Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000353594
Ethics application status
Approved
Date submitted
5/03/2015
Date registered
20/04/2015
Date last updated
4/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Short-Term Effect of Kinesio Taping on The Temperature Distribution at The Site of Application. A Randomized Clinical Trial.
Scientific title
Short-Term Effect of Kinesio Taping on The Temperature Distribution at The Site of Application in healthy volunteers
Secondary ID [1] 286318 0
none
Universal Trial Number (UTN)
U1111-1167-8773
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Potential lumbar muscular strain 294569 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294715 294715 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixty healthy students of the Medical University of Warsaw will be randomly selected and divided into one of two groups.
Arm1 will be consisted of 30 participants both sexes with aged 18 to 25 years. In this group, Kinesio Tape ( K-Active Tape produced by Nitto Denko) will be applied over the insertions of the paraspinal multifidus muscles to the L1-L5 spinous processes using the “I” shape application technique. Tape will be applied without tension during maximal lumbar spinal flexion in a standing position.No tension means applying the tape directly to the skin as it comes off the paper backing

Arm2 will be consisted of 30participants both sexes with aged 18-25 years. In this group, Matopat Classic adhesive tape, produced by TZMO SA, will be used in a similar fashion.

The I-strips will be applied in the same manner as in the arm1 on both sides of lumbar region (l1-l5). All taping applications will be applied in both groups by a certified KT physiotherapist. Nevertheless, the tape applications in experimental (Arm1) and placebo groups (Arm2) will be looked very similar. Only one difference will be color of the tape, blue in the Arm1 and white in the Arm2. The tapes will be left on the patient’s skin for the next four days.

The two study groups will be comparable in terms of BMI and age. Only participants with a body mass index below 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.

Intervention code [1] 291354 0
Rehabilitation
Intervention code [2] 291355 0
Treatment: Other
Comparator / control treatment
In this group, Matopat Classic non elastic adhesive tape, produced by TZMO SA(Poland) will be applied. The I-strips will be applied in the same manner as in the arm1. on both sides of lumbar region. Only one difference will be color of the tape, blue in the Arm1 and white in the Arm2
Control group
Placebo

Outcomes
Primary outcome [1] 294487 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 three times: prior to application of the tape (1st day), immediately after removal (4th day), and one hour after removal of the tape. Readings will be consistently taken between 10:00 am - 11:00 am 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 with their upper extremities abducted at 45-90 degrees. The MobIR M8 thermal imaging camera will be positioned 2 meters away from the participant at a perpendicular angle to the lumbar region.
Skin emissivity will set at 0.98
Timepoint [1] 294487 0
Baseline, and at 4 days after intervention commencement
Secondary outcome [1] 313438 0
none
Timepoint [1] 313438 0
none

Eligibility
Key inclusion criteria
healthy volunteers
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
age <18,low back pain accompanied by radicular symptoms, body mass index over 24 kg/m2, wounds and trauma (l1-l5 area), menstruation cycle ,pregnancy, cold, intolerability of or allergy to kinesio tape

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 (Arm1) and placebo group (Arm2)) 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 code 1 or code 2
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The experimental group (Arm1) will receive code1 and code 2 for placebo group (Arm2). The participants 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.
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 [1]"Assessment of the thermal effects of kinesilogy tape application." Fizjoterapia Polska 2008; 8(3):310-316
t1,t2-temperature

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2015
Actual
18/05/2015
Date of last participant enrolment
Anticipated
21/09/2015
Actual
21/09/2015
Date of last data collection
Anticipated
25/09/2015
Actual
25/09/2015
Sample size
Target
60
Accrual to date
Final
95
Recruitment outside Australia
Country [1] 6717 0
Poland
State/province [1] 6717 0
Warsaw

Funding & Sponsors
Funding source category [1] 290961 0
Self funded/Unfunded
Name [1] 290961 0
Country [1] 290961 0
Primary sponsor type
Individual
Name
Bartosz Slomka
Address
Department of Physiotherapy, Rehabilitation Division, II Faculty of Medicine, Medical University of Warsaw,Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country
Poland
Secondary sponsor category [1] 289565 0
None
Name [1] 289565 0
Address [1] 289565 0
Country [1] 289565 0
Other collaborator category [1] 278385 0
Individual
Name [1] 278385 0
Witold Rongies
Address [1] 278385 0
Department of Physiotherapy, Rehabilitation Division, II Faculty of Medicine, MedicalUniversity of Warsaw, Zwirki i Wigury 61, 02-091 Warsaw,Poland.
Country [1] 278385 0
Poland
Other collaborator category [2] 278415 0
Individual
Name [2] 278415 0
Janusz Sierdzinski
Address [2] 278415 0
Department of Medical Information Technology and Telemedicine Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland;
Country [2] 278415 0
Poland
Other collaborator category [3] 278416 0
Individual
Name [3] 278416 0
Dorota Laskowska
Address [3] 278416 0
Department of Physiotherapy, Rehabilitation Division, II Faculty of Medicine, MedicalUniversity of Warsaw, Poland.
PhD Medical University of Warsaw, Poland.
Country [3] 278416 0
Poland
Other collaborator category [4] 278417 0
Individual
Name [4] 278417 0
Pawel Ruszczuk
Address [4] 278417 0
Department of Neurosurgery, II Faculty of Medicine, Medical University of Warsaw, Poland
PhD Medical University of Warsaw, Poland
Country [4] 278417 0
Poland
Other collaborator category [5] 278418 0
Individual
Name [5] 278418 0
Marta E Worwag
Address [5] 278418 0
II Faculty of Medicine, Medical University of Warsaw, Poland
Country [5] 278418 0
Poland
Other collaborator category [6] 278419 0
Individual
Name [6] 278419 0
Sebastian Zdunski
Address [6] 278419 0
AVI Medical Centre, LUX MED Group, Warsaw, Poland
Country [6] 278419 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292484 0
Bioethics Committee of the Medical University of Warsaw
Ethics committee address [1] 292484 0
Ethics committee country [1] 292484 0
Poland
Date submitted for ethics approval [1] 292484 0
Approval date [1] 292484 0
18/03/2014
Ethics approval number [1] 292484 0
KB/52/2014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 340 340 0 0
/AnzctrAttachments/368116-Approval_Bioethics Committee of the Medical University of Warsaw.pdf

Contacts
Principal investigator
Name 55522 0
Ms Bartosz Slomka
Address 55522 0
Department of Physiotherapy, Rehabilitation Division, II Faculty of Medicine, MedicalUniversity of Warsaw
PhD Medical University of Warsaw,Zwirki i Wigury 61, 02-091 Warsaw, Poland
Country 55522 0
Poland
Phone 55522 0
+48 022 57 20 920
Fax 55522 0
Email 55522 0
[email protected]
Contact person for public queries
Name 55523 0
Bartosz Slomka
Address 55523 0
Department of Physiotherapy, Rehabilitation Division, II Faculty of Medicine, MedicalUniversity of Warsaw
PhD Medical University of Warsaw,Zwirki i Wigury 61, 02-091 Warsaw, Poland
Country 55523 0
Poland
Phone 55523 0
+48 022 57 20 920
Fax 55523 0
Email 55523 0
[email protected]
Contact person for scientific queries
Name 55524 0
Witold Rongies
Address 55524 0
Department of Physical Therapy and Rehabilitation
Medical University of Warsaw
Country 55524 0
Poland
Phone 55524 0
+48 604 538 380
Fax 55524 0
+48 22 599 15 63
Email 55524 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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