Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000523909
Ethics application status
Approved
Date submitted
10/09/2019
Date registered
28/04/2020
Date last updated
28/04/2020
Date data sharing statement initially provided
28/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of kinesiotaping on the temperature distribution and intensity of pain at the site of application. A randomized clinical trial.
Scientific title
The effect of kinesiotaping on the temperature distribution and pain intensity at the site of application in patients after total knee arthroplasty.
Secondary ID [1] 299082 0
none
Universal Trial Number (UTN)
U1111-1239-0553
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subjects after total knee replacement surgery 314114 0
gonarthrosis 314115 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312493 312493 0 0
Physiotherapy
Musculoskeletal 313230 313230 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
60 patients after total knee arthroplasty will be randomly selected and divided into one of two groups.

After randomization, 30 subjects will be included in the experimental group.In this group, Kinesio Tape ( K-Active Tape produced by Nitto Denko) will be applied. Each patient will have KT lymphatic application(fan strips or edema strips).
These strips have a short solid end with the rest of the tape separated into thin strips. They are called fan strips because they are applied in a fan-like pattern over the area of swelling or bruising. This lifts the skin over the lymphatic channels in the area, assisting them in removing excess fluids.
Tape will be applied without tension around knee joint in a standing position. No tension means applying the tape directly to the skin as it comes off the paper backing

The control group will be consisted of 30participants both sexes. In this group, Matopat Classic adhesive tape, produced by TZMO SA, will be used in a simillar fashion.

The K-Active/ Matopat Classic adhesive tape will be applied several days after the surgery, after removing the sutures and healing the postoperative wound. The basic condition for including this therapy will be pain and swelling in the area of the operated knee.

The "fan strips" will be applied in the same manner as in the both groups. "Fan strips" will be put in the area of knee diagonally on both sides of a knee, as the strips would cross. All taping applications will be applied in both groups by a certified KT physiotherapist. Nevertheless, the tape applications in experimental and placebo groups will be looked very similar. Only one difference will be color of the tape, pink in the experimental and white in the placebo group.

The tapes will be left on the patient’s skin for the next five days.
thermograms, pain intensity and swelling in the area of the operated knee will be assesed before taping (1st day) and immendently after removing tapes (5th day)

Only participants with a body mass index above 24 kg/m2 will be excluded in the study to eliminate thermal distortions caused by excess adipose tissue.

To ensure accurate thermal readings, certain study constraints and conditions will be maintained. European Association o Thermology guidelines for thermal imaging, preparation of the study protocol, recording and archiving data will be followed to ensure proper testing conditions.

Prior to infrared thermal measurements, participants will not ingest any food, drugs, or hot liquids and did not take part in strenuous physical activities.

All patients qualified to the study will be asked to assessed the pain intensity of the operated knee joint on the VAS scale before and after taping.

Intervention code [1] 315353 0
Rehabilitation
Comparator / control treatment
In this group, Matopat Classic non elastic adhesive tape, produced by TZMO SA will be applied. The "fan strips" will be applied in the same manner as in the examination. Only one difference will be color of the tape, pink in the experimental and white in the control group.
Control group
Active

Outcomes
Primary outcome [1] 321133 0
The primary outcome will be changes the skin temperature at the site of application tape will be recorded at baseline and after trial.

Thermograms will be taken 2 times: prior to application of the tape (1st day), immediately after removal (5th day) of the tape. Readings will be consistently taken between 10:30 am - 12:30 pm to account for changes in body temperature associated with the circadian rhythm. Prior to each reading, participants will be acclimated to the room for around 15 minutes (ambient temperature of 22-25°C with 40-50% humidity). Then, participants will be asked to stand in front of IR camera. The MobIR M8 thermal imaging camera will be positioned 2 meters away from the participant at a perpendicular angle to the postoperated knee joint.
Skin emissivity will set at 0.98
Timepoint [1] 321133 0
Baseline, and at 5 days after intervention commencement
Secondary outcome [1] 374100 0
Secondary outcome will be changes in the pain intensity of the operated knee
pain intensity will be assessed using VAS scale from 0 to 10 (0 no pain,10 extreme pain)
Timepoint [1] 374100 0
Baseline, and at 5 days after intervention commencement

Eligibility
Key inclusion criteria

Total knee replacement surgery.
The occurrence of pain in the knee in the subject examination.
Current physical edema and increased warming around the operated knee in physical examination.
Value of pain intensity of the operated knee joint on the VAS (30-100mm) scale.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18 years of age
Skin diseases (bacterial, viral and fungal).
Interruption of skin continuity at the site of planned kinesiotaping application.
Presence of an allergic reaction to kinesiotaping tapes.
Value of pain intensity of the operated knee joint on the VAS scale (<30mm).
Rheumatic diseases.
Allergic changes after knee arthroplasty.
mass index over 24 kg/m2
flesh wounds
menstruation cycle
pregnancy
cold

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)
The experimental and placebo group allocations will be determined according to randomized codes.
Main coordinator who will allocate the participants to groups will have 60 opaque, sealed envelopes, each will be contained a piece of paper marked with number 1 or 2. Envelopes will be placed in non-transparent box.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with sealed opaque envelope system.

