- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219917
A Comparison of Kinesio® Taping Methods for Subjects With Patellar Tendonitis
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58102
- North Dakota State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hip
Gluteus medius facilitation 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.
|
|
Experimental: Knee
Patellar sling 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.
|
|
Experimental: Hip and Knee
Gluteus medius facilitation and patellar sling 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale for Kinesiophobia
Time Frame: 24 hours
|
Measures fear of movement, score range 17-68, higher score means higher degree of kinesiophobia
|
24 hours
|
|
Visual Analog Scale
Time Frame: 24 hours
|
Measures overall pain, score range 1-10, higher score indicates more pain
|
24 hours
|
|
Biodex Balance System
Time Frame: 24 hours
|
Measures balance
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE20097
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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