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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04219917
Other study ID # HE20097
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2019
Est. completion date February 18, 2020

Study information

Verified date November 2023
Source North Dakota State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to explore the possible effects Kinesio Tape may have on proprioception in individuals with patellar tendonitis. A supportive knee application, a facilitative hip application, and a combination of the two will be applied and compared. Within and between group comparisons will be drawn. Participants will report for two research sessions with 24-36 hours between. Prior to arrival, they will complete a digital Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P) and email it to the researcher. Participants must score less than 80 (out of a possible 100) to be considered for this study. If the individual meets the inclusion criteria, he/she will be scheduled for the 1st session. Upon arrival to the first session, informed consent will be obtained, the VISA-P will be reviewed, and intance of patellar tendonitis will be confirmed through palpation. Participants will then completed a Tampa Scale for Kinesiophobia (TSK) to measure fear of movement and a Visual Analog Scale (VAS) to measure overall pain. Height and weight measurments will be taken due to requirements of the Biodex Balance System (BBS), which will be used for balance measurements. Participants will take two, twenty-second practice tests, one with eyes open and one with eyes closed, followed by two minutes rest. Baseline testing will then be completed as follows: the participant will complete two tests with eyes open, and two tests with eyes closed on the injured leg, each with one minute rest between. The participant will then be taped with Kinesio Tape to either the hip, knee, or both the hip and knee according to the random group assignment. They will then rest for 15 minutes and complete a second round of balance testing with the same parameters as baseline testing. Participants will be scheduled for a second day no less that 24 hours and no more than 36 hours for re-test purposes. On the second day of testing, participants will be given $10 for their participation on Day 1. If they want to continue with testing procedures, they will participate in the same balance testing procedures as Day 1. The integrety of the tape application will be confirmed, and second TSK and VAS scale will be administered. A final round of balance testing will be completed, and the participant will receive an additional $10 if they choose to complete both days of testing. This research will allow us to compare results of the TSK, the VAS and the BBS testing both within subject and between group.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 18, 2020
Est. primary completion date February 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - score of less than 80 on the Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P) - experienced patellar tendon pain for greater than 14 days - tender to palpation at the patellar tendon. Exclusion Criteria: - knee surgery in the last six months - acute injury to the knee - any pain in the ankles, hips or core that may compromise balance testing - any allergy to adhesive - malignancies - cellulitis - skin infection - diabetes - fragile skin

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesio Tape
Kinesio Tape will be applied to treat the pain associated with patellar tendonitis, to treat the cause of the pain, and to treat both factors.

Locations

Country Name City State
United States North Dakota State University Fargo North Dakota

Sponsors (1)

Lead Sponsor Collaborator
North Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tampa Scale for Kinesiophobia Measures fear of movement, score range 17-68, higher score means higher degree of kinesiophobia 24 hours
Primary Visual Analog Scale Measures overall pain, score range 1-10, higher score indicates more pain 24 hours
Primary Biodex Balance System Measures balance 24 hours
See also
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