Prior to start the study on the first day each participants will select and open an opaque sealed envelope in the presence of a physiotherapist to see the symbol (number 1 or 2) and will then direct the patient to the corresponding group. The experimental group will receive number 1 and number 2 for placebo group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size has been computed as follows. We assumed the effect size d=0.90, a err prob = 0.05 and minimum power (1-ß err prob) = 0.92. For the computation of the effect size we took empirical values of mean and standard deviation (SD) for ..t1...... based on the previous studies [1] - value of mean = 33.34 and SD = 1.2 for the t2... group and value of mean = 34.60 and SD = 1.00 for the control group.
We assumed that the ratio of the t1 group to the control group (allocation ratio) should be 1.0. Computations made with the G*Power 3.0.10 software resulted in the minimum sample size for the treatment group equal to 29 and for the control group equal to 29. In fact the final sample size was 30 and 30 individuals for the t1 and t2 control groups, respectively.

statistical assumptions prepared based on the previous studies "Assessment of the thermal effects of kinesilogy tape application." Fizjoterapia Polska 2008; 8(3):310-316
t1,t2-temperature

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/05/2020
Actual
Date of last participant enrolment
Anticipated
6/07/2020
Actual
Date of last data collection
Anticipated
10/07/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21801 0
Poland
State/province [1] 21801 0
warsaw

Funding & Sponsors
Funding source category [1] 303621 0
Self funded/Unfunded
Name [1] 303621 0
Country [1] 303621 0
Primary sponsor type
Individual
Name
Karen Shahnazaryan
Address
Department of Physiotherapy, Faculty of Medicine, Medical University of Warsaw,Zwirki i Wigury 61, 02-091 Warsaw, Poland
Country
Poland
Secondary sponsor category [1] 303709 0
None
Name [1] 303709 0
Address [1] 303709 0
Country [1] 303709 0
Other collaborator category [1] 280917 0
Individual
Name [1] 280917 0
Bartosz Slomka
Address [1] 280917 0
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw, Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country [1] 280917 0
Poland
Other collaborator category [2] 280918 0
Individual
Name [2] 280918 0
Witold Rongies
Address [2] 280918 0
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw, Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country [2] 280918 0
Poland
Other collaborator category [3] 280919 0
Individual
Name [3] 280919 0
Gabriela Majak
Address [3] 280919 0
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw, Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country [3] 280919 0
Poland
Other collaborator category [4] 280920 0
Individual
Name [4] 280920 0
Janusz Sierdzinski
Address [4] 280920 0
Department of Medical Informatics and Telemedicine, Medical University of Warsaw,
Zwirki i Wigury 61, 02-091 Warsaw,Poland
Country [4] 280920 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304147 0
Bioethics Committee of the Medical University of Warsaw
Ethics committee address [1] 304147 0
Zwirki i Wigury 61, 02-091 Warsaw, Poland
Ethics committee country [1] 304147 0
Poland
Date submitted for ethics approval [1] 304147 0
03/11/2014
Approval date [1] 304147 0
09/12/2014
Ethics approval number [1] 304147 0
KB/237/2014

Summary
Brief summary
The aim of this study is to check how KT application (edema strips) will be act on a skin temperature distibution and pain intensity at the site of application after total knee arthroplasty.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95958 0
Dr Karen Shahnazaryan
Address 95958 0
Department of Physiotherapy, Faculty of Medicine, Medical University of Warsaw,Zwirki i Wigury 61, 02-091 Warsaw, Poland
Country 95958 0
Poland
Phone 95958 0
+48 022 57 20 920
Fax 95958 0
Email 95958 0
[email protected]
Contact person for public queries
Name 95959 0
Dr Bartosz Slomka
Address 95959 0
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw, Poland. Banacha 1a 61, 02-097 Warsaw, Poland
Country 95959 0
Poland
Phone 95959 0
+48 022 57 20 920
Fax 95959 0
Email 95959 0
[email protected]
Contact person for scientific queries
Name 95960 0
Dr Bartosz Slomka
Address 95960 0
Department of Rehabilitation, Public Central Teaching Clinical Hospital University Clinical Center, Medical University of Warsaw, Poland. Banacha 1a 61, 02-097 Warsaw, Poland
Country 95960 0
Poland
Phone 95960 0
+48 022 57 20 920
Fax 95960 0
Email 95960 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4207Ethical approval    378225-(Uploaded-27-08-2019-07-12-29)-Study-related document.pdf



Results publications and other study-related documents

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