Short-Term Effect of Kinesio Taping on The Temperature Distribution at The Site of Application. A Randomized Clinical Trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000353594
• Date of registration: 20/04/2015
• Prospective Registration: Yes
• Primary sponsor: Bartosz Slomka
• 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
• Date of first enrolment: 18/05/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000353594.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Poland

Contacts

• Name: Ms Bartosz Slomka

• Name: A/Prof Witold Rongies

Key inclusion & exclusion criteria

Inclusion criteria: healthy volunteers
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

Age minimum: 18 Years
Age maximum: 25 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Physiotherapy

Potential lumbar muscular strain;
Potential lumbar muscular strain

Intervention(s)

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 i

Primary Outcome(s)

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[ Baseline, and at 4 days after intervention commencement]

Secondary Outcome(s)

none[none]

Secondary ID(s)

none

Ethics review

Status: Approved
Approval date:
Contact:

Bioethics Committee of the Medical University of Warsaw