75 patients in three groups are not enough for parametric analysis and comparing to normal distribution Gauss curve). The nonparametric matched pair Wilcoxon test is used to compare the within-group results before and after therapy. The Kruskal-Wallis analysis of variance (post hoc Tukey’s test) is used to evaluate differences in the changes between the groups in the limb volume and edema values. Two-sided results (p<0.05) are considered to be statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/12/2012
Actual
17/12/2012
Date of last participant enrolment
Anticipated
30/08/2013
Actual
30/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 5524 0
Poland
State/province [1] 5524 0
Silesia

Funding & Sponsors
Funding source category [1] 288140 0
University
Name [1] 288140 0
Academy School of Physical Education
Country [1] 288140 0
Poland
Primary sponsor type
University
Name
Academy School of Physical Education
Address
Mikolowska Street 72 40-065 Katowice
Country
Poland
Secondary sponsor category [1] 286857 0
None
Name [1] 286857 0
Address [1] 286857 0
Country [1] 286857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290053 0
The Research Ethics Committee from the Academy School of Physical Education in Katowice, Poland
Ethics committee address [1] 290053 0
Ethics committee country [1] 290053 0
Poland
Date submitted for ethics approval [1] 290053 0
29/11/2012
Approval date [1] 290053 0
06/12/2012
Ethics approval number [1] 290053 0
1605/12/2012

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

Contacts
Principal investigator
Name 43710 0
Prof Jakub Taradaj
Address 43710 0
Department of Physiotherapy Basics
Academy School of Physical Education
Mikolowska 72 Street 40-065 Katowice
Country 43710 0
Poland
Phone 43710 0
+48668613945
Fax 43710 0
Email 43710 0
j.taradaj@awf.katowice.pl
Contact person for public queries
Name 43711 0
Jakub Taradaj
Address 43711 0
Department of Physiotherapy Basics
Academy School of Physical Education
Mikolowska 72 Street 40-065 Katowice
Country 43711 0
Poland
Phone 43711 0
+48668613945
Fax 43711 0
Email 43711 0
j.taradaj@awf.katowice.pl
Contact person for scientific queries
Name 43712 0
Jakub Taradaj
Address 43712 0
Department of Physiotherapy Basics
Academy School of Physical Education
Mikolowska 72 Street 40-065 Katowice
Country 43712 0
Poland
Phone 43712 0
+48668613945
Fax 43712 0
Email 43712 0
j.taradaj@awf.katowice.pl

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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