Clinical trial NCT06760299: Effect of Kinesio Taping on Lumbar Muscle Temperature
Official title: Investigation of the Effect of Kinesio Taping Applied to Lumbar Paravertebral Muscles Under Different Tensions on Local Body Temperature: a Single-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kinesio Taping
Body Temperature Changes
Keywords: Thermal Imaging
Kinesio Taping
Body Temperature
Lumbar Muscles
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Ege University
First posted: 2025-01-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three groups: a 25% tension Kinesio Taping (KT) group, a 75% tension KT group, and a control group. Each group will receive a different intervention, with the KT applied unilaterally to the lumbar paravertebral muscles based on the designated tension level. The study is single-blind, meaning the researcher assessing the local body temperature using infrared thermography will be blinded to the group assignments. Temperature measurements will be taken at four time points: before the KT application, 15 minutes after, 45 minutes after, and 24 hours post-application, to assess the immediate and lasting effects of the KT interventions. The primary aim is to compare the impact of different KT tensions on local body temperature, serving as an indicator of changes in circulation and the therapeutic effect of KT.
Primary purpose: OTHER

Brief summary: This single-blind, randomized controlled trial aims to investigate the effect of Kinesio Taping (KT) applied to lumbar paravertebral muscles with different tensions (25% and 75%) on local body temperature. The study will compare the changes in local body temperature before and after KT application using infrared thermography. Participants will be randomly allocated to one of three groups with randomization stratified by sex: 25% tension KT, 75% tension KT, and a control group. Temperature measurements will be taken at four time points: before the application, 15 minutes, 45 minutes, and 24 hours post-application. The data will be analyzed using statistical methods to evaluate the impact of KT tension on local body temperature. This study will provide insights into the physiological effects of KT under different tension levels.

Detailed description: This single-blind, randomized controlled trial aims to assess the effects of Kinesio Taping (KT) applied to the lumbar paravertebral muscles at different tension levels (25% and 75%) on local body temperature. KT is an elastic adhesive band that is believed to increase circulation, improve muscle function, support proprioception, and alleviate pain. Previous studies have explored the effects of KT on local temperature, but the impact of varying tension levels on temperature and circulation has not been extensively examined. This study seeks to fill this gap by investigating how different tensions in KT application affect local body temperature, a potential indicator of changes in circulation.

The study will include 54 participants, randomly assigned into three groups: a 25% tension KT group, a 75% tension KT group, and a control group. Participants will be stratified by gender to ensure balanced representation. KT will be applied unilaterally to the paravertebral muscles, with the side (right or left) selected by a coin toss. The KT application will follow the standard "I" shape, with 5 cm anchor segments at both ends, and the tension will be applied along the L1-L5 vertebrae in a neutral standing position. After participants bend forward to their maximum comfort level, the tape will be applied, and adhesion will be ensured by rubbing the tape.

Local body temperature will be measured using a FLIR E5 infrared camera (Teledyne FLIR, USA) at four time points: immediately before the KT application, 15 minutes after the application, 45 minutes after the application, and 24 hours post-application. The thermal measurements will be analyzed using FLIR E5 software to determine the minimum, average, and maximum temperatures of the taped area.

The primary outcome of the study is to determine if KT application under different tension levels influences local body temperature, potentially reflecting changes in blood circulation. Secondary outcomes include the comparison of temperature variations between the tension groups and the control group, and the analysis of how time influences these changes.

Statistical analysis will involve one-way analysis of variance (ANOVA) to compare the demographic characteristics of the groups and a three-way repeated measures ANOVA to assess differences in local body temperature across groups (25% tension, 75% tension, and control), sides (right and left), and time points. Bonferroni post hoc tests will be used to further explore significant interactions or main effects. Descriptive statistics will summarize demographic data, and significance will be set at p \< 0.05.

This study is expected to provide valuable insights into the physiological effects of KT and may contribute to a better understanding of how different tension levels influence local circulation and body temperature. These findings could inform clinical practices related to KT and its potential therapeutic benefits.

Eligibility criteria: Inclusion Criteria:

* Willingness to participate in the study
* Aged between 18 and 35 years
* Ability to read and understand Turkish

Exclusion Criteria:

* Experiencing muscle pain in the upper extremity, torso, or lower extremity
* Use of medication or having a systemic disease that may affect thermoregulation
* Having dermatological conditions in the area where Kinesio Taping will be applied
* Having undergone surgery in the upper extremity, torso, or lower extremity
* Being pregnant

Primary outcomes:
measure: Local Body Temperature
timeFrame: Temperature will be measured before, 15 minutes, 45 minutes, and 24 hours after KT removal using an infrared thermographic camera.
Secondary outcomes:
measure: Thermal Data Analysis
timeFrame: Thermal data will be analyzed at the same time points as the primary outcome: immediately before Kinesio Taping application, 15 minutes after application, 45 minutes after application, and 24 hours after KT removal.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University Physiotherapy and Rehabilitation Research Laboratory
Study officials:
References: