- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06760299
Effect of Kinesio Taping on Lumbar Muscle Temperature
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Umut Z KOCAK, Assistant/Associate Professor
- Phone Number: +90 5052284879
- Email: umut_z_kocak@hotmail.com
Study Locations
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Izmir, Turkey, 35570
- Izmir Katip Celebi University Physiotherapy and Rehabilitation Research Laboratory
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Contact:
- Umut Ziya KOCAK, PhD
- Phone Number: 00905052284879
- Email: umut_z_kocak@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 25% Tension Kinesio Taping Group
Participants in this group will receive Kinesio Taping applied unilaterally to the lumbar paravertebral muscles with 25% tension.
The tape will be applied using an "I" shaped strip with 5 cm anchor segments and 0% tension at both ends.
The application will be conducted while the participant is in a neutral standing position, and the tape will be rubbed to ensure adhesion.
|
"I" shaped Kinesio tape application with 25% tension
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No Intervention: Control Group
Participants in this group will not receive any Kinesio Taping intervention.
This group will serve as a baseline for comparison with the KT groups, allowing for the assessment of the effects of KT on local body temperature.
|
|
|
Active Comparator: 75% Tension Kinesio Taping Group
Participants in this group will receive Kinesio Taping applied unilaterally to the lumbar paravertebral muscles with 75% tension.
The tape will be applied in an "I" shape with 5 cm anchor segments at both ends.
The tension will be adjusted to 75% during the application, and the same adhesion process will be followed.
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"I" shaped Kinesio tape application with 75% tension
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Local Body Temperature
Time Frame: Temperature will be measured before, 15 minutes, 45 minutes, and 24 hours after KT removal using an infrared thermographic camera.
|
The primary outcome measure of this study is the change in local body temperature in the lumbar paravertebral muscles following the application of Kinesio Taping (KT).
Local body temperature will be measured using an infrared thermographic camera to assess the effect of KT on blood circulation and metabolic activity in the targeted area.
The temperature measurements will focus on evaluating the difference in temperature at various time points after the application of KT.
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Temperature will be measured before, 15 minutes, 45 minutes, and 24 hours after KT removal using an infrared thermographic camera.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thermal Data Analysis
Time Frame: 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.
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The analysis of thermal data (minimum, average, and maximum temperatures) using FLIR software will support the primary measure but is considered secondary as it helps to further understand the impact of KT on circulation and tissue temperature.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1649B032404842 (Other Grant/Funding Number: TUBITAK (The Scientific and Technological Research Council of Türkiye) 2211-Graduate Scholarship Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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