- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04263077
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
100
Phase
- 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
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-
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Mugla, Turkey, 48000
- Mugla Sitki Kocman University Health Sciences Faculty
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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
Ages Eligible for Study
16 years to 22 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 |
Intervention / Treatment |
---|---|
Placebo Comparator: PLACEBO
IN THE PLACEBO GROUP, THE ENDS OF THE TAPES WILL BE APPLIED NO TENSION WITHOUT OVERLAPPING EACH OTHER.
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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.
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Kinesiotape will be applied to the lateral epicondyle region with 50% tension.
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Other: 75% TENSION GROUP
KINESIOTAPE WILL BE APPLIED WITH 75% TENSION.
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Kinesiotape will be applied to the lateral epicondyle region with 75% tension.
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Other: 100% TENSION GROUP
KINESIOTAPE WILL BE APPLIED WITH 100% TENSION.
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Kinesiotape will be applied to the lateral epicondyle region with 100% tension.
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What is the study measuring?
Primary Outcome Measures
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.
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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.
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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.
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10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
November 18, 2018
Primary Completion (Actual)
January 17, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
February 5, 2020
First Submitted That Met QC Criteria
February 7, 2020
First Posted (Actual)
February 10, 2020
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
October 2, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID 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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