NCT06760299

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

December 30, 2024

Last Update Submit

January 20, 2025

Conditions

Keywords

Thermal ImagingKinesio TapingBody TemperatureLumbar Muscles

Outcome Measures

Primary Outcomes (1)

  • Local Body Temperature

    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.

    Temperature will be measured before, 15 minutes, 45 minutes, and 24 hours after KT removal using an infrared thermographic camera.

Secondary Outcomes (1)

  • Thermal Data Analysis

    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.

Study Arms (3)

25% Tension Kinesio Taping Group

ACTIVE COMPARATOR

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.

Other: %25 tension Kinesio tape

Control Group

NO INTERVENTION

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.

75% Tension Kinesio Taping Group

ACTIVE COMPARATOR

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.

Other: 75% tension Kinesio tape

Interventions

"I" shaped Kinesio tape application with 25% tension

25% Tension Kinesio Taping Group

"I" shaped Kinesio tape application with 75% tension

75% Tension Kinesio Taping Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University Physiotherapy and Rehabilitation Research Laboratory

Izmir, 35570, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Umut Z KOCAK, Assistant/Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The participants will be aware of the group to which they are assigned (25% tension KT, 75% tension KT, or control group), but the researcher performing the thermal measurements using infrared thermography will be blinded to the group assignments. This ensures that the data collector's knowledge of the group assignment does not influence the measurement process or interpretation of the results. The masking of the researcher conducting the thermal imaging minimizes the risk of bias during data collection and analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 30, 2024

First Posted

January 6, 2025

Study Start

January 1, 2025

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations