The Effect of Kinesio Taping Tension on the Pain Threshold and Tolerance

October 2, 2022 updated by: OYKU AVCI, Muğla Sıtkı Koçman University

The Effect of Kinesio Taping Tension on the Pressure-pain Threshold and Pain Tolerance: a Randomized Controlled Trial

The aim of this study was to investigate the effects of kinesiotape technique applied in different tensions on pain tolerance (PT) of healthy university students. 100 healthy and volunteer male individuals studying at Mugla Sitki Kocman University Faculty of Health Sciences will participate in the research. Study protocol was approved by the ethics committee of Mugla Sitki Kocman University. The study is designed as a randomized, controlled, double-blind study to be performed on 4 groups consisting of 25 individuals in each group (No tension(Placebo), and 50%, 75%, 100% tensions of Kinesiotape). Kinesiotape will be applied over lateral epicondyle of the dominant extremities with diamond shape technique by a KTAI®certified physiotherapist. PT's will be measured with J-Tech algometer before, immediately and 30 minutes after taping by a different physiotherapist who will be blind to taping tension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diamond shape banding method will be applied in a way that 4 bands of 2.5 cm width cut kinesio tape ends on top of each other, leaving the lateral epicondyle region exposed while the elbows are slightly flexed in the supine position. In the groups where different tensions will be applied, the middle points of the tapes will be stretched according to the amount of tensions, and the ends will be taped over each other without tension.In the placebo group, the tapes of the tapes will be applied tensionlessly without overlapping each other. Algometer will be used in the assessment of pressure pain threshold and pain tolerance. Pain severity felt at the level of pain threshold and pain tolerance will be evaluated with the Visual Analogue Scale (VAS). All measurements will be made before taping, immediately after taping and 30 minutes after taping, will be repeated 3 times and their average values will be recorded. There will be a 60 second rest period between each trial to avoid temporal sensitization. Each assessment will be performed bilaterally by another physiotherapist who is blind to the band tension and has no experience with the kinesio banding technique.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mugla, Turkey, 48000
        • Mugla Sitki Kocman University Health Sciences Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 20 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Being a male university student over the age of 18
  • Volunteering for the study
  • Filling out the informed consent form Not having the knowledge and experience about kinesiotaping before

Exclusion Criteria:

  • Being diagnosed with lateral epicondylit and its treatment
  • Having any neurological disease or systemic disease that disrupts sense / pain perception (diabetes, rheumatoid arthritis, peripheral vascular disease, etc.)
  • Skin sensitivity to elastic banding
  • Open wound, ulcer, fungal infection in the area to be taped
  • Exposure to upper extremity and / or cervical injury in the past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: PLACEBO
IN THE PLACEBO GROUP, THE ENDS OF THE TAPES WILL BE APPLIED NO TENSION WITHOUT OVERLAPPING EACH OTHER.
Other: PLACEBO
The diamond shape technique, which is a kinesio tape technique, will be used in the lateral epicondyle region. The ends of the kinesiotapes will be applied tension-free without overlapping.
Other: 50% TENSION GROUP
KINESIOTAPE WILL BE APPLIED WITH 50% TENSION.
Other: 50% TENSION GROUP
Kinesiotape will be applied to the lateral epicondyle region with 50% tension.
Other: 75% TENSION GROUP
KINESIOTAPE WILL BE APPLIED WITH 75% TENSION.
Other: 75% TENSION GROUP
Kinesiotape will be applied to the lateral epicondyle region with 75% tension.
Other: 100% TENSION GROUP
KINESIOTAPE WILL BE APPLIED WITH 100% TENSION.
Other: 100% TENSION GROUP
Kinesiotape will be applied to the lateral epicondyle region with 100% tension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold
Time Frame: 10 minutes
Study will be performed with 4 groups of 25 individuals, each of whom use the kinesiotape at different tensions. 0% tension application will be for Placebo, 50% tension application, 75% tension application 100% tension application. In groups with different tension banding, pressure pain threshold will be measured with algometer bilaterally. Measurements will be repeated 3 times and their average will be recorded.
10 minutes
Pain Tolerance
Time Frame: 10 minutes
After measuring the pressure pain threshold, the pain tolerance of the same groups will be measured with an algometer. Measurements will be repeated 3 times and their average will be recorded.
10 minutes
Visual Analog Scale
Time Frame: 10 minutes
Pain severity felt at the level of pain threshold and pain tolerance will be evaluated with the Visual Analogue Scale (VAS) bilaterally. The pain intensity created by the algometer probe end will be measured by VAS. The patients will mark the severity of their pain on a 100 mm line, one end of which is painless and the other end expressing unbearably severe pain. Values close to 0 mean that the pain is less, and values close to 100 indicate that the pain is high.The VAS assessment will be done immediately after each pressure pain threshold and pain tolerance measurements. Measurements will be repeated 3 times and their average will be recorded.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Muğla Sıtkı Koçman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nazan Tuğay, PhD, Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 180176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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