NCT04263077

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 18, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

February 5, 2020

Last Update Submit

October 2, 2022

Conditions

Keywords

KINESIOTAPING

Outcome Measures

Primary Outcomes (3)

  • Pressure Pain Threshold

    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

    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

    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

Study Arms (4)

PLACEBO

PLACEBO COMPARATOR

IN THE PLACEBO GROUP, THE ENDS OF THE TAPES WILL BE APPLIED NO TENSION WITHOUT OVERLAPPING EACH OTHER.

Other: PLACEBO

50% TENSION GROUP

OTHER

KINESIOTAPE WILL BE APPLIED WITH 50% TENSION.

Other: 50% TENSION GROUP

75% TENSION GROUP

OTHER

KINESIOTAPE WILL BE APPLIED WITH 75% TENSION.

Other: 75% TENSION GROUP

100% TENSION GROUP

OTHER

KINESIOTAPE WILL BE APPLIED WITH 100% TENSION.

Other: 100% TENSION GROUP

Interventions

PLACEBOOTHER

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.

PLACEBO

Kinesiotape will be applied to the lateral epicondyle region with 50% tension.

50% TENSION GROUP

Kinesiotape will be applied to the lateral epicondyle region with 75% tension.

75% TENSION GROUP

Kinesiotape will be applied to the lateral epicondyle region with 100% tension.

100% TENSION GROUP

Eligibility Criteria

Age18 Years - 24 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mugla Sitki Kocman University Health Sciences Faculty

Muğla, 48000, Turkey (Türkiye)

Location

Study Officials

  • Nazan Tuğay, PhD

    Muğla Sıtkı Koçman University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GRADUATE STUDENT

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 10, 2020

Study Start

November 18, 2018

Primary Completion

January 17, 2020

Study Completion

August 1, 2020

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations